SELLAS Announces FDA Rare Pediatric Disease Designation for SLS009 in Treating Pediatric Acute Lymphoblastic Leukemia

June 24, 2024 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a clinical-stage biopharmaceutical company dedicated to developing pioneering cancer therapies, has announced that the U.S. Food and Drug Administration (FDA) has awarded a Rare Pediatric Disease Designation (RPDD) to their product SLS009. This is a highly selective CDK9 inhibitor aimed at treating pediatric acute lymphoblastic leukemia (ALL), the most prevalent type of cancer in children.

Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS, expressed satisfaction with the FDA’s decision. “We are pleased that the FDA has granted Rare Pediatric Disease Designation to SLS009 for the treatment of pediatric ALL, the most common cancer diagnosed in children,” Stergiou noted. He emphasized the company's commitment to advancing SLS009 through the clinical stages for multiple indications, including pediatric ALL. This designation is anticipated to expedite the clinical development process, which is crucial for improving the lives of children and families struggling with ALL.

Pediatric ALL poses a significant threat, with a pressing need for effective treatments. Although there have been considerable advances in therapy for this cancer, relapse remains a frequent cause of treatment failure. Certain patient groups with high-risk and very-high-risk characteristics need less toxic treatment options to enhance their long-term event-free survival (EFS), which currently stands around 50% for very high-risk cases. Clinical trials have shown that SLS009 has a highly favorable safety profile, with no reported higher-grade non-hematologic toxicities.

The FDA grants Rare Pediatric Disease (RPD) Designation to treatments for severe or life-threatening diseases that affect fewer than 200,000 individuals in the U.S., primarily impacting those under 18. If SLS009’s New Drug Application (NDA) for pediatric ALL is approved, SELLAS could receive a Priority Review Voucher (PRV). This voucher can be used for prompt review of any future marketing application or sold to another sponsor. PRVs have recently been sold for about $100 million.

SELLAS is positioned as a late-stage clinical biopharmaceutical company that focuses on developing novel cancer therapies. Besides SLS009, SELLAS is working on another promising product, GPS, which targets the WT1 protein present in various tumors. Licensed from Memorial Sloan Kettering Cancer Center, GPS is being evaluated both as a standalone therapy and in combination with other treatments for a broad range of hematologic malignancies and solid tumors.

SLS009, formerly known as GFH009, is a potentially first and best-in-class differentiated small molecule CDK9 inhibitor. It promises reduced toxicity and enhanced potency compared to other CDK9 inhibitors. Preliminary data suggests a high response rate in AML patients with poor prognostic factors, such as the ASXL1 mutation, typically linked to unfavorable outcomes in various myeloid diseases.

SELLAS continues to push the boundaries in the field of cancer treatment, with its innovative therapies aimed at improving patient outcomes across different cancer types.