INmune Bio Achieves Commercial-Ready Manufacturing for CORDStrom™ Platform, Paving Way for Global Regulatory Filings in RDEB
核心洞察
INmune Bio has successfully completed the first commercial-ready umbilical cord tissue processing at the CGT Catapult Manufacturing Innovation Centre in Stevenage, UK, under its agreement with Anthony Nolan (搜索) Cord Blood Bank.
The manufacturing milestone supports a planned Phase 3 confirmation trial for Ebstrocel™ (搜索) and future commercial supply, with processes now meeting MHRA, EMA, and FDA standards.
The company's regulatory strategy aligns with the MHRA's draft rare disease therapies regulatory framework, which emphasizes flexible evidence generation and patient-centered outcomes.
INmune Bio Inc. (NASDAQ: INMB), a late-stage biotechnology company focused on inflammation and immunology, has announced a significant manufacturing milestone for its CORDStrom™ platform, successfully processing its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult (CGT Catapult) Manufacturing Innovation Centre in Stevenage, UK. The achievement, completed under the company's commercial agreement with Anthony Nolan (搜索) Cord Blood Bank, marks the successful transfer of the mesenchymal stromal cell (MSC) isolation stage for the manufacture of master cell banks (MCBs) 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. This technology transfer positions the company to generate its first US-tested master cell banks for Ebstrocel™ (搜索), the RDEB-specific investigational product derived from the CORDStrom™ platform, supporting both a planned Phase 3 confirmation clinical trial and future commercial supply.
"Completing this manufacturing transfer is one of the most important operational milestones for the CORDStrom platform. We now have the manufacturing infrastructure required to generate master cell banks that support our planned Phase 3 program and future commercial production using a process designed to satisfy both UK and U.S. regulatory expectations," said Professor Mark W. Lowdell, PhD, FRCPath, FRSB, Chief Scientific Officer of INmune Bio. "I am hugely proud of the team for getting to this milestone so quickly."
A Scalable, Off-the-Shelf MSC Platform
The CORDStrom™ platform is a proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell technology engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. By utilizing umbilical cord-derived MSCs that are tested, screened, and pooled to create standardized "MSC Banks," the platform aims to deliver consistent, scalable, and "off-the-shelf" cellular therapies suitable for supply in the UK, EU, US, and other global regions.
The collaboration with Anthony Nolan (搜索)'s Cell Therapy and Laboratory Services, which draws on 50 years of pioneering innovation in stem cell transplantation, ensures that every CORDStrom™ product meets rigorous "Materials Acceptance Criteria," including precise neonatal weight and maternal age specifications, to ensure the highest reproducibility while maintaining regulatory compliance.
"This important milestone reflects the strength of collaboration between Anthony Nolan (搜索), the Cell and Gene Therapy Catapult, and INmune Bio, and marks another critical step towards commercial delivery of Ebstrocel™ (搜索)," said Dr. Ben Weil, MBA, EngD, Head of UK Operations at INmune Bio. "Everyone involved in the CORDStrom™ platform understands the urgency and criticality of developing potentially life-changing medicines to children living with RDEB and other rare diseases."
Regulatory Alignment with MHRA Framework
INmune Bio's approach to developing Ebstrocel™ (搜索) for recessive dystrophic epidermolysis bullosa (搜索) (RDEB), an ultra-rare disease characterized by devastating skin fragility, is directly aligned with the principles recently outlined in the UK Medicines and Healthcare products Regulatory Agency (MHRA) draft rare disease therapies regulatory framework. The company believes the principles proposed within the draft framework validate the regulatory strategy it has already established with the MHRA for Ebstrocel™.
Specifically, the framework emphasizes flexible evidence generation, advanced statistical methodologies, patient-centered outcomes, and lifecycle evidence development — principles reflected in the company's recent written MHRA guidance supporting its planned Conditional Marketing Authorization application.
"Commercial manufacturing is often one of the largest execution risks facing cell therapy companies. Today's milestone demonstrates that we have successfully transitioned from clinical manufacturing toward a scalable commercial process that supports our planned regulatory filings and long-term commercialization strategy," said David Moss, CEO and co-founder of INmune Bio. "Combined with our recent regulatory alignment from the MHRA and the evolving UK rare disease framework, we believe CORDStrom is exceptionally well positioned for the next stage of development."
Expanding Pipeline Beyond RDEB
While the immediate focus remains on Ebstrocel™ (搜索) for RDEB, the CORDStrom™ platform is being developed across a broader pipeline of indications. Under an amended and restated Material Transfer and License Agreement with Anthony Nolan (搜索), effective April 29, 2026, the collaboration also targets CORDStrom-col7a, a next-generation systemic treatment for epidermolysis bullosa designed to address underlying genetic deficiencies; CORDStrom-TRAIL for oncology, utilizing the platform's immunomodulatory capabilities against solid tumors; and applications in inflammatory and degenerative diseases including osteoarthritis (搜索) and systemic lupus erythematosus (搜索) (SLE).
With commercial manufacturing established, pediatric strategy approved, regulatory alignment completed, and the Marketing Authorization Application (MAA) preparation underway, INmune Bio believes Ebstrocel™ (搜索) has entered the final stage of development before planned commercialization in the United Kingdom. The company plans MAA submissions to the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission.