Affimed: Acimtamig, AlloNK combination granted RMAT designation by FDA

Affimed (AFMD) announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager acimtamig and Artiva Biotherapeutic’s (ARTV) AlloNK for the treatment of relapsed or refractory Hodgkin Lymphoma. The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial. RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK combination to R/R HL patients in need.