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CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn (OTCQB: CYDY) will present significant findings on leronlimab's effectiveness in treating metastatic triple-negative breast cancer (mTNBC) at the AACR Special Conference in Montreal. The company's retrospective analysis of 28 patients revealed that leronlimab, when administered at doses >525mg/week, induced PD-L1 expression in 88% of patients.
Key clinical findings showed that 5 out of 5 patients who received both leronlimab and immune checkpoint inhibitors (ICIs) remain alive after approximately 60 months of treatment. The study demonstrated that 18% of heavily pretreated mTNBC patients survived after a median of ~60 months when treated with CCR5 inhibition combined with ICI therapy.
The research suggests leronlimab could potentially enhance the effectiveness of checkpoint inhibitors in treating solid tumors, particularly in cases previously resistant to such treatments.
CytoDyn (OTCQB: CYDY), a clinical-stage oncology company, will present research findings on its lead drug leronlimab at the AACR Special Conference on Cancer Immunity from September 24-27, 2025, in Montreal. The company's Lead Consultant, Dr. Richard Pestell, will deliver both poster and oral presentations focusing on leronlimab's effects on metastatic triple-negative breast cancer (TNBC).
The research suggests that leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, may convert 'cold' tumors to 'hot' tumors, potentially enhancing responsiveness to checkpoint inhibitors. This mechanism could have broad implications for treating solid tumors with limited treatment options.
CytoDyn (OTCQB: CYDY), a clinical-stage biotech company developing leronlimab, has announced a schedule change for its presentation at the H.C. Wainwright 27th Annual Global Investment Conference. The company's CFO, Robert E. Hoffman, will now present on Wednesday, September 10, 2025, at 9:00 AM EDT in New York City.
The presentation will showcase CytoDyn's progress with leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, which shows therapeutic potential across multiple indications. One-on-one meetings with management will be available throughout the conference, which runs from September 8-10, 2025.
CytoDyn (OTCQB: CYDY), a clinical-stage biotech company developing leronlimab, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025. The company's CFO, Robert E. Hoffman, will present on September 10 at 1:30 p.m. EDT at the Lotte New York Palace Hotel.
Leronlimab, the company's lead candidate, is a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with potential applications across multiple indications. The presentation will be available via webcast, and management will be available for one-on-one meetings with conference attendees.
CytoDyn (OTCQB: CYDY) has announced promising survival data for leronlimab in treating metastatic colorectal cancer (mCRC). The clinical findings showed that 3 out of 5 patients treated with leronlimab achieved at least a partial response, with one patient achieving complete response and surviving for five years.
Dr. Benjamin Weinberg from Georgetown University will present these results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona. The data comes from patients treated under a compassionate use protocol and demonstrates both a favorable safety profile and potential clinical benefits. The company is currently conducting a Phase II trial in patients with relapsed/refractory microsatellite stable CRC, with the first patient already dosed.
Additionally, CytoDyn reported evidence of leronlimab's potential as a "priming" agent for cancer patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors, showing particular promise in metastatic triple-negative breast cancer (mTNBC) treatment.
CytoDyn (OTCQB: CYDY) has initiated dosing in its Phase II clinical trial evaluating leronlimab for relapsed/refractory microsatellite stable colorectal cancer (CRC). The trial, conducted in partnership with Syneos Health across eight clinical sites, is led by Dr. Ben Weinberg from Georgetown University. According to WHO data, colorectal cancer represents the third most common cancer globally, with approximately 1.9 million new cases and 900,000 deaths annually.
The study builds on CytoDyn's previous research showing potential clinical benefits of leronlimab in relapsed CRC patients and aims to evaluate its mechanism of action in solid tumor oncology. The company's strategy is influenced by promising survival rates observed in prior metastatic triple-negative breast cancer studies.
CytoDyn (OTCQB: CYDY) has revealed promising new data about leronlimab's mechanism of action in treating solid tumors. The company's analysis of metastatic Triple-Negative Breast Cancer (mTNBC) trials showed that 88% (15/17) of patients receiving weekly doses of 525mg or higher experienced significant increases in PD-L1 expression on circulating tumor cells within 30-90 days.
Notably, 100% (5/5) of patients who showed increased PD-L1 expression and received immune checkpoint inhibitors (ICIs) treatment are still alive, with 80% (4/5) showing no evidence of disease. This suggests leronlimab can potentially convert "cold" tumors to "hot" tumors, making them responsive to checkpoint inhibitor therapy. The company believes this mechanism could benefit various solid tumor types, particularly in patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors.
CytoDyn is now prioritizing prospective confirmation of these findings in TNBC patients and has amended its colorectal cancer trial to collect PD-L1 data.CytoDyn (OTCQB: CYDY) has appointed Robert E. Hoffman as its new Chief Financial Officer, effective May 15, 2025. Hoffman, a seasoned biotech veteran, will replace interim CFO Mitch Cohen. With extensive experience in financial leadership, Hoffman previously served as President, CEO, interim CFO, and Chairperson at Kintara Therapeutics, and held CFO positions at companies including Heron Therapeutics, Innovus Pharmaceuticals, and AnaptysBio.
Hoffman currently serves on the boards of several companies, including Esperion Therapeutics, TuHURA Biosciences, and Fibrobiologics. His appointment aims to support CytoDyn's clinical development pipeline, particularly in oncology indications. The company is developing leronlimab, a CCR5 antagonist with potential for multiple therapeutic applications.
CytoDyn announces its participation in the upcoming ESMO Breast Cancer meeting in Munich, Germany, scheduled for May 14-17, 2025. The company will present promising survival data for its drug leronlimab in treating metastatic triple-negative breast cancer (mTNBC).
Key highlights:
- CEO Dr. Jacob Lalezari and Lead Consultant Dr. Richard Pestell will lead the presentation
- Poster presentation scheduled for May 15, 2025
- Notable survival rates observed at 12, 24, and 36 months
- Four patients show no evidence of disease after 48 months
- One additional patient maintains stable disease
The company reports these outcomes compare favorably to current approved therapies and suggests a potential paradigm shift in solid tumor oncology treatment. CytoDyn has initiated a follow-up protocol to monitor surviving patients.