Creatv Bio Announces Its CAML Biomarker Included In Pivotal Phase 3 Trial In Metastatic Breast Cancer

Creatv Bio, a Division of Creatv MicroTech, Inc. (Creatv) announced that its Cancer Associated Macrophage-Like (CAML) liquid biopsy biomarker has been included as part of the pivotal Phase 3 trial of BriaCell Therapeutics Corporation's lead clinical candidate, Bria-IMT in combination with an immune checkpoint inhibitor in metastatic breast cancer.

This study is expected to enroll a total of 404 patients in two arms – Bria-IMT in combination with an immune checkpoint inhibitor versus treatment of physicians' choice in late-stage metastatic breast cancer patients, with no approved alternative therapies available (listed on ClinicalTrials.gov as NCT06072612). Bria-IMT was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).

Blood samples are being provided to Creatv to analyze for the presence of circulating tumor cells (CTCs), CAML subtyping, and to monitor PD-L1 upregulation in patients. The samples are being taken at baseline and at a designated time following the initial patient treatment.

Creatv previously demonstrated that CAMLs can accurately (i) predict a cancer's aggressiveness as well as multi-organ metastasis, (ii) provide a universal companion diagnostics tool using blood instead of tissue from patients, (iii) predict treatment response within approximately 30 days of receiving a new therapy in any solid tumor type, (iv) detect minimal residual disease, and (v) cancer recurrence.

"The use of biomarkers like CAMLs holds great promise in helping clinicians determine whether a patient is responding to a specific therapy in a timely manner," remarked Dr. Cha-Mei Tang, President and CEO of Creatv Bio. "We are looking forward to participating in this important trial with BriaCell and are confident that as a result, this biomarker will provide clinicians with a valuable tool to guide their treatment choices for cancer patients."