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Ernexa Therapeutics Announces New Data to be Presented at ASCO Annual Meeting 2025

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Ernexa Therapeutics (ERNA) will present new data at the ASCO Annual Meeting 2025 showcasing their innovative iMSC-based immunotherapy platform. The technology uses engineered mesenchymal stem cells (iMSCs) that secrete cytokines IL-7 and IL-15 directly into ovarian tumors. Key findings from the study demonstrate that these iMSCs, derived from adult skin cells, successfully:

- Migrated safely into tumor microenvironment
- Triggered strong immune activation
- Converted immunologically "cold" ovarian tumors into "hot" ones
- Significantly reduced tumor burden and extended survival in mouse models

The study, led by Dr. Michael Andreeff from MD Anderson Cancer Center, will be presented on June 2, 2025 in Chicago. The research validates Ernexa's platform technology and its potential to expand treatment options for patients with limited therapeutic choices.

Ernexa Therapeutics (ERNA) presenterà nuovi dati al ASCO Annual Meeting 2025 che mettono in luce la loro innovativa piattaforma di immunoterapia basata su iMSC. La tecnologia utilizza cellule staminali mesenchimali ingegnerizzate (iMSC) che secernono le citochine IL-7 e IL-15 direttamente nei tumori ovarici. I risultati principali dello studio dimostrano che queste iMSC, derivate da cellule della pelle adulta, hanno efficacemente:

- Migrato in sicurezza all'interno del microambiente tumorale
- Attivato fortemente il sistema immunitario
- Trasformato i tumori ovarici immunologicamente "freddi" in tumori "caldi"
- Ridotto significativamente il carico tumorale e prolungato la sopravvivenza nei modelli murini

Lo studio, guidato dal Dr. Michael Andreeff del MD Anderson Cancer Center, sarà presentato il 2 giugno 2025 a Chicago. La ricerca conferma la validità della tecnologia di Ernexa e il suo potenziale per ampliare le opzioni terapeutiche per pazienti con scarse alternative di trattamento.

Ernexa Therapeutics (ERNA) presentará nuevos datos en el ASCO Annual Meeting 2025 que destacan su innovadora plataforma de inmunoterapia basada en iMSC. La tecnología utiliza células madre mesenquimales modificadas (iMSCs) que secretan las citoquinas IL-7 e IL-15 directamente en tumores ováricos. Los hallazgos clave del estudio demuestran que estas iMSCs, derivadas de células de piel adulta, lograron:

- Migrar de forma segura al microambiente tumoral
- Activar fuertemente el sistema inmunológico
- Convertir tumores ováricos inmunológicamente “fríos” en “calientes”
- Reducir significativamente la carga tumoral y prolongar la supervivencia en modelos murinos

El estudio, dirigido por el Dr. Michael Andreeff del MD Anderson Cancer Center, será presentado el 2 de junio de 2025 en Chicago. La investigación valida la tecnología de plataforma de Ernexa y su potencial para ampliar las opciones de tratamiento para pacientes con pocas alternativas terapéuticas.

Ernexa Therapeutics (ERNA)ASCO 연례회의 2025에서 혁신적인 iMSC 기반 면역치료 플랫폼에 대한 새로운 데이터를 발표할 예정입니다. 이 기술은 조작된 중간엽 줄기세포(iMSC)를 이용하여 IL-7 및 IL-15 사이토카인을 난소 종양에 직접 분비합니다. 연구의 주요 결과는 성인 피부 세포에서 유래한 이 iMSC가 성공적으로:

- 종양 미세환경으로 안전하게 이동
- 강력한 면역 활성화를 유도
- 면역학적으로 '차가운' 난소 종양을 '뜨거운' 종양으로 전환
- 마우스 모델에서 종양 부담을 크게 줄이고 생존 기간을 연장

MD 앤더슨 암 센터의 마이클 안드리프 박사가 주도한 이 연구는 2025년 6월 2일 시카고에서 발표될 예정입니다. 이 연구는 Ernexa의 플랫폼 기술과 제한된 치료 옵션을 가진 환자들을 위한 치료 가능성을 입증합니다.

Ernexa Therapeutics (ERNA) présentera de nouvelles données lors du ASCO Annual Meeting 2025 mettant en avant leur plateforme innovante d'immunothérapie basée sur les iMSC. Cette technologie utilise des cellules souches mésenchymateuses modifiées (iMSC) qui sécrètent les cytokines IL-7 et IL-15 directement dans les tumeurs ovariennes. Les résultats clés de l'étude démontrent que ces iMSC, dérivées de cellules cutanées adultes, ont réussi à :

- Migrer en toute sécurité dans le microenvironnement tumoral
- Déclencher une forte activation immunitaire
- Transformer les tumeurs ovariennes immunologiquement « froides » en « chaudes »
- Réduire significativement la charge tumorale et prolonger la survie dans des modèles murins

L'étude, dirigée par le Dr Michael Andreeff du MD Anderson Cancer Center, sera présentée le 2 juin 2025 à Chicago. Cette recherche valide la technologie de plateforme d'Ernexa et son potentiel à élargir les options de traitement pour les patients disposant de peu d'alternatives thérapeutiques.

