Adaptimmune downgrades trial design after FDA clinical hold

In February 2016 , British T cell receptor (TCR) engineering specialist, Adaptimmune plc extended a 2014 agreement with GSK to co-develop Adaptimmune’s cancer testis antigen programme, NY-ESO-1, and other TCR-targeted candidates to include pivotal trials in synovial sarcoma and development in myxoid round cell liposarcoma. In August 2016, US regulatory agency FDA ordered Adaptimmune to halt a Phase I/II trial of its candidate GSK3377794 in myxoid round cell liposarcoma (MRCLS) therapy and asked for more information about the manufacturing process and the study design. Now, after the company changed the initial trial status from pivotal to pilot, the FDA has lifted its partial clinical hold.

CEO James Noble said that the protocol has been revised. Adaptimmune will now initiate a study in up to 15 MRCLS patients instead of initially 65. Patient enrolment is expected to begin this year. Results from this study will inform a potential future registration trial. Under the agreement, GSK has a licencing option following proof-of-concept in every indication or checkpoint inhibitor combination.

Noble stressed that the clinical hold was not due to safety problems. Our goal remains to be the first company to file for approval with a TCR therapy, he said. Adaptimmune’s lead programme NY-ESO SPEAR T cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumours and in haematologic cancer types, including synovial sarcoma and multiple myeloma.