New York, NY (Press Release) – SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS”), a clin­i­cal-stage bio­pharma­ceutical com­pany focused on novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to its novel drug can­di­date, galin­pepimut-S (GPS), for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

“We are delighted to receive this orphan drug desig­na­tion as it underscores the great need for inno­va­tive, effective treat­ments for this rare cancer, and recog­nizes the poten­tial benefits that GPS may provide for patients with MM,” said Angelos Stergiou, MD, ScD h.c., Pres­i­dent & Chief Executive Officer of SELLAS. “Receiving orphan drug desig­na­tion for the treat­ment of MM is a sig­nif­i­cant regu­la­tory mile­stone in the devel­op­ment of GPS. We have reported median pro­gres­sion-free survival (PFS) of 23.6 months in the high-risk MM disease setting, compared to historically inferior out­comes in such a patient cohort of around 12 months, and GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses as well as multifunctional cross-epitope T cell reactivity.”

GPS has also received orphan drug desig­na­tion for the treat­ment of acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM). SELLAS has Phase 3 clin­i­cal trials planned for GPS in both AML and MPM and is devel­op­ing GPS as a poten­tial treat­ment for a broad range of other cancer indi­ca­tions, in­­clud­ing multiple myeloma.

The FDA's Office of Orphan Drug Products grants orphan status to sup­port devel­op­ment of medicines for safe and effective treat­ment, diag­nosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug desig­na­tion may provide certain benefits, in­­clud­ing a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clin­i­cal trials and an exemption from FDA appli­ca­tion fees.

About SELLAS Life Sciences Group

SELLAS is a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on novel cancer immuno­therapeutics for a broad range of cancer indi­ca­tions. SELLAS’ lead prod­uct can­di­date, galin­pepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has poten­tial as a mono­therapy or in com­bi­na­tion to address a broad spec­trum of hema­to­logic malig­nan­cies and solid tumor indi­ca­tions. SELLAS has Phase 3 clin­i­cal trials planned for GPS in two indi­ca­tions, acute myeloid leukemia (AML) and malignant plural mesothelioma (MPM) and is also devel­op­ing GPS as a poten­tial treat­ment for multiple myeloma and ovarian cancer. SELLAS has received Orphan Drug desig­na­tions from the U.S. Food & Drug Admin­istra­tion (FDA), as well as the European Medicines Agency, for GPS in AML, MPM and MM; GPS also received Fast Track desig­na­tion for AML and MPM from the FDA. SELLAS’ second prod­uct can­di­date, NeuVax™ (nelipepimut-S), is a first-in-class, HER2-directed cancer immuno­therapy being investi­gated for the pre­vention of the recurrence of breast cancer after standard of care treat­ment in the adjuvant setting.

For more in­­for­ma­tion on SELLAS, please visit www.sellaslifesciences.com.

Source: SELLAS.