Study: monoclonal antibody FR 104 shows clinical safety

Data about clinical trial of CD28’s antagonist monoclonal antibody , FR104, has shown a good tolerance of the antibody, and an immunosuppressive activity.

The French company OSE Immunotherapeutics SA has announced the results from a Phase 1 clinical trial of FR104 conducted in healthy subjects, in the online publication  in The Journal of Immunology.

FR 104 is a monoclonal antibody and an antagonist of CD28. This pegylated monovalent antibody inhibits selectively the CD28 receptor and has potential clinical applications in auto-immune diseases and transplantation.

According to the study, the clinical and biological safety of this new product has shown to be very good in 64 healthy subjects who were administered single or repeated ascending doses of the product. Moreover, the first data of clinical activity arising from this study, challenged with a KLH test, clearly demonstrated an inhibition of the antibody response versus KLH and in a dose-dependent manner.

“We have demonstrated a good clinical safety of FR104 on an immunological target of high interest. This study has also confirmed immunosuppressive activity; this key step is a strong basis to pursue the development in immune-mediated diseases”, said Bernard Vanhove, Chief Operating Officer of OSE Immunotherapeutics, in charge of R&D. “I warmly thank our team, Inserm UMR1064, the Nantes University, Nantes University Hospital as well as institutions involved in very early stage, for their committment to the project (Atlanpole Biotherapies, ‘Région Pays de la Loire’, the Loire Atlantique Department, the National Resarch Agency and the Foundation for Medical Research). I also thank our industrial partner, Janssen Biotech Inc., in charge of pursuing the product’s development”.

Maryvonne Hiance, Vice-President and Director of Strategy of OSE Immunotherapeutics adds : “We are very pleased with these first results. They illustrate the implementation of a public-private joint research laboratory within the international hub of the Nantes region which contributes to the growth of the French Biotech”.

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