Calidi Biotherapeutics Announces Demonstrated Ability To Deliver Transient Gene Therapy (Payload) To Tumors Using Systemic Platform
Calidi Biotherapeutics (NYSE: CLDI) has announced promising preclinical results for its systemic RTNova platform, demonstrating successful delivery of transient gene therapy payloads to targeted tumors. The company's tumor-specific virotherapy has shown effectiveness in killing over 60 different tumor cell lines.
The platform utilizes an innovative vaccinia virus strain with human cell membrane protection, designed to treat advanced-stage metastatic cancers, particularly when intratumoral administration isn't feasible. New data reveals that a single dose of their tumor-selective triple knockout (3KO) RT virus with a specific immunotherapeutic payload significantly altered the tumor microenvironment, achieving 80% leukocyte infiltration for 3KO RT and 92% with the payload, compared to 46% in untreated cases.
The treatment demonstrated complete tumor eradication in certain preclinical models, combining direct tumor killing with robust antitumor immune responses. This breakthrough enables potential development of multiple assets for various indications and opens doors for partnership opportunities.
Calidi Biotherapeutics (NYSE: CLDI) ha annunciato risultati preclinici promettenti per la sua piattaforma sistemica RTNova, dimostrando una consegna efficace di payload di terapia genica transitoria ai tumori mirati. La viroterapia specifica per tumori dell'azienda ha mostrato efficacia nell'uccidere oltre 60 diverse linee cellulari tumorali.
La piattaforma utilizza un ceppo innovativo di virus vaccinia con protezione della membrana cellulare umana, progettato per trattare tumori avanzati metastatici, in particolare quando l'amministrazione intratumorale non è fattibile. Nuovi dati rivelano che una singola dose del loro virus RT a triplo knockout (3KO) selettivo per tumori con un payload immunoterapico specifico ha alterato significativamente il microambiente tumorale, raggiungendo l'infiltrazione del 80% di leucociti per 3KO RT e del 92% con il payload, rispetto al 46% nei casi non trattati.
Il trattamento ha dimostrato un'eradicazione completa del tumore in alcuni modelli preclinici, combinando l'uccisione diretta del tumore con robuste risposte immunitarie antitumorali. Questa scoperta consente lo sviluppo potenziale di molteplici asset per varie indicazioni e apre porte a opportunità di partnership.
Calidi Biotherapeutics (NYSE: CLDI) ha anunciado resultados preclínicos prometedores para su plataforma sistémica RTNova, demostrando una entrega exitosa de cargas de terapia génica transitoria a tumores específicos. La viroterapia específica para tumores de la compañía ha demostrado eficacia en la eliminación de más de 60 líneas celulares tumorales diferentes.
La plataforma utiliza una cepa innovadora de virus vaccinia con protección de membrana celular humana, diseñada para tratar cánceres metastásicos en etapa avanzada, especialmente cuando la administración intratumoral no es factible. Nuevos datos revelan que una sola dosis de su virus RT de triple knockout (3KO) selectivo para tumores con una carga inmunoterapéutica específica alteró significativamente el microambiente tumoral, logrando 80% de infiltración de leucocitos para 3KO RT y 92% con la carga, en comparación con el 46% en casos no tratados.
El tratamiento demostró una erradicación completa del tumor en ciertos modelos preclínicos, combinando la eliminación directa del tumor con robustas respuestas inmunitarias antitumorales. Este avance permite el desarrollo potencial de múltiples activos para diversas indicaciones y abre puertas a oportunidades de asociación.
칼리디 바이오테라퓨틱스 (NYSE: CLDI)는 시스템 RTNova 플랫폼의 유망한 전임상 결과를 발표하며, 목표 종양에 일시적인 유전자 치료 화물의 성공적인 전달을 보여주었습니다. 회사의 종양 특이적 바이로테라피는 60개 이상의 다양한 종양 세포주를 죽이는 데 효과적임을 입증했습니다.
