SLS - Sellas Life Sciences gains after leukemia therapy gets FDA fast track status

2024-01-09 09:36:27 ET

Sellas Life Sciences ( NASDAQ: SLS ) shares gained over 5% on Tuesday after the biopharmaceutical company received the U.S. Food and Drug Administration (FDA) fast track designation for its relapsed/refractory (r/r) acute myeloid leukemia (AML) treatment.

SLS009 (formerly GFH009) is a novel and highly selective CDK9 inhibitor currently being evaluated in an open-label, single-arm, multi-center Phase 2a study in patients with relapsed or refractory AML.

The initial positive topline Phase 2a data at the 45 mg (safety) dose level demonstrate that SLS009 in combination with venetoclax and azacitidine (aza/ven) exhibits anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies.

As of the last follow-up, eight of the nine patients enrolled in the 45mg cohort were alive, with significant antileukemic effect observed in 87.5% of evaluable patients.

The company expects to report additional data from the fully enrolled 45mg (safety dose level) cohort and initial data from the 60mg (recommended Phase 2 dose level) cohort in the first quarter of 2024 and expects the 60mg cohort to be analyzed in the second quarter of 2024.

More on SELLAS Life Sciences

• SELLAS Life Sciences announces pricing of $9M public offering
• SELLAS Life Sciences announces launch of proposed public offering
• Seeking Alpha’s Quant Rating on SELLAS Life Sciences
• Historical earnings data for SELLAS Life Sciences
• Financial information for SELLAS Life Sciences

For further details see: