Effimune Announces Major Global License Agreement


Effimune recently announced a global option and license agreement with Janssen Biotech, Inc. The collaboration between Effimune, the London Innovation Centre of Johnson & Johnson Innovation, and the Janssen Immunology Therapeutic Area is focused on the development and commercialization of FR104, a monoclonal antibody fragment in preclinical development for the treatment of immune-mediated disorders.

A number of preclinical studies with FR104 are ongoing across a panel of autoimmune diseases models, including models of rheumatoid arthritis, multiple sclerosis, and psoriasis, as well as in kidney transplantation models. Interim data were reported in 2012 at the American Transplant Congress annual meeting and at the Seventh European Workshop on Immune-Mediated Inflammatory Diseases, and oral presentations were presented at the 11th World Inflammation Congress this past September, along with several other poster presentations.

Under the terms of the agreement, Effimune grants Janssen an exclusive option to develop FR104. Janssen will make success-based milestone payments as well as pre-specified royalty payments on worldwide net sales upon commercialization of FR104.

“This agreement is an opportunity to bring a new form of therapy to patients with immune disorders,” said Maryvonne Hiance, Chairman of Effimune. “FR104 opens a new avenue in the treatment of autoimmune diseases and of transplanted patients, by promoting immune tolerance,” indicates Bernard Vanhove, Senior Scientific Advisor at Effimune and Co-inventor of FR104.

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.

Located in Nantes (France), Effimune is a biotech company dedicated to the discovery and development of drugs that regulate the immune system in autoimmune disease and transplantation. As a member of the Atlanpole Biotherapies cluster, the company was spun out of the Institute for Transplantation Urology, Nephrology (ITUN, Europe’s leading centre for kidney and combined kidney/pancreas transplantation) in December 2007. For more information, visit www.effimune.com.