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Posted On: 09/25/2025 8:39:20 AM
Post# of 157267
CytoDyn to Present on Leronlimab Induction of PD-L1 and Immune Checkpoint Inhibitor Responses in Metastatic Triple-Negative Breast Cancer at the AACR Special Conference: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity
GlobeNewswire
8:30 AM ET Sep-25-2025
Company to deliver oral and poster presentations for data on leronlimab’s action on PD-L1 expression and patient survival in triple-negative breast cancer
VANCOUVER, Washington, Sept. 25, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY.NaE) ("CytoDyn" or the "Company"
, a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and colorectal cancer (CRC), will present a poster and an oral presentation at the AACR Special Conference in Cancer Research: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity, taking place September 24, to September 27, 2025, in Montreal, Canada.
Metastatic triple-negative breast cancer (mTNBC) is associated with a very poor prognosis. The efficacy of a class of drugs called immune checkpoint inhibitors (ICIs) is reduced in patients with mTNBC who have low levels of PD-L1[1]. An immune cell receptor called CCR5 has been observed in up to 95% of patients with TNBC. A recent review of CytoDyn’s prior oncology trials suggests that treatment with leronlimab, a humanized monoclonal antibody targeting CCR5, combined with an ICI, may improve survival in patients with mTNBC [2]. This retrospective analysis of 28 patients demonstrated that leronlimab induced PD-L1 expression on circulating tumor cells in 88% of patients treated at leronlimab doses of > 525mg/week. Moreover, 5/5 patients who induced PD-L1, and received treatment with both leronlimab and an ICI, remain alive after a median of ~60 months since starting leronlimab.
Key Findings:
CCR5 inhibition combined with ICI therapy increased overall survival in patients with mTNBC, with 18% of heavily pretreated mTNBC patients alive after a median of ~60 months.
Inhibition of CCR5 by leronlimab induced PD-L1 expression on patient circulating tumor cells.
Expression levels of CCR5 correlate with T cell infiltration in TNBC.
“These impressive findings on how leronlimab can serve to make metastatic triple-negative breast cancer cells more responsive to checkpoint inhibitors are of great value as we move this asset forward for oncology indications,” said Jacob Lalezari, M.D., CEO of CytoDyn (CYDY.NaE). “Understanding this immune-modulating mechanism not only deepens insight into how leronlimab works, but also supports its potential as a broadly applicable therapy for a range of solid tumors that historically have had limited treatment options.”
“The substantial increases in PD-L1 expression, observed in liquid biopsies of patients treated with leronlimab, may be the key to unlocking the effectiveness of immune checkpoint inhibitors for patient populations previously deemed resistant to such approaches,” said Richard Pestell, M.D., Ph.D., FRCP, AO, Presenter and Lead Consultant in Preclinical and Clinical Oncology at CytoDyn (CYDY.NaE). “These results suggest leronlimab may remodel the tumor immune environment in metastatic triple-negative breast cancer, a particularly challenging form of the disease.”
Details of the oral and poster presentations are as follows:
Abstract Title:
CCR5 inhibition with leronlimab is associated with enhanced PD-L1 expression, ICI response, and long‑term survival in metastatic TNBC
Poster presentation:
September 26, 2025, 6:30 p.m. – 8:30 p.m. EDT
Podium/speaking presentation:
September 27, 2025, 10:25 a.m. – 10:40 a.m. EDT
GlobeNewswire
8:30 AM ET Sep-25-2025
Company to deliver oral and poster presentations for data on leronlimab’s action on PD-L1 expression and patient survival in triple-negative breast cancer
VANCOUVER, Washington, Sept. 25, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY.NaE) ("CytoDyn" or the "Company"
, a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and colorectal cancer (CRC), will present a poster and an oral presentation at the AACR Special Conference in Cancer Research: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity, taking place September 24, to September 27, 2025, in Montreal, Canada. Metastatic triple-negative breast cancer (mTNBC) is associated with a very poor prognosis. The efficacy of a class of drugs called immune checkpoint inhibitors (ICIs) is reduced in patients with mTNBC who have low levels of PD-L1[1]. An immune cell receptor called CCR5 has been observed in up to 95% of patients with TNBC. A recent review of CytoDyn’s prior oncology trials suggests that treatment with leronlimab, a humanized monoclonal antibody targeting CCR5, combined with an ICI, may improve survival in patients with mTNBC [2]. This retrospective analysis of 28 patients demonstrated that leronlimab induced PD-L1 expression on circulating tumor cells in 88% of patients treated at leronlimab doses of > 525mg/week. Moreover, 5/5 patients who induced PD-L1, and received treatment with both leronlimab and an ICI, remain alive after a median of ~60 months since starting leronlimab.
Key Findings:
CCR5 inhibition combined with ICI therapy increased overall survival in patients with mTNBC, with 18% of heavily pretreated mTNBC patients alive after a median of ~60 months.
Inhibition of CCR5 by leronlimab induced PD-L1 expression on patient circulating tumor cells.
Expression levels of CCR5 correlate with T cell infiltration in TNBC.
“These impressive findings on how leronlimab can serve to make metastatic triple-negative breast cancer cells more responsive to checkpoint inhibitors are of great value as we move this asset forward for oncology indications,” said Jacob Lalezari, M.D., CEO of CytoDyn (CYDY.NaE). “Understanding this immune-modulating mechanism not only deepens insight into how leronlimab works, but also supports its potential as a broadly applicable therapy for a range of solid tumors that historically have had limited treatment options.”
“The substantial increases in PD-L1 expression, observed in liquid biopsies of patients treated with leronlimab, may be the key to unlocking the effectiveness of immune checkpoint inhibitors for patient populations previously deemed resistant to such approaches,” said Richard Pestell, M.D., Ph.D., FRCP, AO, Presenter and Lead Consultant in Preclinical and Clinical Oncology at CytoDyn (CYDY.NaE). “These results suggest leronlimab may remodel the tumor immune environment in metastatic triple-negative breast cancer, a particularly challenging form of the disease.”
Details of the oral and poster presentations are as follows:
Abstract Title:
CCR5 inhibition with leronlimab is associated with enhanced PD-L1 expression, ICI response, and long‑term survival in metastatic TNBC
Poster presentation:
September 26, 2025, 6:30 p.m. – 8:30 p.m. EDT
Podium/speaking presentation:
September 27, 2025, 10:25 a.m. – 10:40 a.m. EDT
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