FibroBiologics Announces Significant Advancements in Bone Marrow Organoid Platform Enabling Development for Cancer and Immune-Related Therapies
FibroBiologics (NASDAQ:FBLG) has announced significant progress in its Bone Marrow Organoid platform technology, showing promising potential for treating hematopoietic cancers and immune-related conditions. The company's pre-IND animal trials demonstrated that transplantation of these organoids significantly reduced tumor size in xenografted melanoma mouse models.
Key technological advantages include efficient ex vivo gene editing capabilities and the ability to cryopreserve the organoids for scalable treatment options. The platform shows potential for regenerating immune cell types, addressing age-related immune decline, and restoring immune function in compromised patients. Additionally, the technology could enable in-vivo generation of advanced cell therapies like CAR-T and CAR-NK cells directly within patients.
FibroBiologics (NASDAQ:FBLG) ha annunciato importanti progressi nella sua piattaforma di organoidi midollari, con potenziale promettente per il trattamento di tumori ematopoietici e patologie immunitarie. Nei trial pre-IND su animali, il trapianto di questi organoidi ha ridotto significativamente le dimensioni dei tumori in modelli murini di melanoma xenoinnesto.
I punti di forza tecnologici includono la efficace capacità di editing genico ex vivo e la possibilità di criogenerare gli organoidi per opzioni terapeutiche scalabili. La piattaforma mostra potenzialità nel rigenerare tipi cellulari immunitari, contrastare il declino immunitario legato all’età e ripristinare la funzione immunitaria in pazienti compromessi. Inoltre, la tecnologia potrebbe consentire la generazione in‑vivo di terapie cellulari avanzate, come CAR‑T e CAR‑NK, direttamente nei pazienti.
FibroBiologics (NASDAQ:FBLG) ha anunciado avances significativos en su plataforma de organoides de médula ósea, con un prometedor potencial para tratar cánceres hematopoyéticos y afecciones relacionadas con el sistema inmune. En ensayos pre-IND en animales, el trasplante de estos organoides redujo de forma significativa el tamaño de los tumores en modelos murinos de melanoma xenoinjertado.
Las ventajas tecnológicas clave incluyen la eficiente capacidad de edición génica ex vivo y la posibilidad de criopreservar los organoides para opciones de tratamiento escalables. La plataforma podría regenerar tipos de células inmunitarias, abordar el deterioro inmunológico asociado a la edad y restaurar la función inmune en pacientes inmunocomprometidos. Además, la tecnología podría permitir la generación in vivo de terapias celulares avanzadas, como CAR‑T y CAR‑NK, directamente en los pacientes.
FibroBiologics (NASDAQ:FBLG)는 골수 오가노이드 플랫폼 기술에서 중요한 진전을 발표했으며, 혈액종양 및 면역 관련 질환 치료에 유망한 가능성을 보이고 있습니다. 회사의 pre‑IND 동물시험에서 이 오가노이드를 이식하자 제브라피시가 아닌 인간 종양을 이식한 흑색종 마우스 모델에서 종양 크기가 유의하게 감소했습니다.
주요 기술적 장점으로는 효율적인 ex vivo 유전자 편집 능력과 치료 확장을 위한 오가노이드의 동결보존(크라이프리저베이션) 가능성이 포함됩니다. 이 플랫폼은 면역 세포 유형을 재생하고, 노화에 따른 면역 저하를 개선하며, 면역 기능이 저하된 환자의 면역 회복을 목표로 할 수 있습니다. 또한 해당 기술은 환자 내에서 직접 CAR‑T 및 CAR‑NK와 같은 고도화된 세포치료제를 in‑vivo로 생성할 수 있게 할 잠재력도 지니고 있습니다.
FibroBiologics (NASDAQ:FBLG) a annoncé des progrès significatifs sur sa plateforme d’organoïdes de moelle osseuse, présentant un potentiel prometteur pour le traitement des cancers hématopoïétiques et des pathologies immunitaires. Lors d’essais animaux pré‑IND, la transplantation de ces organoïdes a réduit de manière significative la taille des tumeurs dans des modèles murins de mélanome xénogreffé.
Les atouts technologiques principaux comprennent une capacité efficace d’édition génétique ex vivo et la possibilité de cryopréserver les organoïdes pour des options thérapeutiques évolutives. La plateforme pourrait régénérer des types de cellules immunitaires, contrer le déclin immunitaire lié à l’âge et restaurer la fonction immunitaire chez des patients fragilisés. De plus, la technologie pourrait permettre la génération in vivo de thérapies cellulaires avancées, telles que des CAR‑T et CAR‑NK, directement chez le patient.
