CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab
CytoDyn (OTCQB: CYDY) announced encouraging survival outcomes for metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab, their CCR5 antagonist drug candidate. The company reported favorable survival rates at 12, 24, and 36 months compared to current therapies, with some patients who previously failed treatment now showing no evidence of disease.
Following resolution of a dispute with their former CRO, CytoDyn obtained follow-up records and submitted findings to the upcoming ESMO Breast Cancer meeting in Munich. The company has initiated two pre-clinical studies to evaluate potential synergies between leronlimab and other treatments (sacituzumab govitecan and pembrolizumab).
The drug was reported to be well-tolerated with minimal treatment-related adverse events. The company plans to accelerate its oncology efforts, with future announcements expected in both mTNBC and colorectal cancer treatments.
CytoDyn (OTCQB: CYDY) ha annunciato risultati di sopravvivenza incoraggianti per i pazienti con cancro al seno triplo negativo metastatico (mTNBC) trattati con leronlimab, il loro candidato farmaco antagonista CCR5. L'azienda ha riportato tassi di sopravvivenza favorevoli a 12, 24 e 36 mesi rispetto alle terapie attuali, con alcuni pazienti che avevano precedentemente fallito il trattamento ora privi di evidenza di malattia.
Dopo la risoluzione di una disputa con il loro precedente CRO, CytoDyn ha ottenuto registrazioni di follow-up e ha presentato i risultati alla prossima riunione ESMO sul cancro al seno a Monaco. L'azienda ha avviato due studi preclinici per valutare potenziali sinergie tra leronlimab e altri trattamenti (sacituzumab govitecan e pembrolizumab).
Il farmaco è stato riportato come ben tollerato con eventi avversi legati al trattamento minimi. L'azienda prevede di accelerare i suoi sforzi in oncologia, con futuri annunci attesi sia per il mTNBC che per i trattamenti del cancro colorettale.
CytoDyn (OTCQB: CYDY) anunció resultados de supervivencia alentadores para pacientes con cáncer de mama triple negativo metastásico (mTNBC) tratados con leronlimab, su candidato a fármaco antagonista CCR5. La compañía informó tasas de supervivencia favorables a los 12, 24 y 36 meses en comparación con las terapias actuales, con algunos pacientes que previamente fracasaron en el tratamiento ahora mostrando ausencia de evidencia de enfermedad.
Tras la resolución de una disputa con su anterior CRO, CytoDyn obtuvo registros de seguimiento y presentó hallazgos en la próxima reunión de ESMO sobre cáncer de mama en Múnich. La compañía ha iniciado dos estudios preclínicos para evaluar sinergias potenciales entre leronlimab y otros tratamientos (sacituzumab govitecan y pembrolizumab).
Se informó que el fármaco fue bien tolerado con eventos adversos relacionados con el tratamiento mínimos. La empresa planea acelerar sus esfuerzos en oncología, con futuros anuncios esperados tanto en mTNBC como en tratamientos de cáncer colorrectal.
CytoDyn (OTCQB: CYDY)는 CCR5 길항제 후보 약물인 레론리맙으로 치료받은 전이성 삼중 음성 유방암(mTNBC) 환자들에 대한 고무적인 생존 결과를 발표했습니다. 이 회사는 현재 치료법과 비교하여 12개월, 24개월 및 36개월에서 유리한 생존율을 보고했으며, 이전에 치료에 실패했던 일부 환자들이 이제 질병의 증거가 없는 것으로 나타났습니다.
이전 CRO와의 분쟁이 해결된 후, CytoDyn은 후속 기록을 확보하고 뮌헨에서 열리는 ESMO 유방암 회의에 결과를 제출했습니다. 이 회사는 레론리맙과 다른 치료법(사시투주맙 고비테칸 및 펨브롤리주맙) 간의 잠재적인 시너지를 평가하기 위해 두 개의 전임상 연구를 시작했습니다.
이 약물은 최소한의 치료 관련 부작용으로 잘 견딘 것으로 보고되었습니다. 이 회사는 온콜로지 노력을 가속화할 계획이며, mTNBC 및 대장암 치료에 대한 향후 발표가 기대됩니다.
CytoDyn (OTCQB: CYDY) a annoncé des résultats de survie encourageants pour les patients atteints de cancer du sein triple négatif métastatique (mTNBC) traités avec le léronlimab, leur candidat médicament antagoniste CCR5. La société a rapporté des taux de survie favorables à 12, 24 et 36 mois par rapport aux thérapies actuelles, certains patients ayant précédemment échoué au traitement ne montrant désormais aucune preuve de maladie.
Suite à la résolution d'un différend avec leur ancien CRO, CytoDyn a obtenu des dossiers de suivi et a soumis ses résultats à la prochaine réunion ESMO sur le cancer du sein à Munich. L'entreprise a lancé deux études précliniques pour évaluer les synergies potentielles entre le léronlimab et d'autres traitements (sacituzumab govitecan et pembrolizumab).
Le médicament a été rapporté comme étant bien toléré avec des événements indésirables liés au traitement minimaux. L'entreprise prévoit d'accélérer ses efforts en oncologie, avec de futures annonces attendues tant pour le mTNBC que pour les traitements du cancer colorectal.
CytoDyn (OTCQB: CYDY) hat ermutigende Überlebensresultate für Patienten mit metastasiertem dreifach negativem Brustkrebs (mTNBC) bekannt gegeben, die mit Leronlimab, ihrem CCR5-Antagonisten, behandelt wurden. Das Unternehmen berichtete über günstige Überlebensraten nach 12, 24 und 36 Monaten im Vergleich zu aktuellen Therapien, wobei einige Patienten, die zuvor eine Behandlung nicht erfolgreich abgeschlossen hatten, nun keine Krankheitszeichen mehr zeigen.
Nach der Beilegung eines Streits mit ihrem ehemaligen CRO hat CytoDyn Nachsorgedaten erhalten und die Ergebnisse auf der bevorstehenden ESMO-Brustkrebs-Tagung in München eingereicht. Das Unternehmen hat zwei präklinische Studien initiiert, um potenzielle Synergien zwischen Leronlimab und anderen Behandlungen (Sacituzumab Govitecan und Pembrolizumab) zu bewerten.
Das Medikament wurde als gut verträglich mit minimalen behandlungsbedingten Nebenwirkungen berichtet. Das Unternehmen plant, seine Onkologie-Bemühungen zu beschleunigen, wobei zukünftige Ankündigungen sowohl für mTNBC als auch für Behandlungen von kolorektalem Krebs erwartet werden.
- Favorable survival rates observed at 12, 24, and 36 months compared to existing therapies
- Some patients with previous treatment failure now show no evidence of disease
- Drug demonstrated good tolerability with minimal adverse events
- Two new pre-clinical studies initiated to evaluate treatment synergies
- None.
VANCOUVER, Washington, Feb. 24, 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 encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. Although mTNBC typically has a poor prognosis, observed survival rates at 12, 24, and 36 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.
Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025.
“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care.”
Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.”
Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease.
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 infectious disease, oncology, and autoimmune conditions.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, 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. 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.
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Gagnier Communications
CytoDyn@gagnierfc.com
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