VANCOUVER, Washington — CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”), today announced that new clinical data from its ongoing Phase 2 study in metastatic colorectal cancer (mCRC) were presented at the AACR Annual Meeting 2026, taking place April 17–22, 2026, at the San Diego Convention Center.
The presentation highlighted findings supporting CCR5 inhibition with leronlimab as a strategy to modulate the tumor microenvironment, enhance immune engagement, and improve outcomes in metastatic colorectal cancer (mCRC), particularly in combination with standard-of-care therapies.
Metastatic colorectal cancer remains a significant clinical challenge, particularly in patients with refractory disease who have progressed on multiple prior lines of therapy. While standard regimens such as TAS-102 in combination with bevacizumab provide modest benefit, treatment resistance and immune evasion continue to limit durable responses. Results presented at AACR demonstrate that CCR5 inhibition with leronlimab may enhance anti-tumor activity by modulating the tumor microenvironment and improving immune engagement.
“Preliminary results from our ongoing Phase 2 study suggest that CCR5 inhibition with leronlimab may enhance both biomarker and clinical responses in heavily pretreated mCRC patients,” said Pashtoon M. Kasi, M.D., M.S., Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. “Real-time assessment of novel liquid biopsy biomarkers, including circulating tumor cells, circulating tumor DNA, and cancer-associated macrophage-like cells in blood, along with integrated evaluation of tumor tissue and the tumor microenvironment, is providing insights that conventional imaging and traditional assessment methods cannot capture.”
Key findings from the ongoing Phase 2 mCRC study include:
- Among pre-screened patients with evaluable samples (N=33), CCR5 expression was detected in 100% of cases, supporting its potential as a therapeutic target in mCRC.
- Early clinical and biomarker responses were observed, including rapid and substantial reductions in circulating tumor DNA (ctDNA), with median declines of approximately 70% by week 2 across evaluable patients (N=19).
- The combination regimen has been well tolerated, with no leronlimab-related dose-limiting toxicities (DLTs) observed, and escalation to 700 mg dosing underway.
- The study continues to enroll toward full enrollment, reflecting significant unmet need in previously treated mCRC.
“Building on the translational and clinical data presented earlier in the week in mTNBC, these findings further support CCR5 as a key regulator of the tumor microenvironment across solid tumors,” said Jacob P. Lalezari, M.D., Chief Executive Officer of CytoDyn. “The early biomarker and clinical signals observed in our ongoing Phase 2 mCRC study reinforce the potential of leronlimab-based combination approaches to enhance immune engagement and address resistance in heavily pretreated patients.”
The poster presentation titled “Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer” was presented by Dr. Kasi on April 21, 2026, from 2:00 p.m. – 5:00 p.m. PT (Poster #6466). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section.
About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.
For more information, please visit www.cytodyn.com and follow us on LinkedIn.
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