Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine
Capricor Therapeutics (NASDAQ: CAPR) has announced the initiation of a Phase 1 clinical trial for its StealthX™ exosome-based vaccine, with first subjects already dosed. The trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID) under HHS's Project NextGen, follows FDA clearance of the IND application.
The study includes four dosing arms and initially focuses on the SARS-CoV-2 spike protein, with plans for an additional arm incorporating the nucleocapsid protein pending FDA clearance. The company expects initial data in Q1 2026. StealthX™ represents a potential alternative to mRNA vaccines, featuring no adjuvants and utilizing native proteins for rapid adaptability to emerging targets.
Capricor Therapeutics (NASDAQ: CAPR) ha avviato una sperimentazione clinica di Fase 1 per il suo vaccino a base di esosomi StealthX™, con i primi volontari già trattati. Lo studio è finanziato dal National Institute of Allergy and Infectious Diseases (NIAID) nell'ambito del Project NextGen del Dipartimento della Salute e dei Servizi Umani (HHS), dopo che la domanda IND ha ottenuto il via libera dalla FDA.
La sperimentazione prevede quattro bracci di dosaggio e si concentra inizialmente sulla proteina spike di SARS-CoV-2; è previsto un ulteriore braccio che includa la proteina nucleocapside non appena otterrà l'autorizzazione della FDA. L'azienda prevede di avere i primi dati nel primo trimestre 2026. StealthX™ si propone come possibile alternativa agli attuali vaccini a mRNA, senza adiuvanti e basato su proteine native per un rapido adattamento a nuovi obiettivi antigenici.
Capricor Therapeutics (NASDAQ: CAPR) ha iniciado un ensayo clínico de fase 1 de su vacuna basada en exosomas StealthX™, con los primeros participantes ya dosificados. El estudio está financiado por el National Institute of Allergy and Infectious Diseases (NIAID) dentro del Project NextGen del HHS, tras la autorización de la IND por la FDA.
El ensayo incluye cuatro brazos de dosificación y se centra inicialmente en la proteína spike de SARS-CoV-2; se planifica un brazo adicional que incorpore la proteína nucleocápside una vez reciba la aprobación de la FDA. La compañía espera obtener datos iniciales en el primer trimestre de 2026. StealthX™ plantea una alternativa potencial a las vacunas de ARNm, sin adyuvantes y utilizando proteínas nativas para adaptarse rápidamente a nuevas dianas.
Capricor Therapeutics (NASDAQ: CAPR)가 자체 엑소좀 기반 백신 StealthX™의 임상 1상을 시작했으며, 첫 피험자들이 이미 투여를 받았습니다. 이 임상은 FDA의 IND 승인 후 HHS의 Project NextGen 일환으로 National Institute of Allergy and Infectious Diseases (NIAID)의 자금 지원을 받습니다.
연구는 네 개의 투여군으로 구성되며 초기에는 SARS-CoV-2 스파이크 단백질에 중점을 둡니다. FDA 승인을 전제로 핵심 구조 단백질인 뉴클레오캡시드 단백질을 포함하는 추가 투여군을 계획하고 있습니다. 회사는 2026년 1분기에 초기 데이터를 기대하고 있습니다. StealthX™는 부형제가 없고 네이티브 단백질을 사용해 새로운 표적에 빠르게 적응할 수 있는 mRNA 백신의 대안이 될 가능성이 있습니다.
Capricor Therapeutics (NASDAQ: CAPR) a annoncé le lancement d'un essai clinique de phase 1 pour son vaccin à base d'exosomes StealthX™, les premiers sujets ayant déjà été vaccinés. L'étude est financée par le National Institute of Allergy and Infectious Diseases (NIAID) dans le cadre du Project NextGen du HHS, après l'autorisation de la demande IND par la FDA.
L'étude comprend quatre bras de dosage et se concentre initialement sur la protéine spike de SARS-CoV-2 ; un bras supplémentaire incluant la protéine nucléocapside est prévu sous réserve de l'accord de la FDA. La société prévoit des premières données au 1er trimestre 2026. StealthX™ pourrait constituer une alternative aux vaccins à ARNm, sans adjuvants et utilisant des protéines natives pour une adaptation rapide aux nouvelles cibles.
Capricor Therapeutics (NASDAQ: CAPR) hat den Beginn einer Phase-1-Studie für seinen exosombasierten Impfstoff StealthX™ bekanntgegeben; die ersten Probanden wurden bereits behandelt. Die Studie wird vom National Institute of Allergy and Infectious Diseases (NIAID) im Rahmen des HHS-Programms Project NextGen finanziert, nachdem die IND bei der FDA freigegeben wurde.
