NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a $95 million market cap biopharmaceutical company engaged in developing cancer therapies, has released data from its Phase 2 trial of SLS009 in patients with relapsed/refractory acute myeloid leukemia (AML). According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $4.00 to $7.50, significantly above its current trading price. The company announced that the trial's Cohort 3 results showed a median overall survival (mOS) of 8.9 months in patients with AML-myelodysplasia-related changes (AML-MRC) and 8.8 months in all patients resistant to venetoclax-based regimens. While the clinical results are promising, InvestingPro analysis shows the company maintains a favorable cash position with more debt than cash on its balance sheet, supporting its ongoing research efforts.
This outcome significantly exceeds the historical benchmark of 2.5 months mOS for similar patient profiles. The study also reported an overall response rate (ORR) of 67% in patients with AML-MRC, surpassing the targeted 20% ORR.
Cohort 3 of the trial included 14 patients who had previously not responded to venetoclax-based therapies. Of these patients, 71% had AML-MRC, and a subset presented with a myelomonocytic phenotype, which typically exhibits lower response rates to venetoclax-based treatments.
The trial participants had a median age of 71 and had undergone a range of one to six prior therapies. Out of 14 patients, 13 were evaluable for efficacy, all of whom had adverse risk cytogenetics per ELN 2022. The response rate was notable across various genetic mutations, with 75% of patients with myelomonocytic AML responding to the treatment.
SELLAS emphasized that SLS009 was well-tolerated with no new safety concerns observed. The Phase 2 trial is ongoing, with additional cohorts being enrolled to further assess the drug's potential in addressing unmet medical needs in AML treatment.
The trial is designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels. With the aim of identifying biomarkers for the target patient population, the study continues to expand, including cohorts with ASXL1 mutated AML patients and those with myelodysplasia-related molecular abnormalities other than ASXL1.
The full data and feedback on the FDA regulatory path for SLS009 are expected in the first half of 2025, with the next earnings report scheduled for May 8, 2025. The information reported is based on a press release statement from SELLAS Life Sciences Group, Inc. For deeper insights into SELLAS's financial health and growth prospects, including additional ProTips and detailed metrics, investors can access comprehensive analysis through InvestingPro.
In other recent news, SELLAS Life Sciences Group, Inc. announced promising results from a Phase 2a trial of SLS009 in combination with zanubrutinib for relapsed/refractory Diffuse Large B-Cell Lymphoma, showing a 67% overall response rate. Additionally, the company has secured $25 million through a registered direct offering, with plans to use the proceeds for working capital and potential acquisitions. Meanwhile, the Independent Data Monitoring Committee recommended the continuation of SELLAS's Phase 3 REGAL trial for GPS in Acute Myeloid Leukemia without modifications, despite a negative market reaction. The company also amended severance agreements for two top executives, ensuring stability during potential corporate changes. Furthermore, SELLAS highlighted upcoming clinical milestones for 2025, including interim analysis of its REGAL study and full topline data from its Phase 2 trial of SLS009. The company received multiple regulatory designations for its therapies in 2024, reflecting the significant unmet medical needs they aim to address. These developments underscore SELLAS's focus on advancing its clinical stage portfolio and achieving key milestones.
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