FibroBiologics and Charles River Announce Completion and Release of CYWC628 Master Cell Bank for the Manufacturing of Fibroblast Cell-based Wound Healing Therapeutic
Master cell bank to be used in manufacturing of CYWC628 drug product to support upcoming clinical trial for diabetic foot ulcers
HOUSTON, Feb. 27, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories (“Charles River”), a leading, global provider of drug discovery, development, and manufacturing solutions, today announced the completion of FibroBiologics’ proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing.
FibroBiologics, a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and fibroblast-derived materials. Indications being studied include wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer.
CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. Charles River’s state-of-the-art cGMP manufacturing facilities will serve as the production site for the CYWC628 cell banks and drug product for our upcoming phase I/II diabetic foot ulcer clinical trial slated to begin later this year.
“Completing our master cell bank for CYWC628 is a defining moment in our work to advance fibroblast-based cell therapies,” said Pete O’Heeron, CEO of FibroBiologics. “With this foundation in place, we are progressing on our path to the clinic in 2025 and strengthening our ability to collaborate with research and clinical partners worldwide. Our work with Charles River on this critical step will help ensure that we are fully prepared to scale CYWC628, positioning FibroBiologics at the forefront of fibroblast-based cell therapy innovation.”
“Charles River and FibroBiologics share a common goal of expediting the development of advanced therapies, bringing novel treatments to patients safely and effectively,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “The completion of their master cell bank marks a significant milestone in their program, and highlights the power of scientific collaboration. We are proud to enter this next phase of manufacturing together.”
Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning contract development and manufacturing services to be provided under the master services agreement with Charles River and the location where such services will be provided, expected research targets and indications of interest, plans for, and the timing of, clinical trials, FibroBiologics’ relationship with Charles River and its ability to collaborate with partners, and FibroBiologics’ positioning within the fibroblast-based cell therapy space. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) FibroBiologics' ability to maintain the master services agreement with Charles River and enter into statements of work for manufacturing services; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) expectations regarding the initiation, progress and expected results of R&D efforts and preclinical studies; (d) the unpredictable relationship between R&D and preclinical results and clinical study results; and (e) the ability of FibroBiologics to successfully prosecute its patent applications. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.
About Charles River Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
About FibroBiologics Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 160+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com.
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