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INmune Bio Inc. (NASDAQ:INMB) ("INmune" or "the Company"), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient's innate immune system to fight disease, today 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). This milestone, achieved at the Cell and Gene Therapy Catapult's state-of-the-art Manufacturing Innovation Centre in Stevenage, United Kingdom, marks a critical 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. RDEB causes extreme fragility of the skin and internal linings, leading to widespread blistering, chronic wounds, scarring, and multi-organ complications while sparing the brain from direct damage and increasing the risk of skin cancer. CORDStrom has demonstrated promising results in the blinded-randomized Phase 2 Mission EB trial, including improvements in itch, pain, wound scores, and quality of life. The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, utilizing a proprietary process to ensure high-quality, GMP-compliant product.
Posted In: INMB
