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NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a $127 million market cap biopharmaceutical company specializing in cancer therapies, presented preclinical data at the American Association for Cancer Research (AACR) indicating that its drug candidate SLS009 may provide a new treatment option for Acute Myeloid Leukemia (AML) with TP53 mutations. The company, which InvestingPro analysis shows has delivered a 34% return year-to-date, maintains a strong balance sheet with more cash than debt. The research presented on Monday suggests that SLS009, a CDK9 inhibitor, effectively targets proteins involved in cancer cell survival, leading to a significant reduction in TP53-mutated leukemia cells.
The preclinical studies showed that SLS009, both as a monotherapy and in combination with azacitidine-venetoclax, reduced leukemia cell populations by up to 97%, offering a potential breakthrough for patients with a historically poor prognosis. According to Dr. Angelos Stergiou, President and CEO of SELLAS, the drug’s ability to overcome resistance in TP-53 driven leukemia, coupled with positive Phase 2 clinical trial data, could represent a significant advancement in AML treatment. Analysts tracking the company maintain a strong buy consensus, with price targets ranging from $4 to $7.50 per share. (InvestingPro subscribers can access 10+ additional investment insights about SELLAS.)
SELLAS’s ongoing Phase 2 trials have revealed encouraging survival rates among relapsed or refractory AML patients treated with SLS009. The median overall survival (mOS) reached 8.8 months across all patients, with specific genetic mutation subsets responding at even higher rates.
Dr. Phillip Amrein from Massachusetts General Hospital highlighted the urgent need for effective treatments for TP53-mutated leukemias, noting that the preclinical findings support the potential of CDK9 inhibition to restore sensitivity to existing therapies.
The company is continuing its Phase 2 study, aiming to evaluate the safety and efficacy of SLS009 in combination with standard chemotherapy and to identify biomarkers for patient selection in future trials. The study’s details are available on clinicaltrials.gov under the identifier NCT04588922.
SELLAS emphasizes its commitment to developing novel therapeutics for a broad range of cancer indications, with its lead product candidate, GPS, and SLS009 at the forefront of its pipeline.
This article is based on a press release statement from SELLAS Life Sciences Group, Inc.
In other recent news, SELLAS Life Sciences Group, Inc. reported significant findings from its Phase 2 trial of SLS009 for relapsed/refractory acute myeloid leukemia (AML). The trial’s Cohort 3 showed a median overall survival of 8.9 months in patients with AML-myelodysplasia-related changes, surpassing the historical benchmark of 2.5 months. The trial also achieved a 67% overall response rate in patients with AML-MRC, notably higher than the targeted 20%. Additionally, SELLAS announced promising results from a Phase 2a trial of SLS009 combined with Brukinsa® for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL), with a 67% overall response rate. In another development, the company secured $25 million through a registered direct offering, involving the sale of approximately 19.7 million shares and warrants. The proceeds are intended for working capital and general corporate purposes, including potential future acquisitions. A.G.P./Alliance Global Partners led the offering, with Maxim Group LLC as co-placement agent. These recent developments reflect SELLAS’s ongoing efforts in advancing cancer treatment options.
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