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
CytoDyn (OTCQB: CYDY) will present significant findings on leronlimab's effectiveness in treating metastatic triple-negative breast cancer (mTNBC) at the AACR Special Conference in Montreal. The company's retrospective analysis of 28 patients revealed that leronlimab, when administered at doses >525mg/week, induced PD-L1 expression in 88% of patients.
Key clinical findings showed that 5 out of 5 patients who received both leronlimab and immune checkpoint inhibitors (ICIs) remain alive after approximately 60 months of treatment. The study demonstrated that 18% of heavily pretreated mTNBC patients survived after a median of ~60 months when treated with CCR5 inhibition combined with ICI therapy.
The research suggests leronlimab could potentially enhance the effectiveness of checkpoint inhibitors in treating solid tumors, particularly in cases previously resistant to such treatments.
CytoDyn (OTCQB: CYDY) presenterà importanti risultati sull'efficacia di leronlimab nel trattamento del cancro al seno metastatico triplo negativo (mTNBC) durante la conferenza speciale AACR di Montreal. L'analisi retrospettiva su 28 pazienti ha mostrato che leronlimab, somministrato a dosi superiori a 525 mg/settimana, ha indotto l'espressione di PD-L1 nel 88% dei pazienti.
I risultati clinici chiave indicano che 5 su 5 pazienti che hanno ricevuto sia leronlimab sia inibitori dei checkpoint immunitari (ICIs) sono vivi dopo circa 60 mesi di trattamento. Lo studio ha anche dimostrato che l'18% dei pazienti con mTNBC fortemente pretrattati è sopravvissuto dopo una mediana di circa 60 mesi quando trattato con l'inibizione CCR5 in combinazione con la terapia ICI.
La ricerca suggerisce che leronlimab potrebbe potenziare l'efficacia degli ICIs nel trattamento di tumori solidi, soprattutto nei casi che in precedenza hanno mostrato resistenza a tali terapie.
CytoDyn (OTCQB: CYDY) presentará hallazgos significativos sobre la eficacia de leronlimab en el tratamiento del cáncer de mama metastásico triple negativo (mTNBC) en la Conferencia Especial de AACR en Montreal. El análisis retrospectivo de 28 pacientes reveló que leronlimab, administrado a dosis superiores a 525 mg/semana, indujo la expresión de PD-L1 en el 88% de los pacientes.
Los hallazgos clínicos clave mostraron que 5 de 5 pacientes que recibieron leronlimab y inhibidores de puntos de control inmunitarios (ICIs) siguen vivos tras aproximadamente 60 meses de tratamiento. El estudio demostró que el 18% de pacientes con mTNBC fuertemente pretitulados sobrevivieron después de una mediana de ~60 meses cuando se trató con la inhibición de CCR5 combinada con la terapia ICI.
La investigación sugiere que leronlimab podría potencialmente mejorar la eficacia de los ICIs en el tratamiento de tumores sólidos, especialmente en casos que previamente resultaron resistentes a tales tratamientos.
CytoDyn (OTCQB: CYDY)가 몬트리올에서 열리는 AACR 특별 회의에서 전이성 삼중음성 유방암(mTNBC) 치료에 대한 leronlimab의 효과에 대한 중요한 발표를 할 예정입니다. 28명의 환자를 대상으로 한 후향적 분석에서 주당 525mg을 초과하는 용량으로 투여된 leronlimab은 환자의 88%에서 PD-L1 발현을 유도했습니다.
주요 임상 발견으로는 leronlimab과 면역 점검점 억제제(ICIs)를 모두 받은 환자 5명 중 5명이 약 60개월 정도의 치료 후 생존했습니다. 연구에 따르면, 강하게 선처리된(mTNBC) 환자 중의 18%가 중간값 약 60개월 가량 생존했으며, 이는 CCR5 억제와 ICI 치료를 병용했을 때의 결과입니다.
연구는 leronlimab이 고형 종양의 체크포인트 억제제의 효과를 잠재적으로 향상시킬 수 있으며, 특히 이전에 이러한 치료에 내성이 있던 경우에 더욱 그렇다고 시사합니다.
CytoDyn (OTCQB: CYDY) présentera des résultats significatifs sur l'efficacité du leronlimab dans le traitement du cancer du sein métastatique triple négatif (mTNBC) lors de la Conférence Spéciale AACR à Montréal. L’analyse rétrospective menée sur 28 patient(e)s a révélé que le leronlimab, administré à des doses >525 mg/semaine, a induit l’expression de PD-L1 chez 88% des patient(e)s.
