OSE Immunotherapeutics Receives €1.3 Million Milestone Payment from Bpifrance for OSE-127/S95011

Regulatory News:

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OSE Immunotherapeutics (Paris:OSE) (ISIN: FR0012127173; Mnemo: OSE) today announced it received a milestone payment of €1.3 million from Bpifrance related to the Company’s collaborative program, EFFIMab, focused on evaluating interleukin-7 receptor antagonist OSE-127/S95011, partnered with Servier¹.

This new milestone payment of €1.3 million was triggered by achieving several key steps in the development of OSE-127/S95011 including reinforcement of preclinical and translational data in ulcerative colitis (UC), completion of the Phase 1 clinical trial, obtaining the Phase 2 regulatory authorization as well as specific manufacturing steps.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, commented: “This new milestone payment reflects the significant progress made with OSE-127/S95011, which is now in Phase 2 under OSE’s sponsorship in ulcerative colitis, a disabling chronic inflammatory bowel disease affecting 3.3 million people in the U.S., Europe and Japan. With 70-75% of ulcerative colitis patients² either not responding or losing response to current treatments, ulcerative colitis represents a substantial medical need. There is a large potential market in ulcerative colitis for OSE-127/S95011 as it is the only full-antagonist of IL-7R, with a novel and differentiated mechanism of action. We look forward to confirming the product’s efficacy in both ulcerative colitis and Sjögren’s syndrome, another debilitating autoimmune disease, with a trial launching soon and conducted by our partner Servier.”

OSE-127/S95011 Phase 2 in ulcerative colitis
The Phase 2 clinical trial with OSE-127/S95011 in UC started in December 2020 under OSE Immunotherapeutics’ sponsorship. This study aims to assess the efficacy and safety of OSE-127/S95011 versus placebo in patients with moderate to severe active UC who have previously failed or lost response or are intolerant to previous treatment(s). In parallel to the trial being conducted in UC, an independent Phase 2 clinical study is planned to start shortly in Sjögren’s syndrome under Servier’s sponsorship. Under the terms of the license option agreement, OSE is eligible to receive a €5 million milestone payment from Servier upon enrollment of the first patient in this Phase 2. OSE-127/S95011 is being developed in partnership with Servier under an option agreement up to the completion of both Phase 2 clinical studies.