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Peer-Reviewed Study Validates Renovaro's Genetically Engineered Dendritic Cell Therapy with Potent Anti-Tumor Efficacy

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Renovaro Biosciences (NASDAQ:RENB) has published groundbreaking preclinical data in the journal Vaccines, validating their next-generation dendritic cell (DC) therapy platform. The study demonstrated the platform's effectiveness in treating pancreatic cancer, showing up to 81.7% reduction in tumor size in humanized mouse models.

The engineered DCs, expressing CD93, CD40L, and CXCL13, demonstrated significant anti-tumor efficacy and immune system activation. The therapy's "off-the-shelf" approach, using CD34⁺ stem cells from healthy donors, enables scalable production and cryopreservation, enhancing its clinical potential.

The company plans to expand testing across multiple tumor types and explore combination strategies with other therapies as part of their clinical development roadmap.

Renovaro Biosciences (NASDAQ:RENB) ha pubblicato dati preclinici innovativi sulla rivista Vaccines, confermando l'efficacia della loro piattaforma di terapia con cellule dendritiche (DC) di nuova generazione. Lo studio ha dimostrato l'efficacia della piattaforma nel trattamento del cancro al pancreas, con una riduzione delle dimensioni del tumore fino all'81,7% in modelli murini umanizzati.

Le DC ingegnerizzate, che esprimono CD93, CD40L e CXCL13, hanno mostrato una significativa efficacia antitumorale e attivazione del sistema immunitario. L'approccio “pronto all'uso”, basato su cellule staminali CD34⁺ provenienti da donatori sani, consente una produzione scalabile e la crioconservazione, aumentando il potenziale clinico della terapia.

L'azienda prevede di ampliare i test su diversi tipi di tumore ed esplorare strategie di combinazione con altre terapie nel loro piano di sviluppo clinico.

Renovaro Biosciences (NASDAQ:RENB) ha publicado datos preclínicos innovadores en la revista Vaccines, validando su plataforma de terapia con células dendríticas (DC) de próxima generación. El estudio demostró la eficacia de la plataforma en el tratamiento del cáncer de páncreas, mostrando una reducción del tamaño tumoral de hasta un 81,7% en modelos murinos humanizados.

Las DCs diseñadas, que expresan CD93, CD40L y CXCL13, demostraron una eficacia antitumoral significativa y activación del sistema inmunológico. El enfoque “listo para usar”, que emplea células madre CD34⁺ de donantes sanos, permite una producción escalable y criopreservación, aumentando su potencial clínico.

La compañía planea ampliar las pruebas a múltiples tipos de tumores y explorar estrategias combinadas con otras terapias como parte de su hoja de ruta para el desarrollo clínico.

Renovaro Biosciences (NASDAQ:RENB)는 학술지 Vaccines에 혁신적인 전임상 데이터를 발표하며 차세대 수지상세포(DC) 치료 플랫폼의 효능을 입증했습니다. 연구 결과 인간화 마우스 모델에서 췌장암 치료에 있어 최대 81.7% 종양 크기 감소를 보였습니다.

CD93, CD40L, CXCL13을 발현하는 유전자 조작된 DC는 강력한 항종양 효과와 면역 시스템 활성화를 나타냈습니다. 건강한 기증자의 CD34⁺ 줄기세포를 이용한 “즉시 사용 가능한” 접근법은 대량 생산과 동결 보존을 가능하게 하여 임상적 잠재력을 높입니다.

회사는 임상 개발 로드맵의 일환으로 다양한 종양 유형에 대한 테스트를 확대하고 다른 치료법과의 병용 전략도 모색할 계획입니다.

Renovaro Biosciences (NASDAQ:RENB) a publié des données précliniques révolutionnaires dans la revue Vaccines, validant leur plateforme de thérapie par cellules dendritiques (DC) de nouvelle génération. L'étude a démontré l'efficacité de la plateforme dans le traitement du cancer du pancréas, avec une réduction de la taille tumorale allant jusqu'à 81,7% dans des modèles murins humanisés.

Les DC modifiées, exprimant CD93, CD40L et CXCL13, ont montré une efficacité antitumorale significative et une activation du système immunitaire. L'approche « prête à l'emploi », utilisant des cellules souches CD34⁺ provenant de donneurs sains, permet une production à grande échelle et une cryoconservation, renforçant ainsi son potentiel clinique.

L'entreprise prévoit d'étendre les essais à plusieurs types de tumeurs et d'explorer des stratégies de combinaison avec d'autres thérapies dans le cadre de leur feuille de route de développement clinique.

