What is the story about?
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 designed to treat Recessive Dystrophic Epidermolysis Bullosa (RDEB). This milestone was achieved at the Cell and Gene Therapy Catapult's Manufacturing Innovation Centre in Stevenage, UK. CORDStrom™ utilizes umbilical cord tissue-derived mesenchymal stromal cells to address the severe systemic needs of RDEB patients, who suffer from extreme skin fragility and increased risk of skin cancer. The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, paving the way for regulatory submissions in the UK and US.
Why It's Important?
The successful manufacturing of CORDStrom™ is a significant step forward in providing a potentially life-changing therapy for patients with RDEB, a rare and debilitating condition. This development highlights the progress in cell therapy manufacturing, which could lead to more accessible treatments for complex inflammatory and autoimmune diseases. The scalability and consistency achieved in this pilot run are crucial for ensuring a reliable supply chain, which is essential for global commercialization. The therapy's advancement towards regulatory approval could offer new hope to families affected by RDEB, improving their quality of life and reducing the disease's severe symptoms.
What's Next?
INmune Bio plans to file a Marketing Authorization Application in the UK in the first half of 2026, followed by a Biologics License Application in the US. The company is focused on efficient execution across its pipeline, including preparations for regulatory interactions to support CORDStrom™'s launch. The successful pilot run provides valuable insights into refining and scaling up manufacturing processes, which will be crucial for meeting regulatory requirements and ensuring timely access to the therapy for patients.
Beyond the Headlines
The development of CORDStrom™ reflects broader trends in the biotechnology industry, where cell therapies are increasingly seen as viable treatments for complex diseases. This advancement underscores the importance of collaboration between companies and innovation centers, such as the Cell and Gene Therapy Catapult, in overcoming manufacturing challenges. The therapy's success could stimulate further research and investment in similar treatments, potentially leading to breakthroughs in other rare diseases.
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