CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer

Core Viewpoint - CytoDyn Inc. has received funding from an anonymous benefactor to support its Expanded Access Program (EAP) for patients with triple-negative breast cancer, allowing broader access to its drug leronlimab for those who have exhausted other treatment options [1][2][3]. Group 1: Funding and Program Details - The benefactor is committed to enhancing patient access initiatives and recognizes the potential of leronlimab, which targets the CCR5 receptor [2]. - The EAP will enable CytoDyn to provide access to leronlimab for eligible patients who do not meet the criteria for ongoing clinical trials, as per FDA guidelines [2][3]. - The program is expected to open for patient referrals in March 2026, pending FDA approval of the revised protocol [3]. Group 2: Clinical Research and Future Pathways - With Every Patient (WEP Clinical) has been engaged as the clinical research organization (CRO) for the EAP, which will also allow observation of PD-L1 induction following treatment with leronlimab [3]. - The EAP aims to explore potential treatment pathways towards sustained remission when combined with immune checkpoint inhibitors (ICIs) [3]. Group 3: Company Overview - CytoDyn is a clinical-stage oncology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, which is involved in cancer and other diseases [4]. - The company is dedicated to improving patients' quality of life through innovative therapies and operates with a commitment to integrity and responsibility [4].