Proactiveinvestors Australia Imugene Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia Imugene Ltd RSS feed en Tue, 16 Jul 2019 20:42:58 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Imugene to acquire exclusive licence for potentially transformational oncolytic virus technology ]]> https://www.proactiveinvestors.com.au/companies/news/223858/imugene-to-acquire-exclusive-licence-for-potentially-transformational-oncolytic-virus-technology-223858.html Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) is to acquire the worldwide exclusive licence to oncolytic virus technology known as CF33.

Development and commercialisation of CF33, a chimeric vaccinia poxvirus, will be funded through Imugene’s existing cash reserves and will include ex-Viralytics members as part of its project development team.

 

Imugene chief executive officer Leslie Chong said the company was delighted to licence such a promising next-generation oncolytic virus (OV) in a competitive marketplace, where big pharma companies are actively seeking OV technologies.

Oncolytic viruses are designed to both selectively kill tumours cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

The viruses have the potential to transform oncology by directly causing tumour cell death and also by delivering a potent payload in a targeted fashion that activates the immune system.

READ: Imugene reveals new clinical data for HER-Vaxx vaccine showing cancer-fighting response

Chong continued: “CF33 comes with robust intellectual property and long patent life, compelling pre-clinical efficacy and safety and is anticipated to enter a phase-one clinical trial in 2020.

“The opportunity to separately engage with members of the ex-Viralytics team through Vaxinia was cogent for immune.

“[It] bring to Imugene senior executives with direct involvement in two of the largest OV transaction in biotech history being Amgen’s acquisition of Biovex for US$950 million and Merck’s acquisition of Viralytics for A$502 million.”

READ: Imugene presents new HER-Vaxx cancer vaccine results

The drug was initially developed at Los Angeles-based City of Hope, a world-renowned independent research and treatment centre for cancer, diabetes and other life-threatening diseases.

In consideration for the exclusive licence, City of Hope will receive from Imugene licence fees comprising an upfront, annual maintenance fee creditable against future royalty payments.

The company will also pay performance-based consideration linked to achieving certain milestones and commercial outcomes, as well as net sales-based royalty payments and sub-licencing fees.

READ: Imugene well-funded to progress clinical milestones

As part of the transaction, Imugene entered into a binding agreement to acquire 100% of Vaxinia, of which Imugene executive chairman Paul Hopper is major shareholder.

The transaction includes an up-front cash payment of A$462,500 and the issue of ordinary fully paid Imugene shares valued at A$1.619 million, based on the seven-day volume weighted average price.

The decision to acquire Vaxinia was made by Imugene’s independent directors, with Hopper recused from the process given he is a beneficiary of the transaction.

READ: Imugene presents positive new data validating its human cancer vaccine KEY-Vaxx

Shareholders of Vaxinia include, along with Hopper, City of Hope chair of surgery Professor Yuman Fong, the inventor of CF33, and an ex-Viralytics executive.

They will be eligible for further payments in equity on the achievement of performance-related milestones.

These milestones will be further detailed in the company’s notice to meeting and will include granting of investigational new drug status by the Federal Drug Administration (FDA), dosing the first patient in a phase-one clinical trial and the phase-one clinical trial demonstrating safety.

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Sun, 14 Jul 2019 21:46:00 +1000 https://www.proactiveinvestors.com.au/companies/news/223858/imugene-to-acquire-exclusive-licence-for-potentially-transformational-oncolytic-virus-technology-223858.html
<![CDATA[News - Imugene reveals new clinical data for HER-Vaxx vaccine showing cancer-fighting response ]]> https://www.proactiveinvestors.com.au/companies/news/223460/imugene-reveals-new-clinical-data-for-her-vaxx-vaccine-showing-cancer-fighting-response-223460.html Imugene Ltd (ASX:IMU) has revealed new clinical data from the Phase Ib study of its HER-Vaxx cancer vaccine showing continued positive cancer-fighting antibody and clinical response rates in patients.

Notably, the patients have maintained strong and high levels of HER-2 targeting antibodies indicating a durable response is present with no resistance developed.

In cohort 3, patients that are receiving the optimal biological dose, and selected Phase 2 dose, one patient has seen a total tumour reduction of almost 80% from baseline CT scan with one out of four of their lesions becoming unmeasurable at Day 266 visit.

 

Imugene managing director and chief executive officer Leslie Chong said: “This latest presentation from the HER-Vaxx Phase 1b study further reinforces the very good early results and ongoing interest among the international oncology community in our potentially promising B-cell platform cancer vaccine and clinical development strategy.”

READ: Imugene presents new HER-Vaxx cancer vaccine results

The positive new data was presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona Spain over the weekend.

The data will be published in the prestigious Annals of Oncology after the congress.

New HER-Vaxx Cancer Vaccine trial data presented at the European Society of Medical Oncology World Congress on Gastrointestinal Cancer. Read more our potentionally promising B-cell platform
cancer vaccine and clinical development strategy #endcancer $IMU https://t.co/Jk5xqgEuZ0 pic.twitter.com/BDD0Z49Jxy

— Imugene | Cancer Immunotherapies (@TeamImugene) July 7, 2019

The Phase 1b HER-Vaxx study in metastatic gastric cancer patients overexpressing the HER-2 protein completed enrolment in late 2018 and reported no safety or toxicity issues.

All evaluable patients showed increased antibody responses. The Phase 2 study began enrolment in March 2019 and is scheduled to complete in 2020.

Background

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu.

It has been shown in pre-clinical studies and now in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

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Mon, 08 Jul 2019 12:39:00 +1000 https://www.proactiveinvestors.com.au/companies/news/223460/imugene-reveals-new-clinical-data-for-her-vaxx-vaccine-showing-cancer-fighting-response-223460.html
<![CDATA[Media files - Imugene Limited releases new clinical data for HER-Vaxx cancer vaccine study ]]> https://www.proactiveinvestors.com.au/companies/stocktube/14003/imugene-limited-releases-new-clinical-data-for-her-vaxx-cancer-vaccine-study-14003.html Mon, 08 Jul 2019 12:30:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/14003/imugene-limited-releases-new-clinical-data-for-her-vaxx-cancer-vaccine-study-14003.html <![CDATA[News - Imugene presents new HER-Vaxx cancer vaccine results ]]> https://www.proactiveinvestors.com.au/companies/news/221426/imugene-presents-new-her-vaxx-cancer-vaccine-results-221426.html Imugene Ltd (ASX:IMU) has received positive data from the ongoing patients in the phase Ib study of its HER-Vaxx cancer vaccine.

The study completed enrolment in 2018 and is ongoing, patients receive HER-Vaxx every three months to maintain high levels of cancer-targeting antibodies.

A phase II study was initiated in March 2019 dosing patients at the highest phase Ib dose.

The presentation given at the ASCO annual meeting in Chicago showed that by day 182 of the trial, patients dosed with the highest dose of HER-Vaxx tumours had either shrunk further or stabilised.

In one patient, their tumour has shrunk more than 70% since joining the trial.

 

We've just released news on our positive new 6-month data: our HER-Vaxx-chemo combination shrinks or stabilises tumour growth | Read the ASX announcement here >https://t.co/pZ5q439xSQ #MedTech #Pharma #ASCO19 (ASX: IMU) pic.twitter.com/o2lDThBVZY

— Imugene | Cancer Immunotherapies (@TeamImugene) June 3, 2019

 

All patients on the highest dose have received their day-266 does and these results will be presented in Barcelona on 3-6 July 2019.

Imugene’s managing director and CEO Leslie Chong said: “There is continued interest in the positive data from our phase Ib trial which supports our B-cell platform cancer vaccine strategy for treating HER-2 positive gastric cancer.”

READ: Imugene appoints venture capital executive to board

Last month, Imugene appointed Dr Jens Eckstein as a non-executive director to its board.

Dr Eckstein is a leading biotechnology executive and managing partner of Apollo Ventures, a venture capital firm that invests in seed and early stage biotechnology companies.

He has more than 15 years venture capital experience funding early to clinical stage biopharmaceutical companies.

Strong pipeline of cancer vaccines in development

The company has a strong pipeline of cancer vaccines in development.

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Tue, 04 Jun 2019 10:57:00 +1000 https://www.proactiveinvestors.com.au/companies/news/221426/imugene-presents-new-her-vaxx-cancer-vaccine-results-221426.html
<![CDATA[News - Imugene appoints venture capital executive to board ]]> https://www.proactiveinvestors.com.au/companies/news/220548/imugene-appoints-venture-capital-executive-to-board-220548.html Imugene Ltd (ASX:IMU) has appointed Dr Jens Eckstein as a non-executive director to its board effective as of today.

Dr Eckstein is a leading biotechnology executive and managing partner of Apollo Ventures, a venture capital firm that invests in seed and early stage biotechnology companies.

He has more than 15 years venture capital experience funding early to clinical stage biopharmaceutical companies.

READ: Imugene to present new data from HER-Vaxx cancer vaccine phase 1b trial

Imugene’s executive chairman Paul Hopper said: “Imugene continues to attract a world class team.

“We welcome Dr Eckstein to the board and look forward to working together to advance our highly promising cancer immuno therapy pipeline.”

Strong pipeline of cancer vaccines in development

The company has a strong pipeline of cancer vaccines in development.

