Chimeric Therapeutics expects a phase-1B clinical trial into its “natural killer” cell therapy for newly-diagnosed patients with acute myeloid leukemia (AML) to be open for new enrolments before the end of the year.
The study, which has received investigational new drug clearance from the United States Food and Drug Administration (FDA), is designed to enrol up to 20 patients who are not eligible for intensive chemotherapy or allogeneic stem cell transplant.
AML is the most common acute leukemia in adults, with a median diagnosis age of between 65 and 72 years. Despite treatment advances, patients who are not eligible for intensive chemotherapy or allogeneic stem cell transplant patients currently have limited therapeutic options.
The study is the first clinical trial to evaluate the synergy of Chimeric’s “CHM 0201 NK” cells in combination with the current standard of care that delivers Azacitidine and Venetoclax to AML patients. As the trial progresses beyond dose confirmation, it will also become the first to evaluate cellular therapy in newly-diagnosed AML patients.
The company’s off-the-shelf NK cell platform successfully demonstrated safety and efficacy during the phase-1A trial that was completed at the Seidman Cancer Centre in Ohio last year. Chimeric says the trial showed positive results, particularly in blood cancers, where all patients achieved disease control. One AML patient achieved a complete response that was sustained for more than two years at the time of publication.
As the trial draws closer, the company has been asked to present details of its study to some of the leading figures in the medical industry at the 2023 annual meeting of the American Society of Hematology in San Diego, California on December 11.
One of Chimeric’s key missions is to not just slow cancer’s progress, but cure it by developing cutting-edge cell therapy treatments aimed at killing the molecules that drive cancer cells and promote metastases. The company’s “Core-NK” platform aims to use off-the-shelf and then mass-produced cell therapy products from healthy donors, instead of the existing practice of using blood donated from a patient.
Management says data from the complete phase-1A clinical trial was published in March last year, demonstrating safety and efficacy in blood cancers and solid tumours.
Natural killer cells in humans can recognise and kill cancer cells, but they are often not robust or active enough to overcome the disease as it grows. Core-NK platform cells are made by activating and expanding natural killer cells to make them more active and robust, effectively “supercharging” them and letting them loose on their cancer-killing mission.
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