CytoDyn Engages Syneos Health as CRO For Its Phase II Oncology Trial
CytoDyn Inc. (OTCQB: CYDY) has engaged Syneos Health as the contract research organization (CRO) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). Syneos Health is a leading biopharmaceutical solutions organization with advanced data analytics and AI/ML capabilities.
Dr. Jacob Lalezari, CEO of CytoDyn, stated that investigating leronlimab in oncology remains their top priority. The company expects to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn submitted the final study protocol to the FDA for approval in September 2024 and anticipates starting patient screening in early 2025.
CytoDyn Inc. (OTCQB: CYDY) ha incaricato Syneos Health come organizzazione di ricerca sotto contratto (CRO) per il prossimo studio oncologico di Fase II. Lo studio valuterà l'efficacia di leronlimab nei pazienti con cancro colorettale (CRC) stabile al microsatellite in recidiva/rifrangente. Syneos Health è un'organizzazione leader nelle soluzioni biopharma con avanzate capacità di analisi dei dati e AI/ML.
Il Dr. Jacob Lalezari, CEO di CytoDyn, ha dichiarato che l'indagine su leronlimab in oncologia resta la loro massima priorità. L'azienda prevede di generare dati clinici che confermino l'utilità di leronlimab in combinazione con trifluridina più tipiracil (TAS-102) e bevacizumab. CytoDyn ha presentato il protocollo di studio finale all'FDA per approvazione nel settembre 2024 e prevede di avviare la selezione dei pazienti all'inizio del 2025.
CytoDyn Inc. (OTCQB: CYDY) ha contratado a Syneos Health como la organización de investigación por contrato (CRO) para su próximo ensayo oncológico de Fase II. El ensayo evaluará la eficacia de leronlimab en pacientes con cáncer colorrectal (CRC) estable de microsatélites en recaída/refractario. Syneos Health es una organización líder en soluciones biofarmacéuticas con avanzadas capacidades de análisis de datos e inteligencia artificial/aprendizaje automático.
El Dr. Jacob Lalezari, CEO de CytoDyn, afirmó que investigar leronlimab en oncología sigue siendo su máxima prioridad. La empresa espera generar datos clínicos que confirmen la utilidad de leronlimab en combinación con trifluridina más tipiracilo (TAS-102) y bevacizumab. CytoDyn presentó el protocolo de estudio final a la FDA para su aprobación en septiembre de 2024 y anticipa comenzar la selección de pacientes a principios de 2025.
CytoDyn Inc. (OTCQB: CYDY)는 Syneos Health를 향후 2상 종양학 시험의 계약 연구 기관(CRO)으로 지정했습니다. 이 시험은 재발성/저항성 미세위성 안정형 대장암(CRC) 환자에서 leronlimab의 효능을 평가할 것입니다. Syneos Health는 고급 데이터 분석 및 AI/ML 능력을 갖춘 선도적인 생명공학 솔루션 조직입니다.
CytoDyn의 CEO인 Jacob Lalezari 박사는 종양학에서 leronlimab을 조사하는 것이 그들의 최우선 사항이라고 밝혔습니다. 이 회사는 leronlimab이 트리플루리딘과 타피라실(TAS-102) 및 베바시주맙과의 조합에서 유용하다는 사실을 입증할 임상 데이터를 생성할 것으로 기대하고 있습니다. CytoDyn은 2024년 9월 FDA에 최종 연구 프로토콜을 제출했으며, 2025년 초에 환자 선별을 시작할 것으로 예상하고 있습니다.
CytoDyn Inc. (OTCQB: CYDY) a engagé Syneos Health en tant qu'organisation de recherche sous contrat (CRO) pour son prochain essai oncologique de Phase II. L'essai évaluera l'efficacité de leronlimab chez les patients atteints d'un cancer colorectal (CRC) stable par microsatellite, en rechute/réfractaire. Syneos Health est une organisation de solutions biopharmaceutiques de premier plan, avec des capacités avancées d'analyse de données et d'IA/apprentissage machine.
Le Dr Jacob Lalezari, PDG de CytoDyn, a déclaré que l'étude de leronlimab en oncologie reste leur priorité absolue. L'entreprise s'attend à générer des données cliniques confirmant l'utilité de leronlimab en combinaison avec la trifluridine plus le tipiracil (TAS-102) et le bévacizumab. CytoDyn a soumis le protocole d'étude final à la FDA pour approbation en septembre 2024 et prévoit de commencer le dépistage des patients début 2025.
CytoDyn Inc. (OTCQB: CYDY) hat Syneos Health als Vertragsforschungsorganisation (CRO) für die bevorstehende Phase-II-Onkologie-Studie engagiert. Die Studie wird die Wirksamkeit von leronlimab bei Patienten mit rezidivierendem/refraktärem mikrosatellitenstabilem kolorektalem Krebs (CRC) bewerten. Syneos Health ist eine führende biopharmazeutische Lösungsorganisation mit fortschrittlichen Datenanalyse- und KI/ML-Fähigkeiten.
Dr. Jacob Lalezari, CEO von CytoDyn, erklärte, dass die Forschung zu leronlimab in der Onkologie weiterhin ihre oberste Priorität bleibt. Das Unternehmen erwartet, klinische Daten zu generieren, die die Nützlichkeit von leronlimab in Kombination mit Trifluridin plus Tipiracil (TAS-102) und Bevacizumab bestätigen. CytoDyn hat das endgültige Studienprotokoll im September 2024 zur Genehmigung bei der FDA eingereicht und plant, Anfang 2025 mit der Patientenauswahl zu beginnen.
- Engagement of Syneos Health as CRO for Phase II oncology trial
- Potential for leronlimab in multiple therapeutic indications
- Submission of final study protocol to FDA for approval
- Expected patient screening to begin in early 2025
- None.
VANCOUVER, Washington, Oct. 04, 2024 (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, announced today that it has engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”).
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers in accelerating the delivery of life-saving therapies to market. Syneos Health leverages advanced data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization. Syneos Health has helped to develop or commercialize
“Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health. With this expanded mandate, we expect to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab,” said Dr. Jacob Lalezari, CEO.
As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.
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. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.
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.
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.
CONTACT
CytoDyn
Investor Relations
CytoDyn Inc.
ir@cytodyn.com
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