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INmune Bio Submits Ebstrocel Drug Applications
INmune Bio announced that it has submitted two regulatory packages to the European Medicines Agency, or EMA, for Ebstrocel: an application for orphan drug designation and a scientific advice package to streamline the upcoming marketing authorization application, or MAA, in Europe. Ebstroce is an investigational pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy being developed as a systemic treatment for recessive dystrophic epidermolysis bullosa. The EMA filings are intended to support the company's planned EU MAA in Q1 2027 and form part of a coordinated global registration strategy that includes a planned UK MAA in Q4 2026 and a planned U.S. biologics license application in Q1 2027.
INmune Bio Successfully Processes First Commercial-Ready Umbilical Cord Tissue
INmune Bio announced the company has successfully processed its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage, UK, under its commercial agreement with Anthony Nolan Cord Blood Bank. This achievement marks the transfer of the mesenchymal stromal cell isolation stage for the manufacture of master cell banks into INmune Bio's commercial manufacturing facility. The process is now commercial-ready to MHRA, EMA and FDA standards, including maternal blood samples infectious disease testing in US-CLIA-accredited laboratories. The technology transfer positions the company to generate its first U.S. tested master cell banks for Ebstrocel, the RDEB-specific investigational product derived from the CORDStrom platform, in support of its planned Phase 3 confirmation clinical trial and future commercial supply.
INmune Bio Receives Pediatric Investigation Plan Approval for Ebstrocel
INmune Bio announced that the UK Medicines & Healthcare products Regulatory Agency, or MHRA, has approved the pediatric investigation plan, or PIP, for Ebstrocel for the treatment of Recessive Dystrophic Epidermolysis Bullosa, or RDEB. The approval of the PIP is the first required stage toward a marketing authorization application, or MAA, submission in the United Kingdom. This regulatory milestone remains aligned with the company's established timetable for an MAA filing in 2026 and a US filing for Accelerated Approval in early 2027.
INmune Bio Receives MHRA Meeting Minutes, Plans 2026 Marketing Authorization Application
INmune Bio announced that it has received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application, or pre-MAA, Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency, or MHRA, for CORDStrom in Recessive Dystrophic Epidermolysis Bullosa. The May 12, meeting resulted in written alignment across all questions submitted by the company and provides a regulatory path for INmune Bio's planned 2026 UK Marketing Authorization Application, or MAA, seeking Conditional Marketing Authorization for Ebstrocel in RDEB. Ebstrocel is the name of the RDEB-specific investigational formulation derived from INmune Bio's proprietary CORDStrom off-the-shelf, pooled, human umbilical cord-derived mesenchymal stromal cell platform.
INmune Bio Reports Positive Results from XPro Trial in Early Alzheimer's Disease
INmune Bio announced positive results from exploratory MRI imaging analyses of its MINDFuL Phase 2 trial of XPro in patients with early Alzheimer's disease. "A statistically significant treatment effect on white matter across the full mITT population, strengthening further in inflammation-enriched patients, tells us that XPro is doing exactly what it is designed to do, with increased effect in patients we intend to treat in the registrational study," said David Moss, CEO of INmune Bio. INmune Bio plans to present the complete dataset at the Alzheimer's Association International Conference in July.
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