NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company specializing in cancer therapies with a market capitalization of $80.24 million, has announced encouraging new data from their Phase 2 clinical trial for the investigational drug SLS009. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, positioning it well for continued clinical development. The drug, a selective CDK9 inhibitor, is being studied for its effectiveness in treating patients with relapsed or refractory acute myeloid leukemia (r/r AML).
The latest results from the trial indicate that the median overall survival (mOS) for patients in the 30 mg BIW cohort has not yet been reached but now exceeds 7.7 months. This figure stands out against the historically expected mOS of approximately 2.5 months for patients in similar conditions.
Additionally, the overall response rate (ORR) in two expansion cohorts for patients with AML with myelodysplasia-related changes (AML MRC) reached 56%, surpassing the prespecified target response rate of 33%. These promising results have caught analysts' attention, with InvestingPro reporting that two analysts have recently revised their earnings expectations upward, with price targets ranging from $4 to $7.50 per share. These cohorts included patients with ASXL1 mutations and those with mutations and cytogenetic changes other than ASXL1.
As of December 4, 2024, 14 patients were enrolled in Cohort 3, with 14 more across Cohorts 4 and 5, out of which 9 were evaluable at the time of analysis. The drug has been well-tolerated with no new safety concerns noted as the trial progresses.
The Phase 2 clinical trial, an open-label, single-arm, multi-center study, aims to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine. The trial includes two dose levels, 45 and 60 mg, with patients in the 60 mg cohort randomized to receive either a 60 mg dose weekly or a 30 mg dose biweekly.
SELLAS emphasizes the rapid enrollment in the expansion cohorts, which underscores the urgent need for new treatments in this patient population. The results support the potential of SLS009 as a new therapeutic option for patients with limited alternatives.
The study also seeks to identify biomarkers for the target patient population to enrich further trials. For more information on the study, the clinical trial is registered with identifier NCT04588922.
SELLAS, focused on novel therapeutics for a broad range of cancer indications, continues to develop its lead product candidate, GPS, and SLS009, which may become the first in class CDK9 inhibitor with potential benefits over existing options. With a healthy current ratio of 2.26 and minimal debt-to-equity of 0.04, InvestingPro analysis suggests the company has adequate financial flexibility to advance its clinical programs. Subscribers can access 6 additional ProTips and comprehensive financial metrics to better evaluate SELLAS's investment potential.
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 been making significant strides in its research and development efforts. The U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to the company's immunotherapeutic agent, Galinpepimut-S (GPS), for treating pediatric acute myeloid leukemia. This designation signifies the potential of GPS to treat serious or life-threatening diseases affecting fewer than 200,000 people in the U.S, primarily children.
In addition, the company's drug SLS009 received the same designation for its potential in treating pediatric acute lymphoblastic leukemia. Clinical trials have shown promising results, with the Phase 1 trial demonstrating a 36.4% response rate in peripheral T-cell lymphoma patients, and the Phase 2a trial achieving a 57% overall response rate in acute myeloid leukemia patients.
SELLAS has also extended its lease agreement for its Times Square Tower headquarters through September 2026, maintaining its annual rent without changes. On the financial front, the company is set to raise approximately $21 million through a registered direct offering, with Maxim Group LLC serving as the placement agent. These funds are expected to support the company's ongoing research and development efforts. These are among the recent developments for SELLAS Life Sciences Group.
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