Renovaro Biosciences (NASDAQ:RENB) hat bahnbrechende präklinische Daten in der Fachzeitschrift Vaccines veröffentlicht, die ihre Plattform für dendritische Zelltherapien (DC) der nächsten Generation validieren. Die Studie zeigte die Wirksamkeit der Plattform bei der Behandlung von Bauchspeicheldrüsenkrebs mit einer Reduktion der Tumorgröße um bis zu 81,7% in humanisierten Mausmodellen.

Die gentechnisch veränderten DCs, die CD93, CD40L und CXCL13 exprimieren, zeigten eine signifikante antitumorale Wirksamkeit und Aktivierung des Immunsystems. Der „Off-the-Shelf“-Ansatz der Therapie, der CD34⁺ Stammzellen von gesunden Spendern verwendet, ermöglicht eine skalierbare Produktion und Kryokonservierung, was das klinische Potenzial erhöht.

Das Unternehmen plant, die Tests auf verschiedene Tumorarten auszuweiten und Kombinationsstrategien mit anderen Therapien im Rahmen ihres klinischen Entwicklungsplans zu erforschen.

Positive
  • None.
Negative
  • Still in preclinical stage, requiring extensive clinical trials before potential approval
  • Competition in solid tumor space is intense
  • Additional studies and combination strategies needed before clinical implementation

Insights

Renovaro's engineered dendritic cell therapy shows remarkable 81.7% tumor reduction in preclinical models, validating their platform technology for potential clinical applications.

The peer-reviewed publication in Vaccines represents a significant validation milestone for Renovaro's dendritic cell (DC) therapy platform. The study demonstrates that their genetically engineered DCs expressing CD93, CD40L, and CXCL13 reduced pancreatic tumor burden by up to 81.7% in humanized mouse models – an impressive efficacy signal for this notoriously treatment-resistant cancer type.

What makes this approach scientifically noteworthy is the specific genetic modifications to these dendritic cells. By engineering expression of CD93 (involved in immune cell adhesion), CD40L (a potent T-cell co-stimulator), and CXCL13 (a chemokine that attracts B cells), Renovaro has created DCs with enhanced ability to activate multiple arms of the immune system. The data showing increases in both CD4+ helper T cells and cytotoxic CD8+ T cells indicates successful priming of both branches of adaptive immunity.

Particularly promising is the platform's allogeneic approach, using CD34+ stem cells from healthy donors to generate "off-the-shelf" therapies. This circumvents the manufacturing complexity and time constraints of autologous cell therapies, which require processing each patient's own cells. The cryopreservation capability further enhances clinical practicality.

While these results are encouraging, it's important to note these remain preclinical findings. The translation from humanized mouse models to human patients often sees efficacy reductions. Additionally, pancreatic cancer's dense stromal environment creates significant barriers to immune cell infiltration that may not be fully recapitulated in these models. The company's planned exploration of combination approaches with checkpoint inhibitors suggests recognition of these potential limitations.

Renovaro's preclinical data validates their engineered DC platform, strengthening their competitive position in the challenging solid tumor immunotherapy space.

This peer-reviewed publication significantly enhances Renovaro's scientific credibility and intellectual property position in the competitive cell therapy landscape. The company is addressing several critical limitations that have historically challenged dendritic cell therapies.

First, by using an allogeneic approach derived from CD34+ stem cells, Renovaro potentially solves the manufacturing scalability issues that have hampered previous DC therapies. Traditional dendritic cell approaches like Provenge required complex, patient-specific manufacturing processes that limited commercial viability. An "off-the-shelf" approach could dramatically improve cost structure and market accessibility.

Second, the genetic engineering approach targeting CD93, CD40L, and CXCL13 demonstrates sophisticated immunological understanding. This multi-faceted activation strategy could potentially overcome the immunosuppressive tumor microenvironment that has limited efficacy of previous immunotherapies in pancreatic cancer – a massive unmet medical need with a market potential exceeding $4 billion annually.

The platform nature of this technology is particularly valuable from an investment perspective. Rather than a single-product company, Renovaro appears positioned to potentially address multiple solid tumor indications, enhancing their pipeline opportunities. The mention of future AI-based antigen discovery suggests a technology roadmap that could extend their competitive moat.

While still preclinical, these results represent meaningful de-risking of Renovaro's platform. The publication timing is favorable as investors increasingly focus on solid tumor cell therapies beyond CAR-T approaches. The company's planned expansion into combination therapies with checkpoint inhibitors and radioligand approaches aligns with current clinical development trends in oncology.

Landmark preclinical data validate Renovaro's platform representing a step forward in the fight against pancreatic and solid tumors

LOS ANGELES, CALIFORNIA / ACCESS Newswire / July 17, 2025 / Renovaro Biosciences (NASDAQ:RENB), an oncology and neurology focused TechBio company, today announced the publication of a peer-reviewed study in Vaccines, a leading journal in the field of immunology. The paper details compelling preclinical data on Renovaro's next-generation dendritic cell (DC) therapy platform, showcasing its ability to significantly reduce pancreatic tumor burden and activate robust immune responses in humanized mouse models.

