FibroBiologics has partnered with Charles River Laboratories in a master services agreement to develop and manufacture cell-based therapies targeting chronic diseases. The collaboration aims to advance FibroBiologics' CYWC628, a fibroblast-based spheroids product, through clinical trials for diabetic foot ulcers (DFU), with the trial expected to begin in 2025.
Collaboration Details
Under the agreement, Charles River will manufacture FibroBiologics’ working cell bank, therapeutic master cell bank, and CYWC628. FibroBiologics has already completed the technology transfer to Charles River for current good manufacturing practice (CGMP) manufacturing, and feasibility studies have confirmed the viability of FibroBiologics’ cell manufacturing processes.
Kerstin Dolph, Corporate Senior Vice-President at Charles River Global Manufacturing, stated, “Charles River’s work with FibroBiologics is part of a larger commitment to supporting next-generation regenerative medicine through the adoption of innovative therapies. We are excited to collaborate with FibroBiologics and support the development of a therapy that has the potential to transform patient care for those impacted by diabetic foot wounds.”
CYWC628 and DFU Treatment
CYWC628 represents a novel approach to treating diabetic foot ulcers, a significant complication of diabetes affecting millions worldwide. Diabetic foot ulcers are characterized by impaired wound healing, often leading to infections and potential amputation. Current treatments often involve wound debridement, antibiotics, and advanced wound dressings, but many ulcers remain refractory to these approaches, highlighting the need for innovative therapies.
FibroBiologics' Broader Pipeline
Beyond diabetic foot ulcers, FibroBiologics is exploring the potential of fibroblasts and fibroblast-derived materials in treating other chronic diseases, including multiple sclerosis, wound healing, degenerative disc disease, thymic involution reversal, psoriasis, and cancer.
Executive Perspectives
Pete O’Heeron, founder and CEO of FibroBiologics, commented, “The formalisation of our working relationship with Charles River is a pivotal step as we advance toward a significant wound care clinical trial in 2025 with CYWC628. Working with Charles River opens new possibilities for innovation with its global reach and scalability potential. By combining our unique therapeutic fibroblast-based spheroids approach with Charles River’s expertise and unparalleled support, we are positioned to accelerate progress in delivering this treatment to patients.”
With this agreement, Charles River will serve as the contract development and manufacturing organisation (CDMO) for FibroBiologics, providing comprehensive support from concept to cure in advanced therapies.
