Creatv Bio's LifeTracDx Blood Test Supports CytoDyn's Phase 2 Colorectal Cancer Trial
Key Insights
Creatv Bio (search) has initiated a collaboration with CytoDyn (search) to provide its LifeTracDx liquid biopsy test as an exploratory biomarker in a Phase 2 study evaluating leronlimab combination therapy for metastatic colorectal cancer (search).
The Phase 2 study is enrolling 60 participants with relapsed/refractory metastatic colorectal cancer (search) to evaluate leronlimab combined with TAS-102 and bevacizumab, with objective response rate as the primary endpoint.
LifeTracDx uses circulating tumor cells and Cancer Associated Macrophage-Like cells to monitor PD-L1 (search) expression changes, with prior studies showing leronlimab induced PD-L1 expression in 88% of metastatic breast cancer patients.
Creatv Bio (search) has announced a collaboration with CytoDyn (search) Inc. to provide its LifeTracDx liquid biopsy test as an exploratory biomarker in CytoDyn's Phase 2 study evaluating leronlimab combination therapy in patients with relapsed/refractory metastatic colorectal cancer (search) (mCRC). The partnership represents a significant application of liquid biopsy technology to monitor treatment response in real-time during oncology clinical trials.
Phase 2 Study Design and Objectives
CytoDyn (search)'s Phase 2 study (NCT06699836) is currently enrolling 60 participants with relapsed/refractory metastatic colorectal cancer (search). The trial evaluates the efficacy of leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5 (search)-positive, refractory, microsatellite-stable metastatic colorectal cancer over a 12-month treatment period.
The study's primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a confirmed complete or partial response per RECIST v1.1. Participants will undergo LifeTracDx blood testing at multiple time points throughout the trial to evaluate numeric increases in PD-L1 (search) expression across the patient population.
LifeTracDx Technology and Biomarker Monitoring
LifeTracDx utilizes both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells as sensitive markers for real-time monitoring of tumor response to treatment. CAML cells are macrophages that engulf tumor cells and provide pharmacokinetic changes of both CCR5 (search) and PD-L1 (search) from the tumor microenvironment.
The liquid biopsy test has demonstrated the ability to monitor PD-L1 (search) expression changes at baseline and through sequential sampling after therapy induction, potentially identifying patients who have upregulated PD-L1 expression in their tumors. This capability supports the assessment of whether leronlimab can convert "cold" tumors into "hot," PD-L1-positive tumors.
Previous Clinical Evidence
Prior studies have shown promising results for leronlimab's ability to modulate the tumor immune microenvironment. In metastatic breast cancer patients, leronlimab induced PD-L1 (search) expression on CTCs and CAMLs in 88% of patients treated at doses above 525 mg/week. These findings reinforce the proposed mechanism by which CCR5 (search) blockade can enhance tumor responsiveness to checkpoint blockade therapy.
Changes observed in circulating atypical CAMLs further support leronlimab's role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint inhibitors.
Laboratory Expansion and Drug Development Support
Creatv Bio (search) has recently opened a state-of-the-art CLIA-certified laboratory in Monmouth Junction, New Jersey, expanding its capabilities to support pharmaceutical drug development and clinical trial testing. The facility enables the company to offer comprehensive liquid biopsy services to companies developing oncology therapeutics.
According to Dr. Cha-Mei Tang, President and CEO of Creatv Bio (search), "The opening of our CLIA Laboratory now enables us to offer a fully equipped facility to deliver rapid, reliable analyses to our pharmaceutical partners. This is a major step forward in accelerating cancer drug development."
The LifeTracDx test offers several advantages for cancer drug development, including early treatment response monitoring, improved patient selection for trials, companion diagnostic development, real-time biomarker expression monitoring, and PD-L1 (search) expression measurement for immunotherapy applications. CAMLs have been shown to be detectable in the blood of most cancer patients across all malignancy subtypes and can predict treatment response to most therapies within 30-45 days following drug administration.