CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026
Rhea-AI Summary
CytoDyn (OTCQB: CYDY) presented new Phase 2 data at AACR 2026 showing early clinical and biomarker activity for leronlimab combined with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer (mCRC).
Key findings: CCR5 expression in 100% of pre-screened cases (N=33), median ctDNA declines ~70% by week 2 (evaluable N=19), no leronlimab-related DLTs, and dose escalation to 700 mg underway.
Positive
- CCR5 expression detected in 100% of pre-screened mCRC cases (N=33)
- ctDNA median decline ~70% by week 2 in evaluable patients (N=19)
- No leronlimab-related DLTs observed; dose escalation to 700 mg underway
Negative
- Efficacy evidence limited to early biomarker changes in small cohorts (ctDNA evaluable N=19)
- Study not yet fully enrolled; clinical benefit in larger populations unconfirmed
News Market Reaction – CYDY
In the Apr 22 session, CYDY declined 8.85%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Ongoing Phase 2 study in metastatic colorectal cancer (mCRC) demonstrates early clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, supporting CCR5 as a therapeutic target
VANCOUVER, Washington, April 22, 2026 (GLOBE NEWSWIRE) -- 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.
Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.
Corporate Contact
CytoDyn Inc.
ir@cytodyn.com
Media Contacts
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com