The published study, titled "Therapeutic Efficacy of CD34-derived Allogeneic Dendritic Cells Engineered to Express CD93, CD40L, and CXCL13 in Humanized Mouse Models of Pancreatic Cancer," represents a major milestone in validating the scientific underpinnings of Renovaro's platform. The therapy combines cutting-edge genetic engineering with an allogeneic "off-the-shelf" approach to generate highly potent DCs capable of priming the immune system against aggressive, immunoresistant tumors.

"This publication marks a critical moment for Renovaro," said David Weinstein, Renovaro's CEO. "The data clearly demonstrate the potential of our engineered dendritic cell therapy to overcome tumor-induced immunosuppression, which is one of the greatest challenges in treating pancreatic and other solid tumors. It further validates the broader capabilities of our cell engineering platform."

Key Findings from the Study Include:

  • Robust Anti-Tumor Efficacy: Engineered DCs expressing CD93, CD40L, and CXCL13 significantly reduced tumor weight and volume, namely up to 81.7% in humanized mouse models.

  • Immune Activation: Treated animals showed marked increases in CD4⁺ T cells as well as cytotoxic CD8⁺ T and NK cells in blood, bone marrow, and tumor microenvironments.

  • Antigen-Specific Response: Activated T cells demonstrated selective cytotoxicity against pancreatic tumor cells while sparing unrelated cell types.

  • Scalable, Off-the-Shelf Platform: The use of CD34⁺ hematopoietic stem cells from healthy donors enables scalable production and cryopreservation of engineered DCs, enhancing clinical utility.

This research builds on Renovaro's broader strategy of developing immune-enhancing therapies that can be flexibly adapted for solid tumor indications and lays the foundation for future AI-based antigen discovery that will further specialize these medications toward specific cancer indications and patient sub-populations. The engineered DC platform complements Renovaro's growing pipeline of precision medicines.

"By demonstrating not only efficacy but also scalability and specificity, this work strengthens our competitive moat and reaffirms our position as a platform company built to deliver durable impact," added Dr. Lu Chen, Renovaro's Executive Vice President of Product Development and CMC.

Renovaro plans to initiate additional preclinical studies across multiple tumor types and explore combination strategies with checkpoint inhibitors and radioligand therapies. These efforts are part of a broader roadmap to bring this novel therapeutic platform into the clinic.

This work was performed in collaboration with immunology professor Dr. Anahid Jewett, who sadly passed away last month. Her exceptional guidance and unique expertise allowed this project to progress, and the acceptance of this publication serves as further testament to her extraordinary ability as a researcher.

The full peer-reviewed article is available via Vaccines: https://www.mdpi.com/2076-393X/13/7/749

About Renovaro Biosciences

Renovaro (NASDAQ: RENB) is a TechBio company combining advanced machine learning with breakthrough immunotherapies to transform how cancer and other diseases are detected and treated. Through proprietary platforms in cell therapy, RNA diagnostics, and federated AI, Renovaro is pioneering scalable and personalized approaches to precision medicine.

Contact:

David Weinstein
Chief Executive Officer
investors@renovaro.com
www.renovarogroup.com

SOURCE: Renovaro Biosciences



View the original press release on ACCESS Newswire

FAQ

What are the key results of Renovaro's (NASDAQ:RENB) dendritic cell therapy study?

The study showed up to 81.7% reduction in tumor size in humanized mouse models, with significant increases in CD4⁺ T cells, CD8⁺ T cells, and NK cells in blood, bone marrow, and tumor environments.

How does Renovaro's (RENB) dendritic cell therapy platform work?

The platform uses genetically engineered dendritic cells expressing CD93, CD40L, and CXCL13 to prime the immune system against aggressive tumors, using CD34⁺ stem cells from healthy donors for an 'off-the-shelf' approach.

What are the next steps for Renovaro Biosciences' dendritic cell therapy?

Renovaro plans to initiate additional preclinical studies across multiple tumor types and explore combination strategies with checkpoint inhibitors and radioligand therapies before moving to clinical trials.

What makes Renovaro's (NASDAQ:RENB) dendritic cell therapy platform unique?

The platform combines genetic engineering with an allogeneic 'off-the-shelf' approach, enabling scalable production and cryopreservation while demonstrating selective cytotoxicity against pancreatic tumor cells.

What types of cancer is Renovaro's (RENB) therapy targeting?

The therapy is initially targeting pancreatic cancer, with plans to expand into other solid tumor types through their adaptable platform technology.
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