NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company specializing in cancer therapies, has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its drug SLS009, intended for the treatment of relapsed/refractory peripheral T-cell lymphomas (PTCL), an aggressive form of lymphoma with few current treatment options.
The designation follows similar acknowledgments by the U.S. Food and Drug Administration, which granted Orphan Drug and Fast Track Designations for SLS009 in PTCL. "This additional orphan drug designation...highlights our strong internal regulatory expertise," said Angelos Stergiou, MD, President and CEO of SELLAS.
Data from the completed Phase 1 trial of SLS009 in relapsed/refractory hematological malignancies showed a 36.4% response rate in PTCL patients, with one patient continuing treatment for over 56 weeks. This compares favorably to the current standard of care, belinostat, which demonstrated a 25.8% response rate in its pivotal study.
Orphan Drug Designation in the EU is given to treatments for rare, life-threatening, or chronically debilitating diseases affecting no more than five in 10,000 persons, where no satisfactory therapy exists. The treatment must also provide significant benefit to those affected.
SELLAS, apart from SLS009, is also developing other cancer treatments, including GPS, targeting the WT1 protein found in various tumor types. The company's focus remains on advancing its clinical programs to benefit cancer patients.
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 is set to raise approximately $21 million through a registered direct offering. The deal involves the sale of over 15 million shares and equal warrants to an unnamed institutional investor. The offering, priced at a premium to the market, sets the combined price for each share and accompanying warrant at $1.325. Maxim Group LLC is serving as the sole placement agent. The funds raised are expected to support the company's ongoing research and development efforts.
In terms of clinical developments, SELLAS has made significant strides in its clinical trials for acute myeloid leukemia (AML) and pediatric acute lymphoblastic leukemia (ALL). The company's investigational drug, SLS009, was granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric ALL.
This could potentially make SELLAS eligible for a Priority Review Voucher (PRV). Furthermore, the company's Phase 2a trial of SLS009 achieved a 57% overall response rate, prompting an expansion of the trial and the filing of a provisional patent application related to the ASXL1 mutation and SLS009.
SELLAS's Phase 3 REGAL trial of galinpepimut-S (GPS) for AML patients continues as advised by the Independent Data Monitoring Committee (IDMC). These are among the recent developments for SELLAS, with further updates on these trials expected in the third quarter of 2024.
InvestingPro Insights
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has recently achieved a significant regulatory milestone with the Orphan Drug Designation for its promising cancer therapy, SLS009. As investors consider the implications of this development, certain financial metrics and expert analyses from InvestingPro offer a more comprehensive picture of the company's current market position.
InvestingPro Data reveals a market capitalization of approximately $74.38 million, underscoring the company's status as a smaller player in the biopharmaceutical industry. Despite the potential of SLS009, SELLAS's financial performance indicates challenges, with an operating income adjusted for the last twelve months as of Q1 2024 at a negative $36.23 million and a return on assets of -133.77%. These figures reflect the high costs and risks associated with drug development, especially for companies focused on treating rare diseases.
An InvestingPro Tip highlights the company's financial prudence, noting that SELLAS holds more cash than debt on its balance sheet, which is a positive sign for its ability to fund ongoing research and trials without over-leveraging. However, another InvestingPro Tip points out that analysts do not expect the company to be profitable this year, which is not uncommon for clinical-stage biopharmaceutical companies that have yet to bring a product to market.
Investors may also note the stock's volatility, with a six-month price total return showing a large uptick of 70.74%, contrasting with a one-year price total return at -24.18%. This fluctuation could be indicative of the market's response to the various stages of clinical trial results and regulatory news.
For those interested in a deeper dive into SELLAS's financial health and future prospects, additional InvestingPro Tips are available at https://www.investing.com/pro/SLS, providing a more nuanced understanding of the investment opportunities and risks associated with the company.
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