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Thursday, November 11, 2021

Adaptimmune: Positive Results in Pivotal Sarcoma Trial

 - SPEARHEAD-1 trial will meet its primary endpoint and data will be used to support BLA filing for afami-cel next year -

- The overall response rate (ORR) per Independent Review was 34% (36% in patients with synovial sarcoma and 25% for patients with MRCLS) and the disease control rate was 85% -

- As of the data cut-off, afami-cel has shown a favorable benefit:risk profile -

- Translational data confirm that afami-cel is active against MAGE-A4 expressing targets both in vitro and in vivo, and maintained high levels of persistence in the majority of patients followed for at least 6 months post-infusion -

Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will report updated clinical and translational data from its pivotal SPEARHEAD-1 trial with afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) at the Connective Tissue Oncology Society (CTOS) annual meeting.

“The positive results presented at CTOS further validate the potential of this therapy to address a great unmet medical need for patients with synovial sarcoma and MRCLS,” said Elliot Norry, Adaptimmune’s Chief Medical Officer. “We are confident that these data will support our BLA filing for afami-cel next year.”

“Afami-cel would provide a new treatment option for patients with synovial sarcoma, offering benefits that we have rarely seen with therapies currently available for this patient population,” said Dr. Brian A. Van Tine, Professor of Medicine and of Pediatrics at Washington University School of Medicine in St. Louis. “This is a game changer for patients with a high unmet medical need.”

Clinical data will be presented in an oral presentation by Dr. Brian Van Tine of the Washington University School of Medicine in St. Louis (Abstract #1080870) during the Immunotherapy & Immune Microenvironment Session starting at 10:00 a.m. EST on November 12th.

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