On December 3, 2019, Adaptimmune Therapeutics (Nasdaq:ADAP) announced it has been granted an Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. FDA for ADP-A2M4 in the treatment of Synovial Sarcoma. Previously, the FDA had awarded an Orphan Drug Designation (ODD) to ADP-A2M4 for the treatment of soft tissue sarcomas.
This RMAT designation represents the 38th publicly announced RMAT within the United States.
ADP-A2M4 is a T-cell therapy being developed by Adaptimmune as part of the company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform that enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
RMAT stands for “Regenerative Medicine Advanced Therapy” designation. Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Headquartered in Oxford, UK, in Oxford, with an office in Philadelphia, Pennsylvania (USA), Adaptimmune is a leader in T-cell therapy. Founded in 2008, it is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors.
Click here to learn more about Adaptimmune’s cell therapy product ADP-A2M4.