Benzinga | Sep 2, 2021 05:35AM EDT

Kazia Therapeutics Announced EVT801 Phase I Study Receives Full Regulatory Approval in France

Kazia Therapeutics Limited (NASDAQ:KZIA) is pleased to inform stakeholders that the planned phase I study for EVT801 has received full approval from L'Agence Nationale de Scurit du Mdicament et des Produits de Sant (ANSM), the French regulatory agency.

The study is on track to open to recruitment by the end of CY2021.

Key Points Kazia licensed EVT801 from Evotec SE, an international drug discovery alliance and development partnership company, in April 2021. EVT801 is a small molecule inhibitor of VEGFR3, and inhibits lymphangiogenesis, the formation of new lymphatic vessels within and around a tumour. The drug modulates the activity of the immune system, creating the possibility for synergistic combination with immuno-oncology therapies.

The phase I study will be performed in France. It is planned to recruit patients with advanced tumours at two leading cancer hospitals: Oncopole in Toulouse and Centre Lon Brard in Lyon. Recruitment is expected to start by end of CY2021.

Kazia CEO, Dr James Garner, commented, "since concluding our license agreement with Evotec in April, we have made very swift progress in bringing EVT801 to the clinic. We have been grateful for the exceptional efforts of the Evotec team, working closely with Kazia colleagues to drive the project forward. The study that we have designed is highly innovative, which befits the rich potential of EVT801, and we look forward to commencingrecruitment in the near future."

EVT801 is a novel inhibitor of vascular endothelial growth factor receptor 3 (VEGFR3), which is central to lymphangiogenesis, the formation of new lymphatic vessels within and around a tumour. A number of highly successful cancer drugs have targeted angiogenesis, the formation of new blood vessels, and these include Avastin (bevacizumab), Sutent (sunitinib) and Nexavar (sorafenib). However, anti-angiogenic agents are limited by treatmentresistance and some agents are associated with substantial toxicity. Compelling preclinical evidence suggests that the novel mechanism of EVT801 may circumvent these challenges and provide lasting benefit to patients with lower toxicity.

In addition, EVT801 has shown the ability to enhance the activity of the immune system within the tumour, offering the potential for combination with immuno-oncology agents. It is expected that this combination approach will play a substantial and early role in the clinical development plan for EVT801.