What's Happening?
INmune Bio Inc., a clinical-stage company specializing in inflammation and immunology, has successfully completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This milestone was achieved at the Cell and Gene Therapy Catapult's Manufacturing Innovation Centre in Stevenage, UK. CORDStrom™ is an off-the-shelf, allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy designed to address the severe systemic needs of RDEB patients, who suffer from extreme skin fragility, chronic wounds, and increased risk of skin cancer. The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, utilizing a proprietary process to ensure high-quality, GMP-compliant products. This achievement is a critical step toward regulatory submissions, with plans to file a Marketing Authorization Application in the UK in 2026, followed by a Biologics License Application in the US.
Why It's Important?
The successful manufacturing of CORDStrom™ represents a significant advancement in the treatment of RDEB, a rare and debilitating genetic skin disorder. This development could potentially improve the quality of life for patients by addressing symptoms such as itch, pain, and wound healing. The therapy's scalability and consistency are crucial for ensuring a reliable supply chain, which is essential for global commercialization. The progress made by INmune Bio highlights the importance of innovative cell therapies in addressing unmet medical needs and could pave the way for similar advancements in treating other complex inflammatory and autoimmune diseases. The company's focus on harnessing the innate immune system to fight disease underscores the growing interest in immunology-based treatments.
What's Next?
INmune Bio plans to continue its preparations for regulatory interactions to support the launch of CORDStrom™. The company aims to submit a Marketing Authorization Application in the UK during the first half of 2026, followed by a Biologics License Application in the US. These submissions are critical steps toward making the therapy available to patients. The successful pilot run has provided valuable insights into refining and scaling up manufacturing processes, which will be essential for meeting regulatory requirements and ensuring timely access to the therapy. The company remains committed to advancing its pipeline and bringing potentially life-changing treatments to market.
Beyond the Headlines
The development of CORDStrom™ not only addresses the immediate needs of RDEB patients but also represents a broader shift toward personalized and targeted therapies in the field of immunology. The use of allogeneic, umbilical cord-derived mesenchymal stromal cells highlights the potential of regenerative medicine in treating complex diseases. This approach may lead to new treatment paradigms that focus on modulating the immune system to achieve therapeutic outcomes. The collaboration between INmune Bio and the Cell and Gene Therapy Catapult exemplifies the importance of partnerships in overcoming challenges and advancing the cell and gene therapy industry.
