FibroBiologics and Charles River partner to produce chronic disease treatments

FibroBiologics has established a collaboration with Charles River Laboratories under a master services agreement to advance the development and manufacturing of cell-based therapies aimed at treating chronic diseases. The agreement stipulates that Charles River Laboratories will manufacture FibroBiologics' working cell bank, therapeutic master cell bank, and the product CYWC628, which is intended for a clinical trial addressing diabetic foot ulcers (DFU) projected to start in 2025.

CYWC628 is a product based on fibroblast spheroids, which holds promise for the treatment of DFU, a severe and widespread complication experienced by diabetic patients. FibroBiologics has successfully transferred its technology to Charles River Laboratories to ensure that current good manufacturing practices (CGMP) are followed. Preliminary feasibility studies have confirmed that FibroBiologics' cell manufacturing processes are viable and ready for further development.

The partnership with Charles River Laboratories leverages their extensive capabilities in testing and development, providing a comprehensive solution from concept to cure for advanced therapies. Kerstin Dolph, the corporate senior vice-president of Charles River Global Manufacturing, expressed excitement about the collaboration, emphasizing their commitment to supporting next-generation regenerative medicine through innovative therapies. Dolph highlighted the potential of this collaboration to significantly transform patient care for those suffering from diabetic foot wounds.

With this agreement, Charles River Laboratories will serve as the contract development and manufacturing organization (CDMO) for FibroBiologics. Pete O’Heeron, founder and CEO of FibroBiologics, underscored the importance of formalizing this working relationship as a crucial step toward initiating the significant wound care clinical trial in 2025 using CYWC628. O’Heeron also noted that working with Charles River Laboratories opens new avenues for innovation due to their extensive global reach and scalability potential. By combining FibroBiologics' fibroblast-based spheroids therapeutic approach with Charles River's expertise and support, the collaboration is set to accelerate the delivery of this treatment to patients.

FibroBiologics is deeply engaged in exploring the potential applications of fibroblasts and fibroblast-derived materials in treating various chronic diseases. Their research includes potential treatments for conditions such as multiple sclerosis, wound healing, degenerative disc disease, thymic involution reversal, psoriasis, and cancer.

In addition to their collaboration with FibroBiologics, Charles River Laboratories has entered into other significant agreements. For instance, in June 2024, Charles River signed an agreement with the German company Captain T Cell to produce plasmid DNA and retrovirus vectors for gene-modified cell therapy. This collaboration aims to enhance the production capabilities for gene therapies, which play a crucial role in the advancement of cell and gene therapies.

The cell and gene therapy industry is witnessing rapid growth, with new therapies poised to revolutionize disease treatment and potentially offer cures. The industry faces both opportunities for advancement and significant challenges. The collaboration between FibroBiologics and Charles River Laboratories represents a strategic effort to harness these opportunities and overcome the challenges in delivering innovative and effective treatments for chronic diseases.