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Kazia Therapeutics continues to make good progress on cancer treatment assets

Last updated: 21:10 29 Jun 2022 EDT, First published: 20:56 29 Jun 2022 EDT

Kazia Therapeutics Ltd - Kazia Therapeutics continues to make good progress on its cancer treatment assets

Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) is making good progress with its two pipeline assets, paxalisib and EVT801, with the latter having cleared third dose level and is recruiting well.

The company also notes the GBM AGILE pivotal study has opened in France, the fourth country to start recruitment to the paxalisib arm.

Importantly, the Phase I study of paxalisib in combination with radiotherapy for the treatment of brain metastases at Memorial Sloan Kettering Cancer Center has been accepted for presentation at an upcoming academic conference in Q3 CY2022.

Kazia CEO Dr James Garner said of the latest developments, “Despite a challenging first half equity market for biotech companies, Kazia has continued to make good progress.

"The GBM AGILE pivotal study is progressing well and appears on track for data in 2H CY2023, as anticipated.

"We have been pleased in the first half to see new data presented and milestones delivered from several projects, and we expect that pace to continue and increase during the second half.”

The company has also highlighted its ATM financing facility, which has realised gross proceeds of US$2,956,036 for the period ending June 2022, at an average price of $6.08 (approximately A 0.88 per share).

EVT801 Phase I Study

While the phase I study of EVT801 in patients with advanced cancer continues to recruit well, the drug has also recently finished the third of a potential eight dose levels. It is now anticipated to open recruitment to the fourth dose cohort in the near future.

So far, EVT801 looks to be well-tolerated.

Depending on how many dose cohorts are required to establish a maximum tolerated dose (MTD), interim data from the study is expected in the second half of this year or the first half of 2023.

GBM AGILE

After France started recruitment to the paxalisib arm in June 2022, becoming the fourth country to join the study alongside the United States, Canada and Switzerland, there are now more than 40 sites open to the paxalisib arm of GBM AGILE.

In January 2022, the Global Coalition for Adaptive Research (GCAR), the sponsor of GBM AGILE, stated that more than 1,000 patients had been screened to the study, with enrolment rates approximating 0.75 to 1.00 patients per site per month – around four times higher than would generally be expected in a clinical study of glioblastoma.

Kazia is working closely with GCAR and Simcere Pharmaceutical to open the study in China during the third quarter of 2022.

Multi-drug, genomically-guided study in brain metastases

In June 2022, the company announced that a multi-drug, genomically-guided study in brain metastases run by the Alliance for Clinical Trials in Oncology had seen the paxalisib arm graduate to an expansion cohort in patients with breast cancer brain metastases, having seen positive efficacy signals in the initial exploratory cohort.

Paxalisib continues to recruit to the exploratory cohort in two other patient subgroups.

Interim data from a phase I study of paxalisib in combination with radiotherapy for patients with brain metastases run by Memorial Sloan Kettering Cancer Center has been accepted for an oral presentation at an upcoming international conference in the September quarter of 2022.

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