3 May 2018 - Forty Seven today announced that the U.S. FDA has granted two fast track designations to its lead candidate, 5F9, for the treatment of relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, two forms of B-cell non-Hodgkin lymphoma.
5F9 is a monoclonal antibody against CD47 that is designed to block the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages.
Data justifying these fast track designations were derived from an open-label, multi-center Phase 1b/2 clinical trial of 5F9 in combination with rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma. Forty Seven expects to announce initial safety and efficacy data from the Phase 1b portion of the trial in the second quarter of 2018.