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NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a small-cap biotech company with a market capitalization of $137 million specializing in cancer therapies, has announced the initiation of treatment for the first pediatric patient in a Phase 2 trial of SLS009 for relapsed/refractory acute myeloid leukemia (r/r AML). The company’s stock has shown strong momentum, gaining over 45% year-to-date. The trial expansion to include pediatric patients underscores SELLAS’s focus on addressing unmet medical needs in hematologic conditions, particularly for those with limited treatment options.
The Phase 2 clinical trial is evaluating the safety, efficacy, and tolerability of SLS009, a selective CDK9 inhibitor, in combination with venetoclax and azacitidine. The study includes patients who have not responded to conventional therapies, including those with multi-hit TP53 mutations, azacitidine and venetoclax treatment failure, post-transplant relapse, and resistance to high-intensity chemotherapies. According to InvestingPro data, SELLAS maintains a healthy financial position with more cash than debt and a current ratio of 4.64, providing adequate resources for its clinical programs.
SELLAS was granted the FDA Rare Pediatric Disease Designation (RPDD) for SLS009’s use in treating pediatric AML in July 2024. This designation could provide a pathway to a Priority Review Voucher (PRV) if a New Drug Application (NDA) for the drug is approved. PRVs can expedite the review process for subsequent marketing applications and are a valuable asset, having been sold for around $100 million in recent transactions.
The open-label, single-arm, and multi-center study aims to achieve a target response rate of 20% and a median survival of at least three months. Additionally, the trial seeks to identify biomarkers to enrich further studies. Information on the trial can be found on clinicaltrials.gov under the identifier NCT04588922.
SELLAS’s lead product candidate, GPS, targets the WT1 protein found in various tumor types and has potential as a monotherapy or in combination with other treatments. SLS009, also in development, could become a differentiated small molecule CDK9 inhibitor with a favorable toxicity profile and increased potency compared to existing CDK9 inhibitors.
This news is based on a press release statement and reflects the company’s ongoing efforts in the field of oncology drug development. While InvestingPro analysis shows analyst price targets ranging from $4 to $7.50, suggesting significant upside potential, investors should note that the company is not currently profitable. The forward-looking statements in the press release involve risks and uncertainties, and actual results may differ materially from those projected. SELLAS does not commit to updating any forward-looking statements post the date of the original statement. InvestingPro subscribers have access to 8 additional key insights about SELLAS, including detailed financial health metrics and growth indicators.
In other recent news, SELLAS Life Sciences Group, Inc. has reported promising results from its ongoing Phase 2 trials of SLS009 for treating acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). The company’s Phase 2 trial for AML showed a median overall survival (mOS) of 8.9 months in patients with AML-myelodysplasia-related changes, significantly surpassing the historical benchmark of 2.5 months. The trial also achieved an overall response rate (ORR) of 67% in patients with AML-MRC, exceeding the targeted 20% ORR. In a separate Phase 2a trial for DLBCL, SLS009 in combination with Brukinsa® demonstrated a 67% overall response rate, notably higher than the rate for zanubrutinib alone.
The DLBCL study reported a disease control rate of 83%, with one patient achieving a complete response. SELLAS emphasized that SLS009 was well-tolerated in both trials, with no new safety concerns observed. The company continues to enroll additional cohorts to further assess the drug’s potential, particularly in patients with specific genetic mutations. SELLAS remains committed to advancing its clinical development programs to address unmet medical needs in cancer treatment.
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