An established mechanism of action

FR104 selectively blocks interactions of CD28-CD80/86 and CD28-CD275

  • It inhibits T cell proliferation and synthesis of cytokines (gamma interferon, interleukin 2)
  • It inhibits the response of particular effector T cells (effector memory T cells)
  • It triggers a response from regulator T cells bound to CTLA-4, leading thus to a T cell suppressor activity
  • It induces no spontaneous activation from T cells bound to CD28

FR104, with positive Phase 1 clinical results, is targeted for autoimmune diseases and transplantation

  • FR104 is an immuno-modulator composed of a humanized monovalent Fab’ antibody targeting CD28, a key receptor blocking the destructive function of effector T lymphocytes. These effector T lymphocytes are harmful in the case of autoimmune diseases and transplantation.
  • FR104 specifically blocks the destructive function of effector T lymphocytes without blocking the regulation function of regulator T lymphocytes, thus fostering immuno-tolerance.
  • FR104 fosters induction of immune tolerance in transplantation and autoimmune diseases with T lymphocyte mediation.
  • Arising from OSE Immunotherapeutics R&D, and based on a high-level academic research, FR104 is in development for applications in transplantation and rheumatoid arthritis.  Read more >.

FR104, in development in collaboration with Janssen Biotech (J&J Group, a leading pharmaceutical company), responsible for all clinical development, registration and commercialization activities for FR104, internationally

  • At the end of 2013, with FR104 at a preclinical stage, a global option and license agreement was signed with Janssen Biotech, owned by Johnson & Johnson (J&J Group, a leading pharmaceutical company involved in autoimmune and anti-inflammatory diseases). Janssen exercised this license option in July 2016 and is responsible for the product’s further clinical development, with certain milestone and royalties due to OSE Immunotherapeutics.
  • Positive Phase 1 clinical results with FR104 conducted in healthy subjects published online* in « The Journal of Immunology » (November 2016) have shown a good tolerance and an immunosuppressive activity.
* 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