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.

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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.

"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)."

The study is planning to enrol about 30 patients and is being carried out at six sites.

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Imago BioSciences CEO Hugh Young Rienhoff said: "We are encouraged by the progress of this programme.  

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"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.