NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company specializing in cancer therapies, announced today that its drug candidate SLS009 has been granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric acute myeloid leukemia (AML). This follows a previous Orphan Drug and Fast Track Designation for the same drug in treating AML.
The RPDD for SLS009 marks the second such recognition for SELLAS, with the first granted for the treatment of pediatric acute lymphoblastic leukemia last month. SLS009 is a CDK9 inhibitor that has shown potential in addressing the needs of children with AML, particularly those with treatment-resistant mutations.
AML is a significant health concern, being the second most common hematological malignancy in children and often associated with a poor prognosis. Current treatments offer a limited chance of long-term survival, especially for those who relapse or do not achieve complete remission after initial chemotherapy. SELLAS's ongoing Phase 2 clinical trial has now opened enrollment for pediatric AML patients, aiming to improve treatment outcomes.
The RPDD is awarded to drugs that treat serious or life-threatening diseases affecting fewer than 200,000 people in the U.S., with manifestations primarily in individuals under 18 years of age.
If SLS009 is approved, SELLAS may receive a Priority Review Voucher (PRV), which expedites the review of a subsequent marketing application and can be sold to other companies. PRVs have been sold for approximately $100 million in recent transactions.
SELLAS's development pipeline also includes other candidates, such as GPS, licensed from Memorial Sloan Kettering Cancer Center, targeting the WT1 protein in various tumor types. SLS009, in particular, has demonstrated promising response rates in AML patients with unfavorable prognostic factors, including the ASXL1 mutation.
This information is based on a press release statement from SELLAS Life Sciences Group, Inc. The company cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.
In other recent news, SELLAS Life Sciences Group has been granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for its investigational drug, SLS009, aimed at treating pediatric acute lymphoblastic leukemia. This designation could expedite the development and review of SLS009 and potentially make SELLAS eligible for a Priority Review Voucher.
In addition, SELLAS's Phase 2a trial of SLS009, targeting specific genetic mutations linked to poor patient outcomes in acute myeloid leukemia, achieved a 57% overall response rate. The company has expanded the trial and filed a provisional patent application related to the ASXL1 mutation and SLS009.
Furthermore, SELLAS's Phase 3 REGAL trial of galinpepimut-S for acute myeloid leukemia patients is continuing as advised by the Independent Data Monitoring Committee, which found no safety concerns and deemed the efficacy and safety data sufficient to continue the study. The company has completed enrollment for this trial across the US, Europe, and Asia.
The primary endpoint of the trial is overall survival for 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 FDA regarding an accelerated approval pathway for SLS009. Further updates on these trials are expected in the third quarter of 2024.
InvestingPro Insights
In light of SELLAS Life Sciences Group, Inc.'s recent developments with its drug candidate SLS009, InvestingPro data provides a financial perspective on the company's market position. SELLAS, with a market capitalization of 62.95 million USD, is navigating the biopharmaceutical industry with a focus on cancer therapies.
Despite the potential clinical advancements, the company's financial metrics reflect certain challenges. The company's Price / Book ratio, as of the last twelve months leading up to Q1 2024, stands at a high 6.5, suggesting that the stock may be valued richly in relation to the company's net asset value. Furthermore, SELLAS's stock has experienced significant volatility, as evidenced by a 1-week price total return of -7.63% and a 1-month price total return of -27.33%.
InvestingPro Tips highlight some key considerations for investors. SELLAS holds more cash than debt, which could provide some financial flexibility in advancing its clinical trials. However, analysts are not expecting the company to be profitable this year, and the stock has shown a considerable decline over the past month.
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