Kazia Therapeutics Ltd (ASX:KZA, NASDAQ:KZIA) has received full regulatory approval for its planned phase 1 study for EVT801 from L’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory agency.
Kazia, an oncology-focused drug development company, licensed EVT801 from Evotec SE, an international drug discovery alliance and development partnership company, in April 2021.
The phase 1 study will be conducted in France with recruitment expected to start by end of 2021.
Kazia plans to recruit patients with advanced tumours at two leading French cancer hospitals: Oncopole in Toulouse and Centre Léon Bérard in Lyon.
“Commencing recruitment in near future”
Kazia CEO Dr James Garner said: “Since concluding our licence 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 commencing recruitment in the near future.”
Inhibitor of VEGFR3
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.
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.
Potential for lasting benefits
A number of 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 treatment resistance 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.
Next steps
Kazia expects to provide full details regarding the design and implementation of the study around the time that it begins recruitment.
In the meantime, the company will work closely with the Evotec team and with the participating investigators to activate the study.
- Ephrems Joseph