CytoDyn Announces First Patient Dosed in Phase II Oncology Trial in Colorectal Cancer
CytoDyn (OTCQB: CYDY) has initiated dosing in its Phase II clinical trial evaluating leronlimab for relapsed/refractory microsatellite stable colorectal cancer (CRC). The trial, conducted in partnership with Syneos Health across eight clinical sites, is led by Dr. Ben Weinberg from Georgetown University. According to WHO data, colorectal cancer represents the third most common cancer globally, with approximately 1.9 million new cases and 900,000 deaths annually.
The study builds on CytoDyn's previous research showing potential clinical benefits of leronlimab in relapsed CRC patients and aims to evaluate its mechanism of action in solid tumor oncology. The company's strategy is influenced by promising survival rates observed in prior metastatic triple-negative breast cancer studies.
CytoDyn (OTCQB: CYDY) ha iniziato la somministrazione nel suo studio clinico di Fase II che valuta leronlimab per il cancro colorettale (CRC) microsatellite stabile recidivante/refrattario. Lo studio, condotto in collaborazione con Syneos Health in otto centri clinici, è guidato dal dott. Ben Weinberg dell'Università di Georgetown. Secondo i dati dell'OMS, il cancro colorettale rappresenta il terzo tumore più comune a livello globale, con circa 1,9 milioni di nuovi casi e 900.000 decessi ogni anno.
La ricerca si basa sugli studi precedenti di CytoDyn che hanno evidenziato potenziali benefici clinici del leronlimab nei pazienti con CRC recidivante e mira a valutare il suo meccanismo d'azione nell'oncologia dei tumori solidi. La strategia dell'azienda è influenzata dai promettenti tassi di sopravvivenza osservati in studi precedenti sul carcinoma mammario triplo negativo metastatico.
CytoDyn (OTCQB: CYDY) ha iniciado la dosificación en su ensayo clínico de Fase II que evalúa leronlimab para el cáncer colorrectal (CRC) microsatélite estable en recaída/refractario. El ensayo, realizado en colaboración con Syneos Health en ocho sitios clínicos, está dirigido por el Dr. Ben Weinberg de la Universidad de Georgetown. Según datos de la OMS, el cáncer colorrectal es el tercer cáncer más común a nivel mundial, con aproximadamente 1.9 millones de casos nuevos y 900,000 muertes anuales.
El estudio se basa en investigaciones previas de CytoDyn que mostraron beneficios clínicos potenciales de leronlimab en pacientes con CRC en recaída y busca evaluar su mecanismo de acción en oncología de tumores sólidos. La estrategia de la compañía está influenciada por las prometedoras tasas de supervivencia observadas en estudios anteriores de cáncer de mama triple negativo metastásico.
CytoDyn (OTCQB: CYDY)는 재발/불응성 마이크로새틀라이트 안정 대장암(CRC)을 대상으로 하는 렐론리맙의 2상 임상시험에서 투약을 시작했습니다. Syneos Health와 협력하여 8개 임상 사이트에서 진행되는 이 시험은 조지타운 대학교의 벤 와인버그 박사가 주도하고 있습니다. WHO 데이터에 따르면 대장암은 전 세계에서 세 번째로 흔한 암이며, 연간 약 190만 건의 신규 환자와 90만 명의 사망자가 발생합니다.
이번 연구는 재발한 CRC 환자에서 렐론리맙의 잠재적 임상적 이점을 보여준 CytoDyn의 이전 연구를 바탕으로 하며, 고형 종양 종양학에서의 작용 기전을 평가하는 것을 목표로 합니다. 회사의 전략은 이전 전이성 삼중음성 유방암 연구에서 관찰된 유망한 생존율에 영향을 받았습니다.
CytoDyn (OTCQB : CYDY) a commencé l'administration dans son essai clinique de phase II évaluant le leronlimab pour le cancer colorectal (CRC) stable au niveau des microsatellites, en rechute/réfractaire. L'essai, mené en partenariat avec Syneos Health sur huit sites cliniques, est dirigé par le Dr Ben Weinberg de l'Université de Georgetown. Selon les données de l'OMS, le cancer colorectal représente le troisième cancer le plus fréquent dans le monde, avec environ 1,9 million de nouveaux cas et 900 000 décès chaque année.
Cette étude s'appuie sur les recherches antérieures de CytoDyn montrant des bénéfices cliniques potentiels du leronlimab chez les patients atteints de CRC en rechute, et vise à évaluer son mécanisme d'action en oncologie des tumeurs solides. La stratégie de l'entreprise est influencée par les taux de survie prometteurs observés dans des études antérieures sur le cancer du sein triple négatif métastatique.
CytoDyn (OTCQB: CYDY) hat mit der Dosierung in seiner Phase-II-Studie begonnen, die Leronlimab bei rezidivierendem/refraktärem mikrosatellitenstabilem kolorektalem Krebs (CRC) untersucht. Die Studie, die in Zusammenarbeit mit Syneos Health an acht klinischen Standorten durchgeführt wird, wird von Dr. Ben Weinberg von der Georgetown University geleitet. Laut WHO-Daten ist kolorektales Krebs der dritthäufigste Krebs weltweit mit etwa 1,9 Millionen Neuerkrankungen und 900.000 Todesfällen jährlich.
Die Studie baut auf CytoDyns früheren Forschungen auf, die potenzielle klinische Vorteile von Leronlimab bei Patienten mit rezidivierendem CRC zeigten, und zielt darauf ab, den Wirkmechanismus bei soliden Tumoren in der Onkologie zu evaluieren. Die Strategie des Unternehmens wird von den vielversprechenden Überlebensraten beeinflusst, die in früheren Studien zum metastasierten triple-negativen Brustkrebs beobachtet wurden.
- First patient dosed in Phase II trial for colorectal cancer treatment
- Partnership with Syneos Health and engagement of eight clinical sites
- Building on previous promising research in CRC and breast cancer
- Targeting large market opportunity with 1.9 million new CRC cases annually
- Early-stage Phase II trial with uncertain outcomes
- Operating in highly competitive oncology market
- Trading on OTCQB market rather than major exchange
Enrollment is now underway across multiple clinical sites, in partnership with Syneos Health
VANCOUVER, Washington, June 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 that the first patient has been dosed in the Company’s clinical trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”).
In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway. The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance.
According to the World Health Organization’s International Agency for Research on Cancer (“IARC”), colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year. The IARC also noted that the incidence rates of colorectal cancer in people younger than 50 years old have been increasing for at least 20 years, with some sources dating the increase trend back 30 years or more.
“Dosing the first patient in our Phase II CRC trial is a significant step forward in our mission to bring innovative treatment options to patients facing this challenging disease. This milestone reflects the dedication of our team and clinical partners, and we look forward to advancing this study to better understand the potential impact of our therapy across solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn.
The study builds on the Company’s prior research demonstrating the potential clinical benefit of leronlimab in patients with relapsed CRC, and will also further the evaluation of the potential for the Company’s recently announced mechanism of action for leronlimab in solid tumor oncology. Given the promising survival rates observed in the Company’s prior studies in patients with metastatic triple-negative breast cancer and the Company’s ongoing clinical investigation efforts in CRC, CytoDyn views its current line of scientific evaluation as the most expeditious path to determining how broadly applicable this mechanism may prove to be across various solid tumors.
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.
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Syneos Health brings a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together, Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed its customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how Syneos Health is shortening the distance from lab to life®, visit syneoshealth.com.
Media Contacts
CytoDyn
Riyaz Lalani
Gagnier Communications
CytoDyn@gagnierfc.com
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