Business
SELLAS Life Sciences Receives Favorable FDA Type C Meeting Feedback on Chemistry, Manufacturing, and Controls (CMC) Biologics License Application (BLA) Filing Strategy for Galinpepimut-S (GPS)
– FDA feedback indicates Company’s CMC plans are in alignment with FDA’s requirements and expectations towards a BLA – – CMC regulatory alignment is critical
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"– FDA feedback indicates Company’s CMC plans are in alignment with FDA’s requirements and expectations towards a BLA – – CMC regulatory alignment is critical step in approval pathway for GPS – NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today 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; andMonitoring 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. Andrew Elnatan, Vice President of Regulatory Affairs, CMC & Quality at SELLAS, stated, “We are pleased with the positive outcome of the Type C meeting and FDA’s guidance on the advancement of the CMC plans as part of the GPS program development. The responses to questions regarding our proposed potency assay and manufacturing processes validation are aligned with our expectations and will help guide our plans towards a potential future successful BLA assuming positive data from the REGAL study.” “We look forward to completing our enrollment in the Phase 3 REGAL trial, outside of China, t...