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Mon, 20 May 2019 11:46:00 +1000 https://www.proactiveinvestors.com.au/companies/news/220548/imugene-appoints-venture-capital-executive-to-board-220548.html
<![CDATA[News - Imugene to present new data from HER-Vaxx cancer vaccine phase 1b trial ]]> https://www.proactiveinvestors.com.au/companies/news/219213/imugene-to-present-new-data-from-her-vaxx-cancer-vaccine-phase-1b-trial-219213.html Imugene Ltd (ASX:IMU) will present the updated patient data from its phase 1b study of HER-Vaxx cancer vaccine at the prestigious American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

The abstract will be presented by Dr Yee Chao, director of the Department of Oncology at the Veterans General Hospital in Taipei, Taiwan and a lead investigator in the phase 1b study.

Dr Chao’s presentation will be featured at the ASCO Gastrointestinal (Non-colorectal) Cancer Session on Monday June 3, 2019 between 8:00 am and 11:00 am.

READ: Imugene well-funded to progress clinical milestones

It is worth noting that Imugene’s phase 1b HER-Vaxx study which completed enrolment in 2018 has met all its primary endpoints.

The study is ongoing with patients continuing to receive HER-Vaxx every 3 months to maintain high levels of cancer targeting antibodies. A phase 2 study was initiated in March 2019.

ASCO presentation

Imugene’s ASCO presentation is entitled: ‘A phase Ib study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.’

The ASCO annual meeting attracts more than 40,000 cancer specialists and is one of the largest educational and scientific events in the oncology community where the latest research and clinical results are highlighted.

Imugene managing director and chief executive officer Leslie Chong said: “There is continued interest in the positive data from our Phase 1b trial which clearly supports our B-cell platform cancer vaccine strategy for treating HER-2 positive gastric cancer.”

 

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu.

It has been shown in pre-clinical studies and now in phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

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Mon, 29 Apr 2019 12:51:00 +1000 https://www.proactiveinvestors.com.au/companies/news/219213/imugene-to-present-new-data-from-her-vaxx-cancer-vaccine-phase-1b-trial-219213.html
<![CDATA[News - Imugene appoints global pharmaceutical executive to its board ]]> https://www.proactiveinvestors.com.au/companies/news/218913/imugene-appoints-global-pharmaceutical-executive-to-its-board-218913.html Imugene Ltd (ASX:IMU) has appointed leading global pharmaceutical executive Dr. Lesley Russell as a non-executive director, effective April 23, 2019.

Dr. Russell has more than 25 years of international operational and leadership experience with a number of established and emerging pharmaceutical companies across multiple therapeutic areas including oncology and haematology.

READ: Imugene well-funded to progress clinical milestones

Her experience has been gained at a number of leading companies including Amgen (NASDAQ:AMGN), Eli Lilly (NASDAQ:LLY), Cephalon Inc (NASDAQ:CEPH) and Teva Pharmacaeuticals (NASDAQ:TEVA).

Dr. Russell is currently a non-executive director of AMAG Pharmaceuticals (NASDAQ:AMAG), Enanta Pharmaceuticals (NASDAQ:ENTA) and Sojournix a privately held biotechnology company.

READ: Imugene presents positive new data validating its human cancer vaccine KEY-Vaxx

Imugene executive chairman Paul Hopper said: “Dr. Lesley Russell’s global industry knowledge and direct experience of oncology drug development and strategic joint ventures will further enhance the board’s skill mix.

“We are delighted she is joining our business and look forward to her contributions as we work to advance our promising cancer vaccine pipeline.”

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Tue, 23 Apr 2019 12:16:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218913/imugene-appoints-global-pharmaceutical-executive-to-its-board-218913.html
<![CDATA[News - Imugene well-funded to progress clinical milestones ]]> https://www.proactiveinvestors.com.au/companies/news/218631/imugene-well-funded-to-progress-clinical-milestones-218631.html Imugene Ltd (ASX:IMU) finished the March quarter with $21 million in the bank, positioning it well as it progresses its commercial and clinical milestones over the coming quarters.

The company has a strong pipeline of cancer vaccines in development.

In March 2019, the company dosed its first patient with its HER-Vaxx (IMU131) cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

This marked an important milestone for the company in advancing its Phase II trials.

Additionally, Imugene presented the Phase 1b study results of its HER-Vaxx cancer vaccine at the American Association for Cancer Research (AACR) meeting in April 2019.

READ: Imugene presents positive new data validating its human cancer vaccine KEY-Vaxx

Furthermore, positive new data findings from the active immunisation studies for KEY-Vaxx earlier this year provided proof of concept and validation for the human PD-1 cancer vaccine.

The FDA meeting in February 2019 was productive and provided Imugene with a clear roadmap for a successful IND submission and subsequent clinical development of KEY-Vaxx.

READ: Imugene gets development roadmap for cancer vaccine from FDA meeting

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Tue, 16 Apr 2019 11:52:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218631/imugene-well-funded-to-progress-clinical-milestones-218631.html
<![CDATA[News - Imugene presents positive new data validating its human cancer vaccine KEY-Vaxx ]]> https://www.proactiveinvestors.com.au/companies/news/217820/imugene-presents-positive-new-data-validating-its-human-cancer-vaccine-key-vaxx-217820.html Imugene Ltd (ASX:IMU) and Medical University Vienna have presented positive new data on the PD-1 mimotope cancer vaccine program at the American Association for Cancer Research (AACR) 2019 Annual Meeting.

The presentation by Dr Joshua Tobias from the Medical University Vienna was entitled ‘PD1 B cell mimotopes with functional PD1-PDL1 blocking capacity and anti-tumor activity: New strategy for a multi-level cancer immunotherapy.’

@TeamImugene and MedUni Vienna mimotope vaccines inhibit tumor growth in HER-2+ breast cancer models READ today's ASX news https://t.co/UDejcS62wj $IMU #CancerVaccine #BreastCancer #ImmunoOncology (ASX:IMU) pic.twitter.com/VRyJLdWtMY

— Imugene | Cancer Immunotherapies (@TeamImugene) April 2, 2019

Imugene’s PD-1 B-cell vaccine, known as KEY-Vaxx, aims to induce the body to produce antibodies that block PD-1 signalling, and thus produce an anticancer effect.

The research led by Professor Ursula Wiedermann from the Medical University Vienna successfully inhibited tumor growth in a syngeneic mouse model of HER-2+ breast cancer via both passive and active immunisation strategies with PD-1 targeting B-cell cancer vaccines.

READ: Imugene gets development roadmap for cancer vaccine from FDA meeting

For the active immunisation study, which is of greatest interest and potential value to cancer researchers, the surrogate vaccine derived from mouse PD-1 was able to “brake tolerance” thereby inducing a sustained antibody response to the self-protein PD-1.

Importantly, the findings provide proof of concept and validation for Imugene’s human PD-1 cancer vaccine KEY-Vaxx.

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Wed, 03 Apr 2019 15:40:00 +1100 https://www.proactiveinvestors.com.au/companies/news/217820/imugene-presents-positive-new-data-validating-its-human-cancer-vaccine-key-vaxx-217820.html
<![CDATA[News - Imugene reveals new data on cancer vaccine programs ]]> https://www.proactiveinvestors.com.au/companies/news/217702/imugene-reveals-new-data-on-cancer-vaccine-programs-217702.html Imugene Ltd (ASX:IMU) has welcomed new data being presented on its KEY-Vaxx and B-Vaxx cancer vaccine programs.

The data was presented by Dr Tanios Bekaii-Saabfrom the Mayo Clinic at the American Association for Cancer Research (AACR) 2019 Annual Meeting.

The highlight and key finding of the KEY-Vaxx presentation demonstrated that KEY-Vaxx, when combined with B-Vaxx, is more effective in reducing tumor growth in a validated mouse model of colon carcinoma versus either the PD-1 KEY-Vaxx vaccine alone.

The vaccine combination was found to be safe and did not appear to exhibit toxicity or autoimmunity.

Imugene is working to evaluate KEY-Vaxx and its potential efficacy in a range of cancers.

ASX NEWS: KEY-Vaxx PD-1/B-Vaxx HER-2 cancer vaccine combo inhibits tumor growth in mouse model of colon carcinoma & combo safe with no evidence of autoimmunity & KEY-Vaxx PD-1 cancer vaccine to be trialled in a range of cancers, lung cancer first https://t.co/UDejcS62wj #BioTech pic.twitter.com/nQDXO0vgRA

— Imugene | Cancer Immunotherapies (@TeamImugene) April 1, 2019 New data from phase Ib study of HER-Vaxx

New data was also presented at the same event related to the phase Ib study of the HER-Vaxx cancer vaccine, in which 11 out of 14 evaluable patients showed clinically meaningful responses.

The phase 1b HER-Vaxx study reported no safety or toxicity issues and all evaluable patients showed increased antibody responses.

One patient saw a complete response, five had a partial response and four recorded a stabilisation of their disease.

Due to the success of the phase Ib trial, Imugene dosed its first patient in its phase II study in mid-March 2019.

Imugene’s managing director and CEO Leslie Chong said: “We are encouraged by the overall positive data from the phase Ib trial which clearly supports our B-cell platform cancer vaccine strategy for treating HER-2 positive gastric cancer.”

READ: Imugene gets development roadmap for cancer vaccine from FDA meeting

Recently, Imugene received minutes of its meeting with the (FDA) for its KEY-Vaxx cancer immunotherapy on 8 February 2019.

The meeting was aimed at seeking guidance on the studies required for phase I clinical development of KEY-Vaxx.

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Tue, 02 Apr 2019 12:27:00 +1100 https://www.proactiveinvestors.com.au/companies/news/217702/imugene-reveals-new-data-on-cancer-vaccine-programs-217702.html
<![CDATA[News - Imugene gets development roadmap for cancer vaccine from FDA meeting ]]> https://www.proactiveinvestors.com.au/companies/news/216795/imugene-gets-development-roadmap-for-cancer-vaccine-from-fda-meeting-216795.html Imugene Ltd (ASX:IMU) has received minutes of its meeting with the (FDA) for its KEY-Vaxx cancer immunotherapy on 8 February 2019.

The meeting was aimed at seeking guidance on the studies required for phase I clinical development of KEY-Vaxx.

Topics addressed included the anticipated clinical indication and the treatment of cancers that overexpress PD-L1 including but not limited to non-small cell lung cancer.

Imugene’s managing director and CEO Leslie Chong said: “The meeting was productive and provided Imugene with a clear roadmap for a successful IND submission and subsequent clinical development of KEY-Vaxx.

“The FDA panel members encouraged Imugene to pursue the planned IND submission and subsequent clinical studies.”

READ: Imugene doses milestone first patient for cancer vaccine trial

Imugene is developing cancer immunotherapies targeting B-cell peptide vaccines.

Its most advanced drug being developed is HER-Vaxx cancer vaccine.

Last week Imugene dosed its first patient in its phase II study with its HER-Vaxx cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

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Wed, 20 Mar 2019 11:08:00 +1100 https://www.proactiveinvestors.com.au/companies/news/216795/imugene-gets-development-roadmap-for-cancer-vaccine-from-fda-meeting-216795.html
<![CDATA[Media files - Imugene obtains FDA guidance for KEY-Vaxx immunotherapy clinical development plan ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12652/imugene-obtains-fda-guidance-for-key-vaxx-immunotherapy-clinical-development-plan-12652.html Tue, 19 Mar 2019 20:19:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12652/imugene-obtains-fda-guidance-for-key-vaxx-immunotherapy-clinical-development-plan-12652.html <![CDATA[Media files - Imugene doses first patient in phase-two study of cancer vaccine ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12615/imugene-doses-first-patient-in-phase-two-study-of-cancer-vaccine-12615.html Fri, 15 Mar 2019 01:00:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12615/imugene-doses-first-patient-in-phase-two-study-of-cancer-vaccine-12615.html <![CDATA[News - Imugene doses milestone first patient for cancer vaccine trial ]]> https://www.proactiveinvestors.com.au/companies/news/216427/imugene-doses-milestone-first-patient-for-cancer-vaccine-trial-216427.html Imugene Ltd (ASX:IMU) has dosed its first patient in its phase II study with its HER-Vaxx (IMU-131) cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

HER-Vaxx is a potentially ground-breaking cancer vaccine designed to produce an antibody response against a cancer growth signal receptor protein called HER-2.

HER-2 is found on the cell surface of multiple cancers including breast and gastric cancers.

READ: Imugene to make further cancer vaccine research presentations at AACR annual meeting

Imugene’s managing director and CEO Leslie Chong said: “There is strong medical investigator interest following the good results seen in the recently completed Phase 1b trial, where 11 out of 14 evaluable patients showed clinically meaningful responses.

“We look forward to providing regular recruitment updates as the Phase 2 study moves toward completion in 2020.”

“The start of the Phase 2 study is an important milestone for Imugene and the many medical professionals seeking treatments for patients with advanced HER-2 positive gastric cancer who often have very few medical options.”

Study being conducted in Asia, Europe and India

The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer overexpressing the HER-2 protein.

The study is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-of-care alone.

The primary endpoint is overall survival and secondary endpoint will be progression-free survival. Safety, tolerability and immune response will also be measured.

The Phase 2 trial is being conducted at multiple sites across Asia, Eastern Europe and India.

Patients in these areas have difficulty accessing approved antibody treatments such as Herceptinâ and Perjetaâ marketed by Swiss multinational Roche Holding AG.

There is also a high prevalence of gastric cancer in the countries selected.

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Thu, 14 Mar 2019 10:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/216427/imugene-doses-milestone-first-patient-for-cancer-vaccine-trial-216427.html
<![CDATA[Media files - Imugene presenting all three immuno-oncology programs at AACR Annual Meeting ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12423/imugene-presenting-all-three-immuno-oncology-programs-at-aacr-annual-meeting-12423.html Mon, 04 Mar 2019 10:30:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12423/imugene-presenting-all-three-immuno-oncology-programs-at-aacr-annual-meeting-12423.html <![CDATA[News - Imugene to make further cancer vaccine research presentations at AACR annual meeting ]]> https://www.proactiveinvestors.com.au/companies/news/215661/imugene-to-make-further-cancer-vaccine-research-presentations-at-aacr-annual-meeting-215661.html Imugene Ltd (ASX:IMU) will present on its KEY-Vaxx an B-Vaxx cancer vaccine programs at the American Association for Cancer Research’s (AACR) 2019 annual meeting.

The presentations will be made by Dr Tanios Bekaii-Saab from the Mayo Clinic, the co-inventor of the KEY-Vaxx and B-Vaxx cancer vaccines along with Imugene scientific advisor Professor Pravin Kaumaya.

Content from the presentations remains embargoed until the start of the conference and will be made available online after the annual meeting begins.

 

The first abstract presentation is entitled ‘Development of a novel PD-1 vaccine and in combination with two Chimeric HER-2 peptide vaccine provides synergistic inhibition of tumour growth in a syngeneic Balc/c model challenged with CT26/HER-2 carcinoma cell line’.

The second is called ‘A phase-one active immunotherapy with a combination of two Chimeric (Trastuzumab-like and Pertuzumab-like) human epiderman growth factor receptor 2 (HER-2) B cell peptide vaccine emulsified in ISA 720 and Nor-MDP adjuvant in patients with advanced solid tumours

READ: Imugene to present cancer vaccine research at AACR annual meeting

Imugene’s KEY-Vaxx is a B-cell peptide cancer vaccine designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction.

It is also designed to produce an anti-cancer effect similar to Keytrude, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming cancer treatment.

KEY-Vaxx when combined with B-Vaxx has shown great potential in pre-clinical studies, demonstrating robust PD-1 and HER-2 antibody responses in all vaccinated mice.

This indicates that the combined vaccination is effective in reducing tumour growth in a Balc/c syngeneic model of colon carcinoma versus either the PD-1 vaccine alone or more important the positive control gold standard that is anti-mouse PD-1 monoclonal antibody.

The vaccine combination was found to be safe and did not appear to exhibit toxicity or autoimmunity.

READ: Imugene has cancer vaccine trial data published in prestigious medical journal

B-Vaxx is a proprietary B-cell peptide cancer vaccine being developed that targets multiple oncology indications.

The phase-one B-Vaxx trial studied the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumours.

The open-label, dose escalation study evaluated B-Vaxx in patients with solid tumours that over-express the HER-2/neu receptor.

B-Vaxx has been shown to stimulate a potent polyclonal antibody response to HER-2/nue, a well-established and validated cancer target.

A phase-two study evaluating the activity of B-Vaxx in patient over-expressing HER-2/nue is being conducted at clinical institutions in the US.

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Sun, 03 Mar 2019 20:15:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215661/imugene-to-make-further-cancer-vaccine-research-presentations-at-aacr-annual-meeting-215661.html
<![CDATA[Media files - Imugene will present lead candidate HER-Vaxx at AACR Annual Meeting ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12382/imugene-will-present-lead-candidate-her-vaxx-at-aacr-annual-meeting-12382.html Thu, 28 Feb 2019 09:37:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12382/imugene-will-present-lead-candidate-her-vaxx-at-aacr-annual-meeting-12382.html <![CDATA[News - Imugene to present cancer vaccine research at AACR annual meeting ]]> https://www.proactiveinvestors.com.au/companies/news/215464/imugene-to-present-cancer-vaccine-research-at-aacr-annual-meeting-215464.html Imugene Limited (ASX:IMU) scientific advisor Professor Ursula Wiedermann is to present on the company’s HER-Vaxx cancer vaccine at the American Association for Cancer Research (AACR) 2019 annual meeting.

Wiedermann is the co-inventor of HER-Vaxx and also a member of Imugene’s scientific advisory board.

 

The presentation is authored by Wiedermann and researchers at the Medical University of Vienna in Australia and Imugene.

Its title is ‘A phase1b open label multi-centre study with a HER2/neu peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy shows safety, immunogenicity and clinical response in patients with HER2/neu overexpressed advanced cancer of the stomach.

READ: Imugene targets defender B-cells with cancer vaccines HER-Vaxx and B-Vaxx

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumours that over-express the HER2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

The immunotheraphy is constructed from several B cell epitopes derived from the extracellular domain of HER2/neu.

It has been show in pre-clinical studies and phase-one studies to stimulate a potent polyclonal antibody response to HER2/neu, a well-known and validated cancer target.

READ: Imugene has cancer vaccine trial data published in prestigious medical journal

The company recently had its phase-one clinical trial data for its B cell cancer vaccine B-Vaxx published in the prestigious AACR journal Clinical Cancer Research.

The article was primarily authored by Imugene’s scientific advisory board members Professor Pravin Kaumaya from the Ohio State University and Dr Tanios Bekaii-Saab from the Mayo Clinic.

