AML patient achieves Complete Response in CHM CORE-NK...

AML patient achieves Complete Response in CHM CORE-NK Combination Phase 1b trialSydney, Australia, 7 October 2024: Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), an Australian leader in cell therapy, is pleased to provide an update on the CHM CORE-NK + Vactosertib Phase 1b clinical trial, after a Complete Response from an Acute Myelogenous Leukemia (AML) patient participating in the trial.The ongoing Phase 1b study is building upon the clinical activity seen in the initial CHM CORE-NK Phase 1a clinical trial by adding Vactosertib, an oral TGF-β receptor inhibitor that was designed to disrupt the inhibitory TGF-β signaling pathway. 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. This trial is being led by Dr Eva Selfridge at UH Seidman Cancer Center in Ohio. Chimeric COO 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 CORENK + Vactosertib combination.” The patient will continue on study and be monitored for up to 15years, 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. This new result is in addition to the previous result from the Phase 1a clinical trial announced on 16 May 2024, where a different patient in that trial also achieved a complete response that hasnow been sustained for 48 months(was 15months complete response at time of the initial CORENK study publication).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. CHM CORE-NK was previously studied in a Phase 1a clinical trial that established safety with no GvHD (Graft versus Host Disease), prolonged NK cell persistence at 28 days, and an encouraging early efficacy signal, particularly in blood cancers where all patients achieved disease control. The Phase 1b study (clinicaltrials.gov/study/NCT05400122 ) is designed to treat 12 patients with either locally advanced/metastatic colorectal cancer or relapsed/refractory blood cancers. An overview of the study is attached.The Phase 1b study is funded without financial support from Chimeric Therapeutics; CHM CORENK is manufactured at a cost to Chimeric and supplied for the clinical trial. The company confirms that this trial is unblinded with one participant in the blood cancer arm to date. The complete response was determined by the absence of cancer through standard laboratory testing. The combination therapy is administered intravenously on day 1. Updates will be provided when all subjects are enrolled and the data is collated. ABOUT the CHM CORE NK PlatformThe CHM CORE NK platform is a Clinically validated, Off the shelf, Robust and Enhanced NaturalKiller (NK) cell platform. The platform uses a novel, proprietary genetically-modified feeder cellline to activate and expand universal off-the-shelf allogeneic NK cell products derived fromhealthy donors. The expanded CORE-NK cells exhibit enhanced cytotoxicity, metabolism, andexpression of activating receptors compared to fresh, activated NK cells. From the CORE-NKplatform, Chimeric is developing next generation NK and CAR NK assets with plans for phase 1 clinical trials in solid tumours and blood cancers.