Kazia Therapeutics Ltd’s (ASX:KZA) (NASDAQ:KZIA) (FRA:NV9) chief executive officer and MD James Garner has highlighted the company’s progress over the course of the year to date in its March newsletter, stating that the focus remains on preparing a new drug application (ND) to the US FDA.
While he said the oncology-focused biotechnology company had witnessed a ‘critical watershed’ in its development with the transition of paxalisib into a pivotal study for registration, Kazia was continuing to collect additional data, refining manufacturing and increasing interactions with FDA.
Pathway to approval
Paxalisib, Kazia’s lead program (formerly GDC-0084) was now on the pathway to approval, Garner said, and with it, on to a possible share of a commercial market estimated at US$1.5 billion per annum.
In December 2020, the company executed a Letter of Intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) to launch a clinical trial of multiple therapies, including Kazia’s drug, paxalisib in diffuse midline gliomas including diffuse intrinsic pontine glioma (DIPG).
The new clinical trial, PNOC022, will employ an adaptive trial design to test several therapies in different combinations and in different subsets of patients.
PNOC022 will initially open in the US in the first half of 2021, with expansion to other countries taking place in 2021, with talks ongoing on the potential inclusion of Australian sites.
Presenting at American Association for Cancer Research
Kazia will present new interim data from the ongoing phase-II study of paxalisib in glioblastoma to the Annual Meeting of the American Association for Cancer Research (AACR), which will be held virtually from April 10-15 and May 17-21.
The focus of the poster presentation will be on pharmacokinetic (PK) data from the study.
An important objective has been to understand the right dose for future use, and to establish the difference between taking paxalisib on an empty stomach compared to taking it after food.
The AACR poster is expected to discuss these results.
In addition, Professor Jim Coward has been invited to give a prestigious oral plenary presentation on the final data from the phase I study of Cantrixil in ovarian cancer.
Cantrixil was licensed to Oasmia Pharmaceutical AB of Sweden in March 2021.
Looking ahead
Garner said he was hopeful the company would provide the first drug for newly diagnosed glioblastoma in more than two decades and, with it, hope to patients around the world.
He said: “We will have more to say on this soon, but our various regulatory approvals last year show that Kazia can manage the technical elements of an NDA.
“And our recent partnership with Oasmia for Cantrixil demonstrates the company’s capabilities in licensing and business development.
“The year ahead will not look like last year, but it will be no less important for paxalisib, and for Kazia.”
Kazia has a market cap of approximately A$162 million and shares today have been as much as A$1.39. In the last 12 months, shares have traded from A$0.37 to A$1.78, a new high of more than five years.