We expect to be able to share initial data from (a phase II brain cancer) study in November, which will be an exciting landmark for the GDC-0084 program.
Kazia Therapeutics chief executive officer Dr James Garner
What does Kazia Therapeutics do?
The junior biotechnology company is undertaking a number of clinical trials in humans in the United States and Australia under the guidance of the US Food and Drug Administration.
The Sydney-based company recently won an innovation accolade at the 2019 Australian and New Zealand Leadership Forum (ANZLF) Trans-Tasman Innovation & Growth Awards.
Kazia is focused on sharing results from the study of its glioblastoma multiforme (GBM) therapeutic GDC-0084 in brain cancer patients and Cantrixil therapeutic for ovarian cancer.
The company appeared at this year’s American Association of Cancer Research annual meeting in Atlanta, Georgia, presenting phase I data from Cantrixil in ovarian cancer.
Who leads Kazia Therapeutics?
Kazia is led by chief executive officer & executive director Dr James Garner, a life sciences executive and trained physician.
Garner has strong experience in regional and global new medicine development from preclinical evaluation through to commercialisation staging.
He presented at the recent 2019 Gold Coast Investment Showcase in Queensland about the company’s pipeline and clinical trials program and commercial opportunities in brain cancer.
Garner has worked with Biogen and Takeda, led Asia-Pacific region research and development strategy for Sanofi and was previously a strategy consultant for Bain & Company.
What does Kazia Therapeutics own?
The key assets for the biotech are the potential brain cancer therapeutic GDC-0084 and ovarian cancer therapeutic prospect Cantrixil.
GDC-0084 is being looked at as a potential therapy for a more severe type of brain cancer while Cantrixil is being studied as a treatment for ovarian cancer.
How is Kazia progressing its brain cancer therapeutic?
Brain tumours or malignant glioblastomas have a poor prognosis for people diagnosed with the often fast-growing cancer.
Malignant glioblastomas, such as grade IV glioblastoma multiforme, claim many lives with current treatments proving a challenge for both patients and practitioners.
Kazia’s solution to the problem of glioblastoma multiforme is the targeted therapy GDC-0084 which modulates the phosphoinositide-3-kinase (PI3K) signalling pathway.
PI3K is disordered in more than 85% of GBMs and in a number of other cancers, not just brain tumours.
GDC-0084 works by crossing the blood-brain barrier, an important aspect to affecting brain tissue.
Now Roche Holding Ltd Genussscheine (SWX:ROG) (OTCMKTS:RHHBY) (EPA:RBO) (ETR:RHO) subsidiary Genentech, Inc (NYSE:DNA) previously showed GDC-0084 had acceptable tolerability in a patient group of people with advanced brain tumours, the majority with GBM.
GDC-0084 also reduced tumour size in some patients, as presented at the ASCO Annual Meeting in June 2016.
Kazia’s clinical study of the therapeutic was started last year as it sought definitive proof-of-concept clinical data.
The company’s securities have been on the uptrend in the past month on news in early September 2019 that the company had successfully completed stage one of its phase I study of GDC-0084 in diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas.
Midline gliomas, including DIPG, are one of the most aggressive childhood cancers, and several hundred new cases are diagnosed in the US each year.
Kazia’s study at St Jude Children’s Research Hospital in Memphis, Tennessee, is of 13 treated patients and is aimed at determining a maximum tolerated dose in kids.
The median life expectancy from diagnosis in midline gliomas cases is estimated to be 9 to 11 months and there is no approved pharmacological therapy in the market.
The company went on to present information from its ongoing phase II study of GDC-0084 in glioblastoma during the September 19-22 annual meeting of the European Association of Neuro Oncology (EANO) in France.
Kazia’s study design presentation by Professor Patrick Wen from Dana-Farber Cancer Institute and Dr Jeremy Simpson from Kazia described the company’s approach to GDC-0084 development and targeted clinicians and potential partners.
The company expects to share initial data from the GDC-0084 phase II study in November 2019.
What is the potential of the ovarian cancer therapeutic?
First-in-class development candidate Cantrixil (TRX-E-002-1) targets the full spectrum of cancer cells, including tumour-initiating cells which may cause cancer recurrence.
The study of the intra-peritoneal (IP)-delivered chemotherapy candidate in patients at US and Australian hospitals falls under Kazia’s investigational new drug application approved by the FDA in 2016.
Cantrixil has potential as a treatment for late-stage disease — stages III and IV — which currently have poor survival ratings.
Ovarian cancer has the lowest survival rate of any women's cancer and is the seventh most common cancer in women.
Kazia is hopeful its therapeutic could become a front-line therapy for the killer disease as oncologists seek to extend patient survival times and reduce relapse rates among successfully-treated patients.
Ovarian cancer is a lucrative drug market for cancer therapeutics companies, with the US$500 million industry tipped to grow to US$1 billion within a five-year period.
- December quarter reporting of initial data from a phase II study of GDC-0084 in glioblastoma
- Other clinical trial milestones and endpoints
- Clinical trial phasing and pipeline progression
- Significant transactions
- Funding milestones