NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company specializing in cancer therapies, announced today that its investigational drug, SLS009, has been granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric acute lymphoblastic leukemia (ALL), a common cancer in children.
The RPDD is awarded to drugs that treat serious or life-threatening diseases affecting fewer than 200,000 people in the U.S., with the condition primarily affecting individuals under 18 years of age. This designation may expedite the development and review of SLS009 and, if approved, SELLAS could be eligible for a Priority Review Voucher (PRV). PRVs can be used to receive a priority review for any subsequent marketing application and may be sold or transferred to other parties. Historically, PRVs have been sold for an average of more than $100 million.
Dr. Angelos Stergiou, President and CEO of SELLAS, expressed the company's commitment to advancing the clinical development of SLS009 and improving the lives of children and families affected by ALL. Despite advances in treatment, relapse remains a significant challenge in pediatric ALL, with a particularly high unmet medical need for less toxic therapies that can extend long-term event-free survival, especially in high-risk subpopulations.
SLS009, a highly selective CDK9 inhibitor, has shown a favorable safety profile in clinical trials, with no higher-grade non-hematologic toxicities reported to date. The company also highlighted the potential of SLS009 to address a broad spectrum of hematologic malignancies and solid tumors as both monotherapy and in combination with other therapies.
The information in this article is based on a press release statement from SELLAS Life Sciences Group, Inc.
In other recent news, SELLAS Life Sciences Group has reported significant progress in its acute myeloid leukemia (AML) clinical trials. The biopharmaceutical company's Phase 2a trial of SLS009, targeting specific genetic mutations linked to poor patient outcomes, achieved a 57% overall response rate. Notably, all AML patients with ASXL1 truncating mutations at the selected 30 mg bi-weekly dose have responded to the treatment and remain alive. SELLAS has expanded the trial and filed a provisional patent application related to the ASXL1 mutation and SLS009, which encompasses all CDK9 inhibitor drugs.
Simultaneously, the company's Phase 3 REGAL trial of galinpepimut-S (GPS) for AML patients continues as advised by the Independent Data Monitoring Committee (IDMC). The IDMC found no safety concerns and deemed the efficacy and safety data sufficient to continue the study. SELLAS has completed enrollment for this trial across the US, Europe, and Asia. The primary endpoint of the trial is overall survival for AML patients who have achieved complete remission following second-line salvage therapy.
These are among the recent developments for SELLAS, which is considering initiating discussions with the U.S. Food and Drug Administration regarding an accelerated approval pathway for SLS009. Further updates on these trials are expected in the third quarter of 2024.
InvestingPro Insights
As SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) garners attention with its recent Rare Pediatric Disease Designation, investors are closely monitoring the financial health and market performance of the company. SELLAS, with a market capitalization of $70.46 million, is navigating the biopharmaceutical landscape with a focus on innovative cancer therapies. According to InvestingPro data, the company holds a Price / Book ratio of 7.28 as of the last twelve months leading up to Q1 2024, indicating a valuation that is higher relative to the company's net asset value.
InvestingPro Tips reveal that SELLAS maintains more cash than debt on its balance sheet, a sign of financial stability that could support its ongoing research and development efforts. However, the company faces challenges with weak gross profit margins and is not expected to be profitable this year. Additionally, the stock has experienced significant price volatility and has not been profitable over the last twelve months. These financial nuances are critical for potential investors to consider, especially as the company progresses through the costly clinical trial phases.
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