SELLAS Gets EMA Orphan Drug Status for SLS009 in Treating Peripheral T-cell Lymphomas

On August 6, 2024, SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a late-stage clinical biopharmaceutical company specializing in innovative cancer therapies, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009. This novel and highly selective CDK9 inhibitor is designed for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL).

Dr. Angelos Stergiou, President and CEO of SELLAS, expressed satisfaction with the EMA’s decision, stating that it marks a significant achievement following the U.S. Food and Drug Administration’s (FDA) earlier Orphan Drug and Fast Track Designations for SLS009 in PTCL. He emphasized that PTCL is a particularly aggressive form of lymphoma with limited treatment options, highlighting the urgent need for new therapies. According to Dr. Stergiou, the recognition of SLS009’s potential by both U.S. and European regulatory bodies across multiple indications—including acute myeloid leukemia (AML), pediatric AML, and pediatric acute lymphoblastic leukemia (ALL)—underscores SELLAS’s regulatory expertise. He anticipates that the development of SLS009 will progress, offering significant benefits to cancer patients.

In the completed dose-escalation phase of a Phase 1 trial targeting relapsed/refractory hematological malignancies, SLS009 exhibited favorable safety and tolerability profiles, along with promising clinical efficacy. The trial reported complete or partial responses in patients with AML and lymphoma, achieving a 36.4% response rate specifically among the PTCL patient group. Notably, one patient continued treatment for over 56 weeks. For comparison, belinostat, the current standard of care for r/r PTCL, demonstrated a 25.8% response rate in a similar patient population during its pivotal Phase 2 study.

Orphan Designation is awarded to treatments aimed at life-threatening or chronically debilitating diseases affecting fewer than five in 10,000 individuals in the European Union (EU), particularly where no satisfactory treatment exists. The therapy must offer significant benefits to those affected.

SELLAS, a company in advanced stages of clinical development, focuses on creating novel therapeutics for a diverse range of cancer indications. Another leading product in SELLAS’s portfolio is GPS, which is licensed from Memorial Sloan Kettering Cancer Center. GPS targets the WT1 protein, found in various tumor types, and shows potential as both a monotherapy and in combination with other treatments. It is designed to address a wide range of hematologic malignancies and solid tumors.

SLS009, formerly known as GFH009, represents a potentially first-in-class small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to existing CDK9 inhibitors. Preliminary data indicates that SLS009 has achieved a high response rate in AML patients with unfavorable prognostic factors, such as the ASXL1 mutation, which is often linked to poor outcomes in various myeloid diseases.

SELLAS continues to focus on advancing its clinical programs, driven by a commitment to delivering effective cancer therapies.