SELLAS Announces Positive Phase 2 Preliminary Data of SLS009 in r/r AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation At the Optimal Dose Level

- The Company Filed IP Protection Related to the ASXL1 Mutation, a Highly Prevalent Gene Mutation in Myeloid Malignancies and Solid Tumors With Significant Market Potential –

- 100% Overall Response Rate in Patients with ASXL1 Mutation in the SLS009 30mg BIW Cohort to Date, All Patients Alive: Further Support for Potential Accelerated Approval Pathway in Defined Patient Population –

- SLS009 Exhibits Strong Anti-Leukemic Activity in 62% of Patients with a Favorable Safety Profile Across All Dose Levels and 67% in the 30 mg BIW Cohort –

- Study Enrollment Ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation Patients; Updates Expected in Q3 2024 –

NEW YORK, May 01, 2024 (GLOBE NEWSWIRE) -- 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 announces the preliminary data from Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) and successful filing of a provisional patent application around the ASXL1 mutation and SLS009, including all CDK9 inhibitor drugs. ASXL1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.

SELLAS has observed a high rate of responses in patients with myelodysplasia-related molecular mutations, as defined by the World Health Organization (WHO). Among all myelodysplasia-related mutations, those in the ASXL1 gene accounted for most responders across all dose cohorts. SELLAS has now expanded the ongoing Phase 2 r/r AML study to include two additional cohorts, one with ASXL1 mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1.

“These early clinical results are very promising and could open up a new avenue in the treatment of AML and potentially beyond,” said Joshua Zeidner, MD, Associate Professor of Medicine, Chief of Leukemia Research, Associate Chief of Research in the Division of Hematology, Director of Clinical Cancer Research Commercial Integration at the University of North Carolina Lineberger Comprehensive Cancer Center and the study’s principal investigator. “ASXL1 is a relatively common mutation in AML which leads to poor outcomes with conventional therapies. There are no known targeted therapies that are effective for these AML patients. I am extremely hopeful that SLS009 will make an impact in the management of patients with ASXL1-mutated AML and potentially other myeloid malignancies with similar disease biology.”