FibroBiologics and Charles River Announce Collaboration to Manufacture Fibroblast Cell-based Therapies for Chronic Diseases

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) and Charles River Laboratories have established a master services agreement to develop and manufacture FibroBiologics' therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for a diabetic foot ulcer (DFU) clinical trial planned for 2025. The collaboration aims to leverage Charles River's expertise in cell and gene therapy manufacturing to support FibroBiologics' innovative fibroblast-based therapies for chronic diseases.

Key points:

• Technology transfer and feasibility studies have been successfully completed
• Charles River will serve as the contract development and manufacturing organization (CDMO) for FibroBiologics' clinical trial drug products
• The partnership is expected to accelerate progress in delivering fibroblast-based treatments to patients
• FibroBiologics is investigating fibroblasts and fibroblast-derived materials for multiple indications, including wound healing, multiple sclerosis, and cancer

Positive

• Establishment of a master services agreement with Charles River Laboratories for manufacturing CYWC628
• Successful completion of technology transfer and feasibility studies
• Advancement towards a significant wound care clinical trial in 2025
• Potential for scalability and global reach through partnership with Charles River

Negative

• None.

Insights

Biotech Industry Analyst

This collaboration between FibroBiologics and Charles River is a significant development for FBLG's clinical pipeline. The partnership focuses on manufacturing CYWC628, a fibroblast-based spheroid product for diabetic foot ulcers (DFU), with clinical trials set for 2025. This move strengthens FBLG's position in regenerative medicine, particularly in wound healing. The successful technology transfer and feasibility studies indicate progress towards CGMP manufacturing, important for regulatory approval. Charles River's expertise in cell and gene therapy manufacturing could accelerate FBLG's path to market. For investors, this collaboration reduces manufacturing risks and potentially shortens time-to-market for CYWC628. However, it's important to note that clinical success is still uncertain and the 2025 trial timeline suggests revenue is not imminent. The partnership may also impact FBLG's cash burn rate, a key consideration for a clinical-stage biotech.

Medical Research Analyst

FibroBiologics' approach using fibroblast-based therapies is innovative in the regenerative medicine space. Their focus on multiple indications, including wound healing, multiple sclerosis and cancer, showcases the potential versatility of their technology. The advancement of CYWC628 for diabetic foot ulcers addresses a significant unmet medical need, as DFUs are a common and serious complication of diabetes. The immunomodulatory and regenerative capabilities of fibroblasts could offer a novel treatment paradigm. The collaboration with Charles River, a respected CDMO, adds credibility to FBLG's manufacturing process. However, investors should be aware that while promising, this therapy is still in early stages and will require successful clinical trials to prove efficacy and safety. The 2025 trial start date indicates a long road ahead before potential commercialization.

HOUSTON, Oct. 18, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) (“FibroBiologics”) and Charles River Laboratories (“Charles River”), a leading global drug discovery, development, testing, and manufacturing solutions provider established a master services agreement to develop and manufacture FibroBiologics’ therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for utilization in a diabetic foot ulcer (DFU) clinical trial slated to begin in 2025.

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, thymic involution reversal, and cancer.

The technology transfer from FibroBiologics to Charles River for current good manufacturing practice (CGMP) manufacturing has been successfully completed, along with feasibility studies evaluating FibroBiologics’ proprietary cell manufacturing processes. With the positive results from these feasibility studies and the signed master services agreement, Charles River will now serve as the contract development and manufacturing organization (CDMO), to produce the drug products for FibroBiologics’ upcoming clinical trial.

Charles River’s cell and gene therapy CDMO portfolio helps to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with Charles River’s legacy testing capabilities, Charles River offers an industry-leading “concept to cure” advanced therapies solution.

“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,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.

“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,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “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.”

For more information, please visit FibroBiologics’ website or email FibroBiologics at: info@fibrobiologics.com.

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 CDMO services to be provided under the master services agreement with Charles River, expected research targets and indications of interest, plans for, and the timing of, clinical trials, our relationship with Charles River, and our positioning to accelerate progress in delivering treatments to patients. 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 CDMO 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 our 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 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.

General Inquiries:
info@fibrobiologics.com

Investor Relations:
Nic Johnson
Russo Partners
(212) 845-4242
fibrobiologicsIR@russopr.com
Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com

FAQ

What is the purpose of FibroBiologics' collaboration with Charles River Laboratories?

The collaboration aims to develop and manufacture FibroBiologics' therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for a diabetic foot ulcer (DFU) clinical trial planned for 2025.

When is FibroBiologics (FBLG) planning to begin its diabetic foot ulcer clinical trial?

FibroBiologics is planning to begin its diabetic foot ulcer clinical trial using CYWC628 in 2025.

What therapeutic areas is FibroBiologics (FBLG) investigating using fibroblasts?

FibroBiologics is investigating the potential treatment of chronic diseases including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer using fibroblasts and fibroblast-derived materials.

What role will Charles River Laboratories play in FibroBiologics' (FBLG) clinical trial preparations?

Charles River Laboratories will serve as the contract development and manufacturing organization (CDMO) to produce the drug products for FibroBiologics' upcoming clinical trial.