Clinical Trials

Date: 2016-11-17

Type of information: Publication of results in a medical journal

phase: 1

Announcement: publication of results in the Journal of Immunology

Company: Effimune (France) now OSE Immunotherapeutics (France) Janssen Biotech, a J&J company (USA - NJ)

Product: FR104

Action mechanism:

• monoclonal antibody. FR104 is a new drug candidate, pegylated Fab’ monoclonal antibody fragment inhibitor of CD28, an essential element of the T-cell signaling pathway. CD28 signaling is a critical pathway required for effector T cell expansion and for regulatory T cells inactivation, and FR104 exerts its immunomodulatory function by blocking CD28 signaling and thereby preventing effector T cells but not regulatory T cells function, thereby promoting immune tolerance.
• Since September 2013, FR104 has been under a global license agreement with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson.

Disease: rheumatoid arthritis, kidney transplantation

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Transplantation

Country: Belgium

Trial details:

Latest news:

• • On November 17, 2016, OSE Immunotherapeutics   announced the online publication in  The Journal of Immunology  of positive results from a Phase 1 clinical trial of FR104 conducted in healthy subjects.
• Data published have shown a good tolerance and an immunosuppressive activity. 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. 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. (*First-in-Human Study in Healthy Subjects with FR104, a Pegylated Monoclonal Antibody Fragment Antagonist of CD28 Nicolas Poirier*,†,‡, Gilles Blancho*,†,§, Maryvonne Hiance‡, Caroline Mary*,†,‡,Tim Van Assche¶, Jos Lempoels¶, Steven Ramael¶, Weirong Wang?, Virginie Thepenier*,†,‡, Cecile Braudeau*,†,#, Nina Salabert*,†,§,#, Regis Josien*,†,§,#, Ian Anderson?, Ian Gourley?, Jean-Paul Soulillou*,†, Didier Coquoz** and Bernard Vanhove*,†,‡,# Author affiliations:* Institut National de la Santé et de la Recherche Médicale UMR 1064, Nantes F44093, France; † Institut de Transplantation Urologie Néphrologie, Centre Hospitalier Universitaire, Université de Nantes, Nantes F44000, France; ‡OSE Immunotherapeutics S.A., Nantes F44200, France;§Centre Hospitalier Universitaire Nantes, Laboratoire d’Immunologie, Centre d'immunomonitorage NantesAtlantique, Nantes, F44000, France;¶SGS Life Science Services, Clinical Pharmacology Unit Antwerp, Antwerp 2060, Belgium;Janssen Research & Development, LLC, Spring House, PA 19477;#LabEx ImmunoGraft Oncology, Nantes F44000, Nantes, France; and**Copexis S.A., Pully CH-1009, Switzerland).
• • On July 9, 2015, Effimune announced that it has started its phase I clinical evaluation of FR104, its drug candidate in the immune system regulation control. Following the announcement of regulatory approval by the FAMHP (Federal Agency for Medicines and Health Products, the Belgian regulatory authority), the roll out of the clinical trial has started. To date the first cohort has been successfully included with 22 volunteers recruited for the first phase of the trial, which is an escalating single-dose study of FR104. This double-blind randomized clinical trial is planned on 70 healthy volunteers (both men and women) over a period of 10 months, and will prepare for the future development of FR104 in rheumatoid arthritis treatment and kidney and stem cell transplantation. The primary objectives of the trial are to establish the safety and tolerability of FR104 and assess its pharmacodynamics and pharmacokinetics.
• • On April 15, 2015, Effimune announced  that it had received the authorization from the Belgian regulatory authority, the FAMHP (Federal Agency for Medicines and Health Products) for a Phase I clinical trial of FR104, its drug candidate for controlling the regulation of the immune system. This double-blind randomized clinical trial will take place on 70 healthy volunteers (both men and women) over a period of 9 months, and will prepare the future development of FR104 in rheumatoid arthritis and kidney transplantation.

 

Is general: Yes