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]

Enrollment is now underway across multiple clinical sites, in partnership with Syneos HealthVANCOUVER, Washington, June 24, 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 announced that the first patient has been dosed in the Company’s clinical trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable c ...

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]

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 ...