Ernexa Therapeutics Presented Promising Data on Innovative Cell Therapy Treatment at AACR Annual Meeting 2025
Ernexa Therapeutics presented groundbreaking data at the AACR Annual Meeting 2025 showcasing a novel stem cell therapy for ovarian cancer. The company's lead product, ERNA-101, uses engineered induced pluripotent stem cells (iPSCs) transformed into induced MSCs that secrete immune-boosting cytokines IL-7 and IL-15.
Led by Dr. Michael Andreeff from MD Anderson Cancer Center, the study demonstrated that these engineered cells effectively:
- Slowed tumor growth in ovarian cancer models
- Improved survival rates
- Increased presence of crucial immune cells (T cells, NK cells, macrophages)
- Enhanced T cell growth and multiplication
- Showed better growth and multiplication compared to traditional MSCs
This breakthrough addresses previous limitations of mesenchymal stem cells in cancer treatment, offering a more effective and scalable therapeutic approach. The results support continued development of Ernexa's cancer pipeline.
Ernexa Therapeutics ha presentato dati innovativi al AACR Annual Meeting 2025 riguardanti una nuova terapia con cellule staminali per il cancro ovarico. Il prodotto principale dell'azienda, ERNA-101, utilizza cellule staminali pluripotenti indotte (iPSC) ingegnerizzate, trasformate in MSC indotte che secernono citochine immunostimolanti IL-7 e IL-15.
Guidato dal Dr. Michael Andreeff del MD Anderson Cancer Center, lo studio ha dimostrato che queste cellule ingegnerizzate sono efficaci nel:
- Rallentare la crescita tumorale nei modelli di cancro ovarico
- Migliorare i tassi di sopravvivenza
- Aumentare la presenza di cellule immunitarie fondamentali (cellule T, cellule NK, macrofagi)
- Favorire la crescita e la moltiplicazione delle cellule T
- Mostrare una crescita e moltiplicazione superiori rispetto alle MSC tradizionali
Questa scoperta supera le limitazioni precedenti delle cellule staminali mesenchimali nel trattamento del cancro, offrendo un approccio terapeutico più efficace e scalabile. I risultati supportano lo sviluppo continuo della pipeline oncologica di Ernexa.
Ernexa Therapeutics presentó datos innovadores en el AACR Annual Meeting 2025 que muestran una nueva terapia con células madre para el cáncer de ovario. El producto principal de la compañía, ERNA-101, utiliza células madre pluripotentes inducidas (iPSCs) modificadas, transformadas en MSC inducidas que secretan las citocinas inmunoestimulantes IL-7 e IL-15.
Dirigido por el Dr. Michael Andreeff del MD Anderson Cancer Center, el estudio demostró que estas células modificadas son efectivas para:
- Reducir el crecimiento tumoral en modelos de cáncer de ovario
- Mejorar las tasas de supervivencia
- Aumentar la presencia de células inmunitarias clave (células T, células NK, macrófagos)
- Potenciar el crecimiento y la multiplicación de células T
- Mostrar un mejor crecimiento y multiplicación en comparación con las MSC tradicionales
Este avance supera las limitaciones previas de las células madre mesenquimales en el tratamiento del cáncer, ofreciendo un enfoque terapéutico más eficaz y escalable. Los resultados respaldan el desarrollo continuo de la línea oncológica de Ernexa.
Ernexa Therapeutics는 AACR 연례회의 2025에서 난소암에 대한 혁신적인 줄기세포 치료법에 관한 획기적인 데이터를 발표했습니다. 회사의 주요 제품인 ERNA-101은 유도 만능 줄기세포(iPSC)를 변형시켜 면역 증강 사이토카인 IL-7과 IL-15를 분비하는 유도 중간엽 줄기세포(MSC)로 만든 치료제입니다.
MD Anderson 암센터의 Dr. Michael Andreeff가 주도한 연구는 이 변형된 세포들이 다음과 같은 효과를 보임을 입증했습니다:
- 난소암 모델에서 종양 성장 억제
- 생존율 향상
- 중요한 면역세포(T세포, NK세포, 대식세포) 증가
- T세포 성장 및 증식 촉진
- 전통적인 MSC에 비해 우수한 성장 및 증식
이번 돌파구는 암 치료에서 중간엽 줄기세포의 기존 한계를 극복하며, 보다 효과적이고 확장 가능한 치료법을 제시합니다. 이 결과는 Ernexa의 암 치료 파이프라인 개발을 지속 지원합니다.
