Kazia Therapeutics (ASX: KZA, NASDAQ: KZIA) is developing its lead therapeutic program, GDC-0084, for the deadly brain cancer, glioblastoma multiforme (GBM).
Kazia licensed GDC-0084 in late 2016 from Genentech, a member of the Roche Group, where it had previously completed a phase I clinical study in 47 patients with advanced glioma. Genentech’s phase I study demonstrated a favourable safety profile and provided signals of efficacy. Genentech also conducted an extensive preclinical program which showed encouraging results for GDC-0084 in animal models of glioblastoma.
An international phase II clinical trial of GDC-0084 was initiated in the US today, with Australian sites to open in 2019.
Read the announcement: Novel Australian drug GDC-0084 for glioblastoma brain cancer starts Phase II clinical trial in US
In this interview led by NDF Research’s Senior Analyst, Stuart Roberts, Kazia Therapeutics CEO and Executive Director Dr James Garner talks about:
- Why GDC-0084 could be ‘the next big thing’ on the treatment landscape for glioblastoma
- Why the PI3K signalling pathway is a compelling drug target for glioblastoma, and what distinguishes GDC-0084 from other PI3K inhibitors
- The commercial viability of highly targeted drugs like GDC-0084, which aim to treat patient sub-groups within a broader disease area
- The benefits of the study’s adaptive design
- The extensive work involved in establishing an international drug trial
On the study’s adaptive design and targeting newly diagnosed patients identified as non-responders to the existing treatment, temozolomide, Dr Garner says:
“It gives us the opportunity to position our drug in a head to head setting against an approved standard of care.”
“There really hasn't been much progress in the treatment of glioblastoma for 15 or 20 years,” Dr Garner says.
“The current treatment paradigm is that patients receive surgery, they receive radiotherapy and then they go on temozolomide, a drug that has been around for some time and definitely works - but it only works for about one third of the patients. For the other two thirds of patients, there really is no generally accepted pharmacological therapy that offers benefits, and that’s the gap we're trying to fill with GDC-0084.
“GDC-0084 is an unusual drug because it was developed from the ground up as a brain cancer drug. Most of the drugs that have come to glioblastoma have really been breast cancer drugs or lung cancer drugs, where the company is trying to test them out in brain cancer. Genentech approached this very differently – they started out with a blank sheet of paper and asked: how do we make it great drug for glioblastoma?”
More about GDC-0084