OSE Immunotherapeutics Announces New US Patent Granted for the Use of Tedopi® in Cancer Patients after Failure with PD-1/PD-L1 Immune Checkpoint Inhibitor Treatment

Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that the United States Patent and Trademark Office has granted a new patent protecting Tedopi®, a therapeutic cancer vaccine treating HLA-A2 positive patients after secondary resistance to PD-1/PD-L1 immune checkpoint inhibitor treatment. The new patent further improves the unique value proposition of Tedopi® and provides protection until year 2037 in the US.

This US patent recognises the innovation of a multiepitope combination (all peptides included in Tedopi®) administered after failure to PD-1/PD-L1 immune checkpoint inhibitor in HLA-A2 positive non-small cell lung cancer (NSCLC) patients. This further protection for Tedopi®, OSE Immunotherapeutics’ most advanced late-stage asset, adds significant value to the Company’s product portfolio.

Nicolas Poirier, CEO of OSE Immunotherapeutics, said: “We are very pleased to expand our patent portfolio internationally with this new US patent strengthening the protection rights for Tedopi® in the significant US market. This patent represents an additional milestone in the product’s clinical development based on the first Phase 3 positive results in non-small cell lung cancer after checkpoint inhibitor escape in secondary resistance. These data show a significant overall survival benefit, an improved quality of life and a better safety profile versus chemotherapy. The next confirmatory Phase 3 trial under preparation in second line treatment will address the same high unmet medical need. Tedopi® presents a differentiated mechanism of action activating tumor specific T cells after acquired resistance of immune checkpoint inhibitor.”

This patent family, focused on the same targeted population, has been filed internationally in other territories and has already been granted previously in Japan.

This population in second line treatment after failure to PD-1/PD-L1 inhibitor treatment, targeted with Tedopi®, is estimated to be up to 100,000 patients per year in 7 major markets across the US, Europe, China and Japan. This estimate is based on HLA-A2-positive patients accounting for about 45% of all NSCLC patients, as well as the large and growing use of anti-PD-1/PD-L1 therapies and their failure rate.

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation.

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 first 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): ongoing Phase 1/2 in solid tumors or lymphomas (first patient included). OSE-279 is the backbone therapy of the BiCKI® platform.

• 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); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.).

• OSE-172/BI 765063 (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 Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapties:

• BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI® candidate targeting anti-PD1xIL-7.
• Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com

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Forward-looking statements

This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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