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Wed, 27 Feb 2019 20:12:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215464/imugene-to-present-cancer-vaccine-research-at-aacr-annual-meeting-215464.html
<![CDATA[News - Imugene has cancer vaccine trial data published in prestigious medical journal ]]> https://www.proactiveinvestors.com.au/companies/news/215268/imugene-has-cancer-vaccine-trial-data-published-in-prestigious-medical-journal-215268.html Imugene Ltd’s (ASX:IMU) phase 1 clinical trial data for its B cell peptide cancer vaccine B-Vaxx has been published in the prestigious American Association for Cancer Research journal Clinical Cancer Research.

The title of the article is "Phase 1 Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines emulsified in Montanide ISA 720VG and nor-MDP Adjuvant in Advanced Solid Tumors."

The article is primarily authored by Imugene’s Scientific Advisory Board members Professor Pravin Kaumaya from the Ohio State University and Dr Tanios Bekaii-Saab from the Mayo Clinic.

 

Notably, this first-in-human phase 1 study evaluated the safety profile, optimal immunologic/biologic dose and immunogenicity of the combination of two peptide B-cell epitope vaccines engineered to represent the trastuzumab and pertuzumab HER-2 binding sites.

While the billion dollar blockbusters marketed by Roche/Genentech Herceptinâ and Perjetaâ have been approved for clinical use, patients often develop resistance to these therapies.

READ: Imugene targets defender B-cells with cancer vaccines HER-Vaxx and B-Vaxx

Professor Pravin Kaumaya said: “We have advanced a new paradigm in immunotherapy that focuses on humoral responses based on conformational B-cell epitope vaccines.

“The study vaccine is safe, exhibits anti-tumor activity and shows preliminary indications that peptide vaccination may avoid therapeutic resistance and offers a promising alternative to monoclonal antibody therapies.”

Two lead cancer vaccine candidates

The company’s key assets are B-lymphocyte or B-cell peptide cancer vaccines that link an immunogenic protein with a B-cell epitope peptide and include an adjuvant to induce the body into producing antibodies against normal self-proteins.

Imugene’s two lead therapeutic vaccine candidates are the HER-Vaxx vaccine and the B-Vaxx vaccine.

HER-Vaxx is an anti-HER2/neu product that has been taken through a successful phase 1b study in 14 gastric cancer patients.

B-Vaxx is also another B-cell peptide cancer vaccine and is designed to treat tumours that over-express the HER2/neu receptor.

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Tue, 26 Feb 2019 12:23:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215268/imugene-has-cancer-vaccine-trial-data-published-in-prestigious-medical-journal-215268.html
<![CDATA[News - Imugene targets defender B-cells with cancer vaccines HER-Vaxx and B-Vaxx ]]> https://www.proactiveinvestors.com.au/companies/news/214505/imugene-targets-defender-b-cells-with-cancer-vaccines-her-vaxx-and-b-vaxx-214505.html Imugene Limited (ASX:IMU) specialises in the emerging field of cancer immunotherapy. The immunoncology company is run by Leslie Chong, a biologist with more than 20 years of oncology experience in phase I-III clinical program development. She was previously a senior clinical program lead at Roche Holding Ltd (SWX:ROG) (ETR:RHO) (OTCMKTS:RHHVF) (OTCMKTS:RHHBY) company Genentech.

What does Imugene own?

The company’s key assets are B-lymphocyte or B-cell peptide cancer vaccines that link an immunogenic protein with a B-cell epitope peptide and include an adjuvant to induce the body into producing antibodies against normal self-proteins.

These proteins include the well-known and validated cancer target human epidermal growth factor receptor 2 protein also known as receptor tyrosine-protein kinase erbB-2 or HER2/neu (CD340).

Another protein is the programmed cell death protein 1 (PD1 or CD279).

Imugene’s two lead therapeutic vaccine candidates are the HER-Vaxx vaccine, an anti-HER2/neu product that has been taken through a successful phase 1b study in 14 gastric cancer patients.

Ten of the tumour patients were available for evaluation and were dosed with the HER-Vaxx vaccine along with standard-of-care chemotherapy with cisplatin and fluorouracil or capecitabine.

The vaccine appeared to be well tolerated by the 10 subjects. Five had a partial response — with a 30% or greater decrease in tumour size from baseline scans — while four showed disease stabilisation.

This vaccine was designed to target tumours that over-express the HER2/neu receptor, including gastric, breast, ovarian, lung and pancreatic cancers.

It was developed by scientists at the Medical University of Vienna in Austria and is constructed from several B cell epitopes derived from the extracellular domain of HER2/neu.

Both the phase I and pre-clinical stimulated a potent polyclonal antibody response to the HER2/neu cancer target.

Imugene’s second lead therapeutic vaccine candidate is B-Vaxx, another anti-HER2/neu vaccine which is similar to HER-Vaxx.

B-Vaxx is also another B-cell peptide cancer vaccine and was designed to treat tumours that over-express the HER2/neu receptor.

These cancers include gastric, breast, ovarian, lung and pancreatic cancers.

Also in Imugene’s pipeline is the KEY-Vaxx, developed by Professor Pravin Kaumaya at the Ohio State University in Columbus OH.

KEY-Vaxximmunotherapy is constructed from a single B-cell epitope derived from the extracellular domain of PD1.

The B-cell peptide cancer vaccine aims to induce the body to produce polyclonal antibodies that block PD1 signalling and produce an anticancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming cancer treatments.

Imugene has also in-licensed a number of other B-cell peptide cancer vaccines from OSU in its pipeline, along with peptide mimics that can inhibit growth factor signalling, including programs that targeting HER1, HER3, VEGF, IGF-1R and CD28.

The near-term plan for the company is to develop its HER2 and PD-1 B-cell vaccines.

Imugene hopes to pick up its pipeline products down the track, noting the considerable promise they have shown in preclinical studies.

The company is well-funded to support its commercial and clinical milestones and at December 31, 2018, had A$24.05 million in the bank.

Its efforts are guided by the experience of several recognised leaders in immuno-oncology who have joined Imugene’s Scientific Advisory Board - Dr Josep Tabernero, Professor Tanios Bekaii-Saab, Professor Pravin Kaumaya and Professor Michael Caligiuri.

Inflection points

Success of more advanced study of anti-HER2/neu (CD340) vaccine HER-Vaxx

Success of anti-HER2/neu (CD340) vaccine B-Vaxx

Progression of anti-PD1 (CD279) vaccine KEY-Vaxx and other pipeline products from the clinic

Relative success of other anti-tumour vaccines in the oncology space

Managing director & CEO Leslie Chong confident of approach

“We’re squarely in the immunoncology space where everyone is in the T-cell modulation space,” managing director & CEO Leslie Chong told the Proactive Investors Stocktube channel at the Annual Biotech Showcase in San Francisco last month. “We really think that … waking up your B-cells to create the antibodies is a key to our success and the differentiation.”

 

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Tue, 12 Feb 2019 22:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/214505/imugene-targets-defender-b-cells-with-cancer-vaccines-her-vaxx-and-b-vaxx-214505.html
<![CDATA[Media files - Imugene adds key members to its scientific advisory board to advance company forward ]]> https://www.proactiveinvestors.com.au/companies/stocktube/11802/imugene-adds-key-members-to-its-scientific-advisory-board-to-advance-company-forward-11802.html Fri, 11 Jan 2019 10:00:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/11802/imugene-adds-key-members-to-its-scientific-advisory-board-to-advance-company-forward-11802.html <![CDATA[News - Imugene begins manufacture of its innovative cancer vaccine for trials ]]> https://www.proactiveinvestors.com.au/companies/news/205478/imugene-begins-manufacture-of-its-innovative-cancer-vaccine-for-trials-205478.html Imugene Limited (ASX:IMU) has formally commenced cGMP (current good manufacturing practice) manufacture of the clinical batch of its cancer vaccine KEY-Vaxx.

The cGMP batch is part of the pre-clinical development for the proposed PD-1 phase I clinical trial to be conducted in 2019.

AmbioPharm Inc, a US-based peptide manufacturing company has been appointed to manufacture the vaccine.

We've commenced cGMP manufacturing of the clinical batch of cancer vaccine KEY-Vaxx for the proposed Phase 1 PD-1 clinical trial, after successfully completing pilot studies. AmbioPharm Inc. (APi), a US-based cGMP manufacturer has been appointed $IMU #ASX https://t.co/xL390CKopH pic.twitter.com/YVOYROEtbZ

— Imugene Ltd (@TeamImugene) September 20, 2018

KEY-Vaxx is a B-cell peptide cancer vaccine which aims to induce the body to produce polyclonal antibodies that block PD-1 signalling, and potentially produce an anticancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

KEY-Vaxx has shown potential in preclinical studies, outperforming an industry-standard antibody in a mouse model of HER2+ colorectal cancer.

New provisional patent

The protection of Imugene’s global position in PD-1 B-cell cancer vaccines has been strengthened with the filing of a new provisional patent in Australia titled “A vaccine composition and uses thereof”.

READ: Imugene signs exclusive, world-widelicence for cancer vaccine

Imugene managing director Leslie Chong said: “Maintaining and strengthening our already strong international intellectual property position is a key area of focus in maintaining the competitive advantage of KEY-Vaxx and any future improvements, vaccine formulations and clinical uses.

“We are extremely pleased with the progress made from our expert scientific team.”

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Mon, 24 Sep 2018 08:07:00 +1000 https://www.proactiveinvestors.com.au/companies/news/205478/imugene-begins-manufacture-of-its-innovative-cancer-vaccine-for-trials-205478.html
<![CDATA[News - Imugene signs exclusive, world-wide licence for cancer vaccine ]]> https://www.proactiveinvestors.com.au/companies/news/198408/imugene-signs-exclusive-world-wide-licence-for-cancer-vaccine-198408.html Imugene Ltd (ASX:IMU) has expanded its cancer portfolio via a transformational opportunity, and institutional and sophisticated investors have shown their support through a capital raising.

