Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) is well-funded and ready to progress to human studies for its CF33 and PD1-Vaxx treatments in the near-term as well as continuing enrolment into the HER-Vaxx phase two study.
In September the company boosted its balance sheet with a $5.7 million option underwriting agreement which provides holders with an option to purchase shares in the company at 2.6 cents per share. There are currently 217,462,548 Imugene options which are due to expire on November 30, 2020.
The agreement further strengthens the company’s financial position building on the existing cash balance of $30.1 million as of June 30, 2020.
Funds raised from the issue of options are expected to support the company’s four continuing clinical programs with CF33, PD1- Vaxx and HER-Vaxx as well as provide funding for IP and milestone payments and working capital.
CF33 clinical development
In the recent annual report, Imugene executive chairman Paul Hopper said the company had experienced “significant change and growth” with the acquisition of an important oncolytic virus program from the City of Hope Cancer Centre (COH) in Los Angeles.
He said: “COH oncolytic virus (OV) technology acquisition in November has firmly positioned Imugene in this exciting area of immuno-oncology and we are well advanced in our strategy, notwithstanding the challenges posed by COVID-19, to commence two Phase 1 clinical trials with one study in triple negative breast cancer and another in advanced solid tumors.”
CF33 is a chimeric vaccinia poxvirus from the lab of Professor Yuman Fong, chair of surgery at City of Hope, and a noted expert in the oncolytic virus field which utilises naturally occurring or genetically modified viruses to infect, replicate in, and kill cancer cells, while sparing healthy cells.
Hopper said: “The relationship with the technology founder Professor Yuman Fong and his team at COH is highly productive and is a source of deep scientific and technical knowledge and expertise for Imugene.
“An OV Scientific Advisory Board (SAB) was established at the end of 2019 and we are privileged to have recruited a team of highly eminent OV scientists to the SAB led by Professor Fong as Chairman.
“We warmly welcome Professor Prasad Adusumilli of Memorial Sloan Kettering Cancer Centre in New York and Professor Rebecca Auer of Ottawa Hospital to the SAB.”
In August, Imugene received Human Research Ethics Committee (HREC) approvals to commence a Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx in Australia.
This confirms that Imugene has completed all the necessary pre-clinical safety and efficacy testing of PD1-Vaxx required to begin human clinical trials which will target non-small cell lung cancer (NSCLC), the most common type of lung cancer, accounting for around 80% of cases.
Hopper said: “PD1-Vaxx, our B-cell check point inhibiting vaccine is in advanced stages of planning for a Phase 1 clinical study in lung cancer and we expect to open the study in Australia before Christmas.”
The study is planned to begin in the second half of 2020 and is to be conducted at up to 6-10 sites in North America and Australia under a US Food & Drug Administration (FDA) Investigational New Drug (IND) application.
HER-Vaxx phase two trial
During the year, management continued to monitor the enrolment and data collection for the HER-Vaxx Phase 2 clinical trial for HER2-positive gastric cancer.
Phase 1b study met all key endpoints to identify the optimal dose of HER-Vaxx for the Phase 2 study, confirmed safety and obtained additional immunological data.
Hopper said: “HER-Vaxx, our Phase 2 gastric cancer vaccine continues to recruit patients to the study across centres in Eastern Europe and India.”
VAXinia and CHECKvacc
Additionally, the company received guidance from the US FDA in August on the development pathway for oncolytic virotherapy, VAXinia.
The company plans to conduct a first in human Phase 1, open-label, non-randomised, dose-escalating, multi-centre study of VAXinia (CF33+hNIS) for patients with advanced melanoma, head & neck, TNBC, non- small cell lung, bladder, gastric, colorectal and renal cell carcinoma refractory to standard therapy or for which no standard therapy exists.
The company is also planning to conduct a first in human Phase I, openlabel, non-randomised, dose-escalation, single centre study of intratumoral (IT) administration of CHECKvacc (CF33+hNIS+antiPD-L1), in patients with metastatic TNBC tumors refractory to standard therapy or for which no standard therapy exists and who have injectable lesions.
In early October the company received a Notice of Grant from the US Patent and Trademark Office for Patent Application 16/292032, which protects its cancer growth factor immunotherapy platform.
The patent titled 'HER-1, HER-3 and IGF-1R composition and uses thereof' protects the method of composition and method of use of Imugene’s Ohio State University licensed vaccines from the laboratory of Professor Pravin Kaumaya.
Attaining the US patent is an important milestone for the company and adds extra value to Imugene’s portfolio of B-cell immunotherapies.