SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML

2024-06-11

研发

临床2期临床结果

- 30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule -

- Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively -

- 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet -

- 100% Overall Response Rate in Patients with ASXL1 Mutation in the 30 mg BIW Cohort to Date -

- Trial Continues with Two Expansion Cohorts of Patients with ASXL1 Mutations and Myelodysplasia-Related Molecular Mutations Other Than ASXL1; Additional Update Expected in Q3 2024 -

June 10, 2024 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

“We are pleased to announce the completion of enrollment in the initial portion of our Phase 2a trial representing a significant milestone in the development of SLS009 in AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the AML patient population previously treated with venetoclax-based regimens. We are extremely grateful to everyone who has helped us achieve this important milestone ahead of schedule.”

Dr. Stergiou continued: “In addition, we are excited to share very promising initial data from this Phase 2a trial. Efficacy was demonstrated across all cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS) of 3 months. The results also showed that SLS009 was well-tolerated across all doses. These data give us increased confidence in SLS009 as a potential new treatment for AML. We remain committed to advancing the treatment landscape for this underserved patient population and we look forward to continuing the trial, mainly the expansion cohorts, and reporting additional study updates and data in Q3 of this year.”

Thirty heavily pretreated patients were recruited in 5 centers across the US, reflecting the high unmet need of this refractory/relapsed patient population. Except for one, all patients in this Phase 2a trial had unfavorable/poor cytogenetic and/or molecular genetics risk (97%) and were treated with continued venetoclax – azacytidine combination therapy after having failed it or similar venetoclax combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months.

The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

About SELLAS Life Sciences Group, Inc.

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ other lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com.

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