FX.co ★ SELLAS' Galinpepimut-S Gets Rare Pediatric Disease Designation For Treatment Of Pediatric AML

SELLAS Life Sciences Group, Inc. (SLS), a biopharmaceutical company focused on advanced-stage clinical development, announced on Tuesday that the U.S. Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation to Galinpepimut-S—or GPS—an immunotherapy that targets Wilms Tumor-1, for the treatment of pediatric acute myeloid leukemia (AML).

"GPS has already shown potential in clinical trials for treating AML, and we believe its benefits may extend to pediatric patients," stated Angelos Stergiou, President and CEO of SELLAS.

"Securing the RPDD from the FDA underscores the urgent need for innovative treatment solutions for AML and highlights our results in adult patients. In our Phase 2 trial, which included patients as young as 25, younger patients experienced notably higher clinical benefits. This outcome was anticipated given the mechanism of action of GPS, which involves the immune system, generally better preserved in younger individuals, and particularly in children," Stergiou elaborated.

Current treatment outcomes for AML in pediatric patients who are refractory or have relapsed remain bleak. In a notable study, the 5-year overall survival (OS) rate for relapsed pediatric AML was 33% across all patients and only 15.7% for those whose remission was less than 12 months.

For patients unable to achieve complete remission after one chemotherapy course, the 5-year survival rate was 0%. Approximately half of the pediatric AML patients experience relapse. In such cases, a bone marrow transplant is usually the only curative option, and thus the main objective of chemotherapy is to induce remission to allow for transplantation in pediatric patients.