CytoDyn Announces Funding And Start Of Expanded Access Program For Advanced TNBC Patients Ineligible For Clinical Trials, FDA-Guided Leronlimab Access To Begin March 2026

CytoDyn Inc., a clinical-stage oncology company focused on developing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, announced that an anonymous benefactor has committed funding to support the Company’s Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC). Leronlimab has potential therapeutic applications across multiple cancer types, including TNBC and metastatic colorectal cancer (mCRC).

The benefactor has a longstanding interest in improving patient access to experimental therapies and recognizes the potential of leronlimab. This support will allow CytoDyn to provide access to leronlimab for eligible patients with advanced disease who have exhausted all approved treatment options but do not meet the enrollment criteria for the Company’s ongoing clinical trials. The program will be administered in accordance with U.S. Food and Drug Administration (FDA) guidelines.

“We are honored by this benefactor’s commitment to accelerating patient access to promising cancer therapies such as leronlimab,” said Jacob Lalezari, M.D., CEO of CytoDyn. “This support enables us to responsibly broaden availability while continuing to advance our clinical programs and generate data to guide future regulatory decisions.”

Every Patient (WEP Clinical) has been selected as the clinical research organization (CRO) to manage the EAP. The Company anticipates opening the program for patient referrals in March 2026, pending FDA approval of the revised protocol submission. 

Beyond providing compassionate access, the EAP will allow CytoDyn to gather additional insights into the biological effects of leronlimab, including potential PD-L1 induction, which could inform strategies for combining leronlimab with immune checkpoint inhibitors (ICIs) to support sustained remission. The program will operate under FDA guidelines, and detailed information for physicians and eligible patients will be made available on CytoDyn’s website as the EAP is implemented in the coming weeks.