Imugene has now signed an exclusive, world-wide licence to the entire body of cancer vaccine work and intellectual property developed by Professor Pravin T. P. Kaumaya of The Ohio State University Wexner Medical Center and The Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and The Mayo Clinic.

Professor Kaumaya has developed multiple B-cell cancer vaccines and is a recognised leader in cancer vaccine research with emphasis on peptide cancer vaccines.

There is a growing body of evidence that B-cell peptide vaccines may have a safety and specificity advantage over other immunotherapy approaches.

Importance of the deal

The multiple commercial, strategic and clinical benefits of this transaction secures Imugene’s global leadership in the promising B-cell peptide cancer vaccine sector.

In particular with PD-1 checkpoint inhibitors, where Ohio State University Comprehensive Cancer Centre’s pre-clinical work for a Phase I PD-1 clinical trial is well advanced.

Funding support

Australian and international institutional and sophisticated investors have committed to raise around $12 million in a placement at 2.7 cents.

Imugene last traded at 3 cents.

There is also a 1 for 3 option attached exercisable at 4 cents on or before 30 November 2021.

Imugene will also open a 1 for 9.5 non-renounceable rights issue on the same terms as the placement, raising up to another $8.1 million.

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Thu, 07 Jun 2018 11:29:00 +1000 https://www.proactiveinvestors.com.au/companies/news/198408/imugene-signs-exclusive-world-wide-licence-for-cancer-vaccine-198408.html
<![CDATA[News - Imugene pounces on material acquisition ]]> https://www.proactiveinvestors.com.au/companies/news/198223/imugene-pounces-on-material-acquisition-198223.html Imugene Ltd (ASX:IMU) has been a strong performer on the ASX, last trading at 3 cents, or more than double its value in January 2018.

The company recently appointed Ms Leslie Chong as managing director. As CEO, Ms Chong achieved various important milestones in both the clinical and corporate fronts.

The next steps for Imugene will be interesting, with the company this morning entering a trading halt pending details of a material acquisition, and subsequent capital raising.

Currently, Imugene's lead product is HER-Vaxx, a B Cell peptide vaccine for the treatment of gastric cancer.

The halt will remain in place until the opening of trade on Thursday 7 June 2018, or earlier if an announcement is made to the market.

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Tue, 05 Jun 2018 10:08:00 +1000 https://www.proactiveinvestors.com.au/companies/news/198223/imugene-pounces-on-material-acquisition-198223.html
<![CDATA[News - Imugene’s shares surge higher following early promise in gastric cancer trial ]]> https://www.proactiveinvestors.com.au/companies/news/191263/imugenes-shares-surge-higher-following-early-promise-in-gastric-cancer-trial-191263.html Imugene Limited’s (ASX:IMU) shares are trading circa 21% higher intra-day at $0.017 following early promise in gastric cancer clinical trial for its HER-Vaxx cancer vaccine (IMU-131).

HER-Vaxx is a next generation HER2 cancer therapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

Imugene’s latest clinical results indicate that IMU-131 induces strong immune responses in patients with metastatic gastric cancer, with antibodies to the target cancer biomarker strongly evident in validated assays.

Importantly, clinicians have reported no safety, toxicity or tolerability issues with HER-Vaxx during the first cohort dosing of patients.

Dose escalation recommended

The cohort review committee for the study has reviewed the results and has recommended dose escalation.

The clinicians at eight sites across Hong Kong, Taiwan and Thailand will determine if the administration of HER-Vaxx in combination with chemotherapy will prolong survival, delay tumour progression, or reduce the tumour burden in patients with metastatic gastric cancer.

Multi-billion dollar market

HER-Vaxx works by targeting the same receptor as Herceptin and Perjeta, two leading antibody drugs marketed by Roche, with annual sales of US$8.2 billion.

Unlike Herceptin and Perjeta, which are “injected synthetic antibody” products, HER-Vaxx activates the patient’s own immune system to produce a continuous supply of cancer targeting antibodies and induce a response against the tumours.

The early clinical data for HER-Vaxx is encouraging, indicating immune activation in vaccinated patients in a manner that is consistent with the vaccine’s postulated mechanism of action.

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Wed, 07 Feb 2018 13:01:00 +1100 https://www.proactiveinvestors.com.au/companies/news/191263/imugenes-shares-surge-higher-following-early-promise-in-gastric-cancer-trial-191263.html
<![CDATA[News - Imugene targets cash injection for immuno-oncology clinical testing ]]> https://www.proactiveinvestors.com.au/companies/news/187538/imugene-targets-cash-injection-for-immuno-oncology-clinical-testing-187538.html Imugene Ltd (ASX:IMU) has commenced clinical testing a therapeutic anti-cancer vaccine called HER-Vaxx (IMU131), in HER2+ gastric cancer patients.

HER-Vaxx is a next generation HER2 cancer therapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

HER-Vaxx works by targeting the same receptor as Herceptin and Perjeta, two leading antibody drugs marketed by Roche, with annual sales of US$8.2 billion.

To progress the next steps, Imugene is heading to market with a capital raising, and the ASX has granted the company a trading halt to prepare.

The halt will remain in place until the opening of trade on Thursday 23rd November 2017, or earlier if an announcement is made to the market.

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Tue, 21 Nov 2017 09:56:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187538/imugene-targets-cash-injection-for-immuno-oncology-clinical-testing-187538.html
<![CDATA[News - Imugene granted Canadian patent for proprietary cancer vaccine ]]> https://www.proactiveinvestors.com.au/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.html Imugene (ASX:IMU) has achieved a major milestone by securing a patent for its proprietary cancer vaccine, HER-Vaxx, from the Canadian Patent Office.

The company’s shares were last trading 13% higher intra-day, at A$0.017.

HER-Vaxx is a next generation cancer immunotherapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene is currently enrolling gastric cancer patients at eight key cancer hospital sites in Asia, including Hong Kong, Thailand and Taiwan.

HER-Vaxx works by targeting the same receptor (and additional receptors) as Herceptin and Perjeta, two of the leading antibody drugs on market, with annual sales of US$8.2 billion.

Current immunotherapies are predicted to generate sales of US$36 billion by 2025 but costs remain prohibitive for patients.

The mechanism of action for HER-Vaxx may help generate improved efficacy over existing treatments and at a lower cost.

Gastric cancer is a leading cause of cancer death worldwide, representing 10.1% of male cases, with the incidence of gastric cancer substantially higher in Asia.

Imugene had raised circa A$3 million as part of an option plan which expired on 31 March 2017, at a price of A$0.015 per share.

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Fri, 21 Jul 2017 13:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.html
<![CDATA[News - Imugene raises $3M from option plan to advance immunotherapy studies ]]> https://www.proactiveinvestors.com.au/companies/news/176058/imugene-raises-3m-from-option-plan-to-advance-immunotherapy-studies-176058.html Imugene (ASX:IMU) has raised circa $3 million as part of an option plan which expired on 31 March 2017, at a price of $0.015 per share.

The new capital places Imugene in a solid position to continue the development of its clinical candidate, HER-Vaxx.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene’s three prominent existing shareholders, Private Portfolio Managers, Platinum Asset Management and Celtic Capital, have increased their investment in Imugene via their roles as underwriters to the plan.

In January 2016, Imugene announced a new partnership with the Medical University of Vienna to discover and develop mimotope-based immunotherapies against validated and new oncology targets.

This partnership has the potential to create B Cell peptide vaccines that would replace or augment conventional monoclonal antibodies.

Importantly, Imugene filed four new patent applications with IP Australia in December 2016 related to mimotope B-cell vaccine compositions.

The company’s share price increased circa 78% during the past six months, last trading at $0.016.

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Thu, 06 Apr 2017 14:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/176058/imugene-raises-3m-from-option-plan-to-advance-immunotherapy-studies-176058.html
<![CDATA[News - Imugene Ltd appoints Leslie Chong to chief executive officer ]]> https://www.proactiveinvestors.com.au/companies/news/169291/imugene-ltd-appoints-leslie-chong-to-chief-executive-officer-169291.html Chong joined IMU in September 2015 from the pharmaceutical giant, Genentech, in San Francisco where she had a distinguished career across many aspects of drug development.

Imugene is a clinical stage immuno-oncology company, with its lead product being HER-Vaxx, a B Cell peptide vaccine for the treatment of gastric cancer.

The company is also developing mimotope-based immunotherapies against validated and new oncology targets.

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Tue, 22 Nov 2016 08:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/169291/imugene-ltd-appoints-leslie-chong-to-chief-executive-officer-169291.html
<![CDATA[News - Imugene gets ready to raise ]]> https://www.proactiveinvestors.com.au/companies/news/167599/imugene-gets-ready-to-raise-167599.html The halt will remain in place until the opening of trade on Friday 21st October 2016, or earlier if an announcement is made to the market.

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Wed, 19 Oct 2016 08:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/167599/imugene-gets-ready-to-raise-167599.html
<![CDATA[News - Imugene Ltd gets site approval for gastric cancer study in Thailand ]]> https://www.proactiveinvestors.com.au/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.html Imugene Ltd (ASX:IMU) has received approval from the Faculty of Medicine, Chiang Mai University of Thailand to start site activation process for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval in Thailand follows approvals from Taipei Veterans General Hospital in Taiwan and the University of Hong Kong.

