Capricor publishes new advances for its engineered exosome platform

StealthX™ Exosome Platform Shows Multivalent Vaccine Induces Long-Lasting Immunity to Multiple SARS-CoV-2 Proteins

Capricor Therapeutics a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today the publication of a preclinical study highlighting new advances for its engineered exosome program. The data was published online in bioRxiv and explored the therapeutic potential of Capricor’s proprietary StealthX™ exosome platform, which generated two vaccine candidates (STX-S and STX-N), that independently, and in combination (STX-S+N) induced a strong immune response against two SARS-CoV-2 proteins, spike and nucleocapsid. Results showed that this multivalent, protein-based vaccine candidate has the potential to achieve potent, longer lasting immunization, broaden reactivity and improve T-cell response with only nanograms of protein without any adjuvant. The data from this study suggests that StealthX™ could deliver a more potent vaccine with broader immunity than is currently available, by combining the advantages of both mRNA and recombinant protein vaccines into a potentially superior, rapidly generated, low-dose vaccine.

“We are encouraged with the results of this study as it underscores the therapeutic utility of Capricor’s engineered exosome program and demonstrates StealthX™ has the potential to be used for vaccinology or protein replacement,” said Linda Marban, Ph.D., Capricor’s chief executive officer. “This data shows that exosomes may be used effectively to deliver viral proteins for immunization and induce persistent immune responses to multiple SARS-CoV-2 proteins at extremely low doses, allowing for development of exosome-based vaccines as well as therapeutics. More broadly, this data establishes StealthX™ as a vaccine platform with broad applications across infectious disease, as well as the prospect of combining multiple targets in one vaccine. Additionally, it supports exosomes as a suitable delivery vehicle for a variety of therapeutic cargo. We are looking forward to expanding our pipeline and our partnership opportunities with this platform.”

The current study used engineered exosomes to express either SARS-CoV-2 spike (StealthX-Spike, STX-S) or nucleocapsid (StealthX-Nucleocapsid, STX-N) protein on the exosome surface rapidly, a timeframe similar to mRNA vaccines. When administered as a single product, both STX-S and STX-N induced strong immunization with the production of a potent humoral and cellular immune response simultaneously. These effects were obtained with administration of only nanograms of protein without the use of any adjuvant or lipid nanoparticles which further supports the potential safety profile of this product candidate. The study also investigated the combination of STX-S and STX-N, namely STX-S+N, in two independent animal models. Administration of this multivalent, low dose protein-based vaccine resulted in increased, persistent antibody production, potent neutralizing antibodies with cross-reactivity to other variants of concern, and strong T-cell response. The results show efficacy of this multivalent protein-based vaccine for SARS-CoV-2 and suggests that other vaccines or therapeutics could be rapidly developed using the same StealthX™ platform.

SourceGlobe Newswire

Cacciottolo M, Nice JB, Li Y et al. (2023) Exosome based multivalent vaccine: achieving potent immunization, broaden reactivity and T cell response with nanograms of proteins without any adjuvant. bioRXiv [online preprint]. [abstract]

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