SELLAS Life Sciences Group, Inc. - SLS STOCK NEWS

SELLAS Life Sciences Group announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a selective CDK9 inhibitor, for treating acute myeloid leukemia (AML).

This designation follows positive preliminary Phase 2 data and aligns with the previous FDA ODD. The designation provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.

SLS009 is currently in a Phase 2a clinical trial evaluating its safety and efficacy. The trial targets a 20% response rate and a median survival over three months, focusing on patients with specific myelodysplasia-related mutations.

SELLAS Life Sciences has received Rare Pediatric Disease Designation (RPDD) from the FDA for its drug SLS009, targeting pediatric acute lymphoblastic leukemia (ALL), the most prevalent cancer among children.

This designation makes SLS009 eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be sold, historically fetching around $100 million.

SLS009 is a selective CDK9 inhibitor that has shown a favorable safety profile in clinical trials, with no high-grade non-hematologic toxicities.

The RPDD recognizes the critical need for new treatments in pediatric ALL, where relapse rates remain high, particularly in high-risk groups.

SELLAS aims to expedite the clinical development of SLS009, offering potential new treatment options for children with ALL and improving their long-term event-free survival (EFS).

SELLAS Life Sciences (NASDAQ: SLS) announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL trial in acute myeloid leukemia (AML). The IDMC advised the trial to continue without modifications, citing no safety or futility concerns. The IDMC's review of unblinded data indicated a high level of confidence that an interim analysis will occur by Q4 2024. This recommendation strengthens SELLAS' confidence in GPS (galinpepimut-S) as a potential AML treatment. The REGAL trial targets AML patients in complete remission post-second-line salvage therapy, with the primary endpoint being overall survival.

SELLAS has completed enrollment for its Phase 2a trial of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML) ahead of schedule. The trial includes 30 patients who have not responded to venetoclax-based regimens.

Initial results show promising efficacy with an overall response rate (ORR) of 33% and 50% in the 60 mg QW and 30 mg BIW dosing cohorts, respectively. Median overall survival (OS) was 5.4 months at the 45 mg QW dose, significantly higher than the 2.5 months standard of care. Notably, patients with ASXL1 mutations in the 30 mg BIW cohort achieved a 100% ORR. The trial will now proceed with two additional cohorts focusing on patients with specific genetic mutations, with further updates expected in Q3 2024.

SELLAS Life Sciences (SLS) announced its Q1 2024 financial results, highlighting significant clinical and financial milestones. The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL study without modifications and confirmed the completion of patient enrollment. Positive Phase 2 data for SLS009 in AML patients showed a 100% response rate in those with the ASXL1 mutation at a 30 mg BIW dose. Financially, R&D expenses decreased to $5.1 million, while G&A expenses rose slightly to $4.5 million. The net loss narrowed to $9.6 million, with cash reserves at $18.4 million.

SELLAS Life Sciences Group, Inc. announces positive Phase 2 preliminary data of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML), achieving a 100% response rate in patients with ASXL1 mutation at the optimal dose level. The company has filed IP protection related to the ASXL1 mutation, showing a highly significant market potential. SLS009 exhibits strong anti-leukemic activity with a favorable safety profile across all dose levels. Study enrollment is ongoing, with updates expected in Q3 2024.

SELLAS Life Sciences Group, Inc. announced a positive review by the Independent Data Monitoring Committee (IDMC) of the Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC recommended the trial continue without modifications based on efficacy and safety data, with the next assessment scheduled for June 2024. The trial aims to develop a novel therapy for AML patients who have achieved complete remission following second-line salvage therapy, with overall survival as the primary endpoint.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported positive results from the Phase 2a study of SLS009 in r/r AML, showing a 50% response rate in the selected optimal dose of 30 mg BIW, exceeding the targeted 20%. The company completed enrollment in the Phase 3 REGAL study of Galinpepimut-S in AML, with a potential imminent interim analysis. SLS009 also demonstrated promising results in relapsed/refractory peripheral T-cell lymphoma patients, with top-line data expected in the first half of 2024.

GenFleet Therapeutics collaborates with BeiGene Switzerland for a combination study in DLBCL patients, aiming to provide innovative therapies for relapsed/refractory cases. The agreement involves a phase Ib/II trial of GFH009 and BRUKINSA® targeting DLBCL, a prevalent form of non-Hodgkin's lymphoma in China. The trial marks the first combination study by a Chinese biotech in this field, with promising results from previous trials of GFH009 in other lymphomas.