FDA grants Breakthrough Therapy designation to Adaptimmune for synovial sarcoma

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for Adaptimmune’s (Nasdaq: ADAP) affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma, it has been announced.

The decision was based on the results of a Phase I/II trial in patients with unresectable, metastatic or recurrent synovial sarcoma who have received prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigen.

Patients were treated with lymphodepleting chemotherapy followed by immunotherapy with T-cells engineered to recognize an HLA-A2 restricted NY-ESO-1 peptide.