OSE Immunotherapeutics Announces US Acceptance

  • Based on the global license agreement signed in April 2021, this first step triggers a €5 million payment from Veloxis Pharmaceuticals, Inc. to OSE Immunotherapeutics.

NANTES, France, Jan. 31, 2022 (GLOBE NEWSWIRE) — OSE Immunotherapy (ISIN: FR0012127173; Mnemo: OSE), today announced the acceptance of the IND obtained by Veloxis Pharmaceuticals, Inc. from the Food & Drug Administration (FDA) for a clinical trial with VEL-101/FR104, a CD28 antagonist monoclonal antibody fragment. This trial will be sponsored and conducted by Veloxis Pharmaceuticals, Inc. in the United States.

This significant milestone was achieved by Veloxis Pharmaceuticals, Inc. as part of the worldwide licensing agreement signed in April 2021 under which Veloxis Pharmaceuticals, Inc. obtained from OSE Immunotherapeutics the worldwide rights to develop, manufacture and marketing of FR104, a monoclonal antibody fragment antagonist of CD28. , for all transplant indications. As part of this agreement, acceptance of the US IND application triggered a €5 million milestone payment from Veloxis Pharmaceuticals, Inc. to OSE Immunotherapeutics.

In parallel, OSE Immunotherapeutics retains all product rights to develop FR104 in autoimmune diseases.

Dominique Costantini, Managing Director of OSE Immunotherapy, comments: “We thank Veloxis Pharmaceuticals, Inc. for this key first achievement which demonstrates their commitment and strong belief in the potential of this first-in-class CD28 antagonist as an innovative immunosuppressive therapy and marks a major milestone in expanding the development of the produced in transplantation. The milestone payment, in line with our business model, will strengthen our cash position to advance our immuno-oncology and immunity and inflammatory pipeline.

About Veloxis Pharmaceuticals, Inc.
Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients. Based in Cary, North Carolina, USA, Veloxis Pharmaceuticals, Inc. is focused on the direct commercialization of immunosuppressive drugs in the United States, expanding partnerships for markets around the world, and acquiring active ingredients used in transplant patients and by adjacent medical specialties. For more information, visit www.veloxis.com.

About Asahi Kasei
The Asahi Kasei Group contributes to the life and lives of people around the world. Since its founding in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has grown steadily through proactive transformation of its business portfolio to meet the ever-changing needs of every age. With more than 40,000 employees worldwide, the company contributes to a sustainable society by providing solutions to global challenges through its three business segments: Hardware, Homes and Healthcare. Its healthcare businesses include devices and systems for acute intensive care, dialysis, therapeutic apheresis, transfusion and manufacturing of biotherapeutic products, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

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 autoimmune diseases. Its top-notch balanced clinical and preclinical portfolio presents 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-class products for immunity and inflammation

  • 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. Results of memory T cell responses at 6 months expected in the first quarter of 2022.

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 discussed or identified in the public filings made by OSE Immunotherapeutics 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, 2021, including the annual financial report for the 2020 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.

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