Full Press Release Details
Global Experts in MSC Clinical Translation to Advise Ebstrocel™ Regulatory and Clinical Development and Guide Expansion of CORDStrom Product Opportunities
BOCA RATON, Fla., July 30, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announced the formation of a Scientific Advisory Board ("SAB") to support the late-stage development of Ebstrocel™ for recessive dystrophic epidermolysis bullosa (“RDEB”) and guide the expansion of the Company’s proprietary CORDStrom™ mesenchymal stromal cell ("MSC") platform to target new disease indications.
The SAB brings together internationally recognized leaders with complementary expertise in MSC biology, clinical translation, manufacturing and potency assessment, rare pediatric skin disease and osteoarthritis. The SAB will advise INmune Bio on:
• Ebstrocel regulatory and clinical-development strategy in RDEB and broader epidermolysis bullosa (“EB”);
• Phase 3 trial design, patient selection and clinically meaningful endpoints;
• Mechanism-of-action studies and translational biomarkers;
• Potency assays, product-release criteria and manufacturing consistency; and
• Selection and development of additional indications that could benefit from disease-specific CORDStrom products.
The SAB will be chaired by Professor Mark Lowdell, Ph.D., FRCPath, INmune Bio’s Chief Scientific Officer and Co-Founder. Its inaugural members are:
• Katarina Le Blanc, M.D., Ph.D., Professor and Specialist Physician at Karolinska Institute and a pioneer in the clinical use of MSCs;
• Anna Martinez, MBBS, MRCP, FRCPCH, Consultant Pediatric Dermatologist at Great Ormond Street Hospital and Clinical Lead of the UK National Epidermolysis Bullosa Service;
• Sowmya Viswanathan, Ph.D., Scientist at the Schroeder Arthritis Institute and Krembil Research Institute at University Health Network and Associate Professor at the University of Toronto; and
• Daniel J. Weiss, M.D., Ph.D., Professor of Medicine at the University of Vermont Larner College of Medicine and President of the International Society for Cell & Gene Therapy.
“CORDStrom is entering an important phase in its development, with Ebstrocel advancing toward regulatory submissions and the broader platform offering the potential to generate additional disease-specific cell medicines,” said Professor Lowdell. “We have assembled four internationally recognized leaders whose experience spans the entire development continuum, from MSC biology and manufacturing to clinical-trial design, regulatory strategy and the treatment of patients with RDEB.”
“Importantly, this will be a working advisory board with defined development priorities,” Professor Lowdell continued. “The SAB will help us strengthen the scientific, clinical and regulatory package supporting Ebstrocel, advance its late-stage development, and prioritize additional indications that are best suited to the differentiated biological and manufacturing capabilities of the CORDStrom platform.”
CORDStrom is designed to address the historical MSC challenges by using proprietary donor screening, pooling and expansion to create an off-the-shelf, batch-to-batch consistent, scalable, cGMP-manufactured cell medicine. The platform is intended to enable indication-specific CORDStrom products tuned for selected effector functions, including anti-inflammatory, immunomodulatory, wound healing and other disease-relevant characteristics.
The SAB included internationally recognized leaders in MSC biology and clinical application across a wide range of indications including lung diseases, osteoarthritis, graft-versus-host disease ("GvHD") and rare pediatric skin diseases. These leaders will provide independent, data-driven advice to assist INmune Bio in accelerating, expanding and enhancing the development of the CORDStrom platform. In addition to supporting Ebstrocel’s development, the SAB will evaluate potential CORDStrom applications in osteoarthritis, pulmonary disease, oncology and other inflammatory, immunologic and tissue-repair indications.
Scientific Advisory Board Members
Katarina Le Blanc, M.D., Ph.D. - Dr. Le Blanc is Professor of Clinical Stem Cell Research at Karolinska Institutet and a specialist physician whose research focuses on mesenchymal stem/stromal cells, hematopoietic stem cell transplantation and immunology. Her group was the first to report that adoptive transfer of MSCs ameliorated treatment-resistant acute GvHD, and she was the lead author of the seminal Lancet Phase II study of MSCs in steroid-resistant, severe acute GvHD. Dr. Le Blanc brings decades of expertise in MSC immunobiology, clinical translation, potency evaluations and regulatory affairs.
Anna Martinez, MBBS, MRCP, FRCPCH - Dr. Martinez is a Consultant Pediatric Dermatologist at Great Ormond Street Hospital and has led the National Epidermolysis Bullosa Service while working as a consultant in pediatric dermatology since 2003. She is Clinical Lead for the UK National Epidermolysis Bullosa Service, runs combined dermatology-allergy clinics and the dedicated ichthyosis service, and has led the clinical research as designer and principal investigator for MSC trials in pediatric epidermolysis bullosa in the UK. Dr. Martinez has deep clinical expertise in RDEB, broader EB, genetic skin disease, rare skin-fragility disorders, ichthyoses and Netherton syndrome as well as real-World experience of the delivery of Ebstrocel to challenging pediatric patients.
Sowmya Viswanathan, Ph.D. - Dr. Viswanathan is a Scientist at the Osteoarthritis Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute and the Krembil Research Institute at University Health Network, and an Associate Professor at the University of Toronto. Her research focuses on developing novel cell-based therapies for OA, including advanced engineering and manufacturing approaches to improve the potency and stability of anti-inflammatory MSC therapies. She has published seminal papers on the mechanisms of action of MSCs in OA. She has served as Chair and Co-Chair of the ISCT Mesenchymal Stromal Cell Committee.
Daniel J. Weiss, M.D., Ph.D. - Dr. Weiss is Professor of Medicine, Pulmonary Medicine, at the University of Vermont Larner College of Medicine and an internationally recognized expert in lung regenerative medicine and stem cell biology. He is the current President of the International Society for Cell & Gene Therapy (ISCT). Dr. Weiss brings deep experience in pulmonary and critical care medicine, translational MSC biology and early phase clinical trials.
About CORDStrom™
CORDStrom™ is 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 an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission.
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 an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission early 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 recently granted FDA Fast Track designation and successful 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
Clinical development and regulatory review involve substantial risks and uncertainties, and there can be no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the creation or expected contribution of the SAB, the development or commercialization of product candidates, potential applications of the CORDStrom platform, expansion into additional indications, regulatory strategy and timing, trial results and data, 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 US 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.