SELLAS Life Sciences Group, Inc. announced that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company?s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (?BLA?) for SELLAS? lead product candidate, galinpepimut-S (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 (?AML?) in the maintenance setting after achievement of second complete remission. CMC activities in support of the clinical development leading to this Type C meeting include: Manufacturing lyophilized clinical GMP batches; Qualifying processes; Validating analytical methods; and Monitoring the stability program.

The FDA also agreed on the Company?s proposed stability data generation plan for the commercial presentation of GPS. GPS is expected to be stored at 2-8 C (36 ? 46 F) making it more accessible for end-users.