CytoDyn Secures Breakthrough Funding to Launch Leronlimab Access Program for Triple-Negative Breast Cancer Patients

CytoDyn Inc. (CYDY) has announced the receipt of dedicated funding from a compassionate benefactor to establish an Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC). This initiative represents a significant milestone in expanding availability of Leronlimab, the company’s experimental CCR5-targeting antibody, beyond traditional clinical trial settings. The anonymous benefactor, a long-time supporter of patient-access initiatives, recognizes the therapeutic potential of Leronlimab’s novel mechanism of action in addressing one of oncology’s most challenging disease areas.

Filling the Treatment Gap in Aggressive Breast Cancer

Triple-negative breast cancer represents the most aggressive form of breast malignancy, characterized by limited treatment options—particularly for patients who have completed standard approved therapies or fail to meet eligibility criteria for ongoing clinical trials. Unlike basic care approaches or topical treatments such as breast growth oil products, systemic therapies like Leronlimab target fundamental biological pathways implicated in cancer progression. The funding will enable CytoDyn to establish and operate the EAP under FDA guidelines, allowing a carefully selected cohort of advanced TNBC patients to access Leronlimab outside traditional research protocols.

Clinical Infrastructure and Timeline

With Every Patient (WEP Clinical) has been designated as the Clinical Research Organization responsible for program administration. CytoDyn anticipates opening the platform for physician referrals in March 2026, contingent upon FDA approval of the revised protocol. The structured timeline reflects both the regulatory rigor and the urgency surrounding treatment access for this patient population facing limited options.

Emerging Therapeutic Combinations and Market Implications

Beyond providing compassionate access, the EAP is expected to generate valuable data on PD-L1 induction following Leronlimab treatment—a mechanism that could theoretically enhance synergy with immune checkpoint inhibitors, potentially unlocking more powerful combination therapeutic strategies. CYDY stock has fluctuated between $0.18 and $0.49 over the past twelve months, currently trading at $0.26, up 4%. The company has emphasized that all program operations will adhere strictly to FDA’s expanded-access regulatory framework, with comprehensive information for eligible physicians and patients to be published on its website as the program launches.