FDA hits Adaptimmune with partial hold on T-cell therapy
- British pharma Adaptimmune revealed on Wednesday the U.S. Food and Drug Administration had placed a partial clinical hold on a Phase 3 study of one of its T-cell therapies. The company is testing the therapy, known as NY-ESO Spear, against myxoid round cell liposarcoma.
- No patients have been recruited for the trial yet, which isn't currently active. The FDA requested additional chemistry manufacturing and controls information, as well as more details on the trial design.
- The hold was unrelated to any safety concerns and Adaptimmune said it would provide a full response to the FDA in the near future.
Adaptimmune specializes in T-cell therapies and has partnered with GlaxoSmithKline to develop its NY-ESO T-cell receptor program, which is aimed at a number of different cancers.
In February, Adaptimmune and GSK expanded their partnership to hasten the development of NY-ESO towards pivotal testing in synovial sarcoma.The collaboration, which was initially worth up to $350 million, increased in scope, with a potential for another $150 million in milestone payments for Adaptimmune.
The companies are also collaborating on the now-halted development in myxoid round cell lipsarcoma, which has received a Breakthrough Therapy designation from the FDA.
Given no safety issues were flagged, the partial hold is a minor setback for Adaptimmune.
"Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.," said James Noble, Adaptimmune CEO.
"We will be providing a full response to the FDA shortly and will update the markets when we have further news to report," he said.
- Adaptimmune Statement