SELLAS Receives Orphan Medicinal Product Designation Approval by the Committee for Orphan Medicinal Products of the European Medicines Agency

SELLAS Life Sciences Group (Nasdaq:SLS) a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has approved orphan medicinal product designation (OMPD) for galinpepimut-S (GPS), the Company’s lead product candidate, for the treatment of multiple myeloma (MM).

As quoted in the press release:

“This OMPD endorsement by the COMP of the EMA for GPS in MM complements the orphan designation awarded by the US FDA for this product in the same indication,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The results from our open-label Phase 2 study reinforce the potential of GPS to serve as a therapy for high-risk MM patients in the post-autotransplant maintenance setting. The innovative nature and unique mechanism of action for GPS provide a promising potential addition to the current arsenal of therapies in this indication. We continue to work closely with the FDA and EMA, as well as multiple myeloma KOLs to further advance the clinical development of GPS in this malignancy and look forward to gaining further insights on the potential therapeutic role of GPS in high-risk MM patients.”

The EMA orphan medicinal product designation is granted to medicines being developed for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition with a prevalence of not more than five in 10,000 people in the European Union.  Orphan designations are granted by decisions of the European Commission based on opinions from the Committee for Orphan Medicinal Products within EMA. EMA orphan drug designation benefits include protocol assistance, access to the EU centralized authorization procedure, reduced EU regulatory filing fees and 10 years of market exclusivity across the EU.

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