BOCA RATON, Fla. — September 15, 2025 — Leads & Copy — INmune Bio Inc. (NASDAQ: INMB) has announced the successful completion of its first full-scale pilot commercial manufacturing run of CORDStrom™, an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
The milestone, achieved at the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, United Kingdom, marks a step toward regulatory submissions and keeps the Company on track for filing a Marketing Authorization Application (MAA) in the UK during the first half of 2026 followed by a Biologics License Application (BLA) in the US.
CORDStrom™ is designed to address the severe unmet systemic needs of RDEB patients. The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, utilizing a proprietary process to ensure high-quality, GMP-compliant product.
Ben Weil, Head of UK Operations at INmune Bio, stated the achievement ensures alignment with their regulatory timeline. Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio, added that the manufacturing success reinforces their confidence in delivering a reliable supply chain for global commercialization.
Matthew Durdy, Chief Executive at the Cell and Gene Therapy Catapult, said the initial run has provided valuable learnings on how to refine and scale-up the manufacturing.
David Moss, Chief Financial Officer, (561) 710-0512, info@inmunebio.com
Daniel Carlson, Head of Investor Relations, (415) 509-4590, dcarlson@inmunebio.com
Alice Deeley, Communications and Content Manager, alice.deeley@ct.catapult.org.uk
April Six, cgtcatapult@aprilsix.com
Source: INmune Bio Inc.
