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SELLAS Announces Positive Phase 1 Data with CDK9 Inhibitor GFH009 Monotherapy in Patients with Relapsed/Refractory Hematologic Malignancies
GFH009 is First CDK9 Inhibitor Monotherapy to Achieve Compete Response in Acute Myeloid Leukemia Anticancer Effects Observed Across Multiple Dose Levels in
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"GFH009 is First CDK9 Inhibitor Monotherapy to Achieve Compete Response in Acute Myeloid Leukemia Anticancer Effects Observed Across Multiple Dose Levels in Both Acute Myeloid Leukemia and Lymphoma Patients No Dose Limiting Toxicities Observed at Any Dose Level to Date Biomarkers of CDK9 Activity Decreased in 97.6% of Patients NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (\"SELLAS\" or the “Company”), today announced positive results from its ongoing dose escalating Phase 1 first-in-human study of its highly selective CDK9 inhibitor, GFH009, in patients with relapsed and/or refractory (r/r) hematologic malignancies. Results include preliminary safety and efficacy data presented this week at the American Society of Hematology (ASH) Annual Meeting, along with updated data since the ASH abstract cutoff date of August 2, 2022. One patient treated with GFH009, in the 30 mg once per week cohort, achieved a confirmed complete response (CR), which is the first CR reported in acute myeloid leukemia (AML) with any CDK9 inhibitor monotherapy. No minimal residual disease (MRD) was detected in this CR patient and full neutrophil, platelet and red blood cell recovery was reported. Anti-cancer effects were also observed at multiple dose levels in both the r/r AML and r/r lymphoma treatment groups. Neutrophil counts improved in most patients from both groups while on treatment, and drug-related severe neutropenias were observed in less than 10% of enrolled patients. Dose limiting toxicities have not been identified at any of the levels studied to date and the maximum tolerated dose has not yet been reached. “We are excited to see a CR with GFH009 in a r/r AML patient who had failed all previous lines of therapy, including azacytidine-venetoclax combination, and we were also encouraged that a second patient in the same dosing cohort continued on GFH009 treatment for three months with good health status. These encouraging initial data, with efficacy seen across multiple dose levels, support the potential of GFH009 as a treatment option in AML and lymphoma patients where almost all approved therapies have failed,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The compelling safety profile even at high dose levels, and significant tumor burden reduction even at lo...