OSE Immunotherapeutics’ Global License to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation Becomes Effective

OSE Immunotherapeutics’ Global License to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation Becomes Effective

NANTES, France, April 16, 2024 – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, today announced that the Hart-Scott-Rodino waiting period has expired with respect to its global license with AbbVie to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.

As part of the partnership agreement announced on February 28, 2024, AbbVie received from OSE Immunotherapeutics an exclusive global license and collaboration agreement to develop OSE-230, a monoclonal antibody designed to resolve chronic inflammation.

Under the terms of this agreement, AbbVie will now make an upfront payment of $48 million to OSE Immunotherapeutics. In addition, OSE Immunotherapeutics will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones and potential tiered royalties on global net sales of OSE-230.

About OSE Immunotherapeutics

OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I).

The Company’s current well-balanced first-in-class clinical pipeline includes:

• Tedopi (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi in combination are ongoing in solid tumors.
• OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors.
• OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics).
• FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.).
• BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).
• OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation.

OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: