The FDA has granted Orphan Drug Designation (ODD) to Adaptimmune Therapeutics’ (NASDAQ:ADAP) SPEAR T-cells targeting MAGE-A4 (ADP-A2M4 program) for the treatment of soft tissue sarcomas.
Adaptimmune is currently investigating its ADP-A2M4 SPEAR T-cells in two types of sarcoma: synovial sarcoma and MRCLS.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
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