FibroBiologics and Charles River Announce Completion and Release of CYWC628 Master Cell Bank for the Manufacturing of Fibroblast Cell-based Wound Healing Therapeutic
FibroBiologics (Nasdaq: FBLG) and Charles River Laboratories have announced the completion of a master cell bank for CYWC628, a fibroblast-based therapy targeting diabetic foot ulcers. The cell bank, manufactured under FDA Good Manufacturing Practices (cGMP), has passed all required safety testing.
The master cell bank will support upcoming phase I/II clinical trials for diabetic foot ulcers scheduled to begin in 2025. Charles River's cGMP manufacturing facilities will produce both the cell banks and drug product for the trials.
FibroBiologics, a clinical-stage biotech company with 160+ patents issued and pending, focuses on developing therapeutics using fibroblasts and fibroblast-derived materials. Their research spans multiple indications including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer.
FibroBiologics (Nasdaq: FBLG) e Charles River Laboratories hanno annunciato il completamento di una banca cellulare master per CYWC628, una terapia a base di fibroblasti mirata alle ulcere del piede diabetico. La banca cellulare, prodotta secondo le Buone Pratiche di Fabbricazione (cGMP) della FDA, ha superato tutti i test di sicurezza richiesti.
La banca cellulare master supporterà i prossimi studi clinici di fase I/II per le ulcere del piede diabetico, previsti per iniziare nel 2025. Gli impianti di produzione cGMP di Charles River produrranno sia le banche cellulari che il prodotto farmaceutico per gli studi.
FibroBiologics, un'azienda biotech in fase clinica con oltre 160 brevetti concessi e in attesa, si concentra sullo sviluppo di terapie utilizzando fibroblasti e materiali derivati dai fibroblasti. La loro ricerca copre diverse indicazioni, tra cui la guarigione delle ferite, la sclerosi multipla, la malattia degenerativa del disco, la psoriasi, la longevità umana e il cancro.
FibroBiologics (Nasdaq: FBLG) y Charles River Laboratories han anunciado la finalización de un banco celular maestro para CYWC628, una terapia basada en fibroblastos dirigida a las úlceras del pie diabético. El banco celular, fabricado bajo las Buenas Prácticas de Fabricación (cGMP) de la FDA, ha pasado todas las pruebas de seguridad requeridas.
El banco celular maestro apoyará los próximos ensayos clínicos de fase I/II para las úlceras del pie diabético programados para comenzar en 2025. Las instalaciones de fabricación cGMP de Charles River producirán tanto los bancos celulares como el producto farmacéutico para los ensayos.
FibroBiologics, una empresa biotecnológica en etapa clínica con más de 160 patentes emitidas y pendientes, se enfoca en desarrollar terapias utilizando fibroblastos y materiales derivados de fibroblastos. Su investigación abarca múltiples indicaciones, incluyendo la cicatrización de heridas, la esclerosis múltiple, la enfermedad degenerativa del disco, la psoriasis, la longevidad humana y el cáncer.
FibroBiologics (Nasdaq: FBLG)와 Charles River Laboratories는 당뇨병성 발 궤양을 목표로 하는 섬유아세포 기반 치료제인 CYWC628의 마스터 세포은행 완공을 발표했습니다. FDA의 우수 제조 관리 기준(cGMP)에 따라 제조된 이 세포은행은 모든 필수 안전성 테스트를 통과했습니다.
마스터 세포은행은 2025년에 시작될 예정인 당뇨병성 발 궤양에 대한 1/2상 임상 시험을 지원할 것입니다. Charles River의 cGMP 제조 시설은 임상 시험을 위한 세포은행과 의약품 모두를 생산할 것입니다.
FibroBiologics는 160개 이상의 특허가 발급 및 대기 중인 임상 단계의 생명공학 회사로, 섬유아세포 및 섬유아세포 유래 물질을 이용한 치료제 개발에 집중하고 있습니다. 그들의 연구는 상처 치유, 다발성 경화증, 퇴행성 디스크 질환, 건선, 인간의 장수 및 암 등 여러 적응증을 포함합니다.
FibroBiologics (Nasdaq: FBLG) et Charles River Laboratories ont annoncé l'achèvement d'une banque cellulaire maître pour CYWC628, une thérapie à base de fibroblastes ciblant les ulcères du pied diabétique. La banque cellulaire, fabriquée selon les Bonnes Pratiques de Fabrication (cGMP) de la FDA, a réussi tous les tests de sécurité requis.
