Date: 2016-07-05
Type of information: Exercise of an option agreement
Compound: FR104
Company: Effimune, now OSE Immunotherapeutics (France) Janssen Biotech - J&J (USA)
Therapeutic area: Autoimmune diseases - Immunological diseases - Transplantation
Type agreement: exercise of an option agreement licensing
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. FR104 has been developed by Effimune, now OSE Immunotherapeutics.
Disease: immune-mediated disorders (autoimmune diseases, organ transplantation and graft-versus-host-disease after hematopoietic stem cell transplant)
Details: * On October 3, 2013, Effimune, a biotech company dedicated to the discovery and development of drugs which regulate the immune system in autoimmune disease and transplantation, has announced a global option and license agreement with Janssen Biotech. 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.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.
Financial terms:
Latest news: * On July 5, 2016, OSE Immunotherapeutics announced that Janssen Biotech has exercised its option within the global license agreement between Janssen and OSE Immunotherapeutics. Under the terms of this agreement, Janssen will be responsible for all clinical development, registration and commercialization activities for FR104, internationally, in the areas of autoimmune diseases and transplantation. The deal was facilitated by Effimune and Johnson & Johnson Innovation’s London Innovation Centre in October 2013. Positive results from the recently concluded FR104 Phase 1 clinical trial (NCT02800811), triggered the exercise of the license option and will enable further clinical development of the product by Janssen. The clinical results have shown a good safety profile, have established the pharmacological profile and demonstrated a dose/response relationship. The purely antagonist activity of FR104 has been confirmed. The targeted indications are autoimmune diseases, organ transplantation and graft-versus-host-disease after hematopoietic stem cell transplant. “The exercise of this option is a significant achievement which allows continued development of the company’s compound in collaboration with Janssen’s immunology scientists, thanks to the initial strategic collaboration with Johnson & Johnson Innovation (London Centre),” declared Bernard Vanhove, Chief Operating Officer in charge of R&D and International Scientific Collaborations for OSE Under the terms of the agreement, OSE Immunotherapeutics is eligible to receive up to a potential total of €155 million ($172 million) which includes an option exercise fee of €10 million ($11 million) and potential development, regulatory and commercial milestone payments as well as a royalty.
Immunotherapeutics, and co-inventor of FR104.
