What is the story about?
What's Happening?
INmune Bio Inc. has successfully completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), at the Cell and Gene Therapy Catapult's facility in the UK. This milestone is crucial for the company's plans to file a Marketing Authorization Application in the UK and a Biologics License Application in the US by 2026. CORDStrom™ is an allogeneic, umbilical cord tissue-derived mesenchymal stromal cell therapy designed to address the severe needs of RDEB patients.
Why It's Important?
The successful manufacturing of CORDStrom™ marks a significant step towards providing a new treatment option for RDEB, a rare and debilitating genetic disorder. This development highlights the potential of cell therapies in addressing unmet medical needs and the importance of scalable manufacturing processes in bringing such therapies to market. The achievement also reinforces INmune Bio's position in the field of inflammation and immunology, showcasing its ability to develop innovative treatments that harness the innate immune system.
What's Next?
INmune Bio will focus on preparing for regulatory submissions and ensuring a reliable supply chain for CORDStrom™. The company will continue to engage with regulatory bodies to facilitate the approval process and work towards the commercial launch of the therapy. The success of CORDStrom™ could lead to further advancements in cell therapy applications for other complex diseases.
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