SELLAS' Galinpepimut-S Gets Rare Pediatric Disease Designation For Treatment Of Pediatric AML

(RTTNews) - SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company, Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Galinpepimut-S, an immunotherapeutic targeting Wilms Tumor-1, for the treatment of pediatric acute myeloid leukemia (AML).

"GPS has already demonstrated promise in clinical settings for AML, and we believe its potential could extend to pediatric patients," said Angelos Stergiou, President and Chief Executive Officer of SELLAS.

"Receiving RPDD from the FDA is another acknowledgment of the critical need for new treatment options for AML and our results in adult patients. In our Phase 2 trial in adult patients which included patients as young as 25, clinical benefits were significantly higher in younger patients, which was expected based on the mechanism of action of GPS that is mediated via the immune system that is generally better preserved in younger patients, and even more so in children," Stergiou added.

AML prognosis with currently available treatments in the refractory and/or relapsed pediatric patient population remains poor. In a representative study, the 5-year overall survival (OS) rate in relapsed pediatric AML was 33% for all patients, and in patients whose remission lasted less than 12 months only 15.7%.

In patients who did not achieve complete remission after one course of chemotherapy, 5-year overall survival was 0%. About 50% of children with pediatric AML relapse. Generally, the only therapy considered curative in relapsed and refractory patients is a bone marrow transplant and the primary goal of chemotherapy is to achieve remission so that pediatric patients can be transplanted.