On April 28, 2020 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for Orphan Drug Designation for ADP-A2M4 for the treatment of soft tissue sarcomas (Press release, Adaptimmune, APR 28, 2020, View Source [SID1234556698]).
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Adaptimmune’s SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) is actively enrolling at approximately 25 clinical sites in Canada, France, Spain, the United Kingdom, and the US. The SPEARHEAD-1 trial is intended to support the registration of ADP-A2M4 for the treatment of advanced synovial sarcoma and MRCLS.
"Outcomes with currently available treatments remain unsatisfactory for patients with inoperable or metastatic soft tissue sarcoma, and there is a high unmet medical need for new treatment options for patients with this disease," said Dennis Williams, PharmD, Adaptimmune’s SVP, Late Stage Development. "ADP-A2M4 has the potential to offer substantial improvement in the treatment of advanced soft tissue sarcoma and the COMP’s adoption of a positive opinion for Orphan Drug Designation for ADP-A2M4 is another important milestone for this program."
The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission for endorsement. This designation by the European Commission provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union, and where the treatment provides a significant benefit to those affected by the condition or no satisfactory treatment is available.
Earlier this year, the United States (US) Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of synovial sarcoma.