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SELLAS Life Sciences Announces First Patients Enrolled in 60 mg Dose Cohort in Phase 2a Clinical Trial of SLS009 in Acute Myeloid Leukemia
- Enrollment Completed in 45 mg Safety Cohort; Safety Monitoring Committee Advocated Proceeding to Recommended Phase 2 Dose Level of 60 mg - - Patients in 60
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- Enrollment Completed in 45 mg Safety Cohort; Safety Monitoring Committee Advocated Proceeding to Recommended Phase 2 Dose Level of 60 mg - - Patients in 60 mg Dose Cohort Will be Dosed with 60 mg Once per Week or 30 mg Twice per Week - - Early Data in 45 mg and 60 mg Cohort Expected Around Year-End 2023 - NEW YORK, Dec. 14, 2023 (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 announced that the first patients have been enrolled in the 60 mg dose cohort in its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies. A total of nine patients have been enrolled at the 45 mg safety dose level. Eight patients remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment. The first enrolled patient achieved a complete response and is currently in the seventh month of treatment and the second enrolled patient is in the sixth month of treatment. Significant anti-leukemic effects (≥50% decrease in bone marrow blasts) were observed during treatment in five out of six assessable patients with no significant safety issues to date. No dose limiting toxicities (DLT) were observed in any of the patients. Topline data for the 45 mg cohort are expected around year-end 2023. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival (mOS) of approximately 2.5 months. “We are thrilled with the Safety Monitoring Committee advocating that we proceed to the recommended Phase 2 dose level of 60 mg after finding no safety concerns with the 45 mg cohort, which represents important progress in the clinical advancement of SLS009. Based on the encouraging efficacy data and safety profile that continues to emerge in the Phase 2a trial, we remain excited about the potential for SLS009 as a promising treatment option for the many AML patients with poor prognosis and limited alternatives currently available once th...