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Chimeric Therapeutics set to trial groundbreaking AML cell therapy

By - December 19, 2023

Chimeric Therapeutics (ASX: CHM) has successfully completed the good manufacturing practice (GMP) test to support the company’s ADVENT-AML Phase 1B clinical trial.

Under that trial, Chimeric’s off-the-shelf universal donor natural killer (NK) cell therapy will be evaluated in combination with standard-of-care therapy for patients with newly-diagnosed acute myeloid leukemia (AML).

AML is a cancer of the bone marrow and the blood that progresses rapidly without treatment. Around 1,130 new cases of AML are estimated to have been diagnosed in Australia in 2022.

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CHM 0201 has been named as a potentially best-in-class, clinically validated NK cell platform. Data from a phase 1A clinical trial published in March 2022 demonstrated safety and efficacy in blood cancers and solid tumours.

Based on the promising activity signal demonstrated in that trial, an additional Phase 1B clinical trial investigating CHM 0201 in combination with IL2 and Vactosertib is now underway.

The CHM 0201 NK cells were manufactured and developed at the cellular therapy integrated services laboratory at Case Western Reserve University in Cleveland, USA.

Cells on their way to Texas

Following the completion of the GMP test, the CHM 0201 NK cells are now in transit to the MD Anderson Cancer Centre at the University of Texas for initiation of the phase 1B clinical trial.

The cells will be studied in combination with standard-of-care therapy Azacitidine and Venetoclax in the ADVENT-AML Phase 1B clinical trial.

Up to 20 subjects with newly-diagnosed AML ineligible for intensive chemotherapy or allogeneic stem cell transplant are allowed to enrol in the phase 1B clinical trial.

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

New study a first

The ADVENT-AML study will be the first to evaluate the synergy of NK cell therapy in combination with the current standard of care for AML patients.

It is being conducted under the direction of principal investigator Abhishek Maiti MD, assistant professor in the Department of Leukemia at MD Anderson.

The trial has received Food and Drug Administration IND and MDACC IRB clearance and is scheduled to begin enrolment in late 2023 with only nominal funding from Chimeric.

“MD Anderson is a global leader in cancer research with one of the largest clinical programs for the management of patients with AML in the United States,” Chimeric chief executive officer Jennifer Chow said.

“We are very pleased to be able to support the ADVENT-AML trial with the manufacturing and release of CHM 0201 NK cells as we believe that the novel combination of CHM 0201 and Azacitidine and Venetoclax has the potential to significantly enhance the outcomes for AML patients.”

Cell therapy pioneer

Chimeric Therapeutics is an Australian leader in cell therapy, which is focused on bringing the promise of cell therapy to life for more patients with cancer.

The company’s diversified portfolio includes first-in-class autologous CAR T cell therapies and best-in-class allogeneic NK cell therapies.

Chimeric’s assets are being developed across multiple different disease areas in oncology with three clinical programs currently in progress and plans to open more in 2023.