FR104 shown to be efficacious in a preclinical bone marrow transplant model
Research published in the Journal of Clinical Investigation conducted with multiple international expert partners
NANTES, France, Aug. 22, 2018 (GLOBE NEWSWIRE) — OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today announces new efficacy results from a preclinical study evaluating FR104, an antagonist of CD28, a receptor which controls the activity of effector T lymphocytes. This study, led by OSE Immunotherapeutics and international partners, was published in the August 2018 issue of the Journal of Clinical Investigation (JCI) (1).
FR104 is a monoclonal antibody and an antagonist of CD28. This pegylated monovalent antibody selectively inhibits the CD28 receptor and has potential clinical applications in autoimmune diseases and transplantation.
This latest publication(1) refers to a research conducted in collaboration with Nantes University/Inserm (a French public organization dedicated to human health), Emory University of Atlanta, the University of Minnesota and the Fred Hutchinson Cancer Research Center of Seattle. It focused on the evaluation of selective CD28-antagonist FR104 to determine its impact on T cell activation and graft-versus-host disease (GVHD) when used both as a monotherapy or combined with immunosuppressant rapamycin in a preclinical model of bone marrow transplant. The results demonstrated that FR104 efficiently controlled GVHD, both when used as a monotherapy or in combination, and that this control was superior to the one observed with non-selective CD28-antagonist CTLA4-Ig.
Previous studies conducted with FR104 in preclinical models of transplant and other immune-mediated diseases have generated significant immune data related to the product, and in particular demonstrated its ability to promote immunological tolerance(2) and to reinforce immunosuppression(3). Additionally, the results from a Phase 1 clinical(4) study of FR104 have shown a good clinical and biological safety, and also have confirmed its immunosuppressive activity in human.
“The sum total of all preclinical and clinical data now available on our CD28-antagonist FR104 have built a strong basis to open its further development to various potential indications in immune-mediated diseases. This is indicative of the product’s interest and confirms it as a valuable asset for the Company,” commented Alexis Peyroles, CEO of OSE Immunotherapeutics.
Based on positive Phase 1 clinical results, FR104 is under a licensing agreement with Janssen Biotech to pursue the product’s clinical development with a Phase 2 trial planned in rheumatoid arthritis.
(1) CD28 blockade controls T cell activation to prevent graft-versus-host disease in primates
Benjamin K. Watkins, Victor Tkachev, Scott N. Furlan et al.; J Clin Invest. 2018 Aug 13
(2) Selective blockade of CD28 on human T cells facilitates regulation of alloimmune responses
Masaaki Zaitsu, Fadi Issa, Joanna Hester et al.; JCI Insight. 2017
(3) FR104, an antagonist anti-CD28 monovalent fab’ antibody, prevents alloimmunization and allows calcineurin inhibitor minimization in nonhuman primate renal allograft
Poirier N, Dilek N, Mary C et al.; Am J Transplant. 2015 Jan.
(4) First-in-Human Study in Healthy Subjects with FR104, a Pegylated Monoclonal Antibody Fragment Antagonist of CD28
Nicolas Poirier, Gilles Blancho, Maryvonne Hiance et al. ; The Journal of Immunology, Nov. 2016
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology and autoimmune diseases. Neoepitopes innovation (Tedopi®) is today in Phase 3 in advanced lung cancers (NSCLC) after checkpoint inhibitors failure (anti PD-1 and anti PD-L1). A global license and collaboration agreement was signed in April 2018 with Boehringer Ingelheim to develop checkpoint inhibitor OSE-172 (anti-SIRPa monoclonal antibody) for the treatment of advanced solid tumors. An option to license was exercised in July 2016 by Janssen Biotech to continue clinical development of FR104 (an anti CD28 mAb) in auto-immune diseases after positive Phase 1 results. A 2-step license option was signed in 2016 with Servier Laboratories to develop OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) to develop the product up to the completion of a phase 2 clinical trial planned in autoimmune bowel disease and Sjogren’s syndrome. The company has several scientific and technological platforms: neoepitopes, agonist or antagonist monoclonal antibodies, ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical portfolio offers a diversified risk profile.
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