Chimeric Therapeutics’ CHM 0201 and standard care drugs to transform AML treatment in new clinical study

Cell therapy company Chimeric Therapeutics (ASX: CHM) has confirmed the first patient in a Phase 1B clinical trial to treat acute myeloid leukemia (AML) has been dosed with CHM 0201 in combination with current standard of care drugs.

The ADVENT-AML clinical trial is an investigator-initiated study currently open to enrolment at the MD Anderson Cancer Centre within the University of Texas.

It will be conducted under principal investigator Abhishek Maiti MD, who is also assistant professor for the university’s Department of Leukemia.

It is believed to be the first clinical trial to evaluate NK cell therapy in combination with standard of care drugs Azacitidine and Venetoclax.

The study will recruit up to 20 subjects with newly-diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant.

It will follow a dose confirmation cohort assessing the safety of the novel combination treatment in subjects with relapsed or refractory AML.

Provision and partial funding

Under the terms of the clinical trial agreement with MD Anderson, Chimeric will provide the CHM 0201 drug and partial funding for the study.

It will also be supported by grant funding from multiple sources including the US-based Gateway for Cancer Research.

Chimeric has already completed manufacturing and release testing of CHM 0201 cells for the trial.

Manufacturing took place at a laboratory owned by Cellular Therapy Integrated Services within Case Western Reserve University in Ohio where the cells were originally developed.

Trial progress

Chimeric chief medical officer Jason Litten MD said he was pleased with the trial’s progress so far.

“We are very happy to report this progress in the ADVENT-AML clinical trial,” he said.

“We believe the novel combination of CHM 0201 with the standard of care in AML treatment has the potential to transform frontline therapy and enhance outcomes for AML patients.”

Best-in-class platform

Experts have identified CHM 0201 as a potentially best-in-class, clinically-validated NK cell platform.

Data from a completed Phase 1A clinical trial was published in March 2022, demonstrating safety and efficacy in blood cancers and solid tumours.

The success of that trial paved the way for a planned Phase 1B clinical trial investigating CHM 0201 in combination with IL2 and Vactosertib.

Chimeric is using the CHM 0201 platform to initiate development of new next-generation NK and CAR NK assets.