NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company engaged in developing cancer therapies, has received a favorable review from the Independent Data Monitoring Committee (IDMC) regarding its ongoing Phase 3 REGAL trial for the drug galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML). The trial will proceed without any changes, as the IDMC did not identify any safety or futility concerns after evaluating unblinded data from the study.
The REGAL trial is assessing the efficacy of GPS in AML patients who have achieved a complete remission following second-line salvage therapy. The primary outcome of the trial is overall survival. According to SELLAS, the IDMC's recent analysis suggests that the interim assessment, which is a significant milestone for the trial, is expected to occur by the fourth quarter of 2024.
Angelos Stergiou, MD, ScD hc, President and CEO of SELLAS, expressed confidence in the potential of GPS as a treatment option for AML, citing the positive review and the IDMC's recommendation. Panagiotis Tsirigotis, MD, a principal investigator at a high-enrolling REGAL study site, also conveyed optimism about the upcoming interim analysis and the possibility of expanding the use of GPS to other treatment settings.
GPS, the leading candidate in the trial, targets the WT1 protein commonly found in various tumor types and has potential as both a monotherapy and in combination with other treatments for a range of hematologic malignancies and solid tumors. SELLAS is also developing another candidate, SLS009, outside of Greater China.
The IDMC, composed of medical, scientific, and biostatistics experts, is tasked with ensuring the validity and integrity of the trial by periodically reviewing data related to safety, efficacy, and futility.
This news is based on a press release statement from SELLAS Life Sciences Group, Inc. and reflects the information provided therein. The company's forward-looking statements in the press release are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated.
In other recent news, SELLAS Life Sciences Group has reported significant developments in its clinical trials targeting acute myeloid leukemia (AML). The company released preliminary data from its Phase 2a trial of SLS009, achieving a 57% overall response rate, surpassing the targeted 20% rate.
All AML patients with ASXL1 truncating mutations responded to the treatment at the selected 30 mg bi-weekly dose and remain alive. SELLAS has expanded the trial to include cohorts with ASXL1 mutations and other myelodysplasia-related molecular abnormalities.
SELLAS also announced progress in its Phase 3 REGAL trial of galinpepimut-S (GPS) for AML patients. The Independent Data Monitoring Committee (IDMC) advised the company to continue the study without changes, after finding no safety concerns and deeming the efficacy data sufficient. The IDMC will reconvene earlier than initially scheduled for another assessment in June 2024.
These recent developments underscore SELLAS' commitment to advancing its AML treatment strategies. The company's CEO, Angelos Stergiou, MD, has expressed optimism about SLS009's potential to address unmet medical needs in AML and other tumor types harboring the ASXL1 mutation. Further updates on the trials are expected in Q3 2024.
InvestingPro Insights
As SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) continues to make strides in its REGAL trial for the drug galinpepimut-S, the company's financial health and stock performance offer a mixed picture. With a market capitalization of 86.63 million USD, SELLAS holds more cash than debt on its balance sheet, an InvestingPro Tip that could indicate a stable financial position to support ongoing clinical trials.
Still, the company is not currently profitable, with analysts not expecting profitability this year, and it has a negative operating income of -36.23 million USD over the last twelve months as of Q1 2024. The stock has also been volatile, with a Price / Book ratio of 8.95, suggesting a high valuation compared to the company's book value.
Despite these challenges, the stock has seen a strong return over the last three months, with a 36.36% price total return, and a significant uptick over the last six months at 30.43%. These figures could reflect investor optimism following positive developments in the company's clinical trials. Moreover, SELLAS's stock is currently trading at 78.37% of its 52-week high, with a previous close price of 1.5 USD.
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