Core Insights - Capricor Therapeutics has initiated a Phase 1 clinical trial for its StealthX™ exosome-based vaccine, marking a significant milestone in vaccine development [1][2] - The trial is funded by the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) and follows FDA clearance of the Investigational New Drug (IND) application [1][2] - The StealthX™ platform aims to provide an alternative to mRNA vaccines, utilizing a more natural delivery system without adjuvants [2] Company Overview - Capricor Therapeutics is focused on developing transformative cell and exosome-based therapeutics for rare diseases, with its lead product candidate being Deramiocel, a therapy for Duchenne Muscular Dystrophy (DMD) [5][8] - The company is leveraging its proprietary StealthX™ platform for vaccine development and targeted delivery of therapeutics [5] Clinical Trial Details - The Phase 1 trial includes four dosing arms, initially targeting the spike protein of SARS-CoV-2, with plans for an additional arm focusing on the nucleocapsid protein pending FDA clearance [2] - Initial data from the trial is expected in the first quarter of 2026 [2] Strategic Collaborations - Capricor is collaborating with the NIH on the trial and has held discussions with the FDA regarding its Deramiocel program for DMD [2][8] - The company has entered into an agreement with Nippon Shinyaku Co., Ltd. for the exclusive commercialization and distribution of Deramiocel in the U.S. and Japan, subject to regulatory approval [8]