Thailand, Taiwan and Hong Kong and are three of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asian countries.

Imugene had $1.6 million in cash as at 30 June 2016.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Mon, 22 Aug 2016 13:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.html
<![CDATA[News - Imugene Ltd to start gastric cancer treatment studies in Taiwan ]]> https://www.proactiveinvestors.com.au/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.html Imugene Ltd (ASX:IMU) has received approval from the Institutional Review Board of the Taipei Veterans General Hospital in Taiwan for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Rather than attacking the cancer directly, as chemo does, immunotherapy tries to rally the patient’s own immune system to fight the disease.

The approval in Taiwan follows the University of Hong Kong Institutional Review Board Approval in July.

Hong Kong and Taiwan are two of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asia.

Imugene held $1.6 million in cash as at 30 June 2016.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 11 Aug 2016 12:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.html
<![CDATA[News - Imugene Ltd gains approval for gastric cancer study in Hong Kong ]]> https://www.proactiveinvestors.com.au/companies/news/156526/imugene-ltd-gains-approval-for-gastric-cancer-study-in-hong-kong-69717.html Imugene Ltd (ASX:IMU) has received approval from the University of Hong Kong Institutional Review Board for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy for gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval from the Ethics Committee positions Imugene to enrol patients for the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

For Hong Kong there were around 1,100 new gastric cancer cases last year, representing a market for any product that is commercialised from the studies.

Imugene held $2.4 million in cash as at 31 March 2016.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 11 Jul 2016 12:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156526/imugene-ltd-gains-approval-for-gastric-cancer-study-in-hong-kong-69717.html
<![CDATA[News - Imugene initiates pan-Asia trial of gastric cancer treatment therapy ]]> https://www.proactiveinvestors.com.au/companies/news/156525/imugene-initiates-pan-asia-trial-of-gastric-cancer-treatment-therapy-68218.html Imugene Ltd (ASX:IMU), a clinical stage immuno-oncology company, has initiated a pan-Asia trial of the company’s HER-Vaxx therapy for gastric cancer patients by making a regulatory package submission for the Phase 1b/2 study in Hong Kong.

This filing represents the first submission to various regulators across Asia to initiate clinical testing of Imugene’s HER-Vaxx therapy, given the high unmet need in this area for patients who have HER-2 positive gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

In conjunction with Novotech, Imugene’s contract research organisation for the study, the company has filed to initiate the study with the Department of Health of Hong Kong.

The proposed HER-Vaxx Phase 1b/2 study will be conducted in two parts.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Imugene has identified eight study sites in Asia to participate in the Phase 1b part of the study. Regulatory filings in other jurisdictions will be done in the next two months.

The principal investigator for Imugene’s Hong Kong site will be Dr Thomas Yau, one of Hong Kong’s leading medical oncologists, whose main research priority is gastrointestinal oncology.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 21 Apr 2016 16:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156525/imugene-initiates-pan-asia-trial-of-gastric-cancer-treatment-therapy-68218.html
<![CDATA[News - Imugene rings in changes as gastric cancer trial preparation picks up pace ]]> https://www.proactiveinvestors.com.au/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.html Imugene (ASX:IMU) has added Dr. Anton Uvarov to its Board as a non executive director as the immuno-oncology company picks up the pace of work for its gastric cancer study in 2016.

Dr Uvarov worked for two years in the U.S. healthcare research team at Citigroup Global Markets covering small and mid-cap biotechnology companies and holds a PhD degree in Biochemistry and Medical Genetics.

Stuart Roberts was appointed Head of Corporate Development this week. Previously he worked at Prima BioMed (ASX:PRR).

Imugene is a clinical stage immuno-oncology company with a lead product, HER-Vaxx a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene's unique immunotherapy has been shown in pre-clinical work and in one Phase 1 study to stimulate a potent polyclonal antibody response to HER-2/neu, a known and validated cancer target.

HER-Vaxx’s successful Phase 1 study was in patients with breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer.

Novotech was recently appointed as the lead contract researcher for the upcoming Phase 1b/2 trial of HER-Vaxx in gastric cancer.

The trial design was largely completed with a focus on Asia. Start up activity for the HER-Vaxx Phase 1b/2 study in gastric cancer is underway and clinical commencement is expected in the first half of 2016.

Under Novotech, Imugene’s investigators will recruit patients with HER-2 positive gastric cancer at a number of leading cancer centres in Asia.

The study will be conducted in two parts. The initial Phase 1b will be an open-label dose escalation study designed to evaluate the safety as well as the pharmacokinetics of HER-Vaxx. This will also determine optimal dosage.

A larger Phase 2 study will be a randomised controlled study of HER-Vaxx plus standard of care against standard of care alone.




Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 05 Jan 2016 11:42:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.html
<![CDATA[News - Imugene cashes up ahead of hotly anticipated cancer treatment trials ]]> https://www.proactiveinvestors.com.au/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.html Imugene Limited (ASX:IMU) has further underscored investor confidence in its HER-Vaxx product with about A$756,000 in new government funding as trials for the cancer therapy approach.

The tax refund comes as part of the Australian government’s research and development incentive program, which is aimed at converting innovative research into tangible, market-ready outcomes.

These funds complement Imugene’s $3 million capital raising announced in September and will contribute to the progression of HER-Vaxx, which is due to enter additional human Phase Ib/II gastric cancer clinical trials in 2016.

Imugene chief operating officer Leslie Chong commented:

“This is valuable non-dilutive capital for Imugene. If we succeed in commercialising HER-Vaxx, it will mean a potential Australian blockbuster drug and a better treatment for people who suffer HER2-positive gastric, breast and other cancers.”

Trials of Imugene HER-Vaxx therapy for gastric cancer are expected to demonstrate the medical and commercial viability of the company’s strategy as investors contemplate a multi-decade rollout of patenting and royalties related to a strong intellectual property portfolio.

Imugene IP is exclusive until 2030 and granted in all major jurisdictions. The company, however, is now aiming for an extension of these rights until 2036.

The macro context for this marketing scheme is underpinned by the prevalence and high death rate of gastric cancer, particularly in Japan, Korea and China.


Hot field

The use of immunotherapy to develop vaccines against gastric and breast cancers is considered the hottest area of oncology today thanks to the breakthrough approval last year of the first cancer cell-killing drug for blockading immune checkpoints.

Immune checkpoints are molecules within the immune system which have emerged as increasingly researched targets for treating cancer.

HER-Vaxx trials will explore Imugene’s vaccine on breast cancer by targeting HER-2 receptors on cancer cells. This is a clinically and commercially validated cancer target. The killing of HER-2 receptors results in the host cancer cells stopping growth and dying.

The trial work could improve Imugene’s chances of acquiring orphan drug designation from the U.S. Food and Drug Administration as well as steering development of follow-up clinical candidates using HER-Vaxx technology.


Sharpening profile

In addition to the $3 million share placement last month, the latest R&D refund and the imminent HER-Vaxx trialling, Imugene has bolstered its investment case with the recent appointment of Chong in the role of chief operating officer.

An immune-oncology specialist, Chong served previously as senior clinical program lead at Genetech Inc in the U.S., which is widely regarded as one of the world’s most successful biotech companies with a significant oncology franchise including the best-selling breast cancer drug, Herceptin.

Her deep immuno-oncology experience and industry networks are expected to be invaluable as HER-Vaxx development milestones come into focus.


Analysis

The latest investment has continued to demonstrate the attractiveness of Imugene’s product pipeline, which includes a trial-ready drug targeting the same receptor as the A$6.4 billion breast cancer drug, Herceptin.

This investor enthusiasm also indicates that the upcoming gastric cancer human clinical trials for HER-Vaxx represent a significant share price catalyst next year for this lightly valued $16 million-capped stock.

Imugene's validated HER-2 target and a world-class drug development team in Dr Axel Hoos and Professor Ursula Weidermann provide investors with a credentialed pure-play listed immuno-oncology stock – once the preserve of “big pharma”.

Beyond its HER-Vaxx product holdings, Imugene also owns a drug delivery platform, Linguet, which uses its proprietary technology to improve the efficacy and safety of a diverse number of existing prescription and over-the-counter medicines.

Further product diversification can be found in Imugene’s development of a vitamin D supplement tablet, which melts in the mouth, better known as a “meltlet”. The technology is available for outlicensing to interested parties.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 28 Oct 2015 14:53:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.html
<![CDATA[News - Imugene raises $3M to start gastric cancer clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.html Imugene (ASX:IMU) has received firm commitments to raise $3 million through a placement of shares priced at $0.0075 each to sophisticated investors.

This includes one free attaching option exercisable at $0.015 and expiring on 31st March 2017 for every two shares subscribed.

The company also plans to issue 2 bonus options for every 15 shares held in the company to shareholders. These have the same terms as the placement options.

The capital raising includes a subscription by non-executive director Otto Buttula for shares amounting to $225,000 and non-executive director Charles Walker for $11,250 worth of shares.

Proceeds will be used to initiate the company’s Phase 1b/2 clinical trial for its HER-Vaxx gastric cancer treatment and additional preclinical work on HER-Vaxx drug combinations.
   
The company has already appointed global contract research organisation (CRO) Simbec-Orion to conduct the trial and is targeting late this year or early 2016 to commence the Phase 1b trial.

Shareholder approval will be sought at company’s upcoming annual general meeting for the share placement.

