On March 21, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that the United States Patent and Trademark Office (USPTO) has issued a first notice of allowance for a patent application covering OSE-279, an anti-PD1 monoclonal antibody, and its use in cancer treatment (Press release, OSE Immunotherapeutics, MAR 21, 2022, View Source [SID1234612853]). This patent will strengthen the global intellectual property of OSE-279 and will provide the product protection until 2039.
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OSE-279 is a humanized anti-PD1 monoclonal antibody blocking PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells. PD-L1 and PD-L2 are used by tumor cells to escape the immune system. Upregulation of PD-L1 and PD-L2 on tumor cells and other cell types of the tumor microenvironment is a proposed mechanism of tumor immune escape.
OSE-279 is the key anti-PD-1 backbone of BiCKI-IL-7*, an innovative bifunctional therapy combining anti-PD1 and the cytokine IL-7 and targeting PD1 to sustain exhausted T cell function and to disarm Treg suppressive activity.
Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased with this first notice of allowance for a patent covering OSE-279 in a major territory that simultaneously reinforces the product’s intellectual property and its position in our portfolio as an immunotherapy that has the potential to transform the current anti-PD1 standard of care for hard-to-treat cancers. We look forward advancing our anti-PD1 backbone development with the Phase 1 clinical trial planned to start in 2022."
* Presentation at the 2022 American Society for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (April 8 – 13): "Anti-PD1/IL7v immunocytokine promotes durable T-cell responses and overcomes anti-PD1 resistance"
Session ED015 – Immunocytokines: Strategies for Drug Delivery and Tissue Targeting
April 9, 2022, 2:30 PM – 2:50 PM
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:
Immuno-Oncology first-in-class products
Tedopi (innovative combination of neoepitopes): the company’s most advanced product; positive results for Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure.
Other ongoing combination trials sponsored by cooperative clinical research groups in oncology:
Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
BI 765063 (OSE-172, anti-SIRPα mAb on CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy and in combination with ezabenlimab (PD-1 antagonist); ongoing expansion Phase 1.
OSE-279, anti-PD1 – advanced preclinical stage.
BiCKI: bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target (for example: BiCKI-IL7, preclinical stage) to increase anti-tumor efficacy.
Immunity & Inflammation first-in-class products
OSE-127/S95011 (humanized monoclonal antibody antagonist of IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; ongoing Phase 2 in ulcerative colitis (sponsor OSE) and ongoing Phase 2a in Sjögren’s syndrome (sponsor Servier).
FR104 (anti-CD28 monoclonal antibody): licensing partnership agreement with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); US IND obtained by Veloxis Pharmaceuticals, Inc. for a clinical trial; Phase 2 planned in an autoimmune disease indication.
OSE-230 (ChemR23 agonist mAb): preclinical stage therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
CoVepiT: a prophylactic second-generation vaccine activating cytotoxic T lymphocytes against COVID-19, developed using optimized epitopes from SARS-CoV2 viral proteins, epitopes non impacted by multi-variants. Shows good tolerance and very good level of T cell immune response. In clinical testing, a long-term memory response was confirmed at 6 months.
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