FibroBiologics and Charles River Partner to Produce Fibroblast Cell Therapies for Chronic Diseases

On October 18, 2024, FibroBiologics, Inc. (Nasdaq: FBLG) and Charles River Laboratories announced the establishment of a master services agreement aimed at developing and manufacturing FibroBiologics' therapeutic cell products. This collaboration will focus specifically on creating a cell bank and fibroblast-based spheroids product, known as CYWC628, which will be utilized in a clinical trial for diabetic foot ulcers starting in 2025.

FibroBiologics is an advanced biotechnology firm that holds over 160 patents, both issued and pending, that are centered around using fibroblasts and fibroblast-derived materials to treat chronic diseases. The company is exploring the use of these materials for their immunomodulatory and regenerative properties in treating various conditions such as wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer.

The successful completion of the technology transfer from FibroBiologics to Charles River signifies an important milestone in ensuring compliance with current good manufacturing practices (CGMP). Additionally, feasibility studies evaluating the proprietary cell manufacturing processes of FibroBiologics have yielded positive results. As a result, Charles River will now act as the contract development and manufacturing organization (CDMO) to produce the necessary drug products for the forthcoming clinical trial.

Charles River Laboratories is well-known for its comprehensive cell and gene therapy CDMO portfolio, which aims to streamline complex supply chains and meet increasing demands for services related to plasmid DNA, viral vectors, and cell therapy. By leveraging its robust testing capabilities, Charles River offers a complete solution for advanced therapies, from conception to cure.

Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River, expressed enthusiasm for the collaboration, stating, "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."

Pete O’Heeron, Founder and CEO of FibroBiologics, emphasized the significance of this partnership, noting, "The formalization 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."

FibroBiologics, based in Houston, is dedicated to developing a pipeline of treatments and potential cures for chronic diseases by utilizing fibroblast cells and fibroblast-derived materials. The company’s extensive patent portfolio spans a variety of clinical pathways, including treatments for disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, and cancer. Positioning itself as a leader in cell therapy, FibroBiologics represents a significant advancement in medical treatment.