US-based pharmaceutical company Imago BioSciences has begun enrolment for its Phase I/II study of IMG-7289 to treat high-risk acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS).
The Phase I/II study is being conducted to test the safety and determine the pharmacokinetics, pharmacodynamics profile and anti-neoplastic activity of IMG-7289.
The Phase I portion of the study will use both the dose-escalation and duration-extension cohorts to test IMG-7289 as a single agent and IMG-7289 in combination with all-trans retinoic acid (ATRA).
Patients will be enrolled into the Phase II expansion arm to evaluate the longer-term anti-tumour activity exhibited by IMG-7289.
The study is planning to enrol about 30 patients and is being carried out at six sites.
Imago BioSciences CEO Hugh Young Rienhoff said: "We are encouraged by the progress of this programme.
"This study will provide us with valuable data on the safety, biomarker effects and activity of this novel agent both alone and in combination with all-trans retinoic acid (ATRA).
"In non-clinical models, IMG-7289 has demonstrated potent anti-tumour activity against neoplastic myeloid cells, especially AML cells. These effects were synergised in combination with ATRA."
Imago BioSciences has developed IMG-7289 as a small molecule designed to inhibit lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme considered vital in cancer stem cells, particularly malignant bone marrow cells.
IMG-7289 has exhibited in-vivo anti-tumour efficacy in non-clinical studies across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents.