Immune-Onc Therapeutics has announced data from the dose escalation part of the Phase I trial of IO-202, a IgG1 monoclonal antibody, for the treatment of acute myeloid leukaemia (AML) and chronic myelomonocytic leukaemia (CMML).

Evaluating the tolerability and safety of IO-202 in successive cohorts of relapsed or refractory (R/R) AML and CMML patients is the primary objective of the open-label, multicentre study.

The clinical response rate of IO-202 as a single agent and in combination with azacitidine (AZA), as well as the assessment of the pharmacokinetics, immunogenicity, and pharmacodynamic biomarker effects are included as secondary and exploratory objectives.

IO-202 was found to be well-tolerated with no dose-limiting toxicities and a maximum tolerated dose was not reached.

One AML patient treated in the monotherapy cohorts achieved a partial response while one CMML patient demonstrated clinical benefit for more than a year.

Complete Remission has been achieved in an AML patient with high LILRB4 expression treated in the combination therapy cohorts and will be ongoing for over ten months.

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Three of five CMML patients in these cohorts achieved clinical benefits, including optimal marrow response.

Immune-Onc chief medical officer Paul Woodard said: “Based on the data, we have developed a patient enrichment strategy for the ongoing dose expansion Phase of the study to select AML patients who would most likely respond to IO-202.

“We are also pleased to receive the FDA Fast Track designation for IO-202 for the treatment of R/R CMML, which follows the R/R AML Fast Track designation received in 2022.

“We look forward to working closely with the FDA and trial investigators to accelerate the clinical development of IO-202 in hematologic malignancies.”