(RTTNews) - CytoDyn Inc. (CYDY) has received dedicated funding from a compassionate benefactor to initiate an Expanded Access Program (EAP) for patients with triple-negative breast cancer, marking a key step in broadening access to its investigational CCR5-targeting antibody, Leronlimab.
Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer with limited treatment options, particularly for patients who have exhausted approved therapies or do not qualify for ongoing clinical trials.
CytoDyn said the benefactor- who chose to remain anonymous-has long supported patient-access initiatives and sees potential in Leronlimab's emerging data and mechanism of action.
The funding will allow CytoDyn to establish and administer the EAP under FDA guidelines, enabling a select group of advanced TNBC patients to receive Leronlimab outside of clinical trials.
With Every Patient (WEP Clinical) has been engaged as the CRO, and the company expects to open the program for physician referrals in March 2026, pending FDA allowance of its revised protocol.
In addition to providing compassionate access, the EAP may offer further insights into the PD-L1 induction following Leronlimab treatment- an effect that could, in theory, support combination strategies with immune checkpoint inhibitors.
CytoDyn emphasized that the program will operate within FDA's expanded-access framework, with additional details for physicians and eligible patients to be posted on its website as rollout begins.
CYDY has traded between $0.18 and $0.49 over the past year. The stock is currently trading at $0.26, up 4%.
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