Imago BioSciences, Inc. (“Imago”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that the first participant has been dosed in an investigator-sponsored Phase 1 study of bomedemstat, an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor, in combination with venetoclax (Venclexa®) in patients with relapsed or refractory acute myeloid leukemia (AML).
Venetoclax is a BCL-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of several hematologic cancers, including in combination with azacytidine for elderly patients with AML unable to tolerate the standard of care.
The Phase 1 open-label study is being conducted at the University of Miami, led by Terrence J. Bradley, M.D. It will enroll approximately 18 adult participants diagnosed with AML who have failed at least one standard, front-line therapy and will assess the safety and efficacy of bomedemstat in combination with venetoclax (VenBom therapy). This combination regimen consists of once daily, oral administration of both bomedemstat and venetoclax. Participants will receive three cycles of the treatment, and may continue to receive treatment as long as they experience clinical benefit or until disease progression.
“This study is the first clinical study grounded on the pre-clinical work by Dr. Sheng Cai demonstrating that this combination had the potential to offer a unique benefit to patients with AML who have limited treatment options,” said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. “We are very pleased that such an experienced team as that at the University of Miami has initiated this trial.”
In ongoing Phase 2 studies, bomedemstat has been generally well-tolerated and has demonstrated significant symptom improvement for patients with myelofibrosis and essential thrombocythemia. Additional information about the study can be found at www.clinicaltrials.gov using the identifier NCT05597306.