CERo Therapeutics Holdings, Inc. Continues to Progress Toward Initial Dosing of Patients in Phase 1 Trial with Agreement with University of California Davis for Manufacturing Services
CERo Therapeutics Holdings (Nasdaq: CERO) has secured a manufacturing agreement with the University of California Davis for CER-1236, advancing towards its Phase 1 clinical trial for Acute Myeloid Leukemia (AML). The agreement represents one of the final steps before patient dosing, which is anticipated in the first half of 2025.
The company emphasizes the critical importance of precision and compliance in manufacturing for successful clinical trial development and execution, highlighting UC Davis's leading reputation in this field. This development positions CERo to progress with its innovative immunotherapy program, which focuses on engineered T cell therapeutics utilizing phagocytic mechanisms.
CERo Therapeutics Holdings (Nasdaq: CERO) ha stipulato un accordo di produzione con l'Università della California Davis per CER-1236, avanzando verso il suo trial clinico di Fase 1 per la Leucemia Mieloide Acuta (LMA). L'accordo rappresenta uno degli ultimi passi prima della somministrazione ai pazienti, prevista nella prima metà del 2025.
L'azienda sottolinea l'importanza cruciale della precisione e della conformità nella produzione per lo sviluppo e l'esecuzione di trial clinici di successo, evidenziando la reputazione di leadership di UC Davis in questo campo. Questo sviluppo posiziona CERo per progredire con il suo innovativo programma di immunoterapia, che si concentra su terapie con cellule T ingegnerizzate che utilizzano meccanismi fagocitici.
CERo Therapeutics Holdings (Nasdaq: CERO) ha asegurado un acuerdo de fabricación con la Universidad de California Davis para CER-1236, avanzando hacia su ensayo clínico de Fase 1 para la Leucemia Mieloide Aguda (LMA). El acuerdo representa uno de los pasos finales antes de la dosificación en pacientes, que se anticipa para la primera mitad de 2025.
La empresa enfatiza la importancia crítica de la precisión y el cumplimiento en la fabricación para el desarrollo y la ejecución exitosa de ensayos clínicos, destacando la reputación de liderazgo de UC Davis en este campo. Este desarrollo posiciona a CERo para avanzar con su innovador programa de inmunoterapia, que se centra en terapias con células T ingenierizadas que utilizan mecanismos fagocíticos.
CERo Therapeutics Holdings (Nasdaq: CERO)는 CER-1236을 위한 캘리포니아 대학교 데이비스와 제조 계약을 체결하여 급성 골수성 백혈병(AML)을 위한 1상 임상 시험에 나아가고 있습니다. 이 계약은 환자 투여 전에 필요한 마지막 단계 중 하나로, 2025년 상반기에 예상됩니다.
회사는 성공적인 임상 시험 개발 및 실행을 위한 제조에서의 정확성과 준수의 중요성을 강조하며, 이 분야에서 UC 데이비스의 선도적인 명성을 강조합니다. 이 개발은 CERo가 식세포 메커니즘을 활용한 공학적 T세포 치료법에 집중하는 혁신적인 면역 요법 프로그램을 진행할 수 있도록 합니다.
CERo Therapeutics Holdings (Nasdaq: CERO) a conclu un accord de fabrication avec l'Université de Californie à Davis pour CER-1236, avançant vers son essai clinique de Phase 1 pour la Leucémie Myéloïde Aiguë (LMA). Cet accord représente l'une des dernières étapes avant l'administration aux patients, prévue pour la première moitié de 2025.
L'entreprise souligne l'importance cruciale de la précision et de la conformité dans la fabrication pour le développement et l'exécution réussis des essais cliniques, mettant en avant la réputation de leader de l'UC Davis dans ce domaine. Ce développement positionne CERo pour progresser avec son programme innovant d'immunothérapie, qui se concentre sur des thérapies par cellules T ingénierées utilisant des mécanismes phagocytaires.
CERo Therapeutics Holdings (Nasdaq: CERO) hat einen Herstellungsvertrag mit der Universität von Kalifornien Davis für CER-1236 gesichert und schreitet auf die Phase-1-Studie für akute myeloische Leukämie (AML) zu. Der Vertrag stellt einen der letzten Schritte vor der Patientendosierung dar, die in der ersten Hälfte des Jahres 2025 erwartet wird.
Das Unternehmen betont die entscheidende Bedeutung von Präzision und Compliance in der Herstellung für den erfolgreichen Verlauf und die Durchführung klinischer Studien und hebt den führenden Ruf von UC Davis in diesem Bereich hervor. Diese Entwicklung positioniert CERo, um mit seinem innovativen Immuntherapie-Programm voranzukommen, das sich auf ingenierte T-Zell-Therapeutika konzentriert, die phagozytische Mechanismen nutzen.
- Manufacturing agreement secured with prestigious UC Davis institution
- On track for Phase 1 trial initiation in H1 2025
- Completion of one of the final steps before patient dosing
- None.
Company continues to improve its market position as it nears launch of its Phase 1 clinical trial in AML
SOUTH SAN FRANSCISCO, Calif., March 19, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces an agreement with the University of California Davis for the manufacturing of CER-1236 to be used in the Company’s upcoming Phase 1 clinical trial for Acute Myeloid Leukemia (AML). The Company believes it is on track for dosing the first patient in the first half of 2025.
CEO Chris Ehrlich commented, “The precision and compliance in manufacturing is critical to successful development and execution of clinical trials and UC Davis is a leading institution with an impeccable reputation in this area. The manufacturing of product is among the final steps necessary to have completed prior to patient dosing, and we are looking forward to continuing to drive the process forward.”
About CERo Therapeutics Holdings, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2025 for hematological malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo the timing and completion of the reverse stock split, and the acceptance and implementation of its proposed plan of compliance with Nasdaq continued listing standards. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Chris Ehrlich
Chief Executive Officer
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
FAQ
When will CERo Therapeutics (CERO) begin patient dosing for its AML Phase 1 trial?
What is the purpose of CERo's manufacturing agreement with UC Davis?
What type of therapy is CERo Therapeutics (CERO) developing?
What is the significance of the UC Davis manufacturing agreement for CERO's clinical timeline?
