Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA)’s second half of calendar 2021 followed a period earlier in the year, during which the company advanced its lead program, paxalisib, into an international pivotal study, and executed three substantial cross-border partnering transactions.
As such, the last six months has been, by contrast, a period characterised by diligent consolidation, operational execution, and consistent delivery of Kazia’s plans.
At the forefront of these is the task of achieving readiness for a potential regulatory filing in respect of paxalisib.
Pivotal study
GBM AGILE, the pivotal study of paxalisib in glioblastoma, is well-advanced, having commenced recruitment to the paxalisib arm in January 2021.
Kazia expects data from GBM AGILE in calendar 2023.
If that data reflects the company’s expectations for the drug, it will lead Kazia directly into a new drug application (NDA) with the United States Food and Drug Administration (FDA), a process that could see paxalisib become the first new drug treatment approved for newly diagnosed glioblastoma patients in over twenty years.
In the complex process of drug development, this stage may be considered the endgame, and it points to an important transition ahead, both for paxalisib and for Kazia.
Commercial potential
Kazia has already started considering paxalisib as a potential commercial product.
At its AGM in November 2021, Kazia shared some initial primary market research which spoke to the commercial potential of paxalisib.
Management changes
In parallel, Kazia itself is undergoing a period of maturation as it progresses its pipeline.
One visible manifestation of this is the augmentation of Kazia’s management team, with two highly experienced, US-based colleagues joining the company in the fourth quarter of calendar 2021.
New appointees Dr John Friend, Chief Medical Officer, and Karen Krumeich, Chief Financial Officer, will work closely with Dr James Garner, Chief Executive Officer, and the other members of the Kazia team.
Much more than a glioblastoma drug
For most of the development of paxalisib, the primary focus has been on glioblastoma.
However, paxalisib is very much more than a glioblastoma drug.
Kazia has always believed that it has broad and substantial potential in a range of brain cancers, and even potentially in diseases outside the central nervous system.
The company has deployed a diverse program of clinical trials, in partnership with some of the world’s leading cancer centres, to explore that potential.
Kazia expects several of these studies to report initial data through calendar 2022.
Positive results may cement the notion that paxalisib is a brain cancer therapy rather than purely a glioblastoma therapy, and Kazia expects its prospects to scale accordingly.
Another promising drug
Meanwhile, the company now has a second world-class asset in its pipeline.
In April 2021, Kazia licensed EVT801 from Evotec SE.
Just seven months later, a phase I clinical trial of EVT801 commenced recruitment in France.
Essentially, EVT801 is a small molecule inhibitor that works against a growth factor receptor known as VEGFR3.
It acts by inhibiting lymphangiogenesis, the formation of new lymphatic vessels around the cancerous tumour.
As EVT801 moves through early clinical development, Kazia expects further positive news flow.