Les résultats cliniques clés montrent que 5 sur 5 patient(e)s ayant reçu à la fois leronlimab et inhibiteurs du point de contrôle immunitaire (ICI) sont vivant(e)s après environ 60 mois de traitement. L’étude a démontré que 18% des patient(e)s atteint(e)s d’un mTNBC fortement prétraité ont survécu après une médiane d’environ ~60 mois lorsqu’ils ont été traités par l’inhibition de CCR5 en association avec une thérapie ICI.
La recherche suggère que le leronlimab pourrait potentiellement améliorer l’efficacité des inhibiteurs de point de contrôle dans le traitement des tumeurs solides, en particulier dans les cas antérieurement résistants à ce type de traitement.
CytoDyn (OTCQB: CYDY) wird auf der AACR-Sonderkonferenz in Montreal bedeutende Erkenntnisse zur Wirksamkeit von Leronlimab bei der Behandlung von metastasiertem triple-negativem Brustkrebs (mTNBC) vorstellen. Die retrospektive Analyse von 28 Patienten zeigte, dass Leronlimab bei Dosen >525 mg/Woche die PD-L1-Expression bei 88% der Patienten induzierte.
Wichtige klinische Ergebnisse zeigten, dass 5 von 5 Patienten, die sowohl Leronlimab als auch Immun-Checkpoint-Inhibitoren (ICIs) erhielten, nach ca. 60 Monaten Behandlung noch leben. Die Studie zeigte, dass 18% der stark vorbehandelten mTNBC-Patienten nach einer Median-Behandlungsdauer von ~60 Monaten überlebten, wenn sie mit CCR5-Hemmung in Kombination mit ICI-Therapie behandelt wurden.
Die Forschung legt nahe, dass Leronlimab die Wirksamkeit von Checkpoint-Inhibitoren bei soliden Tumoren potenziell erhöhen könnte, insbesondere bei Fällen, die zuvor resistent gegen solche Behandlungen waren.
CytoDyn (OTCQB: CYDY) ستقدم نتائج مهمة حول فعالية leronlimab في علاج سرطان الثدي النقيلي ثلاثي السلبية (mTNBC) في المؤتمر الخاص لـ AACR في مونتريال. التحليل الرجوعي لـ28 مريضا أظهر أن leronlimab، عند جرعات >525 mg/أسبوع، حث تعبير PD-L1 لدى حوالي 88% من المرضى.
أظهرت النتائج السريرية الرئيسية أن 5 من 5 مرضى تلقوا leronlimab مع مثبطات نقاط التفتيش المناعي (ICIs) ما زالوا على قيد الحياة بعد نحو 60 شهراً من العلاج. أظهرت الدراسة أن حوالي 18% من مرضى mTNBC المجهزين بشكل مكثف صمدوا بعد وسيط يصل إلى ~60 شهراً عندما عولجوا بوقف CCR5 المشترك مع علاج ICI.
تشير الأبحاث إلى أن leronlimab قد يعزز بشكل محتمل فاعلية مثبطات نقاط التفتيش في علاج الأورام الصلبة، خصوصاً في الحالات التي كانت مقاومة سابقاً لهذه العلاجات.
CytoDyn (OTCQB: CYDY) 将在蒙特利尔的 AACR 特别会议上公布 leronlimab 对治疗转移性三阴性乳腺癌 (mTNBC) 的显著疗效。对28名患者的回顾性分析显示，若 leronlimab 的剂量大于 525 mg/周，则在 88% 的患者中诱导了 PD-L1 表达。
关键临床发现显示，5/5 同时接受 leronlimab 与免疫检查点抑制剂（ICIs）的患者，在约60个月的治疗后仍存活。研究还表明，经过大量前期治疗的 18% 的 mTNBC 患者在中位治疗时间约60个月后存活，治疗方式为 CCR5 抑制与 ICI 疗法联合。
研究提示 leronlimab 可能提高检查点抑制剂在实体瘤治疗中的效果，尤其是对以往对该治疗耐药的病例。
- 88% of patients showed induced PD-L1 expression with leronlimab doses >525mg/week
- 100% survival rate (5/5 patients) after 60 months for those treated with both leronlimab and ICI
- 18% survival rate in heavily pretreated mTNBC patients after ~60 months
- CCR5 receptor presence in up to 95% of TNBC patients indicates broad potential application
- None.
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. (OTCQB: CYDY) ("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
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. “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. “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
About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. By unlocking a well-validated mechanism of action with broad therapeutic potential, CytoDyn is developing a versatile platform designed to address serious unmet medical needs and serve multiple high-value markets. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.
For more information, please visit www.cytodyn.com and follow us on LinkedIn.
Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.
Corporate Contact
CytoDyn Inc.
ir@cytodyn.com
Media Contacts
Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com
1. Winer et al. Lancet Oncol 2021. 22 (4)
2. Pestell, R. et al. 369P ESMO Breast Munich, Germany. May 15, 2025
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