What Are Exosomes?

Exosomes are nanosized extracellular vesicles that serve as an intercellular communication system. Exosomes can be found in all tissues and biological fluids and can transport, protect and deliver biologically active molecules or cargo that have the ability to alter the function of recipient cells. Exosomes are highly concentrated with just one milliliter of solution having as many as 1 billion to 15 billion exosomes.

Exosomes act as messengers to regulate the functions of neighboring cells. Preclinical research has shown that exosomes can direct, or in some cases, re-direct cellular activity. Their size, ease of crossing cell membranes and ability to communicate in native cellular language make them an exciting, emerging class of potential therapeutic agents. Additionally, because exosomes are cell-free, they can be stored, handled, reconstituted and administered similarly to common biopharmaceutical products such as antibodies.

Capricor’s Exosomes Technology

StealthX™ is Capricor’s proprietary exosome platform for designer protein surface expression, cargo loading and targeted delivery. StealthX™ technology is at the core of our exosome platform, and we are currently exploring its deployment in two broad modalities: precision therapeutics and vaccinology.

The ability to decorate the surface of exosomes with proteins or other ligands or antigens, as well as to load potential therapeutic cargo inside the exosome coupled with their relatively low toxicity compared to synthetic lipid nanoparticles, allows us to explore a number of potential disease targets.

Capricor is internally developing a streamlined manufacturing process to support future development efforts. This foundational work drives our platform strategy to leverage the development of external partnerships with companies that have therapeutics that can benefit from our StealthX™ targeted delivery vehicle. Our StealthX™ platform builds on advances in fundamental protein and RNA science, targeting technology and biological manufacturing, providing Capricor the opportunity to unlock the potential power of exosomes as an exciting modality for drug delivery.

We recently announced a collaboration with the National Institutes of Health (NIH) investigating our proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2. Our vaccine was 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 our StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.