The FDA has removed the partial clinical hold it placed on an Adaptimmune ($ADAP) trial in August. The move clears Adaptimmune to start enrolling patients with myxoid round cell liposarcoma (MRCLS) in a trial of its GlaxoSmithKline ($GSK)-partnered NY‑ESO T-cell therapy.
Adaptimmune plans to start screening patients to participate in the 15-subject study in the fourth quarter. The goal is to generate results that inform a planned pivotal trial in the indication.
GSK triggered the advance of the MRCLS program when it expanded its alliance with Adaptimmune in February. The program suffered a setback in August when the FDA hit it with a partial clinical hold. At that time, Adaptimmune planned to get its response to the FDA within a few days, receive a reply from the regulator at most 30 days later and, if all went smoothly, open the study around the end of the year as originally planned.
Adaptimmune’s confidence in its ability to meet the FDA’s demands stemmed from the nature of the clinical hold. The hold had nothing to do with safety. Rather, the FDA wanted information regarding the move from an academically derived to a commercially viable manufacturing process, including data on the comparability of the two methods. The FDA also requested details regarding patient monitoring and other aspects of the protocol design.
Having met the demands, Adaptimmune is positioned to add the MRCLS study to its slate of NY-ESO TCR trials. Early-stage trials in synovial sarcoma, multiple myeloma, ovarian cancer, melanoma and non-small cell lung cancer are already underway. The plan is to add a pivotal trial in synovial sarcoma to the roster in the middle of next year.
Shares in Adaptimmune rose 14% in after-hours trading, adding to the 16% gain made by the stock over the preceding three days. Over that period, Adaptimmune revealed Tal Zaks had joined its board of directors. Zaks joined deep-pocketed mRNA player Moderna Therapeutics as CMO last year after a spell heading up oncology at Sanofi ($SNY).