Chimeric Therapeutics begins innovative therapy trial for acute myeloid leukaemia
Australian cell therapy specialist Chimeric Therapeutics (ASX: CHM) has opened the door for enrolment in its international trial of a potential treatment for acute myeloid leukaemia (AML).
The phase 1B ADVENT-AML clinical trial is to be conducted at the University of Texas (UT) MD Anderson Cancer Centre.
It will evaluate Chimeric’s off-the-shelf universal donor NK cell therapy CHM 0201 in combination with standard-of-care therapy for patients with newly-diagnosed AML.
The trial is an investigator-initiated study under principal investigator Abhishek Maiti MD, assistant professor in the Department of Leukemia at UT.
This is the first trial of a potential synergy of NK cell therapy in combination with the current standard-of-care, Azacitidine and Venetoclax.
The study is designed to enrol up to 20 subjects with newly-diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant, following an initial dose confirmation cohort assessing the safety of this novel combination treatment in subjects with relapsed or refractory AML.
“We are very excited that the ADVENT AML clinical trial is now open to enrolment as it marks a first and important milestone in the investigation of NK cells in combination with current AML standard-of-care therapy,” said Jennifer Chow, Chimeric’s chief executive officer and managing director.
“With the high unmet medical needs in AML and the promising synergy demonstrated with NK cells in combination with Azacitidine and Venetoclax, this trial has potential to significantly enhance outcomes for AML patients.”
Multiple funding participants
Under the terms of the clinical trial agreement with MD Anderson, Chimeric will provide the CHM 0201 drug as well as partial financing for the study, which is also being supported by grant funding from multiple sources including Gateway for Cancer Research.
Experts have identified Chimeric’s CHM 0201 as a potentially best-in-class, clinically validated NK cell platform.
Data from the complete phase 1A clinical trial was published in March 2022, demonstrating safety and efficacy in blood cancers and solid tumors.
The success of that trial has paved the way for the 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.
Major Australian impact
The Leukaemia Foundation says over 4,600 Australians are living with blood cancer, the vast majority of whom face significant emotional challenges after their blood cancer diagnosis and that every year thousands are left in the dark about treatment and available support.
Chimeric currently has a wide portfolio that includes first-in-class autologous CAR T cell therapies and best in class allogeneic NK cell therapies.
The company’s assets are being developed across multiple different disease areas in oncology with three clinical programs currently underway and more planned.