Die Untersuchung umfasst vier Dosierungsarme und konzentriert sich zunächst auf das Spike-Protein von SARS-CoV-2; ein weiterer Arm mit dem Nukleokapsid-Protein ist nach FDA-Freigabe geplant. Das Unternehmen erwartet erste Daten im ersten Quartal 2026. StealthX™ stellt eine potenzielle Alternative zu mRNA-Impfstoffen dar: ohne Adjuvantien und mit nativen Proteinen, um sich schnell auf neue Ziele einstellen zu können.
- None.
- Initial data not expected until Q1 2026
- Additional arm pending separate FDA clearance
- Early-stage Phase 1 trial with unproven efficacy in humans
Insights
Capricor's first-in-human trial of exosome vaccine demonstrates platform validation and diversifies beyond Deramiocel, though commercial impact remains years away.
The dosing of first subjects in Capricor's Phase 1 trial for their StealthX™ exosome-based vaccine represents a significant technology validation milestone. This platform differentiates itself from conventional mRNA vaccines by utilizing exosomes—natural cell-derived nanoparticles—to display viral proteins without requiring adjuvants. The federally-funded trial through Project NextGen substantially de-risks the early clinical development as NIAID is conducting and funding the study.
The strategic implications extend beyond this single vaccine candidate. Capricor is positioning StealthX™ as a versatile platform technology with applications across various therapeutic areas, particularly for targeted payload delivery in rare diseases. This approach could eventually complement their lead Deramiocel program for Duchenne muscular dystrophy, creating a more diversified pipeline.
While promising, several factors temper immediate impact. Data isn't expected until Q1 2026, placing any commercial application years away. The initial focus on SARS-CoV-2 targets a heavily saturated market with established vaccines. The true value proposition lies in demonstrating platform versatility and safety, which could drive partnership opportunities across multiple disease areas.
The brief mention of a recent Type A meeting with FDA regarding their Deramiocel program suggests ongoing regulatory discussions for their lead asset, though specific outcomes await written feedback. This parallel development highlights Capricor's dual-technology approach, balancing near-term potential with Deramiocel against longer-term platform opportunities with StealthX™.
- First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGen
- Trial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID)
SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome-based vaccine. The study, funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) under the U.S. Department of Health and Human Services’ Project NextGen, follows review and clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial is being conducted by an NIAID-funded network of clinical trial sites.
“The initiation of this study marks an important milestone in vaccine development as StealthX™ potentially offers an alternative to mRNA vaccines as this platform contains no adjuvants, offers a more natural delivery system, and uses native proteins, allowing for rapid adaptability to emerging targets,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “We are proud to collaborate with the NIH on this important trial, enabling us to evaluate the clinical profile of StealthX™ in humans for the first time. While the study is initially focused on SARS-CoV-2, our broader vision is to position StealthX™ as a versatile exosome-based platform with potential across a range of therapeutic areas, including rare diseases and other conditions requiring targeted payload delivery. With first-in-human dosing achieved, this trial advances the platform clinically while also potentially laying the groundwork for strategic partnerships, pipeline expansion and long-term value creation. The NIAID expects initial data from the study in the first quarter of 2026, and we look forward to sharing additional details as they become available. In parallel, we recently held a constructive Type A meeting with FDA on our Deramiocel program for DMD and will provide updates when written feedback is available as we continue working collaboratively to shape the next steps in the program.”
Project NextGen is a federal initiative aimed at accelerating the development of next-generation vaccine platforms that provide broader and more durable protection against respiratory viruses and other infectious threats. Capricor’s vaccine is among several candidates selected for evaluation through this NIAID-sponsored program. The Phase 1 trial includes four dosing arms and is initially focused on the spike (S) protein of SARS-CoV-2. An additional arm of Capricor’s StealthX™ multivalent vaccine incorporating the nucleocapsid (N) protein is planned, pending separate FDA clearance.
For more information, please visit clinicaltrials.gov.
About Capricor’s StealthX™ Vaccine
The StealthX™ vaccine is a proprietary exosome-based platform developed internally by Capricor, using exosomes engineered to display either the spike or nucleocapsid proteins on their surface. Preclinical results published in Microbiology Spectrum demonstrated that StealthX™ elicited robust antibody production, potent neutralizing activity, a strong T-cell response and a favorable safety profile. Exosomes represent a novel antigen delivery system with potential to enable the rapid development of multivalent, protein-based vaccines. Exosomes, originally identified as extracellular vesicles, are nano-sized particles enriched with select proteins, RNAs, and lipids that play a key role in cell-to-cell communication.
About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Deramiocel, an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown Deramiocel to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. Deramiocel is currently in late-stage development for the treatment of Duchenne Muscular Dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics with potential to treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and Twitter.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the Securities and Exchange Commission on August 11, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
Capricor has entered into an agreement for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.
For more information, please contact:
Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204
Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755
FAQ
What is Capricor's StealthX vaccine and how does it differ from mRNA vaccines?
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