BOCA RATON, Fla. | July 20, 2026
INmune Bio Inc. announced the successful completion of a major commercial manufacturing milestone for its CORDStrom™ cell therapy platform, supporting the company’s planned global regulatory submissions and future commercialization strategy. The company confirmed that it has successfully processed its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult (CGT Catapult) Manufacturing Innovation Centre in Stevenage, United Kingdom, under its commercial partnership with Anthony Nolan Cord Blood Bank. The achievement completes the transfer of the mesenchymal stromal cell (MSC) isolation process into a commercial manufacturing environment designed to meet MHRA, EMA, and FDA regulatory standards, positioning the company to manufacture master cell banks for Ebstrocel™, its investigational therapy for recessive dystrophic epidermolysis bullosa (RDEB). The milestone establishes the manufacturing foundation needed to support the planned Phase 3 confirmation trial, future commercial production, and upcoming regulatory submissions across multiple global markets.
Commercial Manufacturing Strengthens Phase 3 and Regulatory Readiness
The successful technology transfer represents one of the most significant operational achievements for the CORDStrom™ platform, enabling commercial-scale production using processes designed to satisfy regulatory expectations in both the United States and Europe. The commercial manufacturing workflow includes maternal infectious disease testing performed in U.S. CLIA-accredited laboratories, supporting future regulatory compliance for global commercialization. INmune Bio stated that the completed manufacturing infrastructure will generate U.S.-tested master cell banks for Ebstrocel™, providing the material required for its planned Phase 3 confirmation clinical study and eventual commercial supply. Company leadership highlighted that commercial manufacturing has historically represented one of the largest execution risks for cell therapy developers, making this successful transition from clinical-scale manufacturing to commercial production an important step toward product registration and market readiness.
Regulatory Strategy Aligns with Emerging Rare Disease Framework
Alongside the manufacturing milestone, INmune Bio reaffirmed that its regulatory strategy closely aligns with the UK Medicines and Healthcare products Regulatory Agency (MHRA) draft framework for rare disease therapies. The company believes the proposed framework supports its existing development strategy for Ebstrocel™, particularly through flexible evidence generation, advanced statistical approaches, patient-centered clinical outcomes, and lifecycle evidence development. According to the company, these principles are consistent with previous written guidance received from the MHRA supporting its planned Conditional Marketing Authorization application. With commercial manufacturing completed, pediatric development plans finalized, regulatory alignment achieved, and Marketing Authorization Application (MAA) preparations underway, INmune Bio believes Ebstrocel™ has entered the final development stage before planned commercialization in the United Kingdom.
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CORDStrom Platform Positions INmune Bio for Global Expansion
The commercial manufacturing achievement strengthens INmune Bio’s long-term strategy to establish the CORDStrom™ platform as a scalable allogeneic cell therapy platform targeting rare diseases and other unmet medical needs. The company continues advancing Ebstrocel™ toward planned UK MHRA, European Medicines Agency (EMA), and U.S. FDA regulatory submissions while simultaneously progressing its XPro1595™ neuroinflammation program for early Alzheimer’s disease. Company executives emphasized that the collaboration with Anthony Nolan and the Cell and Gene Therapy Catapult has enabled development of a reliable, scalable, and commercial-ready manufacturing platform capable of supporting future global demand. With commercial manufacturing now established and regulatory pathways continuing to advance, INmune Bio believes the CORDStrom™ platform is well positioned to support Phase 3 development, international regulatory filings, and future commercialization of regenerative cell therapies for patients with rare diseases.
Source: INmune Bio press release
