Australian cell therapy company Chimeric Therapeutics (ASX:CHM) has announced that a patient with Acute Myelogenous Leukemia has recorded a complete response in its Phase 1b CHM CORE-NK and Vactosertib combination.
The company said the ongoing Phase 1b study builds upon the clinical activity in the initial CHM CORE-NK Phase 1a clinical trial by adding vactosertib, an oral TGF-β receptor inhibitor.
The trial is the first ever to assess NK cells in combination with Vactosertib in patients with advanced colorectal and blood cancers. This is the first and currently only patient treated in the blood cancer arm of the Phase 1b trial.
Dr Eva Selfridge at UH Seidman Cancer Center in Ohio leads this trial.
Chimeric chief operating officer Dr Rebecca McQualter said, “As the study continues to enrol subjects with advanced cancer, we are pleased to see the clinical combination can be delivered safely, and we are very happy to report that one study subject with advanced Acute Myelogenous Leukemia (AML) experienced a Complete Response at Day 28 after starting treatment with the CHM CORE-NK + Vactosertib combination.” The patient will continue on study and be monitored for up to 15 years, a standard FDA requirement for all cell therapy trials. 3 patients are currently enrolled in the Phase 1b study with the goal to enrol 12 patients.
Chimeric said the new result is in addition to the previous result from the Phase 1a clinical trial, where a different patient also achieved a complete response that has now been sustained for 48 months.
CHM CORE-NK is a universal, off-the-shelf NK cell therapy manufactured with the CORE-NK platform, which can produce hundreds of doses in a single manufacturing run.