CORDStrom - (MissionEB)

July 20, 2026: INmune Bio Inc. (NASDAQ: INMB) reported a manufacturing milestone for its CORDStrom™ umbilical cord-derived mesenchymal stromal cell platform, completing the first processing of “commercial-ready” umbilical cord tissue at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre (Stevenage, UK) under a commercial agreement with Anthony Nolan Cord Blood Bank. The company said the MSC isolation stage for master cell bank (MCB) manufacturing has been transferred into its commercial manufacturing facility, to MHRA/EMA/FDA standards (including maternal blood infectious disease testing in US-CLIA-accredited labs). INmune Bio plans to generate its first US-tested MCBs for Ebstrocel™ (RDEB-specific investigational product) to support a planned Phase 3 confirmation trial and future commercial supply; it also noted pediatric strategy approval, regulatory alignment completed, and MAA preparation underway, positioning Ebstrocel for the final stage before planned commercialization in the UK.

Regulatory catalysts cited: Ebstrocel MAA submissions planned to the UK MHRA and EU EMA in 2026, and a planned U.S. BLA submission. The company also expressed support for MHRA’s draft rare disease therapies regulatory framework and said it has written MHRA guidance supporting a planned Conditional Marketing Authorization application.

Other program: XPro1595™ (DN-TNF) has FDA Fast Track designation and End-of-Phase 2 regulatory alignment; planned next step is an integrated Phase 2b/3 seamless adaptive registrational program in early Alzheimer’s disease (neuroinflammation-enriched).