Adaptimmune Granted Access to PRIority MEdicines (PRIME) Regulatory Support by the European Medicines Agency for ADP-A2M4 for the Treatment of Synovial Sarcoma

PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 23, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, announced that the European Medicines Agency (EMA) has granted access to the PRIME initiative to the Company for ADP-A2M4 for the treatment of synovial sarcoma. PRIME access provides enhanced scientific and regulatory support by the EMA to developers of medicines with the potential to significantly address unmet medical needs.

“We are thrilled that the EMA has acknowledged the potential of ADP-A2M4 to address an unmet medical need for more effective treatment options for patients with advanced synovial sarcoma,” said Dennis Williams, PharmD, Adaptimmune’s Senior Vice President, Late Stage Development. “Access to the enhanced EMA support and guidance offered in the PRIME scheme will facilitate the development of ADP-A2M4 to ensure this important medicine reaches patients with sarcoma as early as possible.”

Access to the PRIME initiative for ADP-A2M4 was granted based on clinical data from the Phase 1 trial demonstrating compelling efficacy and early promising durability, with tolerable safety in patients with synovial sarcoma. Based on these data the Company initiated the SPEARHEAD-1 trial with ADP-A2M4, enrolling people with advanced synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS) at clinical sites in Canada, France, Spain, the United Kingdom, and the United States (US). The SPEARHEAD-1 trial is intended to support the registration of ADP‑A2M4 for the treatment of advanced synovial sarcoma and MRCLS.

In recent months, the US Food and Drug Administration granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy designation for the treatment of synovial sarcoma. In addition, The EMA’s Committee for Orphan Medicinal Products adopted a positive opinion for ODD for ADP-A2M4 for the treatment of soft tissue sarcomas.

The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. To be eligible and accepted for PRIME, a medicine must show potential to benefit patients with unmet medical needs based on early clinical data coupled with non-clinical data. Through the PRIME program, the EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency. The program is intended to optimize development plans and expedite the review and approval process so that these medicines may reach patients as early as possible.