La banque cellulaire maître soutiendra les prochains essais cliniques de phase I/II pour les ulcères du pied diabétique, prévus pour commencer en 2025. Les installations de fabrication cGMP de Charles River produiront à la fois les banques cellulaires et le produit pharmaceutique pour les essais.
FibroBiologics, une entreprise biopharmaceutique en phase clinique avec plus de 160 brevets délivrés et en attente, se concentre sur le développement de thérapies utilisant des fibroblastes et des matériaux dérivés des fibroblastes. Leur recherche couvre plusieurs indications, notamment la cicatrisation des plaies, la sclérose en plaques, la maladie dégénérative du disque, le psoriasis, la longévité humaine et le cancer.
FibroBiologics (Nasdaq: FBLG) und Charles River Laboratories haben den Abschluss einer Masterzellbank für CYWC628 bekannt gegeben, einer auf Fibroblasten basierenden Therapie zur Behandlung von diabetischen Fußgeschwüren. Die Zellbank, die gemäß den Good Manufacturing Practices (cGMP) der FDA hergestellt wurde, hat alle erforderlichen Sicherheitstests bestanden.
Die Masterzellbank wird die bevorstehenden klinischen Studien der Phase I/II für diabetische Fußgeschwüre unterstützen, die für 2025 geplant sind. Die cGMP-Herstellungseinrichtungen von Charles River werden sowohl die Zellbanken als auch das Arzneimittelprodukt für die Studien produzieren.
FibroBiologics, ein biopharmazeutisches Unternehmen in der klinischen Phase mit über 160 Patenten in Erteilung und Warteschlange, konzentriert sich auf die Entwicklung von Therapeutika unter Verwendung von Fibroblasten und aus Fibroblasten gewonnenen Materialien. Ihre Forschung umfasst mehrere Indikationen, darunter Wundheilung, Multiple Sklerose, degenerative Bandscheibenerkrankungen, Psoriasis, menschliche Langlebigkeit und Krebs.
- FDA-compliant master cell bank successfully completed and passed safety testing
- Phase I/II clinical trials for diabetic foot ulcer treatment to begin in 2025
- Partnership with major manufacturer Charles River Laboratories secured
- Strong intellectual property portfolio with 160+ patents
- No current revenue from therapeutic products
- Clinical trials yet to commence
- Faces liquidity risks as mentioned in forward-looking statements
Insights
FibroBiologics has reached a critical manufacturing milestone with the completion of its cGMP-compliant master cell bank for CYWC628, its lead fibroblast-based therapy for diabetic foot ulcers. This development significantly de-risks the company's manufacturing pathway and represents the foundation for all future production batches of this therapy.
The master cell bank—essentially a repository of identical cells frozen under controlled conditions—serves as the source material for manufacturing consistent batches of cell therapy products. For cell therapy companies, establishing this validated starting material is a important step in the clinical development process that addresses key regulatory requirements and manufacturing scalability.
The diabetic foot ulcer market presents a substantial opportunity, with approximately 20 million patients suffering from this condition globally. Current standard-of-care treatments show efficacy, with many ulcers becoming chronic and leading to amputations. CYWC628 leverages fibroblasts' natural wound healing properties, potentially offering a more effective regenerative approach.
The partnership with Charles River Laboratories provides FibroBiologics with access to established cGMP manufacturing infrastructure without significant capital investment in facilities. This strategic approach preserves capital while maintaining manufacturing quality and regulatory compliance—critical for a clinical-stage company with a $38M market cap.
With the Phase I/II trial for diabetic foot ulcers scheduled to begin later this year, FibroBiologics is executing on its clinical development timeline. This progress, combined with their extensive IP portfolio covering multiple therapeutic areas, positions them in the emerging field of fibroblast-based regenerative medicine. Investors should monitor upcoming trial initiation announcements, preliminary safety data, and any business development activities that could validate their technology platform.
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.”
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 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.
Charles River Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com
Charles River Media Contact:
Amy Cianciaruso
Corporate Vice President,
Chief Communications Officer
781.222.6168
amy.cianciaruso@crl.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 significance of FBLG's master cell bank completion for diabetic foot ulcer treatment?
When will FBLG begin clinical trials for CYWC628 diabetic foot ulcer treatment?
How many patents does FBLG hold for fibroblast-based therapies?
What medical conditions is FBLG targeting with their fibroblast technology?
