On December 5, 2020 Imago BioSciences, Inc., ("Imago") a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported interim data from 49 patients in its ongoing Phase 2b study evaluating bomedemstat (IMG-7289) for the treatment of myelofibrosis (Press release, Imago BioSciences, DEC 5, 2020, View Source [SID1234572241]). The data demonstrated sustained clinical activity and a favorable tolerability profile for the investigational treatment. The data were presented in an oral session by Kristen M. Pettit, M.D., assistant professor of medicine at the University of Michigan Rogel Cancer Center, during the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
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The interim results included an analysis of total symptom score (TSS) reduction at 12 weeks in 32 patients, with 78% of patients showing an improvement. In addition, 86% of patients evaluable (N=14) for spleen volume showed a reduction at 12 weeks. In this patient population in which 51% were classified as high molecular risk for evolution to AML, a serial analysis of mutant alleles revealed that 32% of patients experienced a decrease in the frequency of mutant alleles from baseline and 55% remained at stable frequencies. In patients followed for up to 570 days, no patient acquired new mutations in any of the 261 genes associated with myeloid malignancies and none to date have developed leukemia.
"As we continue to advance bomedemstat through Phase 2b clinical trials in myelofibrosis and essential thrombocythemia, we are encouraged by the interim results presented today," said Hugh Young Rienhoff, Jr. MD, CEO, Imago BioSciences. "There is a grave unmet need today among patients with myeloid diseases, and we look forward to realizing the promise of bomedemstat as a new therapeutic option with the potential to alter the natural history of these diseases."
Safety data were presented showing a total of 917 adverse events including 6 serious adverse events each occurring once deemed by Investigators as possibly related to IMG-7289. There have been no safety signals, dose-limiting toxicities, or deaths related to the drug.
About Bomedemstat (IMG-7289)
Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other therapeutic agents. Bomedemstat is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141, NCT04254978 and NCT04081220).
Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.
Bomedemstat is being evaluated in three open-label Phase 2 clinical trials for the treatment of advanced myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET), bone marrow cancers that interfere with the production of blood cells. MF patients who are resistant to a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat. ET patients who have failed one standard of care treatment are eligible for the bomedemstat ET study.