AstraZeneca has reached a clinical development milestone with immuno-oncology candidate AZD4635, thus triggering a $15 million payment to its partner, Sosei Group.
The candidate AZD4635 is a potent and selective, orally available, small molecule adenosine 2A receptor antagonist discovered by the Sosei and exclusively licensed to AstraZeneca globally in 2015. It passed through a Phase 1 clinical program as a single agent and in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab (IMFINZI) in patients with solid tumours.
Sosei noted that the clinical study to date has established the maximum-tolerated dose of AZD4635 as a single agent and in combination with durvalumab. The study has progressed successfully to the point where the therapeutic potential of AZD4635 is being explored in multiple solid tumours. That result moved AstraZeneca to take the trial towards Phase 2, which kicked off the milestone payment to Sosei Heptares.
Headline data from the Phase 1 study is planned to be presented at a scientific congress in 2019.
Susan Galbraith, Senior Vice President and Head of Oncology, Innovative Medicines and Early Development (IMED) Biotech Unit at AstraZeneca, said: “At AstraZeneca, we are exploring next generation immuno-oncology approaches by seeking to develop novel combinations that overcome key immunosuppressive mechanisms, and thereby expand the potential for anti-tumour activity of immune checkpoint inhibition. It is increasingly recognised that the adenosine pathway is critical in tumour immunosuppression and AZD4635 complements our portfolio in this area.”
Dr. Malcolm Weir, Executive VP and Chief R&D Officer, said: “Adenosine production in the tumour microenvironment is becoming well-recognised as a key survival mechanism employed by tumour cells to evade immune detection and destruction. Our A2A antagonist AZD4635, which aims to block this mechanism and make tumour cells vulnerable again to the immune system, has made very encouraging and rapid progress in partnership with AstraZeneca, a world leader in immuno-oncology. We believe this is a very exciting candidate and look forward to results from these initial clinical studies in due course.”
The $15 million payment should be completed by the end of the first quarter ended 31 March 2019, Sosei said.