Ernexa Therapeutics (ERNA) wird auf dem ASCO Annual Meeting 2025 neue Daten präsentieren, die ihre innovative immuntherapeutische Plattform auf Basis von iMSCs vorstellen. Die Technologie nutzt gentechnisch veränderte mesenchymale Stammzellen (iMSCs), die die Zytokine IL-7 und IL-15 direkt in Eierstocktumoren ausschütten. Wichtige Erkenntnisse der Studie zeigen, dass diese iMSCs, die aus erwachsenen Hautzellen gewonnen wurden, erfolgreich:

- Sicher in die Tumormikroumgebung migrierten
- Eine starke Immunaktivierung auslösten
- Immunologisch „kalte“ Eierstocktumoren in „heiße“ verwandelten
- Die Tumorlast signifikant reduzierten und das Überleben in Mausmodellen verlängerten

Die Studie unter der Leitung von Dr. Michael Andreeff vom MD Anderson Cancer Center wird am 2. Juni 2025 in Chicago vorgestellt. Die Forschung bestätigt die Plattformtechnologie von Ernexa und ihr Potenzial, Behandlungsoptionen für Patienten mit begrenzten therapeutischen Möglichkeiten zu erweitern.

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Insights

Ernexa's engineered stem cells show promising ability to convert immunologically 'cold' ovarian tumors to 'hot', potentially unlocking new treatment pathways.

This presentation at ASCO highlights a significant scientific advancement in Ernexa's cell therapy platform. The company's approach of using induced mesenchymal stem cells (iMSCs) engineered to secrete specific cytokines (IL-7 and IL-15) addresses one of the most challenging aspects of immunotherapy - treating "cold" tumors where immune cells are largely absent.

The data demonstrates these engineered stem cells successfully migrate into the tumor microenvironment and trigger immune activation through T cell and macrophage infiltration. This is particularly noteworthy for ovarian cancer, which typically presents as immunologically "cold" and has historically shown limited response to immunotherapies.

The preclinical results showing reduced tumor burden and extended survival in mouse models represent an early but promising signal. Converting "cold" tumors to "hot" could potentially make these cancers susceptible to additional immunotherapeutic approaches, creating combination opportunities.

What's technically innovative here is the use of induced pluripotent stem cell technology to create these engineered cells, which offers theoretical advantages in scalability and manufacturing compared to autologous cell therapies. The involvement of MD Anderson Cancer Center and presentation at a premier oncology conference adds scientific credibility to these findings.

However, it's important to recognize these are still preclinical results in mouse models, representing an early stage in the development process. The translation to human efficacy remains to be demonstrated, and the company faces the typical long development timeline of cell therapies before potential commercialization.

New data finds novel cell therapy successfully converts “cold” ovarian tumors into “hot,” demonstrating potential to unlock immune response and improve outcomes

CAMBRIDGE, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that new data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 on June 2 in Chicago.

The study explored the technology behind Ernexa’s novel iMSC-based immunotherapy platform, which uses induced mesenchymal stem cells (iMSCs) engineered to secrete cytokines IL-7 and IL-15 directly into ovarian tumors. These iMSCs, derived from adult skin cells, safely migrated into the tumor microenvironment and triggered strong immune activation, including T cell and macrophage infiltration, turning immunologically “cold” tumors into “hot” ones.

In a syngeneic ovarian cancer mouse model, treatment with IL-7/IL-15-secreting iMSCs significantly reduced tumor burden and extended survival. The study was led by Michael Andreeff, M.D., Ph.D., from The University of Texas MD Anderson Cancer Center.

“This work represents the kind of breakthrough that has the potential to redefine how we treat cancer,” said Sanjeev Luther, President and CEO of Ernexa Therapeutics. “By addressing the challenge of immunologically ‘cold’ tumors – where the immune system is largely absent – we’re opening the door to more effective options for patients who currently face limited therapeutic choices. It’s a powerful validation of Ernexa’s iMSC platform and a meaningful step toward realizing the promise of innovative, scalable, and effective cell therapies.”

Details of the poster presentation session include:

Date and Time: Monday, June 2 at 1:30 PM – 4:30 PM CDT
Location: Hall A - Posters and Exhibits
Poster Title: Engineering iPSC-derived mesenchymal stem cells (i MSCs) to secrete IL-7/IL-15 for modulation of the tumor microenvironment in a "cold" ovarian tumor model
Track: Developmental Therapeutics—Immunotherapy
Sub Track: Cellular Immunotherapy
Abstract Number: 2538
Poster Board Number: 185

The abstract can also be accessed online here: https://meetings.asco.org/abstracts-presentations/246879

Conference attendees will have the opportunity to meet with Ernexa's Chief Scientific Officer and study author Robert Pierce, M.D., as well as the other authors, to discuss the study.

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.

Media & Investor Relations Contact

investors@ernexatx.com


FAQ

What breakthrough technology will ERNA present at ASCO 2025?

ERNA will present data on their iMSC-based immunotherapy platform that uses engineered mesenchymal stem cells to secrete cytokines IL-7 and IL-15 into ovarian tumors, successfully converting 'cold' tumors into 'hot' ones.

What are the key findings from ERNA's ovarian cancer study?

The study showed that iMSCs safely migrated into tumors, triggered immune activation, converted 'cold' tumors to 'hot', and significantly reduced tumor burden and extended survival in mouse models.

When and where will Ernexa Therapeutics present their ASCO 2025 data?

Ernexa will present their data on Monday, June 2, 2025, from 1:30 PM to 4:30 PM CDT in Hall A at the ASCO Annual Meeting in Chicago.

Who led the research study for ERNA's cancer immunotherapy?

The study was led by Dr. Michael Andreeff from The University of Texas MD Anderson Cancer Center.

What type of cancer does ERNA's immunotherapy target?

The immunotherapy targets ovarian cancer, specifically addressing 'cold' ovarian tumors where the immune system is largely absent.
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