OSE Immunotherapeutics Announces Grant of New European Patent Covering CLEC-1, Novel Myeloid Immune Checkpoint Target for Cancer Immunotherapy

NANTES, France–(BUSINESS WIRE)–Regulatory news:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Ticker: OSE) (Paris:OSE) today announced the issuance of a new patent by the European Patent Office (EPO) enhancing protection of its novel myeloid cell immune checkpoint target, CLEC-1 (a C-type lectin receptor) , and its use in the treatment of cancer. This patent provides protection until 2037.

CLEC-1 is a C-type lectin receptor with demonstrated potential to inhibit myeloid cell functions and to block anti-tumor reactivity of T cells. Myeloid cells have the ability to accumulate in the tumor microenvironment and deregulate the immune activation of T lymphocytes. CLEC-1 is a new therapeutic target of interest in immuno-oncology.

Dominique Costantini, Managing Director of OSE Immunotherapy, comments: “This European patent is a major step which offers products targeting CLEC-1 strong intellectual property and a wide scope of application since it notably covers the use of antagonist antibodies targeting CLEC-1 in the treatment of cancer. The patent was extended to other major territories with the Notice of Allowance already granted in the United States and the patent granted in Japan.

Nicolas Poirier, Scientific Director of OSE Immunotherapeutics adds“Building on our fruitful collaboration with the CR2TI* research team, we now have preclinical results identifying CLEC-1 and its antagonists as an innovative immunotherapy that removes the brakes on macrophage phagocytosis and dendritic cell antigen presentation. and demonstrates synergistic anticancer effects, especially when combined with chemotherapy. The latest preclinical efficacy data pave the way for the development of monoclonal antagonist antibodies targeting the novel target CLEC-1, a myeloid checkpoint inhibitor, and for the future translational clinical development of an innovative cancer immunotherapy.

*Collaborative program between OSE Immunotherapy and the research teams of Dr Elise Chiffoleau (https://cr2ti.univ-nantes.fr/research/team-1) (Centre for Research in Transplantation and Translational Immunology (CR2TI), UMR1064, INSERM , University of Nantes at the University Hospital of Nantes).

ABOUT OSE Immunotherapy

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and immuno-inflammation. Its top-notch balanced clinical and preclinical portfolio has a diversified risk profile:

First-in-class immuno-oncology products

Tedopi® (innovative combination of neoepitopes): the Company’s most advanced product; positive results for the phase 3 trial (Atalante 1) in patients with non-small cell lung cancer in secondary resistance after failure of a checkpoint inhibitor.

Other ongoing combined trials sponsored by cooperative clinical research groups in oncology:

Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.

Phase 2 in ovarian cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.

Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor of the Italian foundation FoRT.

BI 765063 (OSE-172, anti-SIRPα mAb on the CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 as monotherapy and in combination with ezabenlimab (PD-1 antagonist); current expansion phase 1.

OSE-279anti-PD1 – advanced preclinical stage.

BiCKI®: bispecific fusion protein platform built on the key component of the anti-PD1 framework combined with a new immunotherapy target (e.g.: BiCKI®-IL7, preclinical stage) to increase anti-tumor efficacy .

First-in-class Immuno-Inflammation Products

OSE-127/S95011 (humanized monoclonal antibody antagonist of the IL-7 receptor): developed in partnership with Servier; positive results from phase 1; Phase 2 in progress in ulcerative colitis (sponsor OSE) and Phase 2a in progress in Sjögren’s syndrome (sponsor Servier).

FR104 (anti-CD28 monoclonal antibody): licensing partnership agreement with Veloxis Pharmaceuticals, Inc. in transplantation; Phase 1/2 in progress in kidney transplantation (supported by the University Hospital of Nantes); IND US obtained by Veloxis Pharmaceuticals, Inc. for clinical trial; Phase 2 planned in an indication of autoimmune disease.

OSE-230 (ChemR23 agonist mAb): preclinical-stage therapeutic agent with the potential to resolve chronic inflammation by driving affected tissue towards tissue integrity.

CoVépiT: a second-generation prophylactic vaccine activating cytotoxic T lymphocytes against COVID-19, developed from optimized epitopes from the viral proteins of SARS-CoV2, epitopes not impacted by multi-variants. Shows good tolerance and a very good level of T-cell immune response. In clinical tests, a long-term memory response was confirmed at 6 months.

For more information: https://ose-immuno.com/fr/

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Forward-looking statements

This press release contains express or implied information and statements that could be considered forward-looking information and statements regarding OSE Immunotherapeutics. They are not historical facts. Such information and statements include financial projections based on certain assumptions and assessments made by the management of OSE Immunotherapeutics in light of its experience and perception of historical trends, current economic and industry conditions, expected future developments and other factors they deem appropriate. .

These forward-looking statements include statements generally using the conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan” or “estimate”, their declensions and conjugations and words of of similar importance. Although OSE Immunotherapeutics’ management believes that forward-looking statements and information are reasonable, OSE Immunotherapeutics shareholders and other investors are cautioned that the achievement of such expectations is inherently subject to various known and unknown risks and uncertainties that 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, implied or projected by the forward-looking statements. These risks include those mentioned or identified in the public filings made by OSE Immunothérapie with the AMF. These forward-looking statements are not guarantees of future performance. This press release only contains summary information and should be read together with OSE Immunothérapie’s Universal Registration Document filed with the AMF on April 15, 2022, including the annual financial report for the 2021 financial year, available on OSE Immunotherapy website. Except as required by applicable law, OSE Immunotherapeutics is issuing this press release as of the date hereof and undertakes no obligation to update or revise any forward-looking information or statements.

Irene B. Bowles