INmune Bio Inc. has achieved a critical manufacturing milestone for its experimental cell therapy CORDStrom™, successfully completing its first full-scale pilot commercial manufacturing run at the Cell and Gene Therapy Catapult's Manufacturing Innovation Centre in Stevenage, United Kingdom. The achievement marks a pivotal step toward regulatory submissions for the umbilical cord tissue-derived mesenchymal stromal cell therapy designed to treat Recessive Dystrophic Epidermolysis Bullosa (RDEB).
The successful manufacturing run keeps INmune Bio 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 United States. The milestone confirms the scalability and consistency of CORDStrom™ production using a proprietary process to ensure high-quality, GMP-compliant product.
Addressing Severe Unmet Medical Need
RDEB represents a devastating rare disease that causes extreme fragility of the skin and internal linings, leading to widespread blistering, chronic wounds, scarring, and multi-organ complications while increasing the risk of skin cancer. CORDStrom™ is designed to address the severe unmet systemic needs of RDEB patients through its off-the-shelf, allogeneic approach.
The therapy has demonstrated promising results in the blinded-randomized Phase 2 Mission EB trial, including improvements in itch, pain, wound scores, and quality of life for patients with this rare genetic condition.
"This achievement at a commercial-ready UK facility is a testament to our team's dedication, operational excellence, and strength of the collaboration with the Cell and Gene Therapy Catapult," said Ben Weil, Head of UK Operations at INmune Bio. "By successfully scaling up production in a commercial-ready facility, we're paving the way for timely access to this potentially life-changing therapy for RDEB patients."
Manufacturing Platform Technology
CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The platform leverages proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases.
The therapy is designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification, independent of donor characteristics. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products that can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
Regulatory Path Forward
Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio, emphasized the significance of the manufacturing achievement: "The completion of this first commercial pilot run is a pivotal moment in our journey to bring CORDStrom™ to market. Building on the positive safety and efficacy data from the Phase 2 trial, this manufacturing success reinforces our confidence in delivering a reliable supply chain for global commercialization."
Matthew Durdy, Chief Executive at the Cell and Gene Therapy Catapult, noted that the successful completion represents "a major accomplishment for INmune Bio as it looks to accelerate its path to commercial manufacturing. This initial run has provided valuable learnings on how to refine and scale-up the manufacturing."
The company continues to prioritize efficient execution across its pipeline, including ongoing preparations for regulatory interactions to support CORDStrom™'s launch. INmune Bio's broader portfolio includes three product platforms targeting the innate immune system, with CORDStrom™ representing the company's cell therapy platform alongside its Dominant-Negative Tumor Necrosis Factor platform and Natural Killer Cell Priming Platform.
