On March 4, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv") reported the initiation of a collaboration with CytoDyn Inc. of Vancouver, Washington ("CytoDyn") to provide its’ LifeTracDx liquid biopsy test to support a Phase 2 study evaluating CytoDyn’s leronlimab in combination with TAS-102 and Bevacizumab in previously treated patients with relapsed/refractory metastatic Colorectal Cancer (mCRC).
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CytoDyn’s Phase 2 study in mCRC (NCT06699836), now underway, is enrolling 60 participants who will be tested with the LifeTracDx blood test at multiple-time points over the course of the trial. Collected under the study protocol as an exploratory biomarker, Creatv Bio’s LifeTracDx Blood Test will be used to evaluate numeric increases in PD-L1 expression across the patient population. 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, evaluating the efficacy of leronlimab in combination with trifluridine and tipiracil plus bevacizumab in patients with CCR5-positive, refractory, microsatellite-stable metastatic colorectal cancer (mCRC) over a 12-month treatment period.
LifeTracDx uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response to all forms of treatment and provides pharmacokinetic changes of both CCR5 and PD-L1 from the tumor microenvironment.
In prior studies, leronlimab induced PD-L1 expression on CTCs and CAMLS in 88% of metastatic breast cancer patients treated at doses above 525 mg/week, reinforcing the proposed ability of CCR5 blockade to convert "cold" tumors into "hot," PD-L1–positive tumors. In addition, changes observed in circulating atypical CAMLs further support leronlimab’s role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint blockade.
Creatv Bio has demonstrated that monitoring the expressions of PD-L1 using the LifeTracDx blood test at baseline, followed by sequential sampling after induction of therapy, may identify patients who have upregulated PD-L1 expression in their tumors.
(Press release, CytoDyn, MAR 4, 2026, View Source [SID1234663263])