... but generally the trial patients had lines of treatments...

... but generally the trial patients had lines of treatments before they were eligible for CHM / IMU trials.

Sydney, Australia, 13 September 2023: Chimeric Therapeutics (ASX:CHM, “Chimeric” or the
“Company”), an Australian leader in cell therapy, today announced the execution of a clinical
study agreement with The University of Texas MD Anderson Cancer Center to support the
“ADVENT-AML” Phase 1B study, in which Chimeric’s off-the-shelf universal donor NK cell
therapy CHM 0201 will be evaluated in combination with standard of care therapy for patients
with newly diagnosed Acute Myeloid Leukemia (AML).
The ADVENT-AML (NCT05834244) study is designed to enroll up to 20 subjects with newly
diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell
transplant, following completion of a dose confirmation cohort assessing the safety of this
novel combination treatment in subjects with relapsed or refractory AML.
ADVENT-AML will be the first trial to evaluate the synergy of NK cell therapy in combination
with the current standard of care of Azacitidine with Venetoclax (AZA-VEN). As the trial
progresses beyond dose confirmation, it will also be the first trial to evaluate cellular therapy in
newly diagnosed AML patients.
The study, which has received IND clearance by the FDA and is expected to open to enrollment
at MD Anderson by year end 2023, will be led by Principal Investigator Abhishek Maiti MD,
Assistant Professor in the Department of Leukemia at MD Anderson.
Acute Myeloid Leukemia (AML) is the most common acute leukemia in adults with a median
age at diagnosis between 65-72 years. Despite treatment advances, patients who are not
eligible for intensive chemotherapy or allogeneic stem cell transplant patients have limited
therapeutic options. Outcomes for these high-risk subgroups are poor with median overall
survival (mOS) of 6 to 9 months in the newly diagnosed setting1 and 2.4 months for patients
with relapse or refractory disease². Consequently, novel therapies are urgently needed to
improve outcomes for patients with AML.
“This exciting new clinical trial aligns with the emerging evidence that cell therapies provide the
best clinical outcomes in the earliest line of treatment,” said Jason B Litten, MD, Chief Medical
Officer of Chimeric Therapeutics.
“By combining CHM 0201 with the current standard of care for AML patients we may be able to
significantly enhance the outcomes for these patients.”
Under the terms of the clinical study agreement, Chimeric will provide CHM 0201 study drug as
well as partial financial support for study. In addition to the modest financial support from
Chimeric, the study will be supported by grant funding from multiple funding sources including
Gateway for Cancer Researc