OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) announces that it has strengthened its intellectual property rights for its Phase 2-ready product FR104, a monoclonal antibody antagonist of CD28, through the granting of a patent by the Canadian Intellectual Property Office (CIPO). The patent covers the product and its therapeutic applications in T-lymphocyte-mediated autoimmune diseases, chronic inflammatory diseases and graft applications. OSE has also received a notice of allowance of a patent from the United States Patent and Trademark Office (USPTO), providing additional protection covering the use of FR104 in the treatment of T-lymphocyte-mediated chronic inflammatory diseases.

“These new allowances from the CIPO and USPTO reinforce the global patent protection of FR104 and its position as a key product in our autoimmune diseases portfolio. As a Phase 2-ready product with a strong clinical and biological safety profile, and initial signals of clinical efficacy, FR104 is a valuable asset with great potential for further development in a number of autoimmune conditions. We are exploring the best options for continuing the development of our product in autoimmune diseases, including worldwide partnering opportunities,” comments Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

CD28 blockade by FR104 controls T effector functions while potentiating regulatory T cells. This novel mechanism of controlling immune synapses potentially offers new therapeutic options in multiple inflammatory and autoimmune diseases where T cells are involved and there are important unmet medical needs. Positive safety and biological activity results from FR104’s Phase 1 proof-of-concept clinical study, alongside the preclinical safety profile and efficacy data in multiple preclinical models of autoimmune and inflammatory diseases, further support the continued clinical development of this asset in phase 2.

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim ; this checkpoint inhibitor has received CTA from French and Belgian health authorities for a Phase 1 clinical trial in multiple cancer indications. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.

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