Ernexa Therapeutics a présenté des données révolutionnaires lors du AACR Annual Meeting 2025 mettant en avant une nouvelle thérapie par cellules souches pour le cancer de l’ovaire. Le produit principal de la société, ERNA-101, utilise des cellules souches pluripotentes induites (iPSCs) modifiées, transformées en MSC induites sécrétant les cytokines immunostimulantes IL-7 et IL-15.
Dirigée par le Dr Michael Andreeff du MD Anderson Cancer Center, l’étude a démontré que ces cellules modifiées étaient efficaces pour :
- Ralentir la croissance tumorale dans des modèles de cancer de l’ovaire
- Améliorer les taux de survie
- Augmenter la présence de cellules immunitaires clés (cellules T, cellules NK, macrophages)
- Stimuler la croissance et la multiplication des cellules T
- Montrer une meilleure croissance et multiplication comparées aux MSC traditionnelles
Cette avancée surmonte les limites précédentes des cellules souches mésenchymateuses dans le traitement du cancer, offrant une approche thérapeutique plus efficace et évolutive. Les résultats soutiennent le développement continu du pipeline oncologique d’Ernexa.
Ernexa Therapeutics präsentierte bahnbrechende Daten auf dem AACR Annual Meeting 2025, die eine neuartige Stammzelltherapie für Eierstockkrebs vorstellen. Das führende Produkt des Unternehmens, ERNA-101, nutzt gentechnisch veränderte induzierte pluripotente Stammzellen (iPSCs), die in induzierte MSCs umgewandelt werden und immunstimulierende Zytokine IL-7 und IL-15 ausschütten.
Unter der Leitung von Dr. Michael Andreeff vom MD Anderson Cancer Center zeigte die Studie, dass diese modifizierten Zellen effektiv:
- Das Tumorwachstum in Eierstockkrebsmodellen verlangsamten
- Die Überlebensraten verbesserten
- Die Präsenz wichtiger Immunzellen (T-Zellen, NK-Zellen, Makrophagen) erhöhten
- Das Wachstum und die Vermehrung von T-Zellen förderten
- Bessere Wachstums- und Vermehrungsraten im Vergleich zu herkömmlichen MSCs zeigten
Dieser Durchbruch überwindet frühere Einschränkungen von mesenchymalen Stammzellen in der Krebsbehandlung und bietet einen effektiveren und skalierbaren therapeutischen Ansatz. Die Ergebnisse unterstützen die weitere Entwicklung der Krebs-Pipeline von Ernexa.
- Successful preclinical data showing tumor growth reduction in ovarian cancer models
- Enhanced immune cell recruitment demonstrated in tumor microenvironment
- Technology shows improved scalability compared to traditional MSCs
- Lead product ERNA-101 shows promise in treating drug-resistant cancers
- Collaboration with prestigious MD Anderson Cancer Center
- Still in early preclinical stage - long pathway to commercialization
- Current data limited to mouse models only
- No human trial data available yet
- Previous MSC-based treatments faced implementation challenges
Insights
Ernexa's preclinical data shows promising efficacy for ERNA-101 in ovarian cancer models, validating their engineered stem cell platform technology.
Ernexa Therapeutics' (NASDAQ: ERNA) latest preclinical data unveiled at AACR 2025 represents a significant validation point for the company's lead product candidate ERNA-101. The data demonstrates that their engineered induced mesenchymal stem cells (iMSCs) effectively slow tumor growth and improve survival rates in ovarian cancer mouse models - a cancer type that has historically been challenging to treat.
What's particularly noteworthy is the dual mechanism of action: the cells not only directly impact tumor growth but also enhance the immune response by increasing infiltration of T cells, natural killer cells, and macrophages. This immune recruitment aspect addresses a fundamental challenge in cancer immunotherapy - converting immunologically "cold" tumors into "hot" responsive ones.
From a development perspective, Ernexa's technological approach resolves two persistent challenges with traditional MSC therapies: their immune-suppressing nature and manufacturing limitations. By engineering induced pluripotent stem cells to secrete specific immune-boosting cytokines (IL-7 and IL-15), they've created a potentially more effective and scalable therapeutic candidate.
