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Kazia Therapeutics set to release interim paxalisib data via ASX after cancellation of AACR annual meeting

The Australian oncology-focused biotechnology company has two clinical-stage drug development candidates - paxalisib (GDC-0084) and TRX-E-002-1 (Cantrixil).

Kazia Therapeutics Ltd - Kazia Therapeutics set to release interim paxalisib data via ASX after AACR annual meeting cancelled
Paxalisib is expected to become a commercial product in the near term

Kazia Therapeutics Ltd (ASX:KZA) has provided its latest investor newsletter, with managing director chief executive officer Dr James Garner announcing that the Annual Meeting of the American Association for Cancer Research (AACR) scheduled for 24-29 March has been cancelled due to COVID-19.

He said: “We recognise that these activities take place against the background of the global COVID-19 outbreak.

“Kazia has proactively implemented pandemic preparedness measures, and we remain in very close contact with all our partners to ensure that our clinical trials are not disrupted.

“As a prerevenue company, we are in a certain sense insulated from much of the immediate economic impact, but our first priority is to ensure that patients in our clinical trials continue to be fully supported.”

Instead of presenting at the AACR, the company now intends to release interim data from the ongoing phase II study of the paxalisib drug via the ASX in March/April.

Clinical trials progress

Garner said: “2020 has been highly productive for Kazia, with great progress across all of our clinical trial programs.

“Our phase II study in glioblastoma has completed recruitment, well ahead of schedule.

“The other four studies of paxalisib are open to recruitment, and the Cantrixil phase I study will shortly complete clinical activities.”

Path to market

Kazia has released details of the clinical trial which will provide a path-to-market for paxalisib.

GBM AGILE is a ‘platform study’ set up by leading experts in brain cancer to facilitate approval of new drugs in glioblastoma.

It runs over a period of years, and companies can insert their drugs into it in order to generate the clinical data required for registration and it is expected that paxalisib will be the second drug to join.

Garner said: “This year is a critical one for Kazia: our lead program, paxalisib, will make the transition into a pivotal study for registration.

“This is the final inflection point on the way to a commercial product, and a hugely exciting step for the program.

“We are now on a direct track to a marketing approval.”

Recruitment planned for 2020

The study is supported by Federal Drug Administration (US) and is managed operationally by the Global Coalition for Adaptive Research (GCAR), a non-profit group dedicated to pioneering innovative clinical trial designs in high-need disease areas.

Garner said: “GBM AGILE is highly innovative, and we think it provides the perfect path to market for our drug.

“We are delighted and honoured to be joining, and we expect to begin recruitment of patients in the second half of this calendar year.”

Kazia’s strategy of seeking a partner to commercialise paxalisib remains unchanged and the company is confident that having a clearly-defined path to registration, which is strongly supported by the FDA, can only increase the attractiveness of paxalisib to potential partners.

Award for paxalisib data analysis

Kazia also took the time to congratulate UCLA Professor Ben Ellingson on the receipt of an award for the retrospective analysis of paxalisib data

Ellingson presented a groundbreaking analysis of data from the phase I study of paxalisib at the Society for Neuro-Oncology (SNO) annual meeting in November 2019.

This cutting-edge work linked the concentration of paxalisib in the blood to measurable changes on brain scans, and to potential clinical efficacy.

The project won the inaugural neuro-imaging award at the conference.

Quick facts: Kazia Therapeutics Ltd

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ASX:KZA
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Market Cap: $31.39 m
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Kazia Therapeutics working on moving its flagship Paxalisib drug into...

  Kazia Therapeutics Ltd's (ASX:KZA) James Garner speaks to Proactive's Andrew Scott after releasing a poster presentation of interim data from the ongoing phase II study of Paxalisib in glioblastoma at the prestigious American Society of Clinical Oncology (ASCO) annual meeting. Analysis...

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