Kazia Therapeutics to Present EVT801 Data at Ovarian Cancer Symposium

Kazia Therapeutics Limited, an oncology-focused drug development company listed on NASDAQ under the ticker KZIA, has unveiled promising data regarding the clinical activity of EVT801 in patients with high-grade serous (HGS) ovarian cancer. This data was presented at the 15th Biennial Ovarian Cancer Research Symposium, an event co-hosted by the American Association of Cancer Research (AACR) and the Rivkin Center for Ovarian Cancer Research on September 21, 2024, in Seattle, Washington.

Dr. John Friend, CEO of Kazia Therapeutics, shared preliminary findings from a Phase 1 clinical trial that evaluated EVT801's safety and tolerability. EVT801 is a small molecule VEGFR3 inhibitor that targets tumor angiogenesis. The study successfully identified the maximal tolerated dose at 500mg administered twice daily (BID) and recommended the Phase 2 dose to start at 400mg BID. Across all doses, EVT801 was generally well-tolerated, with most toxicities being mild to moderate and transient.

Key points from the presentation include the treatment of 26 patients across six dosing cohorts, ranging from 50mg once daily (QD) to 500mg BID. The study enrolled patients with eleven different types of cancer, most notably advanced ovarian cancer, which was the primary condition in 11 patients. Biomarker analysis revealed strong VEGFR3 expression in various cancer types, including ovarian cancer. Encouraging clinical activity was observed in patients with high-grade serous ovarian cancer, with 46% of patients experiencing stable disease for at least three cycles, and two patients continuing treatment for nine cycles. Notably, one patient achieved a partial response with a 39% reduction in tumor size after just two cycles of EVT801 therapy.

Dr. Friend expressed his honor in presenting these findings at the symposium, highlighting the significance of the data given the typically poor prognosis associated with late-stage ovarian cancer diagnoses. He conveyed optimism that EVT801 has the potential to become a first-in-class VEGFR-3 inhibitor for patients suffering from this challenging condition.

Kazia Therapeutics Limited, headquartered in Sydney, Australia, focuses on developing oncology drugs. The company’s leading program, paxalisib, is an investigational inhibitor of the PI3K / Akt / mTOR pathway designed to treat various brain cancers. Licensed from Genentech in late 2016, paxalisib has undergone ten clinical trials. A Phase 2 study in glioblastoma reported preliminary signs of clinical activity in 2021, and the data from a pivotal study in glioblastoma, GBM AGILE, is expected to be presented later in 2024. Other ongoing clinical trials for paxalisib include those targeting brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several reporting encouraging interim data.

Paxalisib has received several designations from the FDA, including Orphan Drug Designation for glioblastoma in February 2018, Fast Track Designation (FTD) for glioblastoma in August 2020, and FTD in July 2023 for treating solid tumor brain metastases with PI3K pathway mutations in combination with radiation therapy. Additionally, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid/rhabdoid tumors in June and July 2022, respectively.

Kazia is also advancing EVT801, licensed from Evotec SE in April 2021. Preclinical studies show that EVT801 is effective against a broad range of tumors and can work synergistically with immuno-oncology agents. Preliminary data from the Phase 1 study of EVT801 was presented at the Ovarian Cancer Research Symposium in September 2024.