SAN DIEGO, August 18, 2025 — Leads & Copy — Capricor Therapeutics (NASDAQ: CAPR) has initiated a Phase 1 clinical trial of its StealthX™ exosome-based vaccine, with the first subjects dosed. The trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID) under HHS’s Project NextGen, follows FDA clearance of the Investigational New Drug (IND) application.
The study is being conducted by an NIAID-funded network of clinical trial sites. Capricor’s CEO, Linda Marbán, Ph.D., noted that StealthX™ potentially offers an alternative to mRNA vaccines, featuring a natural delivery system and native proteins for rapid adaptability. The trial is initially focused on SARS-CoV-2, with plans to expand StealthX™ as a versatile platform across therapeutic areas.
NIAID anticipates initial data in Q1 2026. Capricor also held a Type A meeting with the FDA on its Deramiocel program for DMD and will provide updates when written feedback is available.
Project NextGen is a federal initiative to accelerate the development of next-generation vaccine platforms. Capricor’s StealthX™ vaccine utilizes exosomes engineered to display spike or nucleocapsid proteins. Preclinical results demonstrated robust antibody production, potent neutralizing activity, a strong T-cell response, and a favorable safety profile.
Capricor is dedicated to advancing cell and exosome-based therapeutics for rare diseases, with Deramiocel in late-stage development for Duchenne Muscular Dystrophy.
Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755
Source: Capricor Therapeutics
