Imago BioSciences announced the Phase 1/2a clinical trial of IMG-7289 for the treatment of high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) has fully enrolled at 45 patients. This study assessed the safety, pharmacokinetics, pharmacodynamics and anti-neoplastic activity of IMG-7289, an inhibitor of the epigenetic enzyme lysine-specific demethylase.

"We are extremely grateful to have worked with terrific investigators and staff that enrolled and cared for a population of patients in great need of therapeutic options," said Hugh Young Rienhoff, Jr. M.D., Imago’s Chief Executive Officer. "This study generated a wealth of knowledge about the pharmacokinetics, pharmacodynamics, and safety profile of our LSD1 inhibitor IMG-7289 as a single agent and in combination with ATRA. This study provides very clear guidance on how to use IMG-7289 at a variety of doses and in a variety of indications."

Upon the successful completion of the Phase 1 multiple ascending dose portion of the trial assessing IMG-7289 as a single agent, the study progressed into the Phase 2a expansion arm which evaluated the combination treatment regimen of IMG-7289 plus ATRA for extended dosing durations. Treatment of the final 2a expansion cohort remains ongoing.

IMG-7289 is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and shown to be vital in sustaining self-renewal in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies and models of myeloproliferative neoplasms as a single agent and in combination with other therapeutic agents. IMG-7289 also shows activity against solid tumors in combination with other agents in non-clinical models.

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