Sellas Life Sciences announces initial topline Phase 2a data of SLS009

SELLAS Life Sciences announced positive initial topline data at the 45 mg dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies. Topline data for the recommended Phase 2 dose is expected later this quarter. 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. All patients enrolled were alive at the time of their last follow-up and four continue treatment. Anti-leukemic effects have been observed in all patients without any significant safety issues to date. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival of approximately 2.5 months. “This initial outcome that includes a complete response, anti-leukemic activity in all patients, good safety profile across the patients and indications of extended survival for our enrolled patients still continuing treatment, we believe opens multiple registrational opportunities for SLS009. We will be exploring these options in the coming weeks as we treat patients with the recommended Phase 2 dose, 60 mg, in this study,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “While these results are early, they are extremely encouraging and consistent with the Phase 1 study results, and further strengthen our initial proposition that the addition of CDK9 inhibition in combination with BCL-2 inhibition and hypomethylating agents could provide patients with a triple hit to increase response rates and survival outcomes without sacrificing safety and tolerability due to the specificity of SLS009. We look forward to providing additional updates this quarter from this study.”