INmune Bio Announces Successful Completion of First Commercial Pilot-Scale Manufacturing Run of CORDStrom™ at CGT Catapult
INmune Bio (NASDAQ: INMB) has successfully completed its first commercial pilot-scale manufacturing run of CORDStrom™, a cell therapy treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB), at the Cell and Gene Therapy Catapult facility in the UK.
The milestone keeps the company on track for filing a Marketing Authorization Application (MAA) in the UK during H1 2026, followed by a Biologics License Application (BLA) in the US. CORDStrom™, which showed promising results in Phase 2 trials, is an off-the-shelf, allogeneic therapy derived from umbilical cord tissue mesenchymal stromal cells.
The successful manufacturing run demonstrates the scalability and consistency of CORDStrom™ production using a proprietary GMP-compliant process, marking a crucial step toward commercialization for treating RDEB patients.
- Successful completion of first commercial pilot-scale manufacturing run demonstrates production scalability
- Phase 2 trial showed promising results in improving itch, pain, wound scores, and quality of life
- On track for regulatory submissions in UK (H1 2026) and US
- Manufacturing achieved at commercial-ready UK facility ensures reliable supply chain
- None.
Insights
INmune Bio achieves critical manufacturing milestone for CORDStrom therapy, advancing regulatory timeline for RDEB treatment approval in 2026.
INmune Bio has reached a significant regulatory milestone with the successful completion of its first commercial pilot-scale manufacturing run for CORDStrom™ at the Cell and Gene Therapy Catapult facility in the UK. This achievement validates the scalability and consistency of their manufacturing process for this allogeneic cell therapy targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB).
The manufacturing success is particularly noteworthy as cell therapy production presents complex challenges in maintaining quality, consistency, and scalability. By demonstrating commercial-scale production capabilities in a GMP-compliant facility, INmune has cleared a critical hurdle in the regulatory pathway that often delays advanced therapies.
This milestone keeps the company on track for their regulatory submission timeline: a Marketing Authorization Application (MAA) in the UK during first half of 2026, followed by a Biologics License Application (BLA) in the US. For rare disease therapies like CORDStrom, manufacturing validation is especially crucial as regulatory agencies scrutinize production consistency and quality control measures extensively.
RDEB represents a serious unmet medical need characterized by skin fragility, chronic wounds, and increased skin cancer risk. CORDStrom's performance in the Phase 2 Mission EB trial, with improvements in itch, pain, wound scores, and quality of life, positions it well for the upcoming regulatory submissions. The company's ability to execute on manufacturing at this stage significantly derisks the commercial viability of the therapy, should it receive approval.
BOCA RATON, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or “the Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced the successful completion of its first full-scale pilot commercial manufacturing run of CORDStrom™, an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). This milestone, achieved at the Cell and Gene Therapy Catapult’s state-of-the-art Manufacturing Innovation Centre in Stevenage, United Kingdom, marks a critical step toward regulatory submissions and keeps the Company 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 US.
CORDStrom™ is designed to address the severe unmet systemic needs of RDEB patients. RDEB causes extreme fragility of the skin and internal linings, leading to widespread blistering, chronic wounds, scarring, and multi-organ complications while sparing the brain from direct damage and increasing the risk of skin cancer. CORDStrom has demonstrated promising results in the blinded-randomized Phase 2 Mission EB trial, including improvements in itch, pain, wound scores, and quality of life. The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, utilizing a proprietary process to ensure high-quality, GMP-compliant product.
“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. It is a milestone which ensures we remain aligned with our aggressive regulatory timeline,” 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. I am incredibly proud of our dedicated team and researchers as we work tirelessly to bring this therapy to patients and families.”
Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio, added, “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. We're excited to advance toward MAA and BLA submissions in 2026, with the goal of providing hope to families affected by this devastating disease.”
Matthew Durdy, Chief Executive at the Cell and Gene Therapy Catapult said, “The successful completion of this first pilot run is 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, and we are committed to supporting INmune Bio on its ambition ensure the potentially life-changing benefits of CORDStrom™ reach patients with RDEB.”
INmune Bio continues to prioritize efficient execution across its pipeline, including ongoing preparations for regulatory interactions to support CORDStrom™'s launch.
About CORDStrom™
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 CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at 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, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation & immunology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical development to determine if they can treat Alzheimer’s disease and other indications (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa.
About the Cell and Gene Therapy Catapult:
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of the cell and gene therapy industry with a vision of a thriving industry delivering life-changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. The Cell and Gene Therapy Catapult works was established by, and works with, Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.
Forward Looking Statements
Clinical trials are in early stages 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 results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of diseases, 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 US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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 Contact:
David Moss
Chief Financial Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
CGT Catapult Contact:
Alice Deeley
Communications and Content Manager
alice.deeley@ct.catapult.org.uk
April Six
cgtcatapult@aprilsix.com
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