Paul Hopper, executive chairman, commented:

“We are delighted to welcome new and existing shareholders to Imugene in this placement. The funds raised from this placement, subject to shareholder approval, in addition to our existing cash position, places us in a strong position to move ahead with our program.

“With our newly appointed COO, Ms. Leslie Chong, commencing her role shortly and the start of clinical trials, we look forward to an exciting time ahead for Imugene.”


Recent Activity

Imugene is in the later stages of planning to conduct a new preclinical study of HER-Vaxx in an additional disease model of gastric cancer.

This could improve the company’s case to achieve orphan drug designation from the United States Food and Drug Administration as well as steering development of follow up clinical candidates using the HER-Vaxx technology.

Chief Scientific Officer Professor Ursula Wiedermann is also conducting additional work at the Medical University of Vienna on the final chosen formulation of HER-Vaxx.

This work is looking to further establish additional evidence of the enhanced efficacy from the new formulation of HER-Vaxx.


HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.


Analysis

The $3 million to be raised will allow Imugene to start the HER-Vaxx gastric cancer human clinical trial, which is a key inflection point.

Pre-clinical data had previously showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 08 Sep 2015 12:17:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.html
<![CDATA[News - Imugene Limited on road to raising ]]> https://www.proactiveinvestors.com.au/companies/news/156520/imugene-limited-on-road-to-raising-64387.html Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) has been granted a trading halt by the ASX, with its shares placed in pre-open.

Imugene is currently preparing to release capital raising details.

The company is developing HER-2+ gastric and breast cancer immunotherapies.

The halt will remain in place until the opening of trade on Wednesday 9th September 2015, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 07 Sep 2015 16:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156520/imugene-limited-on-road-to-raising-64387.html
<![CDATA[News - Imugene Limited appoints Leslie Chong as chief operating officer ]]> https://www.proactiveinvestors.com.au/companies/news/156519/imugene-limited-appoints-leslie-chong-as-chief-operating-officer-64236.html Imugene Limited (ASX:IMU) has appointed Leslie Chong as its chief operating officer with effect from mid-September.

She was most recently a senior clinical program leader at San Francisco-based Genentech, Inc, a global leader in immuno-oncology and developer of Herceptin before it was acquired by Roche in 2009 for US$46.8 billion.

Paul Hopper, executive chairman, commented:

“We are delighted that someone of Leslie’s calibre, deep immuno-oncology experience, industry networks, and from one of the world’s most successful and prestigious drug developers, has agreed to join our team.

“IMU is at an important stage of its clinical development and Leslie’s deep, hands-on clinical trial experience across many studies will be invaluable to us.”

Separately, managing director Charles Walker will step down from his position and continue as a non-executive director of the company.

In July, the company selected global contract research organisation (CRO) Simbec-Orion to conduct the upcoming HER-Vaxx gastric cancer human clinical trial.
   
The Phase 1b/2 clinical study is on track to begin in the second half of 2015. Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 27 Aug 2015 16:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156519/imugene-limited-appoints-leslie-chong-as-chief-operating-officer-64236.html
<![CDATA[News - Imugene on track to start gastric cancer clinical trial in 2H 2015 ]]> https://www.proactiveinvestors.com.au/companies/news/156518/imugene-on-track-to-start-gastric-cancer-clinical-trial-in-2h-2015-63226.html Imugene (ASX:IMU) has hit a milestone with global contract research organisation (CRO) Simbec-Orion selected to conduct the upcoming HER-Vaxx gastric cancer human clinical trial.
   
The Phase 1b/2 clinical study is on track to begin in the second half of 2015.

Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Charles Walker, managing director, said:

“This is another milestone passed as the selection of specialist CRO Orion will greatly assist the company conduct a thorough and well prepared immuno-oncology clinical trial.

“Our trial is designed to be statistically robust and also yield early significant data. The trial has been designed to appeal to potential partners and help steer the Phase 3 clinical trial design.

“We look forward to working with our new partner and reporting on the inevitable progress.”

Ronald Openshaw, Simbec-Orion chief executive officer, added:

“We are pleased to prevail in Imugene’s stringent selection process and look forward to driving this important clinical trial.

“We will ensure a combination of rigour and efficiency and are adamant about achieving on timelines and quality of data that should satisfy the US FDA.”


HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

This study will be a key inflection point underpinned by many years of research.

In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

Manufacturing has also been simplified with increased reliability and lower cost.

Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.


Analysis

The appointment of global CRO Simbec-Orion to fast track plans and logistics for the upcoming HER-Vaxx gastric cancer human clinical trial is a key milestone for Imugene.

The upcoming Phase 1b/2 clinical study in the second half of 2015 is expected to be closely watched given the encouraging pre-clinical data.

Share Price Catalysts
- Grant of US FDA IND;
- Appoint Principal Investigator;
- Announce preclinical toxicology results;
- Recruit and run lead in Phase 1b trial 2H 2015;
- Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
- Report Phase 1 trial results 2H 2015 to 1H 2016; and
- Report Phase 2 results 2H 2017/1H 2018.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 01 Jul 2015 08:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156518/imugene-on-track-to-start-gastric-cancer-clinical-trial-in-2h-2015-63226.html
<![CDATA[News - Imugene issuing 5 million options to non-executive director Dr Axel Hoos ]]> https://www.proactiveinvestors.com.au/companies/news/156517/imugene-issuing-5-million-options-to-non-executive-director-dr-axel-hoos-63187.html Imugene Limited (ASX:IMU) is issuing 5 million options to non-executive director Dr Axel Hoos as a cost effective incentive based form of remuneration.

This further aligns his interests and remuneration to the achievement of operational milestones, share price appreciation and improved shareholder value.

Dr Hoos is a highly qualified and internationally respected medical research professional who has played a key role in the development of Imugene's HER-2+ gastric and breast cancer therapies and his ongoing involvement and incentivisation is critical for Imugene as it focusses on delivering key milestones.

The issue of options is subject to shareholder approval and the following terms and conditions:

- 2.5 million options exercisable at $0.0125 per option and vest upon recruitment of first patient for Phase 1b trial;
- 2.5 million options are exercisable at $0.0175 per option and vest on recruitment of first patient for Phase 2 trial;
- Options expire 4 years from the date of issue; and
- Any options not vested will lapse if Dr. Hoos ceases to be a director of the company.


Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
   
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 29 Jun 2015 17:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156517/imugene-issuing-5-million-options-to-non-executive-director-dr-axel-hoos-63187.html
<![CDATA[News - Imugene Limited appoints Dr Ursula Wiedermann as chief scientific officer ]]> https://www.proactiveinvestors.com.au/companies/news/156516/imugene-limited-appoints-dr-ursula-wiedermann-as-chief-scientific-officer-62767.html Imugene Limited (ASX:IMU) has appointed Medical University of Vienna Professor of Vaccinology Dr Ursula Wiedermann as its chief scientific officer.

Notably, she worked as the principal investigator for the preclinical development of the company’s HER-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer alongside Professor Christophe Zielinski.

Together they performed the Phase I Clinical trial of HER-Vaxx in metastatic breast cancer patients.

Wiedermann has a distinguished scientific career with a particular interest in immunology and vaccines with over 110 publications in peer reviewed scientific journals to her credit.

She currently serves on the company’s scientific advisory board.

“This is a real coup for Imugene and we are delighted to have a scientist of such international renown as Prof Dr Wiedermann formalise her position in the Company as CSO,” managing director Charles Walker said.

“Ursula is a founding inventor of HER-Vaxx and her resume reflects her extraordinary prowess as a scientist, physician and educator and confirms her status as one of the leading lights in immuno-oncology globally.

“The CSO appointment is part of our ongoing initiative to put in place a first class management team capable of realizing the very significant opportunity that is our HER-Vaxx technology.”

Wiedermann added:

“Since my first introduction to Imugene several years ago I have strongly supported the HER-Vaxx development strategy and believe both our interests are aligned in bringing this exciting cancer technology to market as soon as possible.

“As the coinventor of the science and my new closer role in the company we can surely develop HER-Vaxx in a shorter time-frame.”


Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
   
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 05 Jun 2015 13:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/156516/imugene-limited-appoints-dr-ursula-wiedermann-as-chief-scientific-officer-62767.html
<![CDATA[News - Imugene: research shows Her-Vaxx tumour inhibition promise ]]> https://www.proactiveinvestors.com.au/companies/news/107296/imugene-research-shows-her-vaxx-tumour-inhibition-promise-107296.html Imugene Limited’s (ASX:IMU) research has demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Herceptin, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

“With improvements to the formulation of HER-Vaxx, and empirical-based optimism that HER-Vaxx appears superior to Herceptin, we are rapidly finalising plans to trial our novel HER-Vaxx immunotherapeutic vaccine in patients with gastric cancer later this year,” managing director Charles Walker said.

“We are developing HER-Vaxx to generate a fast and strong stimulation of patients’ immune systems to produce natural antibodies superior to Herceptin.”

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
   
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.


HER-Vaxx Pre-Clinical Research

The research was conducted by a team at the Medical University of Vienna under the direction of Professor Dr Ursula Wiedermann.

Human breast cancer cell line SK-BR-3 overexpressing HER-2/neu was incubated with increasing concentrations of purified HER-Vaxx antibody or with Trastuzamab (Herceptin).

Her-Vaxx inhibited the proliferation of SK-BR-3 cells expressing high levels of HER-2/neu by 39% for 18.75ug dose, 58% for a 37.5ug dose and 66% for a 75ug dose.