FibroBiologics (NASDAQ:FBLG) hat bedeutende Fortschritte an seiner Knochenmark‑Organoidplattform bekanntgegeben, die vielversprechendes Potenzial zur Behandlung hämatopoetischer Krebserkrankungen und immunbezogener Leiden zeigt. In prä‑IND‑Tierversuchen führte die Transplantation dieser Organoide zu einer signifikanten Verringerung der Tumorgröße in xenotransplantierten Melanom‑Mausmodellen.
Wesentliche technologische Vorteile sind die effiziente ex‑vivo‑Geneditierung und die Möglichkeit, die Organoide kryokonserviert bereitzustellen, was skalierbare Behandlungsoptionen ermöglicht. Die Plattform könnte Immunzelltypen regenerieren, altersbedingten Immunabbau adressieren und die Immunfunktion bei geschwächten Patienten wiederherstellen. Zudem könnte die Technologie die in‑vivo‑Erzeugung fortschrittlicher Zelltherapien wie CAR‑T und CAR‑NK direkt im Patienten ermöglichen.
- Pre-IND animal trials showed significant tumor reduction in melanoma models
- Technology enables efficient ex vivo gene editing for targeted interventions
- Organoids can be cryopreserved, enabling scalable treatment options
- Platform shows versatility across multiple therapeutic applications
- Company has strong IP position with 270+ patents issued and pending
- Still in early pre-IND stage, requiring extensive clinical validation
- No human clinical trial data available yet
- Faces typical biotech development risks and uncertainties
Insights
FibroBiologics advances Bone Marrow Organoid platform showing tumor reduction in pre-IND studies, with multiple promising therapeutic applications.
FibroBiologics has announced critical progress with their proprietary Bone Marrow Organoid platform, marking a significant milestone in their pre-IND development pathway. The company's preclinical studies have demonstrated measurable tumor reduction in xenografted melanoma mouse models, positioning this technology as a potential treatment for hematopoietic cancers.
What makes this platform particularly valuable is its versatility. Beyond oncology applications, the technology shows promise for immune system regeneration, addressing age-related immune decline, and potentially enabling in-vivo generation of advanced cell therapies like CAR-T and CAR-NK cells directly within patients. This represents a potentially significant advancement over current ex-vivo cell manufacturing approaches.
The platform features several technical advantages worth noting: the ability to perform efficient ex vivo gene editing before transplantation, and importantly, the organoids can be cryopreserved, which addresses critical manufacturing scalability challenges inherent to cellular therapies.
While the results are encouraging, investors should recognize these are still early-stage findings. The press release specifically mentions "pilot studies" and "pre-IND" stage work, indicating significant clinical development milestones remain before commercialization. The technology will need to demonstrate safety and efficacy in human trials, which typically follows successful IND approval. The company appears to be positioning this platform as potentially transformative across multiple therapeutic applications, which expands its market potential but also increases development complexity.
Pilot studies have shown encouraging results that are supporting the company’s pre-IND enabling development, marking a critical step toward clinical translation of the Bone Marrow Organoid technology
HOUSTON, Sept. 10, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ 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 significant advancements in its Bone Marrow Organoid platform, which may offer promising new treatment options for hematopoietic cancers and age-related immune decline.
The company’s proprietary Bone Marrow Organoids have demonstrated potential in multiple therapeutic applications:
- Our Pre-IND animal trials show that Transplantation of Bone Marrow Organoids into xenografted melanoma mouse model significantly reduced tumor size.
- The organoids enable efficient ex vivo gene editing, allowing for swift and targeted therapeutic interventions before transplantation.
- FibroBiologics’ Bone Marrow Organoids can be cryopreserved, offering a scalable and readily available treatment option for bone marrow transplantation.
“Our organoid platform has the potential to do much more than target cancer,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics. “We see potential opportunities to help regenerate one or more desired immune cell type, counter age-related immune system decline, and restore immune function in patients with a compromised immune system. Looking ahead, this approach could also potentially enable the in-vivo generation of advanced cell therapies, such as CAR-T and CAR-NK cells, directly within patients.”
“These breakthroughs are an important milestone in the journey to transform the way we approach cancer and immune-related diseases,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Our pilot studies are laying the foundation for IND-enabling preclinical development and positioning our Bone Marrow Organoid technology for clinical advancement. The real power of this platform is its versatility and scalability, designed to deliver meaningful impact across multiple therapeutic areas.”
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 the potential and capabilities of bone marrow organoids to treat cancer and immune-related therapies. 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. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. 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) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (b) the unpredictable relationship between R&D and preclinical results and clinical study results; (c) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business, 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 270+ 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.
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
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