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Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine
First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s P...
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[{"type":"text","content":"Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine\n\n\n\n\n\n First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGen\n \n\n\n\n Trial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID)\n \n\n\n\n SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) --\n \n Capricor Therapeutics\n \n (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.\n \n\n “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 FD...