This compared to a 39% inhibition by Trastuzamab at a 50ug dose.

The results indicate that Her-Vaxx is able inhibit the cancer cell growth with a dose of less than half that required for Herceptin while the higher dose is able to generate a response 70% greater.


Enhanced Formulation

In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

Manufacturing has also been simplified with increased reliability and lower cost.

Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.


Upcoming Clinical Trial

The upcoming Phase 1b/2 trial is designed to yield as much data and information as possible to guide the company and potential partners to develop HER-Vaxx into a commercial pharmaceutical as quickly and as efficiently as possible.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

This study will be a key inflection point underpinned by many years of research.

Once the study begins, the company will increase business development work and meet with prospective partners to inform them of our progress, our innovative technology and trial design.

With the depreciation in the Australian dollar and incentives in Australia, Imugene plans to conduct the trial in as many Australian hospitals as possible without compromising speed or efficiency.

This will be better value for money, trial management will be more efficient and will likely benefit Australian trial participants with gastric cancer.


Analysis

The empirical data demonstrating that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin is promising.

Shares in the company should trade higher on the news.

It also ensures the upcoming Phase 1b/2 clinical trial, which could provide a clinical demonstration of this efficacy, will be closely watched.

Success will allow Imugene to provide a superior alternative to Herceptin, which is a US$6 billion to US$7 billion per annum global market, providing significant upside.

HER-Vaxx also has lower production costs and potentially an opportunity for a single vaccination unlike Herceptin, which requires a more expansive treatment cycle.

Share Price Catalysts

- Appoint CRO to run trial 1H 2015;
- US FDA IND granted 1H 2015;
- Appoint Principal Investigator 1H 2015;
- Announce preclinical toxicology results 1H 2015;
- Recruit and run lead in Phase 1b trial 2H 2015;
- Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
- Report Phase 1 trial results 2H 2015 to 1H 2016; and
- Report Phase 2 results 2H 2017/1H 2018.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 22 May 2015 09:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/107296/imugene-research-shows-her-vaxx-tumour-inhibition-promise-107296.html
<![CDATA[News - Imugene therapy targets cancer at Melbourne, Sydney Luncheons ]]> https://www.proactiveinvestors.com.au/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.html Imugene (ASX:IMU) is preparing to initiate this year the clinical program for its Her-Vaxx peptide vaccine, a B-cell based immunotherapy for HER-2 positive gastric & breast cancer.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.


Proactive Investors has secured MD Charles Walker to present to investors at the "Melbourne Investor Luncheon" on Tuesday 10th February and the "Sydney Investor Luncheon" on Wednesday 11th February.

REGISTER by clicking on the city below for additional details: Melbourne OR Sydney. Otherwise call (02) 9299 5001(02) 9299 5001 and ask for John.


HER-Vaxx is a proprietary peptide vaccine developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

It causes the immune system to generate cancer-fighting antibodies by stimulating a polyclonal antibody response to biomarker HER-2/neu.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015.

Recently, Imugene achieved two milestones, substantially finalising the clinical protocol for the Phase Ib/II clinical trial and appointing respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies.


Multiple price catalysts for near term valuation increase

- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 06 Feb 2015 10:11:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.html
<![CDATA[News - Imugene hits milestones on the road to Her-Vaxx 2015 clinical program ]]> https://www.proactiveinvestors.com.au/companies/news/156514/imugene-hits-milestones-on-the-road-to-her-vaxx-2015-clinical-program-59822.html Australian immuno-oncology company Imugene (ASX:IMU) has met two more milestones as it prepares to initiate the clinical program for its Her-Vaxx peptide vaccine in 2015.

The company has substantially finalised the clinical protocol for the Phase Ib/II clinical trial in patients with gastric cancer.

It has also appointed respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies to support the clinical trial planned by the company.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

Imugene chief executive officer Charles Walker said the milestones emphasised the company’s focus to conduct an efficient high quality Phase II trial that pharmaceutical companies prefer to see.
   
“The next step is to appoint an internationally regarded CRO in 1H 2015 to efficiently manage the clinical trial. The trial remains on track to start in the second half of next year.”

The company has raised over $3.5 million through two recent placements and a share purchase plan to fund development of Her-Vaxx.

WIL Research is a global CRO that provides a range of premium discovery support services, product safety toxicological research, analytical chemistry and formulation services.

It has over 1,200 employees across world-class facilities in the US, Netherlands, France and Japan.   


HER-Vaxx

HER-Vaxx is a proprietary peptide vaccine or immunotherapy that causes the immune system to generate cancer-fighting antibodies..

It achieves this by stimulating a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.4 billion per annum drug Herceptin.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015 following the appointment of a CRO to manage the trial.

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered.  This will include 18 patients divided into 3 groups of 6.

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks.

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy.

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.

This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.


Gastric cancer global overview

Gastric cancer is the second leading cause of cancer mortality, and the fourth most common cancer in the world. Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year.

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year.

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.


Multiple share price catalysts for near term valuation increase

- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018


Analysis

Imugene has achieved two milestones as it continues preparations to initiate the clinical program for its Her-Vaxx peptide vaccine in the second half of 2015

The finalisation of the clinical protocol for the Phase Ib/II clinical trial and appointment of WIL Research to conduct important FDA IND enabling preclinical studies are both key steps towards conducting an efficient high quality Phase II trial that will draw attention from pharmaceutical companies.

With significant news flow and price catalysts milestones in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines in sight, there is potential for the current valuation to lift in 2014/15.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has estimated a 6-12 month share price target of $0.034 - $0.047.


 
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 30 Dec 2014 11:58:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156514/imugene-hits-milestones-on-the-road-to-her-vaxx-2015-clinical-program-59822.html
<![CDATA[Media files - Imugene Limited CEO Charles Walker speaks about using Immuno-oncology in the fight against cancer ]]> https://www.proactiveinvestors.com.au/companies/stocktube/5740/imugene-limited-ceo-charles-walker-speaks-about-using-immuno-oncology-in-the-fight-against-cancer-471.html Wed, 10 Dec 2014 11:27:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/5740/imugene-limited-ceo-charles-walker-speaks-about-using-immuno-oncology-in-the-fight-against-cancer-471.html <![CDATA[News - Imugene Limited looks to boost funds for cancer research ]]> https://www.proactiveinvestors.com.au/companies/news/156513/imugene-limited-looks-to-boost-funds-for-cancer-research-58635.html Immuno-oncology company Imugene Limited (ASX:IMU) is heading to market with a capital raising.

The ASX has granted the company a trading halt, with its shares placed in pre-open.

Imugene is developing B-cell based immunotherapies, known as HER-Vaxx, for HER-2 positive gastric and breast cancer.

The halt will remain in place until the opening of trade on Wednesday 5th November 2014, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 03 Nov 2014 10:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156513/imugene-limited-looks-to-boost-funds-for-cancer-research-58635.html
<![CDATA[News - Imugene to be granted patent for cancer vaccine in Israel ]]> https://www.proactiveinvestors.com.au/companies/news/156512/imugene-to-be-granted-patent-for-cancer-vaccine-in-israel-53848.html Imugene Limited (ASX:IMU) may trade firmer after the Israeli Patent Office issued an Intention to Grant for its proprietary cancer vaccine, HER-Vaxx.

The patent will protect specific cancer vaccine formulations in Israel until 2027.

HER-Vaxx stimulates a polyclonal antibody response to the HER-2/neu receptor, the same biomarker targeted by the $US6.9 billion per annum drug Herceptin®.

HER-2/neu is known to be over-expressed on various tumours including gastric, breast, ovarian and pancreatic cancers.

HERVaxx has completed a Phase 1 study in breast cancer; the next stage of development will be a Phase 2 study in gastric cancer, which is the second most common cause of cancer-related death in the world

Imugene secured full rights to manufacture the cancer immunotherapy as part of its acquisition of BioLife Science in December last year.

The first patent was assigned from Pevion Biotech of Switzerland, protecting Her-Vaxx in several major markets until 2030.

Imugene also holds an exclusive global license covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

 

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Mon, 24 Mar 2014 11:46:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156512/imugene-to-be-granted-patent-for-cancer-vaccine-in-israel-53848.html
<![CDATA[News - Imugene secures intellectual property over a proposed cancer vaccine ]]> https://www.proactiveinvestors.com.au/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.html Imugene (ASX: IMU) has secured full rights to manufacture the cancer immunotherapy Her-Vaxx as part of its acquisition of BioLife Science QLD, which is due to close on December 20th.

The first patent has been assigned to Biolife from Pevion Biotech of Switzerland, protecting Her-Vaxx in major markets until 2030.

Biolife has additionally been granted an exclusive global license from Pevion in the field of oncology covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.

Biloife acquired the rights to the novel cancer immunotherapy treatment platform, developed by reseach scientists at the University Medical School in Austria.

The immunotherapy induces an antibody response against breast and gastric cancers.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 19 Dec 2013 15:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.html
<![CDATA[News - Imugene Limited to disclose acquisition, capital raising ]]> https://www.proactiveinvestors.com.au/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.html Imugene Limited (ASX: IMU) is preparing to divulge details of an acquisition, along with a capital raising.

The ASX this morning has granted the company a trading halt, with its shares placed in pre-open.

Imugene is currently focused on drug delivery technology, and is looking to commercialising these based on its novel buccal (drugs administered via the cheek) Linguet™ technology.

The halt will last until the opening of trade on Wednesday 23rd October 2013, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 21 Oct 2013 12:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.html