SELLAS Announces Positive Initial Topline Data in Acute Myeloid Leukemia Patients
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) has announced positive initial topline data from 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.
SLS009 is the first CDK9 inhibitor in combination with AZA/VEN to achieve a complete response in AML patients resistant to venetoclax combination therapies. Anti-leukemic effects have been observed in all patients without any significant safety issues to date.
Dr. Omer Jamy, a principal investigator in the study and Assistant Professor of Medicine at the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) and Associate Director of the Bone Marrow Transplant Program at UAB, said, “This outcome may represent a long-awaited breakthrough in treating patients refractory to venetoclax combination therapies after multiple lines of treatment. Based on what we have seen to date in this Phase 2a study of SLS009, we have managed to reverse this resistance to therapy and, equally important, extend survival in addition to a very good safety profile and quality of life. I hope to see continuation of this pattern in other patients enrolled later.”
Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.
The Phase 2a clinical trial of SLS009 is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels, 45 mg and 60 mg, in combination with aza/ven. In addition to safety and tolerability of SLS009 in combination with aza/ven, the primary endpoints are composite complete response rate (CRc) and duration of response (DOR).
A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level.
The first patient enrolled in the study achieved a complete response, remains alive and is currently in the fifth month of treatment after relapsing on venetoclax, and the second patient is alive and in the fourth month of treatment.
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.
SELLAS stated that the study’s results open up multiple registrational opportunities for SLS009.
About SELLAS Life Sciences
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ 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 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.