INmune Bio Inc. (NASDAQ: INMB) has formed a strategic partnership with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing capabilities for its innovative cell therapy platforms. The collaboration, announced on April 14, 2025, aims to accelerate the path to market for treatments targeting several serious conditions, with an initial focus on a rare genetic skin disorder.
The partnership builds upon INmune Bio's existing manufacturing infrastructure at the Royal Free Hospital and will utilize CGT Catapult's specialized expertise at its Stevenage Manufacturing Innovation Centre in the UK. CGT Catapult, an independent technology and innovation organization established in partnership with Innovate UK, specializes in advancing cell and gene therapy development and commercialization.
Scaling Production for Rare Skin Disease Treatment
The initial focus of the collaboration is scaling production of CORDStrom™, INmune Bio's promising therapy for recessive dystrophic epidermolysis bullosa (RDEB), a rare and debilitating genetic skin disorder. Recent Phase 2 randomized trial results showed that CORDStrom™ reduced pain and itch while demonstrating potential to improve skin integrity and disease activity.
RDEB affects approximately 4,000 children with intermediate to severe forms across the US, UK, and EU. The condition causes extremely fragile skin that blisters and tears from minor friction or trauma, leading to chronic wounds, scarring, and significant pain.
"The unmatched scale of this UK-based facility provides INmune Bio with an exceptional platform to advance our next phase of corporate growth, developing and trialing UK-invented products," said Professor Mark Lowdell, CSO and co-founder of INmune Bio. "This partnership stands as an excellent example of cross-border collaboration, harnessing global expertise to potentially deliver groundbreaking treatments to market."
The company believes CORDStrom™ could become the first cell therapy to address the systemic nature of RDEB, positioning it for eventual Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions following successful clinical trials.
Expanding Manufacturing Capabilities for Cancer Treatment
Following the establishment of CORDStrom™ production, INmune Bio plans to transition manufacturing of INKmune®, its Natural Killer (NK) cell-priming therapy for solid tumors, to the same facility. This will support ongoing and future clinical trials in the US and UK, including a Phase 2 study currently underway in metastatic castration-resistant prostate cancer.
INKmune® is designed to prime a patient's NK cells to eliminate minimal residual disease in cancer patients, potentially offering a novel approach to preventing cancer recurrence and progression.
Advancing Innate Immune System Therapies
INmune Bio's therapeutic approach focuses on harnessing the innate immune system—the body's first line of defense—to treat a diverse range of conditions. Beyond RDEB and prostate cancer, the company is developing treatments for Alzheimer's disease, Mild Cognitive Impairment, and treatment-resistant depression through its Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform.
The company currently has active clinical trials across multiple countries, including the UK, Europe, Australia, Canada, and the US, addressing significant unmet medical needs.
Matthew Durdy, Chief Executive of the CGT Catapult, highlighted the significance of the partnership: "INmune Bio's therapies address important healthcare challenges, and we are delighted to be working with them to support their journey to becoming a commercial scale developer and manufacturer of cell therapies, and help them meet rising demand for their products. The decision to strengthen their presence in the UK will help ensure that patients here benefit from novel cell therapies and support the UK's position as a global hub for advanced therapies."
Commercial Manufacturing Strategy
This partnership represents a strategic move for INmune Bio, accelerating its path to commercialization by establishing efficient, scalable manufacturing capabilities while maintaining operational control. The company's CORDStrom™ platform utilizes proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal stromal/stem cells (hucMSCs).
For patients with RDEB, the development of commercial-scale manufacturing brings hope for a potential treatment option where few currently exist. The condition typically requires intensive supportive care and wound management, with no approved disease-modifying therapies available in many markets.
As INmune Bio advances its manufacturing capabilities through this collaboration, the company positions itself to address the growing demand for innovative cell therapies across multiple therapeutic areas, potentially transforming treatment paradigms for patients with limited options.
