Sellas Life Sciences receives favorable FDA feedback on BLA for galinpepimut-S

Sellas Life Sciences concluded a Type C meeting with the FDA regarding the company’s Chemistry, Manufacturing, and Controls sections in a potential biologics license application – BLA – for Sellas’ lead product candidate, galinpepimut-S, or GPS. Sellas submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance. To date, the company has successfully completed numerous clinical development and CMC objectives in advancing GPS monotherapy into its Phase 3 REGAL study in patients with acute myeloid leukemia in the maintenance setting after achievement of second complete remission.