Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2
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Insights
The selection of Capricor Therapeutics' StealthX™ vaccine for inclusion in Project NextGen represents a significant milestone in the company's development of exosome-based therapeutics. Exosomes are small vesicles released by cells that can transfer molecules between cells and their use in vaccine development is an emerging area of interest due to their potential for targeted delivery and immune system modulation.
The multivalent nature of the StealthX™ vaccine, which targets both the S protein and the N protein of SARS-CoV-2, could indeed provide broader immunity. This is particularly relevant given the ongoing evolution of the virus and the need for vaccines that can maintain efficacy against emerging variants. Moreover, the fact that the vaccine is free of adjuvants and lipid nanoparticles may reduce the risk of side effects, a common concern with current COVID-19 vaccines.
However, it is important to note that the Phase 1 clinical study is still subject to regulatory approval and the vaccine's efficacy and safety will only be confirmed through rigorous clinical trials. The non-dilutive funding from NIH is a positive aspect, as it allows Capricor to advance in clinical trials without the need to raise additional capital that could dilute existing shareholders' equity.
From a financial perspective, Capricor's collaboration with the National Institutes of Health (NIH) under Project NextGen is a strategic move. Non-dilutive funding support is a strong positive for Capricor's financial health, as it preserves shareholder value while enabling the advancement of the StealthX™ vaccine into clinical trials. Furthermore, the support from a reputable institution like NIH not only validates the scientific premise of Capricor's technology but could also enhance investor confidence.
While the announcement is promising, investors should consider the inherent risks of biotechnology ventures, especially in the early stages of clinical development. The success of the StealthX™ vaccine in Phase 1 trials is crucial for subsequent funding and development milestones. Positive trial results could lead to an increase in Capricor's stock value, while negative outcomes could have the opposite effect. Additionally, the potential for the platform's application beyond COVID-19 to other infectious diseases suggests a larger market opportunity, which could be a significant growth driver for the company in the long term.
As an epidemiologist, the development of a multivalent vaccine that targets multiple proteins of the SARS-CoV-2 virus is of particular interest. The StealthX™ vaccine's approach to targeting both the S protein, which is prone to mutations and the N protein, which is more stable, could theoretically result in a vaccine that provides longer-lasting immunity and is less susceptible to being rendered ineffective by viral mutations. This is significant given the ongoing global challenge of COVID-19 and the need for vaccines that can adapt to its evolving nature.
Furthermore, the potential for a platform that combines the rapid response capability of mRNA vaccines with the efficacy of protein vaccines could be a game-changer in vaccine technology. The ability to generate a strong immune response at low doses, as indicated in preclinical studies, is also promising for reducing vaccine dosage requirements and improving global vaccine accessibility.
-Project NextGen Collaboration will Support Capricor’s StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic-
SAN DIEGO, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.
“We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.”
Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.”
About Capricor’s StealthX™ Vaccine
The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases. 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; 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; scope, duration, validity and enforceability of intellectual property rights; future royalty streams and revenue 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, 2022, as filed with the Securities and Exchange Commission on March 17, 2023 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the Securities and Exchange Commission on November 14, 2023. 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.
CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.
For more information, please contact:
Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755
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