By Chris Wack
Sellas Life Sciences Group has received favorable Type C meeting feedback from the Food and Drug Administration for its lead product, galinpepimut-S.
The recently concluded Type C meeting with the FDA covered the biopharmaceutical company’s Chemistry, Manufacturing, and Controls sections in a potential biologics license application for galinpepimut-S.
Sellas submitted a CMC Briefing Package to the FDA, which provided an up-to-date overview of the extensive work completed for the galinpepimut-S CMC program and commercial manufacturing and regulatory plans. The FDA reviewed the package of data and accompanying questions to the agency and responded with favorable guidance.
The FDA also agreed on the company’s proposed stability data generation plan for the commercial presentation of galinpepimut-S. Galinpepimut-S is expected to be stored at 2 degrees Celsius to 8 degrees.
Write to Chris Wack at [email protected]