On November 13, 2023 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, reported 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) (Press release, Sellas Life Sciences, NOV 13, 2023, View Source [SID1234637562]). 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.
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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.
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, this month and working closely with the FDA as we continue to advance our GPS development program. GPS, through its unique mechanism of action and novel technology, has the potential to become the first immunotherapy, cancer vaccine to reach the market for AML. There are currently no FDA-approved drugs to address the high unmet medical need that exists in treating patients in the maintenance setting in second complete remission," said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer at SELLAS. "Our off-the-shelf therapy, GPS, was precisely and deliberately designed to target Wilms Tumor 1 and the multivalent approach of GPS targets 25 carefully selected WT1 epitopes, allowing it to be maximally immunogenic by eliciting both CD4 and CD8 immune responses. GPS has the potential to offer clinical benefit to this population of leukemia patients and the positive CMC regulatory feedback is a critical step in its development."