CytoDyn Inc. (OTCQB: CYDY) presented new translational data on its lead antibody leronlimab at the AACR Annual Meeting in San Diego on April 19 2026. The poster, #1033, demonstrated that leronlimab’s CCR5 inhibition induces PD‑L1 expression in metastatic triple‑negative breast cancer (mTNBC) patients and is associated with long‑term survival in a heavily pre‑treated cohort.
The data showed that leronlimab induced PD‑L1 expression and reduced key mediators of immune suppression, including soluble B7‑H3 and soluble Tyro3 signaling. Among 28 heavily pre‑treated patients, 5 (17.9%) remained alive after more than 60 months of follow‑up, a survival rate that aligns with other reports of 5 of 28 patients surviving beyond 63 months. The findings suggest that leronlimab can convert “cold” tumors into a state that is responsive to checkpoint inhibitors.
"Our findings suggest that CCR5 plays a key role in immune exhaustion and therapy resistance pathways in TNBC. Induction of PD‑L1 predicts response to immune checkpoint therapy. Leronlimab‑mediated CCR5 inhibition induced PD‑L1 expression and reduced key mediators of immune suppression, including sB7‑H3 and sTyro3 signaling. These data support the hypothesis that leronlimab may help prime tumors for immune checkpoint therapy and improve clinical outcomes in patients with otherwise limited therapeutic options," said Richard G. Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. "These results reinforce the potential role of CCR5 as a critical regulator of the tumor microenvironment in TNBC. The observed induction of PD‑L1 and association with long‑term survival in mTNBC support continued clinical development of leronlimab in combination approaches designed to enhance immune response and overcome treatment resistance," added Jacob P. Lalezari, M.D., Chief Executive Officer of CytoDyn. "We are encouraged by the continued progress being made as we advance leronlimab and explore its potential applications across solid tumors. The research being presented at AACR reflects the growing body of scientific work examining CCR5 biology and its role in the tumor microenvironment. Together, these studies help deepen our understanding of how leronlimab may enhance immune responses and inform our broader strategy to develop new treatment approaches for patients with difficult‑to‑treat cancers," the CEO added.
CytoDyn remains a clinical‑stage biotechnology company with no reported revenue. In the first quarter ended August 31 2025, the company posted a net loss of $5.54 million, compared with a net income of $19.23 million a year earlier. The company’s financials reflect its focus on research and development and the absence of commercial product sales.
The data presented at AACR 2026 positions leronlimab as a promising sensitizer for immune checkpoint therapy in mTNBC, a disease with limited treatment options. If validated in larger, controlled trials, the platform could broaden the market for immunotherapy in mTNBC and other solid tumors, potentially unlocking new revenue streams for CytoDyn and reinforcing its strategic focus on oncology.
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