Kazia Completes Stage 1 of EVT801 Phase 1 Trial in Advanced Cancer

SYDNEY, May 1, 2024 -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company focusing on oncology, has announced the successful completion of stage 1 of its EVT801 Phase 1 clinical trial. The Safety Review Team (SRT), which includes the lead investigators, an independent medical monitor, and key members from Kazia Therapeutics, has reviewed the preliminary safety and pharmacokinetic (PK) data. They have unanimously determined that the maximal tolerated dose (MTD) of EVT801 is 500mg twice a day (BID) and identified 400mg BID as the starting recommended phase 2 dose (RP2D) for continuous monotherapy administration.

The trial included 26 patients divided across six dosing groups ranging from 50mg daily to 500mg BID. The drug was generally well-tolerated across all doses, with most toxicities being mild to moderate and transient. The study enrolled patients with eleven different cancer types, including colon, renal cell, and pancreatic cancers, with advanced ovarian cancer being the most common. Among the 11 patients with ovarian cancer, the average age was 67 years, and 46% of them had stable disease or better for at least three cycles of EVT801 therapy.

EVT801 is a highly selective small molecule VEGFR3 tyrosine kinase inhibitor targeting tumor angiogenesis. Unlike traditional angiokinase inhibitors, EVT801, based on preclinical data, appears to have favorable immune activity by reducing immunosuppressive cells without impacting CD3+ T-cell proliferation. It also stabilizes tumor blood vessels, minimizing hypoxia and reducing the potential for metastatic spread. The Phase 1 EVT801 monotherapy dose-finding trial targets patients with histologically confirmed advanced or metastatic solid tumors that are unresponsive to standard treatments or for whom no standard treatment is available or suitable.

Kazia Therapeutics CEO, Dr. John Friend, expressed satisfaction with the trial's progress, stating, "We are extremely pleased that the primary and secondary endpoints of stage 1 of the Phase 1 clinical trial have been met. The signals of clinical activity, especially in patients with advanced ovarian cancer, are highly encouraging as we continue to progress the clinical development program for EVT801 as a potential first-in-class VEGFR3 inhibitor." He highlighted the significant unmet need for new therapies in patients with high-grade serous ovarian cancer, noting the median survival time of less than four years for these patients.

The Phase 1, open-label study is designed to evaluate the safety, tolerability, and PK of EVT801 in patients with advanced or metastatic solid tumors unresponsive to standard treatments. Kazia looks forward to sharing the final stage 1 data and the next steps in development at a scientific conference in the latter half of 2024.

Kazia Therapeutics Limited, based in Sydney, Australia, is dedicated to developing oncology-focused drugs. Their lead program, paxalisib, is an inhibitor of the PI3K / Akt / mTOR pathway aimed at treating various forms of brain cancer. Licensed from Genentech in late 2016, paxalisib has been the subject of multiple clinical trials. Significant studies include a completed Phase 2 trial in glioblastoma, with early signals of clinical activity reported in 2021, and an ongoing pivotal study, GBM AGILE, with final data expected in the first half of 2024. Additional trials are ongoing for brain metastases, diffuse midline gliomas, and primary CNS lymphoma.

Paxalisib has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation (FTD) for glioblastoma, as well as Rare Pediatric Disease Designation for diffuse intrinsic pontine glioma. EVT801, another key focus for Kazia, received its licensing from Evotec SE in April 2021. Preclinical data suggests EVT801's broad-range tumor activity and its synergy with immuno-oncology agents. Stage one of the Phase 1 study for EVT801 is complete, with preliminary data expected in 2024.

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