Capricor Therapeutics (CAPR) 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(TM) 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 Marban, 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.”
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