CytoDyn Inc. (OTCQB: CYDY) announced that it has enrolled and dosed the first participant in its Expanded Access Program (EAP) for metastatic triple‑negative breast cancer (mTNBC). The program, which began on April 27 2026, provides patients who have exhausted standard treatment options and are ineligible for ongoing clinical studies with urgent access to leronlimab under FDA‑approved compassionate use guidelines.
The EAP is designed to collect real‑world data on how leronlimab, a monoclonal antibody that targets the CCR5 receptor, affects the tumor microenvironment. By studying CCR5 inhibition’s impact on PD‑L1 expression, the program aims to generate insights that could enhance responses to immune checkpoint inhibitors and inform future clinical development of the drug.
"Dosing the first patient in our EAP marks an important step in making leronlimab available to individuals with urgent unmet medical needs, while also advancing our understanding of CCR5 biology in the treatment of aggressive cancers," said CEO Jacob Lalezari. "Data generated through this program may further inform how CCR5 inhibition influences the tumor microenvironment, including its potential role in modulating PD‑L1 expression and supporting combination approaches with immune checkpoint inhibitors."
The program is open for physician referrals and will expand as additional sites are activated. Funding for the EAP comes from a benefactor, and the initiative is conducted under FDA guidelines to responsibly broaden the availability of leronlimab while continuing to advance CytoDyn’s clinical programs and generate data to inform future regulatory pathways.
CytoDyn’s oncology strategy focuses on converting "cold" tumors into immunotherapy‑responsive "hot" tumors. The launch of the EAP demonstrates the company’s commitment to patient access and data generation, and it aligns with broader efforts to support future approvals. No immediate market reaction was reported following the announcement, and CytoDyn is expected to release its Q3 2026 results on April 14 2026, with analysts anticipating a loss of $0.05 per share.
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