FibroBiologics has established a strategic partnership with Charles River Laboratories to support the development and manufacturing of its fibroblast-based therapy for diabetic foot ulcers (DFUs), a chronic and debilitating condition affecting millions of patients worldwide.
The clinical-stage biotechnology company has successfully completed a proprietary master cell bank for its lead product candidate CYWC628, manufactured in accordance with FDA Good Manufacturing Practices (cGMP) and having passed all required safety testing. This master cell bank will serve as the foundation for upcoming clinical trials, with the Phase I/II trial scheduled to begin in the second quarter of 2025 in Australia.
Strategic Manufacturing Partnership
Under the agreement, FibroBiologics will gain access to Charles River's manufacturing facilities to produce the CYWC628 cell bank and drug products for the upcoming clinical trial. This collaboration is crucial for ensuring consistent quality and scalability as the company advances toward commercialization.
"Charles River is an expert in the field, and their ability to meet our manufacturing requirements will be critical as we scale up for future clinical trials and commercialization," explained Hamid Khoja, Chief Scientific Officer at FibroBiologics.
The master cell bank utilizes primary cells to accelerate the healing process. "We've isolated multiple subtypes of fibroblasts to develop the master cell bank for our diabetic foot ulcers," Khoja noted. "These primary cells have been isolated and cultured in our master cell bank. This will accelerate GMP manufacturing."
Clinical Trial Design and Timeline
The Phase I/II clinical trial will assess the efficacy of two different doses of CYWC628, primarily focusing on safety and efficacy by measuring the percentage of wound closure within 12 weeks. The trial will compare the therapeutic outcomes against the current standard of care for diabetic foot ulcers.
FibroBiologics has engaged Southern Star Research to provide clinical research organization (CRO) services in Australia for the planned trial. The company strategically chose Australia for its more conducive regulatory environment for early-phase trials.
"We hope to complete the primary outcomes for safety and efficacy by the end of this year. The 12-week duration of the clinical trial means that we can potentially have all results completed by the close of 2025," Khoja stated.
Fibroblast Technology Advantages
FibroBiologics' approach centers on fibroblasts—cells that naturally play a crucial role in the wound healing process—which offers several advantages over competing technologies. Unlike stem cells, fibroblasts grow faster, are more cost-effective, and don't require the complex growth factors typically necessary for stem cell culture.
"Our scientific team is pioneering new ways to leverage fibroblasts in regenerative medicine. This enables us to deliver therapies that are both effective and easier to produce at scale," Khoja emphasized.
The company's intellectual property portfolio is substantial, with more than 240 patents issued and pending covering a wide range of clinical indications beyond diabetic foot ulcers, including degenerative disc disease, multiple sclerosis, psoriasis, and cancer.
Regulatory Strategy and Future Plans
Cell-based therapies face unique regulatory challenges, particularly in the United States. However, FibroBiologics is confident that the evolving regulatory landscape will benefit the company.
"Cell therapy is distinct from traditional small molecules, and the FDA has made significant progress in adapting clinical trial processes for cell-based therapeutics. They are working to make the approval process more efficient, which will ultimately benefit companies developing these innovative treatments," Khoja explained.
The data gathered from the Australian trials will support future US-based trials, including a Phase III trial slated to begin in 2026. FibroBiologics previously received IND clearance from the FDA in 2018 for CybroCell™, its investigational allogeneic fibroblast cell-based therapy for degenerative disc disease.
Financial Position
FibroBiologics reported approximately $14.0 million in cash and cash equivalents as of December 31, 2024. The company has also secured additional financing options through a Standby Equity Purchase Agreement with YA II PN LTD, allowing access to up to $25.0 million over two years.
"We entered 2025 with $14 million in cash and cash equivalents and access to additional financing, which enables us to continue to push forward our clinical programs and explore new opportunities," said Pete O'Heeron, CEO and Co-founder of FibroBiologics.
Expanding Research Pipeline
Beyond diabetic foot ulcers, FibroBiologics is advancing several other programs. The company has moved its discovery phase project, CYPS317, to the product candidate pipeline for the treatment of psoriasis, with pre-clinical IND-enabling studies expected to be completed by the end of 2025.
Additionally, FibroBiologics has announced early-stage research and development efforts in its human longevity program, which includes potential extension of life applications such as recovery of lost thymic functionality using transplanted artificial thymic organoids.
"We are a pioneer in fibroblast-based therapies, and within the next five years, we expect to have at least one product approved by the FDA and marketed to patients," Khoja concluded, highlighting the company's ambitious goals for transforming regenerative medicine through its innovative fibroblast technology platform.
