SELLAS Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia (AML) who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009. No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of a 75 mg once-a-week dose cohort, which is planned to be the highest dose level for that group.

“We are very encouraged by the strong efficacy signals and safety profile of our highly selective CDK9 inhibitor, GFH009, observed in this positive Phase 1 trial. We believe GFH009 could have the potential to address a major unmet medical need of patients with AML who relapse following treatment,” said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO of SELLAS. “We are highly motivated to expedite advancement of GFH009 with our upcoming Phase 2a trial, in order to potentially bring this novel treatment to AML patients who need it as quickly as possible.”

“I am very much looking forward to participation in the Phase 2a clinical trial of GFH009,” said M. Yair Levy, MD, the Director of Hematologic Malignancies research at Texas Oncology Baylor Charles A. Simmons Cancer Center in Dallas, TX. “Although venetoclax is a backbone of many AML treatments, some patients do not respond to treatment and many relapse after initial response. CDK9 inhibition in general, and GFH009 in particular with the AML data seen thus far, has a strong biological basis of synergy with the BCL2 inhibitor venetoclax and we hope that it may overcome leukemic cell resistance in the upcoming trial, given that it appears that MCL-1 upregulation plays a key role in developing venetoclax resistance and we have seen in the Phase 1 trial that GFH009 decreases MCL-1 levels.”

The Company is finalizing the comprehensive data analysis to determine the recommended Phase 2 dose (RP2D) in AML, which will be announced following review by the U.S. Food and Drug Administration (FDA). SELLAS plans to commence a Phase 2a clinical trial during the second quarter of 2023 with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML who relapsed after or are refractory to treatment with venetoclax based therapies. The trial will be a single arm open label dose ranging study with one dose level at the RP2D and one dose below RP2D. Primary endpoints will be complete response composite (CRc) rate and safety, and secondary endpoints will include duration of response (DOR), event free survival (EFS), overall survival (OS) and proportion of patients proceeding to transplant. The trial will include several sites in the United States, will initially enroll approximately 20 patients and, based on initial results, may be expanded into a registrational trial. Topline data from this study are expected in the fourth quarter of 2023.

 

Source: globenewswire.com

Report Abuse