Benzinga | Sep 9, 2020 08:31AM EDT

SELLAS Reports Receives Investigational Medicinal Product Dossier Approval From French Regulatory Authority, Agence Nationale de Scurit du Mdicament et des Produits de Sant, To Advance Pivotal Phase 3 REGAL Study

SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that it has received approval of its Investigational Medicinal Product Dossier (IMPD) from the French regulatory authority, Agence Nationale de S?curit? du M?dicament et des Produits de Sant? (ANSM), to advance in France its pivotal Phase 3 REGAL study of galinpepimut-S (GPS) in patients with Acute Myeloid Leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2).

"This clearance marks an important milestone for SELLAS, as the IMPD allows us to expand AML patient enrollment for our pivotal Phase 3 REGAL study of GPS in France," commented Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Obtaining IMPD clearance is a stringent process, and includes submission of information related to the quality, manufacture and controls of GPS as well as data from non-clinical and clinical studies. We look forward to advancing our REGAL study in France and, upon the receipt of requisite approvals, other countries in Europe, particularly given the previously obtained orphan drug designation for GPS in AML by the European Medicines Agency. "



In February 2020, SELLAS announced positive follow-up data from its Phase 2 study of GPS in CR2 AML patients. The final data showed a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well tolerated throughout the study.