ASX RELEASE
6 May 2019
KAZIA ANNOUNCES SUPERIOR SAFETY AND TOLERABILITY DATA FROM PHASE IIA STUDY OF
GDC-0084
IN
NEWLY-DIAGNOSED
GLIOBLASTOMA PATIENTS
Dose Expansion Cohort to Begin Recruitment
Immediately;
Top-line Data Expected in 4Q Calendar 2019
Sydney, 6 May 2019
– Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to
announce new safety data from its ongoing phase IIa study of GDC-0084 in newly-diagnosed patients with glioblastoma (GBM).
Licensed from Genentech in
October 2016, GDC-0084 is a novel targeted therapy that inhibits the PI3K pathway, which is important in many forms of cancer and is activated in 85-90% of GBM cases. GDC-0084 is administered orally, once daily.
The phase IIa study has determined a maximum tolerated dose (MTD) of 60mg, which is substantially higher than the 45mg dose found during Genentech’s
phase I study in patients with recurrent disease. Dose-limiting toxicities in this phase IIa study included oral mucositis (mouth ulcers) and hyperglycemia (elevated blood sugar), both of which are expected effects of the PI3K inhibitor class
of drugs.
Dr James Garner, Chief Executive Officer of Kazia Therapeutics commented, “this is an important milestone, and we are very encouraged by
these results. Genentech’s original phase I study examined GDC-0084 in very advanced patients, who are often less able to tolerate therapy. They reached an MTD of 45mg, which is expected to be within the therapeutic range. When we licensed the
drug from Genentech, we recognized the opportunity to refocus around newly-diagnosed patients, who are often in generally better health. The fact that the drug appears better tolerated here than in the previous study validates our strategy for
GDC-0084,
and bodes well for the clinical efficacy of the drug.”
Kazia’s phase IIa study of GDC-0084 is
designed in two parts. The first part, which began dosing in September 2018 and is now complete, is a dose optimization component, designed to determine if newly-diagnosed patients could tolerate a higher dose of
GDC-0084
than advanced recurrent patients. This part of the trial was expected to enroll between 6 and 18 patients, depending on the safety signal observed. Ultimately, a total of eight patients were required
for this part. The study will now immediately transition into the dose expansion cohort, in which an additional 20 patients will be recruited. It is planned that these patients will receive a dose of 60mg. This second part of the study will be
designed to provide confirmatory efficacy signals, and is expected to report initial data in the fourth quarter of calendar 2019.
Board of Directors
Mr Iain Ross
Chairman,
Non-Executive
Director
Mr Bryce Carmine
Non-Executive
Director
Mr Steven Coffey
Non-Executive
Director
Dr James Garner
Chief Executive Officer, Managing Director