Компания INmune Bio подала заявки на статус орфанированного препарата и научные рекомендации для лечения буллезного эпидермолиза в ЕС

Orphan Drug Designation application and pre-MAA Scientific Advice package submitted for Ebstrocel in RDEB Filings support a planned EU MAA in Q1 2027; orphan designation, if granted and maintained through approval, may provide regulatory incentives and 10 years of market exclusivity BOCA RATON, Fla., Aug. 26, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) ("INmune Bio" or the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted two regulatory packages to the European Medicines Agency (EMA) for Ebstrocel: an application for Orphan Drug Designation and a Scientific Advice package to streamline the upcoming Marketing Authorization Application (MAA- in Europe. Ebstrocel, the first product from the Company's CORDStrom platform, is an investigational pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy being developed as a systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB). 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 (BLA) in Q1 2027. "These EMA submissions are another execution milestone as we move Ebstrocel from late-stage clinical development toward potential commercialization," said David Moss, co-founder and Chief Executive Officer of INmune Bio. "Our focus is on converting the clinical, regulatory and manufacturing progress achieved to date into a defined sequence of registration milestones across the UK, European Union and United States. Each step advances Ebstrocel toward patients and provides an opportunity to validate the broader regulatory and commercial potential of the CORDStrom platform." Regulatory and Strategic Highlights - EU orphan designation: The application seeks orphan medicinal product designation for Ebstrocel in RDEB in Europe to align with the ODD already granted in USA. If granted, sponsors may receive incentives that include protocol assistance and fee reductions. If Ebstrocel later receives marketing authorization and maintains orphan status, the approved orphan indication may benefit from 10 years of EU market exclusivity, subject to applicable requirements. - Pre-MAA engagement: The Scientific Advice package is intended to support dialogue with EMA on scientific, regulatory and procedural requirements before the planned MAA, helping the Company identify and address key questions earlier in the filing process. - Defined global catalyst sequence: The Company is targeting a UK MAA in Q4 2026, followed by planned EU MAA and U.S. BLA submissions in Q1 2027. - Platform leverage: Ebstrocel is the first disease-specific CORDStrom product to advance toward potential marketing authorization. Progress with Ebstrocel is expected to inform development of additional scalable, off-the-shelf therapies from the platform. RDEB and the Ebstrocel Opportunity RDEB is a rare, debilitating genetic disease characterized by extreme skin fragility, chronic wounds, scarring and significant systemic complications. Ebstrocel is being developed as a systemic therapy intended to address disease manifestations beyond topical wound care. "RDEB is a systemic disease with substantial unmet need beyond the visible manifestations of skin injury," said Mark Lowdell, Ph.D., Chief Scientific Officer of INmune Bio and inventor of the CORDStrom platform. "Advancing Ebstrocel through European regulatory pathways is important for patients and for CORDStrom. Ebstrocel is our first opportunity to demonstrate how a pooled, scalable, off-the-shelf stromal cell platform can progress through late-stage regulatory development." About the European Regulatory Submissions Orphan Drug Designation in the European Union is intended to support the development of medicines for rare, serious conditions. If granted, the designation can provide access to regulatory incentives during development. Market exclusivity is available only after marketing authorization and maintenance of orphan status at the time of approval. The pre-MAA Scientific Advice process is designed to facilitate interaction with EMA in advance of an MAA submission and to help sponsors address scientific, regulatory and procedural considerations as they prepare a marketing authorization package. About Ebstrocel and CORDStrom Ebstrocel is the RDEB-specific investigational product from INmune Bio's proprietary CORDStrom platform. CORDStrom is a platform of pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell therapies designed to reduce donor variability and manufacturing inconsistency. The Company's fully closed, semi-automated manufacturing approach is intended to support scalable, reproducible and off-the-shelf products that can be tailored for different therapeutic applications and routes of administration. INmune Bio plans to continue its interactions with European regulators as it advances toward the planned MAA for Ebstrocel. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company's clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: - CORDStrom: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with a UK MAA planned for 2026 and an EU MAA and U.S. BLA planned for Q1 2027. - XPro1595: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by FDA Fast Track designation and regulatory alignment from an End-of-Phase 2 meeting, XPro1595 is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer's disease. To learn more about INmune Bio's pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com. Forward Looking Statements The Company's product candidates are in clinical development and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom, XPro1595 (XPro, pegipanermin), and INKmune have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the U.S. Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. INmune Bio Contacts David Moss Chief Executive Officer (561) 710-0512 [email protected] Daniel Carlson Head of Investor Relations (415) 509-4590 [email protected]