For a biotech company, positive preclinical data for a lead asset often serves as a critical milestone that strengthens the company's scientific foundation and pipeline potential. Though still requiring clinical validation in humans, these results provide important proof-of-concept for ERNA-101 and Ernexa's broader technological platform in the competitive oncology landscape.
ERNA-101's innovative cytokine-secreting stem cells demonstrate impressive tumor control and immune activation in ovarian cancer models.
The preclinical data presented by Ernexa Therapeutics represents a mechanistically sophisticated approach to addressing a significant unmet need in ovarian cancer treatment. The engineered stem cell-derived therapy (ERNA-101) leverages two potent immunomodulatory cytokines—IL-7 and IL-15—that work synergistically to create a favorable immune environment.
The biological rationale is compelling: IL-7 supports T-cell development and survival, while IL-15 activates natural killer cells and CD8+ T cells. This combination addresses multiple aspects of anti-tumor immunity, potentially overcoming the immunosuppressive microenvironment that characterizes many solid tumors, particularly ovarian cancer.
What distinguishes this approach is how it solves the paradox of traditional mesenchymal stem cell therapies. While MSCs naturally home to tumors, they've been limited by their inherent immunosuppressive properties. By using engineered induced MSCs derived from pluripotent stem cells, Ernexa has potentially transformed this limitation into an advantage.
The observed increase in tumor-infiltrating immune cells is particularly significant, as this correlates with better treatment outcomes across multiple cancer types. Additionally, the data showing activity against drug-resistant cancer cells suggests potential utility in refractory disease settings.
While mouse models have known translational limitations, these results provide a robust foundation for advancing ERNA-101 toward clinical development. The involvement of Dr. Andreeff from MD Anderson, a recognized leader in cell therapy research, adds further credibility to this innovative approach.
Study showed engineered stem cell-derived therapy recruits key immune cells and slows tumor growth, supporting continued development of Ernexa’s advanced cancer pipeline
CAMBRIDGE, Mass., April 29, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, presented noteworthy new data at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago on April 28. The study showed how engineered cells derived from stem cells could transform the treatment of ovarian cancer. The data revealed that these engineered cells, which release powerful immune-boosting cytokines, not only shrink tumors but also help the body’s immune system to attack the cancer more effectively.
“We’ve taken cells that normally help repair tissues in the body and reprogrammed them to support the immune system in fighting cancer,” said Michael Andreeff, M.D., Ph.D., from The University of Texas MD Anderson Cancer Center. Dr. Andreeff was the principal investigator on the study and has long been at the forefront of cancer cell therapy. “This could be a game-changer for cancers that don’t respond well to current treatments.”
This new data builds on earlier work led by Dr. Andreeff, which showed the potential of mesenchymal stem cells (MSCs) in cancer treatment. In earlier trials, engineered MSCs helped slow the growth of ovarian cancer in patients, but they have not been widely used due to their immune-suppressing nature and other challenges. To address these issues, Ernexa engineered induced pluripotent stem cells (iPSCs) and transformed them into induced MSCs (iMSCs). These iMSCs were engineered to secrete IL-7 and IL-15, two cytokines that help boost the immune system’s ability to fight cancer. This is the technology behind Ernexa's lead product ERNA-101.
In this study using mice with ovarian cancer, the iMSCs significantly slowed tumor growth and improved survival rates. The treatment led to a greater presence of immune cells in the tumor, including T cells, natural killer (NK) cells, and macrophages – all key players in the body’s defense against cancer. In additional tests, the iMSCs also helped T cells grow and multiply, even in cases of drug-resistant cancer cells. Further tests have shown that these iMSCs are much better at growing and multiplying compared to traditional MSCs.
Overall, the study demonstrated significant promise for ERNA-101 as a more effective, accessible, and scalable treatment for patients in the future. It reinforces Ernexa’s commitment to pushing the boundaries of cancer treatment with innovative and effective therapies.
About Ernexa Therapeutics
Ernexa Therapeutics (Nasdaq: ERNA) is developing innovative cell therapies for the treatment of advanced solid tumors 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 solution, without needing patient-specific cell harvesting.
Ernexa is developing two highly innovative cell therapy products, both currently in preclinical stages. 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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