Creatv Bio's CAML Biomarker in Phase 3 Metastatic Breast Cancer Trial

Creatv Bio, a division of Creatv MicroTech, Inc., has announced the inclusion of its Cancer Associated Macrophage-Like (CAML) liquid biopsy biomarker in the pivotal Phase 3 trial of BriaCell Therapeutics Corporation's lead clinical candidate, Bria-IMT. This trial combines Bria-IMT with an immune checkpoint inhibitor to tackle metastatic breast cancer.

The study aims to enroll 404 patients across two arms: one receiving Bria-IMT combined with an immune checkpoint inhibitor, and the other receiving the treatment of physicians' choice. This is specifically for patients with late-stage metastatic breast cancer who have no alternative approved therapies. The trial is registered on ClinicalTrials.gov under the identifier NCT06072612. Notably, Bria-IMT has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).

In this study, blood samples are provided to Creatv for analysis. The focus is on detecting circulating tumor cells (CTCs), CAML subtyping, and monitoring PD-L1 upregulation. These samples are collected at the baseline and at a designated time after the initial treatment.

Creatv has previously shown that CAMLs can predict a cancer's aggressiveness and the likelihood of multi-organ metastasis. They also provide a universal diagnostic tool using blood instead of tissue, predict treatment response within about 30 days of starting a new therapy, detect minimal residual disease, and identify cancer recurrence.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio, emphasized the significance of biomarkers like CAMLs in helping clinicians determine a patient's response to a specific therapy in a timely manner. "We are looking forward to participating in this important trial with BriaCell and are confident that this biomarker will provide clinicians with a valuable tool to guide their treatment choices for cancer patients," remarked Dr. Tang.

Creatv Bio specializes in cancer screening and diagnostics, offering testing services to patients and supporting drug development from its CLIA/CAP-accredited laboratory in New Jersey. Creatv's scientists were pioneers in publishing findings on CAMLs in the blood of cancer patients back in 2014. Since then, CAMLs have been validated by numerous independent groups globally.

The company's involvement in the Phase 3 trial with BriaCell underscores the potential of CAMLs in the realm of cancer diagnostics and treatment. By providing crucial data on the presence of CTCs and the subtyping of CAMLs, Creatv aims to enhance the understanding of how metastatic breast cancer progresses and responds to therapy. This could lead to more personalized and effective treatment strategies for patients who currently have limited options.

In summary, Creatv Bio's participation in this pivotal trial highlights the promising role of CAMLs as biomarkers for assessing treatment response and disease progression in metastatic breast cancer. This collaboration with BriaCell Therapeutics marks a significant step forward in the quest to improve outcomes for patients facing this challenging condition.

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