VANCOUVER, Washington, Aug. 28, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage biotechnology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, today announced that management will participate in the H.C. Wainwright 27th Annual Global Investment Conference being held September 8 to 10, 2025, at the Lotte New York Palace Hotel in New York City. Robe ...

Core Insights - CytoDyn Inc. announced positive clinical findings for leronlimab in patients with advanced metastatic colorectal cancer (mCRC), with 3 out of 5 patients showing at least a partial response, including one complete response [1][3] - Dr. Benjamin Weinberg will present the final results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona, Spain [2] - The results support the ongoing Phase II trial for relapsed/refractory microsatellite stable CRC, with the first patient recently dosed and additional patients being enrolled [3][5] Clinical Significance - The findings from the compassionate use protocol highlight a favorable safety profile for leronlimab and its potential clinical benefits in mCRC [3] - If confirmed, leronlimab could be effective for a variety of solid tumor types, and it has shown promise as a "priming" agent for patients with low PD-L1 levels who are unresponsive to checkpoint inhibitors [4] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a humanized IgG4 monoclonal antibody targeting CCR5, with applications in oncology, infectious diseases, and autoimmune conditions [6]

Core Insights - CytoDyn Inc. has initiated patient enrollment for a clinical trial assessing the efficacy of leronlimab in relapsed/refractory microsatellite stable colorectal cancer [1][2] - The trial is being conducted in partnership with Syneos Health, involving multiple clinical sites [2] - Colorectal cancer is a significant global health issue, with approximately 1.9 million new cases and over 900,000 deaths annually [3] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a monoclonal antibody targeting CCR5, with applications in oncology and other therapeutic areas [6] - The company aims to provide innovative treatment options for challenging diseases, as highlighted by the dosing of the first patient in the Phase II CRC trial [4] Clinical Trial Details - The trial is led by Dr. Ben Weinberg from Georgetown University and aims to evaluate the potential clinical benefits of leronlimab in colorectal cancer [2][5] - Previous studies have shown promising survival rates for leronlimab in metastatic triple-negative breast cancer, indicating its potential applicability across various solid tumors [5] Industry Context - The World Health Organization's IARC identifies colorectal cancer as the third most common cancer type and the second leading cause of cancer-related deaths globally [3] - The increasing incidence of colorectal cancer in individuals under 50 years old has been noted for over 20 years, indicating a growing public health concern [3]

VANCOUVER, Washington, May 15, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today shared the Company's poster presented at the European Society for Medical Oncology's ("ESMO") Breast Cancer meeting on May 14-17, 2025, in Munich, Germany. This news release may contain forward-looking statements relating to, among other things, clinical trial results, p ...

Core Insights - CytoDyn Inc. has announced new data indicating that leronlimab may enhance PD-L1 expression in patients with metastatic Triple-Negative Breast Cancer (mTNBC), potentially transforming "cold" tumors into "hot" tumors suitable for immune checkpoint inhibitors [1][2][3] Group 1: Mechanism of Action - Leronlimab treatment correlated with increased PD-L1 expression on circulating tumor cells (CTCs) in 88% of patients receiving a weekly dose of 525 mg or higher over a 30-to-90-day period [2] - The increase in PD-L1 expression is significant as it may allow patients to benefit from subsequent treatment with immune checkpoint inhibitors [2][3] Group 2: Clinical Outcomes - Among patients with mTNBC who had failed a median of two prior treatments, 100% of those showing increased PD-L1 expression after leronlimab treatment remain alive, with 80% having no evidence of disease [3] - The company believes that if these results are confirmed, the mechanism could be effective across various solid tumor types, particularly for patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors [3][4] Group 3: Future Directions - CytoDyn aims to confirm these findings prospectively and has amended its colorectal cancer trial to collect PD-L1 data in another solid tumor type [4] - The company expresses optimism that leronlimab's ability to induce a "hot" tumor environment could significantly improve treatment options for patients with aggressive cancers [4]

About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, oncology, and autoimmune conditions. Note Regar ...

This news release contains forward-looking statements relating to, among other things, 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 ...