OSE Immunotherapeutics is pleased to announce that Veloxis Pharmaceuticals, Inc., its transplant partner, has received FDA Fast-Track Designation for the CD28 antagonist VEL-101/FR104


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

OSE Immunotherapeutics SA (ISIN: FR0012127173; Ticker: OSE) (Paris:OSE) today announced that Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, has received accelerated designation from the United States Food & Drug Administration (FDA) for VEL-101/FR104, a novel maintenance immunosuppressive agent experimental drug under development for the prophylaxis of renal allograft rejection in kidney transplant recipients. Fast track designation is granted by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and address an unmet medical need.

“We are encouraged to receive accelerated designation for VEL-101 as it demonstrates that the FDA recognizes the serious need to improve outcomes in kidney transplant recipients,” said Mark Hensley, CEO of Veloxis. “Veloxis is committed to developing innovative therapies with the goal of improving the lives of the thousands of people who receive kidney transplants each year.”

“We are very pleased with the fast-track FDA designation granted to VEL-101/FR104. We thank our partner Veloxis for this major milestone and for its commitment to advancing the clinical development of a promising candidate addressing a key therapeutic challenge.”comments Dominique Costantini, CEO of OSE Immunotherapy.

VEL-101 is a pegylated monoclonal antibody fragment that binds and blocks CD28-mediated costimulation of effector T cells, without blocking CTLA-4, an important protein present on T cells that acts as a natural brake on immune responses of the organism. VEL-101 is therefore expected to impact immune function both directly by blocking CD28-mediated T-cell activation and indirectly by preserving CTLA-4-mediated immunoregulatory function.

“Despite short-term improvements in outcomes, long-term outcomes of kidney transplants have not improved in part due to challenges with maintaining long-term immunosuppression,” said Dr. Ulf Meier-Kriesche, scientific director of Veloxis and transplant nephrologist. “By receiving accelerated designation for the VEL-101 clinical development program, we hope that more frequent interactions with the FDA and potential regulatory submissions can shorten the time it takes to make VEL-101 available to kidney transplant recipients. “

About the VEL-101 Clinical Program

VEL-101 has been evaluated in a first-in-man study to assess the safety, pharmacokinetics, pharmacodynamics, and potency of IV administrations in healthy subjects (learn more about the study here (1)). VEL-101, a CD28 antagonist pegylated monoclonal antibody fragment, selectively attenuates CD28 co-stimulation while sparing the CTLA-4 co-inhibition signal. The net effect of CD28 antagonism is downregulation of effector T cells while potentially promoting regulatory T cell (Treg) activity.

VEL-101, also known as FR104, was licensed by Veloxis Pharmaceuticals, Inc. from OSE Immunotherapeutics in April 2021. As part of the license agreement, Veloxis Pharmaceuticals, Inc. obtained worldwide rights development, manufacturing and marketing of VEL-101 for all transplant indications.

(1) Poirier N., et al. J Immunol 2016; 197:4593-4602

About Veloxis Pharmaceuticals, Inc.

Veloxis Pharmaceuticals, 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 is focused on the development and worldwide commercialization of medicines used by transplant patients and patients with serious related diseases. 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 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, 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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