Ernexa Therapeutics Establishes Texas Subsidiary to Support Continued Development of ERNA-101 and Future Clinical Operations
Ernexa Therapeutics (NASDAQ: ERNA) has announced the formation of ErnexaTX2, a wholly owned subsidiary in Texas. This strategic move is designed to support the development of ERNA-101, the company's lead program targeting ovarian cancer. The subsidiary will facilitate ongoing research collaboration with Dr. Michael Andreeff from The University of Texas MD Anderson Cancer Center, an expert in cell therapy and tumor microenvironment.
The new Texas entity will help Ernexa build infrastructure for future clinical operations, including clinical manufacturing, regulatory interactions, and site activation. The company remains on schedule for IND-enabling studies in 2025, with first-in-human trials planned for 2026.
Ernexa Therapeutics (NASDAQ: ERNA) ha annunciato la creazione di ErnexaTX2, una filiale interamente controllata con sede in Texas. Questa mossa strategica è pensata per sostenere lo sviluppo di ERNA-101, il programma principale dell'azienda focalizzato sul cancro ovarico. La filiale faciliterà la collaborazione di ricerca in corso con Dr. Michael Andreeff dell'Università del Texas MD Anderson Cancer Center, esperto in terapia cellulare e microambiente tumorale.
La nuova entità texana aiuterà Ernexa a costruire l'infrastruttura per le future operazioni cliniche, inclusi la produzione clinica, le interazioni regolatorie e l'attivazione dei siti. L'azienda conferma di essere in linea con i tempi per gli studi abilitanti IND nel 2025, con i primi trial sull'uomo previsti per il 2026.
Ernexa Therapeutics (NASDAQ: ERNA) ha anunciado la creación de ErnexaTX2, una filial de propiedad total en Texas. Esta estrategia está diseñada para apoyar el desarrollo de ERNA-101, el programa principal de la compañía dirigido al cáncer de ovario. La filial facilitará la colaboración continua en investigación con el Dr. Michael Andreeff de la Universidad de Texas MD Anderson Cancer Center, experto en terapia celular y microambiente tumoral.
La nueva entidad en Texas ayudará a Ernexa a construir la infraestructura para futuras operaciones clínicas, incluyendo la fabricación clínica, interacciones regulatorias y activación de sitios. La compañía mantiene su cronograma para estudios de habilitación IND en 2025, con ensayos en humanos previstos para 2026.
Ernexa Therapeutics (NASDAQ: ERNA)가 텍사스에 100% 자회사인 ErnexaTX2를 설립했다고 발표했습니다. 이 전략적 조치는 난소암을 타깃으로 하는 회사의 주요 프로그램인 ERNA-101 개발을 지원하기 위한 것입니다. 이 자회사는 세포 치료 및 종양 미세환경 전문가인 텍사스 대학교 MD 앤더슨 암센터의 마이클 안드리프 박사와의 지속적인 연구 협력을 용이하게 할 것입니다.
새로운 텍사스 법인은 임상 제조, 규제 대응, 사이트 활성화 등 향후 임상 운영을 위한 인프라 구축을 돕습니다. 회사는 2025년 IND 승인 연구를 예정대로 진행 중이며, 2026년 첫 임상 시험도 계획하고 있습니다.
Ernexa Therapeutics (NASDAQ : ERNA) a annoncé la création de ErnexaTX2, une filiale détenue à 100 % au Texas. Cette initiative stratégique vise à soutenir le développement de ERNA-101, le programme principal de la société ciblant le cancer de l'ovaire. La filiale facilitera la collaboration de recherche en cours avec le Dr Michael Andreeff de l'Université du Texas MD Anderson Cancer Center, expert en thérapie cellulaire et microenvironnement tumoral.
La nouvelle entité texane aidera Ernexa à mettre en place l'infrastructure nécessaire pour les futures opérations cliniques, y compris la fabrication clinique, les interactions réglementaires et l'activation des sites. La société reste dans les délais pour les études de validation IND en 2025, avec les premiers essais chez l'humain prévus pour 2026.
Ernexa Therapeutics (NASDAQ: ERNA) hat die Gründung von ErnexaTX2 angekündigt, einer vollständig im Besitz befindlichen Tochtergesellschaft in Texas. Dieser strategische Schritt dient der Unterstützung der Entwicklung von ERNA-101, dem Hauptprogramm des Unternehmens zur Behandlung von Eierstockkrebs. Die Tochtergesellschaft wird die laufende Forschungszusammenarbeit mit Dr. Michael Andreeff vom University of Texas MD Anderson Cancer Center, einem Experten für Zelltherapie und Tumormikroumgebung, erleichtern.
Die neue texanische Einheit wird Ernexa beim Aufbau der Infrastruktur für zukünftige klinische Abläufe unterstützen, einschließlich klinischer Herstellung, regulatorischer Interaktionen und Standortaktivierung. Das Unternehmen bleibt im Zeitplan für IND-fähige Studien im Jahr 2025 mit erstmaligen Studien am Menschen, die für 2026 geplant sind.
- Strategic expansion into Texas biotech ecosystem through new subsidiary
- Collaboration with renowned cell therapy expert Dr. Michael Andreeff
- On track for IND-enabling studies in 2025 and human trials in 2026
- Positioning for clinical manufacturing and regulatory advancement
- None.
New entity, ErnexaTX2, reflects progress toward clinical readiness
CAMBRIDGE, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the formation of ErnexaTX2, a wholly owned subsidiary based in Texas. The new entity has been established to support ongoing preclinical development of the company’s lead program, ERNA-101 for ovarian cancer, and to lay the operational groundwork for anticipated clinical activity in 2026.
“As we continue to progress ERNA-101 through key preclinical milestones, we’re also setting the stage for a seamless transition into clinical work,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “The formation of ErnexaTX2 reflects both our long-term commitment to the Texas ecosystem and our strategic readiness to support clinical manufacturing, regulatory interactions, and site activation in the years ahead.”
The subsidiary will support ongoing research being conducted under a sponsored research agreement with Michael Andreeff, M.D., Ph.D., from The University of Texas MD Anderson Cancer Center. Dr. Andreeff is an internationally recognized cell therapy expert and a longtime leader in targeting the tumor microenvironment in ovarian and other solid tumors.
In parallel with scientific advancements, Ernexa continues to evolve its infrastructure in anticipation of future Investigational New Drug (IND)-enabling activities. With its new footprint in Texas, the company is positioned to accelerate clinical partnerships, navigate regulatory planning, and engage local biomanufacturing partners to support scale-up efforts.
ERNA-101 remains on track for IND-enabling studies in 2025, with first-in-human studies targeted for 2026.
About Ernexa Therapeutics
Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative stem cell therapies for the treatment of advanced cancer and autoimmune disease. Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment, without needing patient-specific cell harvesting.
ERNA-101 is the company’s lead cell therapy product, designed to activate and regulate the immune system’s response to recognize and attack cancer cells. ERNA-102 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company’s initial focus is to develop ERNA-101 for the treatment of ovarian cancer.
For more information, visit www.ernexatx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Ernexa’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: progress and possible outcomes of the Company’s lead research project, ERNA-101, and future research projects. Forward-looking statements are based upon Ernexa’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Ernexa’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including its recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Ernexa does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as required by applicable law.
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