CytoDyn Presents Novel CCR5 Inhibition Mechanisms and Long-Term Survival Signals for Leronlimab in Metastatic Breast Cancer at AACR Immuno-Oncology Conference
MWN-AI** Summary
CytoDyn Inc. recently presented groundbreaking findings regarding its investigational drug, leronlimab, at the AACR Immuno-Oncology Conference held in Los Angeles. Leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, shows potential across several cancers, including metastatic triple-negative breast cancer (mTNBC) and metastatic colorectal cancer (mCRC). The company highlighted new preclinical, translational, and clinical data supporting leronlimab's potential to improve treatment outcomes for mTNBC patients.
The key focus of the presentation was the mechanisms by which CCR5 blockade may address immune checkpoint resistance in TNBC. Findings suggest that leronlimab can modulate pathways tied to T-cell exhaustion and the regulation of PD-L1, which is pivotal for the efficacy of immune checkpoint inhibitors (ICIs). A significant correlation was observed between CCR5 expression and markers of T-cell activity and exhaustion in various TNBC patient datasets, indicating that targeting this receptor could enhance immune responses.
In addition to theoretical insights, clinical data was also presented. Among a pooled retrospective analysis of 28 heavily pretreated mTNBC patients, leronlimab exhibited a favorable safety profile with no severe adverse effects, and notable long-term survival signals were observed, with 17.9% of patients remaining alive after more than 63 months of follow-up.
Dr. Jacob Lalezari, CEO of CytoDyn, emphasized that the alignment of mechanistic and clinical findings strengthens the case for advancing leronlimab, notably in combination immunotherapy strategies. As CytoDyn continues its development of leronlimab, the data presented at AACR provides an optimistic outlook for its role in treating challenging cancers like mTNBC.
MWN-AI** Analysis
CytoDyn Inc. (OTCQB: CYDY) has recently garnered attention following its presentation of promising data surrounding leronlimab, a monoclonal antibody targeting the CCR5 receptor, at the AACR Immuno-Oncology Conference. With encouraging results in heavily pretreated metastatic triple-negative breast cancer (mTNBC) patients and a favorable safety profile, investors might want to consider the implications of this data on CytoDyn’s stock performance.
The findings suggest that leronlimab actively modulates the tumor immune microenvironment, enhancing immune responses through the regulatory pathways of PD-L1 and T-cell exhaustion. This mechanism could address the significant challenge posed by immune checkpoint resistance, particularly in a patient demographic that has limited treatment options. The retrospective analysis highlights that 17.9% of patients remain alive after over five years, a compelling signal for the longevity of leronlimab’s efficacy.
From a market perspective, CytoDyn's stock may experience volatility as investors react to ongoing developments, such as further trials assessing the combined use of leronlimab with immune checkpoint inhibitors (ICIs). The current landscape of oncology treatments heavily favors therapies providing personalized and lasting responses, making a nuanced understanding of leronlimab's role essential for potential investors.
However, it’s crucial to approach CytoDyn with caution, as the biotechnology sector is often fraught with uncertainties, especially surrounding clinical trial results and regulatory approvals. Macroeconomic conditions and market sentiment can also impact stock performance significantly.
In conclusion, while CytoDyn represents a potentially high-reward investment opportunity, it should be weighed against the inherent risks in clinical-stage companies. Investors should stay abreast of upcoming results while assessing the broader market environment before making significant investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Leronlimab-mediated CCR5 blockade modulates T-Cell exhaustion pathways and PD-L1 Biology relevant to ICI response
Durable Clinical Observations and Favorable Safety Profile Observed in Heavily Pretreated mTNBC Patients
VANCOUVER, Washington, Feb. 20, 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 preclinical, translational, and clinical data supporting leronlimab’s proposed role in the treatment of metastatic triple-negative breast cancer was presented at the AACR Immuno-Oncology Conference (AACR IO), held February 18-21, 2026 in Los Angeles, California.
Leronlimab is being evaluated for its ability to modulate the tumor immune microenvironment by targeting the CCR5 receptor, a key regulator of immune function implicated in cancer progression and immune resistance. The data presented explore mechanisms of immune checkpoint resistance in TNBC and offer insight into how CCR5 blockade may enhance responses to immune checkpoint inhibitors (“ICIs”).
“In this study, we continued to explore how CCR5 signaling may contribute to immune checkpoint resistance in metastatic triple-negative breast cancer by integrating patient-derived datasets with molecular, cellular, and translational analyses involving leronlimab,” said Professor Richard Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. “Mechanistic findings suggest that CCR5 blockade with leronlimab may modulate pathways associated with T-cell exhaustion and PD-L1/PD1 regulation, providing a mechanistic rationale for combination strategies with immune checkpoint inhibitors.”
Key findings:
- Across multiple TNBC patient gene expression datasets, CCR5 expression correlated with elevated cytotoxic T-lymphocyte signatures and T-cell exhaustion profiles, identifying immune states potentially amenable to CCR5 inhibition.
- PD-L1 and PD1, the abundance of which correlates with improved response to immune checkpoint therapies, was increased by leronlimab.
- In cell culture and histology analyses, CCR5 inhibition with leronlimab increased the abundance of PD-L1 in breast cancer cells.
- In Rhesus monkeys, leronlimab induced PD1 in T cells.
- CCR5 activity was associated with the secretion of immunosuppressive mediators from triple-negative breast cancer cells, [sB7-H3 (CD276), BAFF (sTNFSF13B), and sTyro3], which were significantly reduced following leronlimab treatment.
- In a pooled retrospective clinical analysis of 28 heavily pretreated patients with metastatic triple-negative breast cancer from three clinical trials, leronlimab demonstrated a favorable safety profile with no therapy-limiting toxicities, and 5 of 28 patients (17.9%) remain alive after a median follow-up of more than 63 months.
“These data strengthen the clinical case for leronlimab in metastatic TNBC by aligning mechanistic insights with encouraging safety and long-term survival observations, while adding important clinical perspective to the emerging role of CCR5 inhibition in this disease,” said Dr. Jacob Lalezari, M.D., Chief Executive Officer of CytoDyn. “The consistency of the mechanistic and clinical findings supports our decision to continue the clinical development and investigation of leronlimab, including further evaluation in combination immunotherapy settings.”
Associate Professor Xuanmao Jiao of the Pennsylvania Cancer and Regenerative Medicine Center at the Baruch S. Blumberg Institute presented the poster, titled “Leronlimab is associated with long?term survival in metastatic TNBC: Enhancing PD-L1 expression, ICI response, and the role of T cell exhaustion,” on February 19, 2026, from 12:15 p.m. – 3:25 p.m. PST. 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
FAQ**
How does the CCR5 blockade via Leronlimab influence T-cell exhaustion pathways in the context of mTNBC, and what implications does this have for the therapeutic strategy of CytoDyn Inc. (CYDY)?
What specific molecular mechanisms involved in PD-L1 biology does CytoDyn Inc. (CYDY) aim to target with Leronlimab to enhance ICI response in mTNBC patients?
Can you elaborate on the observed correlation between CCR5 expression and T-cell exhaustion profiles in TNBC patients presented by CytoDyn Inc. (CYDY), and its potential impact on treatment outcomes?
What are the potential next steps for CytoDyn Inc. (CYDY) in further developing Leronlimab based on the safety profile and long-term survival data reported in heavily pretreated mTNBC patients?
**MWN-AI FAQ is based on asking OpenAI questions about Cytodyn Inc (OTC: CYDY).
NASDAQ: CYDY
CYDY Trading
8.15% G/L:
$0.2348 Last:
160,842 Volume:
$0.223 Open:
