FibroBiologics Confirms Ability to Manufacture CybroCell™ for Degenerative Disc Disease and Cartilage Repair Programs from Existing CYWC628 Master Cell Bank
FibroBiologics (NASDAQ: FBLG) has achieved a significant milestone in its cartilage repair program by confirming that CYWC628 spheroids from its existing master cell bank can be differentiated into chondrocytes for cartilage formation. This breakthrough enables the company to manufacture CybroCell™, its investigational cell therapy for degenerative disc disease (DDD).
The development allows FibroBiologics to proceed with amending its FDA IND clearance for the planned Phase I clinical trial for DDD. The company's ability to use the existing master cell bank is expected to streamline manufacturing, reduce development time, and lower associated costs. This advancement demonstrates the potential versatility of FibroBiologics' fibroblast-based platform to support multiple therapeutic indications from a common cell source.
FibroBiologics (NASDAQ: FBLG) ha raggiunto un traguardo importante nel suo programma di riparazione della cartilagine, confermando che gli sfere CYWC628 provenienti dalla sua banca cellulare master esistente possono essere differenziate in condrociti per la formazione della cartilagine. Questa scoperta consente all'azienda di produrre CybroCell™, la sua terapia cellulare sperimentale per la malattia degenerativa del disco (DDD).
Questo sviluppo permette a FibroBiologics di procedere con la modifica dell'autorizzazione FDA IND per il previsto trial clinico di Fase I per la DDD. La capacità dell'azienda di utilizzare la banca cellulare master esistente dovrebbe semplificare la produzione, ridurre i tempi di sviluppo e abbassare i costi associati. Questo progresso dimostra la potenziale versatilità della piattaforma basata sui fibroblasti di FibroBiologics nel supportare molteplici indicazioni terapeutiche da una fonte cellulare comune.
FibroBiologics (NASDAQ: FBLG) ha alcanzado un hito significativo en su programa de reparación de cartílago al confirmar que los esferoides CYWC628 de su banco maestro de células existente pueden diferenciarse en condrocitos para la formación de cartílago. Este avance permite a la empresa fabricar CybroCell™, su terapia celular en investigación para la enfermedad degenerativa del disco (DDD).
Este desarrollo permite a FibroBiologics proceder con la enmienda de la autorización IND de la FDA para el ensayo clínico de Fase I planificado para la DDD. La capacidad de la empresa para utilizar el banco maestro de células existente se espera que agilice la fabricación, reduzca el tiempo de desarrollo y disminuya los costos asociados. Este avance demuestra la potencial versatilidad de la plataforma basada en fibroblastos de FibroBiologics para apoyar múltiples indicaciones terapéuticas desde una fuente celular común.
FibroBiologics (NASDAQ: FBLG)는 연골 재생 프로그램에서 중요한 이정표를 달성했으며, 기존 마스터 세포 은행에서 유래한 CYWC628 스페로이드가 연골 형성을 위한 연골세포로 분화될 수 있음을 확인했습니다. 이 돌파구는 회사가 퇴행성 디스크 질환(DDD)을 위한 임상 시험용 세포 치료제인 CybroCell™을 제조할 수 있게 합니다.
이 개발은 FibroBiologics가 계획된 1상 임상시험을 위한 FDA IND 승인 수정 절차를 진행할 수 있도록 합니다. 기존 마스터 세포 은행을 사용할 수 있는 회사의 능력은 제조 과정을 간소화하고 개발 시간을 단축하며 관련 비용을 절감할 것으로 예상됩니다. 이번 진전은 공통 세포원을 이용해 다양한 치료 적응증을 지원할 수 있는 FibroBiologics의 섬유아세포 기반 플랫폼의 잠재적 유연성을 보여줍니다.
FibroBiologics (NASDAQ: FBLG) a franchi une étape importante dans son programme de réparation du cartilage en confirmant que les sphéroïdes CYWC628 issus de sa banque de cellules maîtresse existante peuvent être différenciés en chondrocytes pour la formation du cartilage. Cette avancée permet à l'entreprise de fabriquer CybroCell™, sa thérapie cellulaire expérimentale pour la maladie dégénérative du disque (DDD).
Ce développement permet à FibroBiologics de procéder à la modification de son autorisation IND de la FDA pour l'essai clinique de phase I prévu pour la DDD. La capacité de l'entreprise à utiliser la banque de cellules maîtresse existante devrait rationaliser la fabrication, réduire le temps de développement et diminuer les coûts associés. Cette avancée démontre la polyvalence potentielle de la plateforme à base de fibroblastes de FibroBiologics pour soutenir plusieurs indications thérapeutiques à partir d'une source cellulaire commune.
FibroBiologics (NASDAQ: FBLG) hat einen bedeutenden Meilenstein in seinem Knorpelreparaturprogramm erreicht, indem bestätigt wurde, dass CYWC628-Sphäroide aus seiner bestehenden Masterzellbank in Chondrozyten zur Knorpelbildung differenziert werden können. Dieser Durchbruch ermöglicht es dem Unternehmen, CybroCell™ herzustellen, seine experimentelle Zelltherapie für degenerative Bandscheibenerkrankungen (DDD).
Diese Entwicklung erlaubt es FibroBiologics, die FDA IND-Freigabe für die geplante Phase-I-Studie bei DDD zu ändern. Die Fähigkeit des Unternehmens, die bestehende Masterzellbank zu verwenden, soll die Herstellung vereinfachen, die Entwicklungszeit verkürzen und die damit verbundenen Kosten senken. Dieser Fortschritt zeigt die potenzielle Vielseitigkeit der fibroblastbasierten Plattform von FibroBiologics, mehrere therapeutische Indikationen aus einer gemeinsamen Zellquelle zu unterstützen.
- Confirmation of CYWC628 spheroids differentiation capability enables streamlined manufacturing process
- Ability to use existing master cell bank reduces development time and costs
- Platform demonstrates potential for multiple therapeutic applications from single cell source
- Progress toward Phase I clinical trial for degenerative disc disease treatment
- Still requires FDA IND clearance amendment before proceeding with clinical trials
- Early-stage development with no guaranteed clinical success
Insights
FibroBiologics achieves manufacturing efficiency by confirming existing cell bank can produce CybroCell™, accelerating clinical timeline for degenerative disc disease.
FibroBiologics has reached a significant scientific milestone in their cartilage repair program with broad implications for their development pipeline. Through both immunohistochemistry and transcriptomic analysis, they've confirmed that their existing CYWC628 spheroids (currently used in their wound healing program) can be directly differentiated into chondrocytes—the specialized cells responsible for cartilage formation.
This confirmation carries three key advantages:
- Manufacturing efficiency: Using the established CYWC628 master cell bank for CybroCell™ production creates a streamlined pathway
- Cost reduction: Leveraging existing cell banks eliminates the need to develop entirely new master cell banks
- Accelerated development timeline: This approach should reduce both development and manufacturing time
Most importantly, this development validates their platform technology concept—demonstrating that their fibroblast-based approach can potentially support multiple therapeutic indications from a common cell source. This is critical for biotechnology platforms, as it suggests scalability across their pipeline.
This advancement allows FibroBiologics to proceed with amending their IND clearance with the FDA for their planned Phase I clinical trial for degenerative disc disease. While still in pre-clinical stages, this manufacturing confirmation represents meaningful progress toward entering clinical development for their CybroCell™ therapy.
HOUSTON, July 09, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced an advancement in its cartilage repair program. FibroBiologics has confirmed, through both immunohistochemistry and transcriptomic analysis, that the CYWC628 spheroids used in its wound healing program can be directly differentiated into chondrocytes, the specialized cells responsible for cartilage formation.
This confirmation means that FibroBiologics can use its current CYWC628 master cell bank to produce a working cell bank and manufacture CybroCell™, the company’s investigational cell therapy for the treatment of degenerative disc disease (DDD). This development allows FibroBiologics to move forward with amending its IND clearance with the FDA for the planned Phase I clinical trial for DDD and represents a major milestone in platform scalability.
“Using our current CYWC628 master cell bank will enable a more rapid and streamlined manufacturing pathway for CybroCell, reducing both development and manufacturing time and associated costs,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “Our approach continues to demonstrate the ability of our fibroblast-based platform to support multiple indications from a common cell source, helping us advance toward our ultimate goal of delivering effective, regenerative therapies for patients with chronic conditions such as DDD.”
“We are making steady progress toward launching our clinical programs, and this milestone underscores the potential of fibroblasts as the basis of our cell therapy platform,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “By harnessing the unique biology of these cells, we’re working to develop scalable solutions and potential universality of our platform for some of the most persistent and challenging chronic conditions.”
To learn more about this program and the broader pipeline, please visit https://fibrobiologics.com/pipeline/.
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 plans for, and the anticipated timing of the initiation of and results from, FibroBiologics’ current and future preclinical studies, clinical trials and research and development programs, the potential clinical benefits of fibroblasts and fibroblast-derived materials, the potential of product candidates as platform technologies, the potential for manufacturing efficiencies, the potential indications for FibroBiologics’ programs, and plans for, and the timing of, regulatory filings. 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) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; and (d) 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 seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 275+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com.
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