Oncology-focused drug developer Kazia Therapeutics (ASX: KZA) has made good progress in the first six months of the year with pipeline assets paxalisib and EVT801 despite a challenging equity market for biotech companies.
A phase I study of novel drug EVT801 in patients with advanced cancer continued to recruit well.
The drug recently completed the third of a potential eight dose levels and appears to be well tolerated by patients to date.
It is expected to open recruitment to a fourth dose cohort in the near future.
Interim data is anticipated later this year but will depend on how many dose cohorts are required to establish a maximum tolerated dose (MTD).
More than 40 sites are currently open to the paxalisib arm of global multi-drug platform study GBM AGILE, designed to identify promising new therapies for glioblastoma, which is the most common and most aggressive form of primary brain cancer in adults.
The pivotal study is sponsored by the Global Coalition for Adaptive Research (GCAR) and involves three drug candidates — Bayer’s regorafenib, Kazia’s paxalisib, and Kintara Therapeutics’ VAL-083.
The first site to commence recruitment to the paxalisib arm in France opened this month, making France the fourth country to join the study, alongside the US, Canada, and Switzerland.
In January, the GCAR stated that over 1000 patients had been screened for recruitment, with enrolment rates approximating 0.75 to 1.00 patients per site per month, which is around four times higher than would generally be expected in a clinical study of glioblastoma.
Kazia is working closely with GCAR and China-based Simcere Pharmaceutical to open the study in that country later this year.
Brain metastases study
This month, Kazia confirmed a multi-drug, genomically-guided study into brain metastases run by the US-based Alliance for Clinical Trials in Oncology had seen the paxalisib arm graduate to an expansion cohort in patients with breast cancer metastases.
It follows positive efficacy signals in the initial exploratory cohort.
Paxalisib continues to recruit to the exploratory cohort in two other patient sub-groups.
Advancing to plan
Kazia chief executive officer Dr James Garner said the first half of the year had advanced to plan.
“The GBM AGILE pivotal study is progressing well and appears on track for data in the second half of 2023 as anticipated,” he said.
“We have been pleased in the first half to also see new data presented and milestones delivered from several projects, and we expect that pace to continue and increase during the remainder of the year.”