이 플랫폼은 인간 세포막 보호가 있는 혁신적인 백시니아 바이러스 균주를 사용하여, 특히 종양 내 투여가 불가능할 때 진행된 전이성 암을 치료하도록 설계되었습니다. 새로운 데이터에 따르면, 특정 면역치료 화물이 포함된 종양 선택적 삼중 결손(3KO) RT 바이러스의 단일 용량이 종양 미세환경을 상당히 변화시켜, 치료되지 않은 경우의 46%에 비해 3KO RT의 경우 80%, 화물 포함 시 92%의 백혈구 침투를 달성했습니다.
이 치료법은 특정 전임상 모델에서 종양을 완전히 제거하는 것을 보여주었으며, 직접적인 종양 제거와 강력한 항종양 면역 반응을 결합했습니다. 이 혁신은 다양한 적응증을 위한 여러 자산의 잠재적 개발을 가능하게 하며, 파트너십 기회를 열어줍니다.
Calidi Biotherapeutics (NYSE: CLDI) a annoncé des résultats précliniques prometteurs pour sa plateforme systémique RTNova, démontrant une livraison réussie de charges de thérapie génique transitoires vers des tumeurs ciblées. La virothérapie spécifique aux tumeurs de l'entreprise a montré son efficacité à tuer plus de 60 lignées cellulaires tumorales différentes.
La plateforme utilise une souche innovante de virus vaccinia avec protection de la membrane cellulaire humaine, conçue pour traiter les cancers métastatiques avancés, en particulier lorsque l'administration intratumorale n'est pas faisable. De nouvelles données révèlent qu'une seule dose de leur virus RT à triple knockout (3KO) sélectif pour les tumeurs avec une charge immunothérapeutique spécifique a considérablement modifié le microenvironnement tumoral, atteignant 80% d'infiltration de leucocytes pour 3KO RT et 92% avec la charge, par rapport à 46% dans les cas non traités.
Le traitement a démontré une éradication complète de la tumeur dans certains modèles précliniques, combinant la destruction directe de la tumeur avec de robustes réponses immunitaires antitumorales. Cette avancée permet le développement potentiel de plusieurs actifs pour diverses indications et ouvre des portes à des opportunités de partenariat.
Calidi Biotherapeutics (NYSE: CLDI) hat vielversprechende präklinische Ergebnisse für seine systemische RTNova-Plattform bekannt gegeben, die eine erfolgreiche Lieferung transienter Gentherapie-Lasten an gezielte Tumoren demonstriert. Die tumorspezifische Virotherapie des Unternehmens hat sich als wirksam erwiesen, um über 60 verschiedene Tumorzelllinien abzutöten.
Die Plattform nutzt einen innovativen Vaccinia-Virus-Stamm mit Schutz der menschlichen Zellmembran, der zur Behandlung von fortgeschrittenen metastatischen Krebserkrankungen entwickelt wurde, insbesondere wenn eine intratumorale Verabreichung nicht möglich ist. Neue Daten zeigen, dass eine einzelne Dosis ihres tumorselektiven Triple-Knockout (3KO) RT-Virus mit einer spezifischen immuntherapeutischen Last das Tumormikroenvironment signifikant veränderte und 80% Leukozyteninfiltration für 3KO RT und 92% mit der Last erreichte, verglichen mit 46% in unbehandelten Fällen.
Die Behandlung zeigte in bestimmten präklinischen Modellen eine vollständige Tumoreradikation und kombinierte die direkte Tumorzerstörung mit robusten antitumoralen Immunreaktionen. Dieser Durchbruch ermöglicht die potenzielle Entwicklung mehrerer Vermögenswerte für verschiedene Indikationen und eröffnet Möglichkeiten für Partnerschaften.
- Demonstrated efficacy in killing over 60 different tumor cell lines
- Achieved 92% leukocyte infiltration with payload vs 46% untreated
- Complete tumor eradication achieved in certain preclinical models
- Platform enables development of multiple assets for various cancer indications
- Results are only preclinical stage, not yet proven in human trials
- Specific immunotherapeutic payload remains undisclosed
Insights
Calidi Biotherapeutics has announced significant preclinical advancements for its systemic RTNova platform, demonstrating the ability to deliver transient gene therapy payloads specifically to tumor sites. The technology utilizes an innovative vaccinia virus strain with a human cell membrane envelope that protects it in the bloodstream while enabling targeted tumor delivery.
