Charles River Laboratories, Inc.

Cost and research cuts across biotech and pharma are affecting some of the contracting companies that rely on the industry. The latest victim is Icon, a Dublin-based contract research organization that reported earnings on Thursday that missed investor expectations by about $100 million and were 1.2% below prior year figures. CEO Steve Cutler said the company was “not where we anticipated to be at this point in the year.” Analysts at William Blair were more blunt: “Worse-than-feared results and macro commentary drive shares meaningfully lower.” Investors ran for the hills, with Icon’s stock $ICLR down almost 20% on Thursday. Three negative trends hit the company in the third quarter, Icon said: Large pharma companies are cutting budgets, including two unnamed customers that had “slower than expected ramp of new project work”; a volatile biotech industry that’s led to cuts and pullbacks at smaller companies; and a reduction on vaccine R&D. In response, it plans to make its own cost cuts this quarter. That includes “looking at where we have an excess of people in certain areas,” Cutler said, adding that Icon will be “taking fairly decisive action” to save money. Cutler believes that Icon is at or near the bottom of the slowdown with those two large pharma customers and said he anticipates improvement by the back half of 2025. But he conceded that Icon only has clear visibility into 2025 budgets on one of the two companies. Overall, Icon has “a transition period to work through over the next two to three quarters.” While Icon didn’t disclose the names of the two large companies that have pulled back, it has a longstanding relationship with Pfizer, which has announced several rounds of cost-cutting over the last 12 months. UBS analyst Dan Leonard presumed on the call that Pfizer was one of the two companies that pulled back, which Cutler declined to confirm. A spokesperson for Pfizer did not immediately respond to a request for comment. Icon’s relationship with small biotech companies has been uncertain as well. Cutler said that his business has somewhat mirrored the up-and-down trends in financing, but even when companies raise capital, they’ve been slow to spend it. “They have delayed decisions, they have delayed awards, de-scoped projects and there has been some uptick in the cancellation side of things,” he said. Icon’s troubles continue a chill that swept through the contract sector in the second quarter, forewarned in August by Charles River Laboratories . The large contractor said then that it was seeing a large decline in discovery and safety assessment offerings, describing the changes as “unusual activity for our pharma clients.” But Cutler rejected the notion that preclinical slowdowns would result in a larger, more sustained worsening of the clinical development business. Numerous large pharmaceutical companies have been trimming pipelines and staff as part of a wave of restructurings. Pfizer , Bayer , Roche , Johnson & Johnson and Bristol Myers Squibb are just a few of the major drugmakers who have looked to shave costs and narrow R&D priorities.

Oct. 18, 2024 -- 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.” 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. The content above comes from the network. if any infringement, please contact us to modify.

The agreement is intended for the development and manufacture of a cell-based therapy for a diabetic foot ulcer clinical trial. Credit: Olga Apanasenko/Shutterstock. FibroBiologics has entered a master services agreement with Charles River Laboratories to develop and manufacture cell-based therapies for chronic diseases. The agreement will involve the manufacture of FibroBiologics’ working cell bank, therapeutic master cell bank and CYWC628, for use in a diabetic foot ulcer (DFU) clinical trial, which is expected to commence in 2025. CYWC628 is a fibroblast-based spheroids product. FibroBiologics has concluded the technology transfer to Charles River for current good manufacturing practice (CGMP) manufacturing. Feasibility studies have also been conducted, confirming the viability of FibroBiologics’ cell manufacturing processes. See Also: Thermo Fisher’s Oncomine gains FDA approval as brain tumor diagnostic AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients The collaboration with FibroBiologics leverages Charles River’s extensive testing capabilities, offering a comprehensive “concept to cure” solution in advanced therapies. Charles River Global Manufacturing corporate senior vice-president Kerstin Dolph 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.” With the master services agreement in place, Charles River will act as the contract development and manufacturing organisation (CDMO) for FibroBiologics. FibroBiologics founder and CEO Pete O’Heeron said: “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.” FibroBiologics is investigating the potential of fibroblasts and fibroblast-derived materials in treating chronic diseases. These include multiple sclerosis, wound healing, degenerative disc disease, thymic involution reversal, psoriasis and cancer. In June 2024, Charles River signed an agreement with German company Captain T Cell to focus on the production of plasmid DNA and retrovirus vectors for gene-modified cell therapy. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy