CytoDyn Announces Data Suggesting Novel Mechanism of Action of Leronlimab for the Treatment of Solid Tumors
CytoDyn (OTCQB: CYDY) has revealed promising new data about leronlimab's mechanism of action in treating solid tumors. The company's analysis of metastatic Triple-Negative Breast Cancer (mTNBC) trials showed that 88% (15/17) of patients receiving weekly doses of 525mg or higher experienced significant increases in PD-L1 expression on circulating tumor cells within 30-90 days.
Notably, 100% (5/5) of patients who showed increased PD-L1 expression and received immune checkpoint inhibitors (ICIs) treatment are still alive, with 80% (4/5) showing no evidence of disease. This suggests leronlimab can potentially convert "cold" tumors to "hot" tumors, making them responsive to checkpoint inhibitor therapy. The company believes this mechanism could benefit various solid tumor types, particularly in patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors.
CytoDyn is now prioritizing prospective confirmation of these findings in TNBC patients and has amended its colorectal cancer trial to collect PD-L1 data.CytoDyn (OTCQB: CYDY) ha comunicato nuovi dati promettenti sul meccanismo d'azione di leronlimab nel trattamento dei tumori solidi. L'analisi dell'azienda sugli studi clinici nel carcinoma mammario triplo negativo metastatico (mTNBC) ha mostrato che il 88% (15/17) dei pazienti che hanno ricevuto dosi settimanali di 525 mg o più ha manifestato un aumento significativo dell'espressione di PD-L1 sulle cellule tumorali circolanti entro 30-90 giorni.
In particolare, il 100% (5/5) dei pazienti con aumento di PD-L1 trattati con inibitori del checkpoint immunitario (ICI) è ancora vivo, con il 80% (4/5) che non presenta evidenza di malattia. Ciò suggerisce che leronlimab possa trasformare i tumori “freddi” in “caldi”, rendendoli sensibili alla terapia con inibitori del checkpoint. L'azienda ritiene che questo meccanismo possa essere vantaggioso per diversi tipi di tumori solidi, soprattutto in pazienti con bassi livelli di PD-L1 che in precedenza non rispondevano agli inibitori del checkpoint.
CytoDyn ora sta dando priorità alla conferma prospettica di questi risultati nei pazienti con TNBC e ha modificato il suo studio sul cancro colorettale per raccogliere dati su PD-L1.
CytoDyn (OTCQB: CYDY) ha revelado nuevos datos prometedores sobre el mecanismo de acción de leronlimab en el tratamiento de tumores sólidos. El análisis de la compañía sobre los ensayos en cáncer de mama triple negativo metastásico (mTNBC) mostró que el 88% (15/17) de los pacientes que recibieron dosis semanales de 525 mg o más experimentaron aumentos significativos en la expresión de PD-L1 en células tumorales circulantes dentro de 30-90 días.
Notablemente, el 100% (5/5) de los pacientes que mostraron aumento de PD-L1 y recibieron tratamiento con inhibidores de puntos de control inmunitarios (ICI) siguen vivos, con un 80% (4/5) sin evidencia de enfermedad. Esto sugiere que leronlimab podría convertir tumores “fríos” en “calientes”, haciéndolos sensibles a la terapia con inhibidores de puntos de control. La compañía cree que este mecanismo podría beneficiar a varios tipos de tumores sólidos, especialmente en pacientes con bajos niveles de PD-L1 que antes no respondían a estos inhibidores.
CytoDyn está ahora priorizando la confirmación prospectiva de estos hallazgos en pacientes con TNBC y ha modificado su ensayo de cáncer colorrectal para recopilar datos de PD-L1.
CytoDyn (OTCQB: CYDY)는 고형 종양 치료에서 leronlimab의 작용 기전에 대한 유망한 새로운 데이터를 공개했습니다. 회사의 전이성 삼중 음성 유방암(mTNBC) 임상시험 분석 결과, 주당 525mg 이상 용량을 투여받은 환자의 88% (15/17)가 30-90일 내에 순환 종양 세포에서 PD-L1 발현이 크게 증가한 것으로 나타났습니다.
특히, PD-L1 발현이 증가하고 면역관문억제제(ICI) 치료를 받은 환자 중 100% (5/5)가 아직 생존해 있으며, 80% (4/5)는 질병 증거가 없습니다. 이는 leronlimab이 '차가운' 종양을 '뜨거운' 종양으로 전환시켜 면역관문억제제 치료에 반응하게 만들 수 있음을 시사합니다. 회사는 이 기전이 PD-L1 수치가 낮아 이전에 면역관문억제제에 반응하지 않았던 다양한 고형 종양 환자들에게 도움이 될 수 있다고 믿고 있습니다.
CytoDyn은 현재 TNBC 환자에서 이러한 결과를 전향적으로 확인하는 것을 우선시하며, 대장암 임상시험을 수정하여 PD-L1 데이터를 수집하고 있습니다.
CytoDyn (OTCQB : CYDY) a révélé de nouvelles données prometteuses sur le mécanisme d'action de leronlimab dans le traitement des tumeurs solides. L'analyse de la société sur les essais du cancer du sein triple négatif métastatique (mTNBC) a montré que 88 % (15/17) des patients recevant des doses hebdomadaires de 525 mg ou plus ont présenté une augmentation significative de l'expression de PD-L1 sur les cellules tumorales circulantes en 30 à 90 jours.