The preclinical data shows impressive efficacy against over 60 different tumor cell lines, with the platform's 3KO RT virus dramatically altering the tumor microenvironment. Most notably, the treatment led to marked increases in immune cell infiltration, with leukocyte infiltration reaching
This represents a meaningful technological advancement in Calidi's platform capabilities. The ability to systemically deliver targeted therapies addresses a critical limitation in current cancer treatment approaches, particularly for metastatic cancers where direct injection isn't feasible. The multimodal mechanism combines direct tumor killing with immune activation, potentially enhancing efficacy.
The platform's versatility as a viral vector for delivering therapeutic genes to tumors expands Calidi's potential pipeline opportunities and opens possibilities for strategic partnerships. However, investors should note these are preclinical results, and significant development work remains before potential clinical applications.
Calidi's RTNova platform represents a particularly innovative approach to virotherapy by addressing two fundamental challenges: systemic delivery and tumor-specific targeting. The vaccinia virus enveloped with human cell membrane creates a protective shield in circulation while maintaining tumor tropism – a significant technical achievement in the field.
What's most compelling about these results is the detailed immune profile changes observed in the tumor microenvironment. The dramatic increase in CD45+ leukocytes, CD3+ and CD8+ T cells suggests the platform is effectively converting "cold" tumors into "hot" immunologically active ones. This immune conversion, reaching
The "triple knockout" (3KO) design likely removes viral genes that would attenuate immune responses, while preserving tumor-selective replication capabilities. Complete tumor eradication in preclinical models, while promising, must be viewed cautiously as mouse models often overpredict clinical efficacy.
The potential to use this system as a viral vector for therapeutic payload delivery adds another dimension to Calidi's platform. This approach could enable localized expression of immunomodulatory proteins directly in the tumor microenvironment, potentially minimizing systemic toxicity associated with conventional administration of these agents.
SAN DIEGO, March 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced promising preclinical results for its systemic RTNova platform. The platform has successfully delivered transient gene therapy payloads to targeted tumors. Additionally, Calidi's tumor-specific virotherapy has demonstrated efficacy in killing over 60 different tumor cell lines.
The RTNova platform addresses the challenges of treating advanced-stage metastatic cancers, including lung cancer, when intratumoral administration is not feasible. Calidi designed an innovative vaccinia virus strain enveloped with a human cell membrane (extracellular enveloped virus or EEV), providing protection in the bloodstream while targeting distant tumors. Once inside the tumor, virotherapies are designed to selectively replicate and destroy tumor cells. This process induces an immune response, training the immune system to recognize and target future cancer cells. Additionally, the platform's ability to target distant tumors allows it to act as a viral vector, delivering specific gene therapies directly to tumor sites.
New data showed that a single dose of a tumor-selective triple knockout (“3KO”) RT virus with a specific immunotherapeutic payload (undisclosed) has dramatically altered the tumor microenvironment, characterized by marked increases in CD45+ leukocytes, CD3+ and CD8+ T cells. Specifically, the leukocyte infiltration reached
“Targeting tumors with a systemic virotherapy with a multimodal mechanism of action which includes direct killing of the tumors and robust activation of antitumor immune responses may revolutionize the way we approach cancer treatments. We are excited to have shown that our systemic platform can act also as a viral vector to express therapeutic genes in target tumors which will maximize the potential of the designed treatment,” said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. “With this breakthrough, we can use our platform to develop multiple assets for various indications, opening the door for potential partnerships opportunities.”
Calidi updated its corporate deck to include this new information and is available here.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
Corporate Communications:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
Source: Calidi Biotherapeutics, Inc.
FAQ
What are the key findings of Calidi Biotherapeutics' (CLDI) RTNova platform in preclinical trials?
How does Calidi Biotherapeutics' (CLDI) systemic platform work in treating metastatic cancers?
What are the leukocyte infiltration rates achieved by CLDI's 3KO RT virus in March 2025 trials?
What types of cancer can Calidi Biotherapeutics' (CLDI) RTNova platform potentially treat?