Notamment, 100 % (5/5) des patients ayant montré une augmentation de PD-L1 et ayant reçu un traitement par inhibiteurs de points de contrôle immunitaire (ICI) sont toujours en vie, avec 80 % (4/5) sans signe de maladie. Cela suggère que leronlimab pourrait transformer les tumeurs « froides » en tumeurs « chaudes », les rendant sensibles à la thérapie par inhibiteurs de points de contrôle. La société estime que ce mécanisme pourrait bénéficier à divers types de tumeurs solides, en particulier chez les patients présentant de faibles niveaux de PD-L1 qui ne répondaient pas auparavant aux inhibiteurs de points de contrôle.
CytoDyn donne désormais la priorité à la confirmation prospective de ces résultats chez les patients atteints de TNBC et a modifié son essai sur le cancer colorectal pour collecter des données sur PD-L1.
CytoDyn (OTCQB: CYDY) hat vielversprechende neue Daten zum Wirkmechanismus von Leronlimab bei der Behandlung solider Tumoren veröffentlicht. Die Analyse des Unternehmens zu Studien bei metastasiertem triple-negativem Brustkrebs (mTNBC) zeigte, dass 88% (15/17) der Patienten, die wöchentlich 525 mg oder mehr erhielten, innerhalb von 30-90 Tagen signifikante Erhöhungen der PD-L1-Expression auf zirkulierenden Tumorzellen aufwiesen.
Bemerkenswert ist, dass 100% (5/5) der Patienten mit erhöhter PD-L1-Expression, die mit Immun-Checkpoint-Inhibitoren (ICIs) behandelt wurden, noch am Leben sind, wobei 80% (4/5) keine Krankheitsanzeichen zeigen. Dies deutet darauf hin, dass Leronlimab „kalte“ Tumoren in „heiße“ Tumoren umwandeln kann, die auf Checkpoint-Inhibitor-Therapien ansprechen. Das Unternehmen ist der Ansicht, dass dieser Mechanismus verschiedenen Arten solider Tumoren zugutekommen könnte, insbesondere Patienten mit niedrigen PD-L1-Werten, die zuvor nicht auf Checkpoint-Inhibitoren angesprochen haben.
CytoDyn priorisiert nun die prospektive Bestätigung dieser Ergebnisse bei TNBC-Patienten und hat seine Studie zum kolorektalen Krebs angepasst, um PD-L1-Daten zu erfassen.
- 88% of patients (15/17) showed significant increase in PD-L1 expression after leronlimab treatment
- 100% survival rate (5/5 patients) in those who received both leronlimab and immune checkpoint inhibitors
- 80% of surviving patients (4/5) show no evidence of disease
- Potential application across multiple solid tumor types
- Novel mechanism of action could expand treatment options for previously unresponsive patients
- Results are preliminary and need prospective confirmation
- Small sample size in survival data (only 5 patients)
- Limited to patients who failed previous treatments
Survival observations in mTNBC patients correlated with increased PD-L1 expression
Preliminary evidence suggests leronlimab has potential to turn “cold” tumors “hot”
VANCOUVER, Washington, May 13, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced new data suggesting a novel mechanism of action of leronlimab for the treatment of solid tumors.
CytoDyn analyzed data from its prior clinical trials of patients with metastatic Triple-Negative Breast Cancer (“mTNBC”) and found that leronlimab treatment correlated with increased expression of an immune cell protein or “checkpoint inhibitor” known as programmed death-ligand 1 (“PD-L1”) on patient’s circulating tumor cells (“CTCs”). CytoDyn’s results indicate that 15/17 (
As previously announced, CytoDyn identified a group of patients with mTNBC who had failed a median of two prior lines of treatment in the metastatic setting but showed improved overall survival rates after receiving leronlimab. The Company confirmed that 5/5 patients (
If the results above are confirmed prospectively, the Company believes the mechanism could be effective across a wide range of solid tumor types, and in particular benefit cancer patients with low levels of PD-L1 who were previously unresponsive to or ineligible for checkpoint inhibitors.
“Leronlimab’s induction of PD-L1 on CTCs in patients with otherwise “cold” tumors opens a promising field of exploration for what could amount to significant improvements to patient care and outcomes in solid tumor oncology,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “We are hopeful that further short-term investigation will confirm our working theory and open new pathways for patients with a range of common and aggressive forms of cancer to access treatment options that were previously out of reach.”
“We are thrilled to announce this apparent mechanism behind the improved survival in patients with refractory and metastatic TNBC,” said Dr. Jacob Lalezari, CEO of CytoDyn. “Leronlimab’s ability to induce an inflamed or “hot” tumor environment, that could then be treated with ICIs, would be a game changer in solid tumor oncology. Prospectively confirming these findings in patients with TNBC is a top priority. We have also amended our current colorectal cancer trial to ensure the prospective collection of PD-L1 data in a second type of solid tumor.”
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including oncology, infectious disease, and autoimmune conditions.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, 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, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A, and in 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.
Media Contacts
CytoDyn Inc.
Riyaz Lalani
Gagnier Communications
CytoDyn@gagnierfc.com
FAQ
What is the new mechanism of action discovered for CYDY's leronlimab in cancer treatment?
What percentage of CYDY's mTNBC patients responded to leronlimab treatment?
What are the survival rates for CYDY's leronlimab in combination with checkpoint inhibitors?
How could CYDY's leronlimab benefit cancer patients?
What are CYDY's next steps for leronlimab in cancer treatment?
