NurExone Biologic Achieves Key Milestone in Support of Robust Exosome Manufacturing Process
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) has announced significant advancements in their exosome manufacturing process, important for their ExoPTEN product development. The company demonstrated consistent exosome production from multiple biological sources, comparing exosomes from bone marrow-derived mesenchymal stem cells (MSCs) of different donors. Despite natural variability in starting materials, the exosomes showed consistent yields and similar size distribution.
NurExone also tested the effectiveness of exosomes in an animal model of spinal cord injury, demonstrating excellent and comparable homing abilities to the injured area. The company compared exosomes produced using 2D and 3D culture methods, finding similar homing and targeting capabilities. This advancement supports NurExone's ability to scale up production for potential commercial applications in regenerative medicine treatments.
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) ha annunciato importanti progressi nel loro processo di produzione di esosomi, fondamentali per lo sviluppo del prodotto ExoPTEN. L'azienda ha dimostrato una produzione costante di esosomi da diverse fonti biologiche, confrontando gli esosomi provenienti da cellule staminali mesenchimali (MSC) derivate dal midollo osseo di diversi donatori. Nonostante la variabilità naturale nei materiali di partenza, gli esosomi hanno mostrato rendimenti costanti e una distribuzione delle dimensioni simile.
NurExone ha anche testato l'efficacia degli esosomi in un modello animale di lesione del midollo spinale, dimostrando eccellenti e comparabili capacità di targeting verso l'area infortunata. L'azienda ha confrontato gli esosomi prodotti con metodi di coltura 2D e 3D, riscontrando capacità di oming e targeting simili. Questo progresso supporta la capacità di NurExone di ampliare la produzione per potenziali applicazioni commerciali nei trattamenti di medicina rigenerativa.
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) ha anunciado importantes avances en su proceso de fabricación de exosomas, cruciales para el desarrollo de su producto ExoPTEN. La empresa demostró una producción constante de exosomas a partir de múltiples fuentes biológicas, comparando exosomas de células madre mesenquimatosas (MSCs) derivadas de médula ósea de diferentes donantes. A pesar de la variabilidad natural en los materiales de partida, los exosomas mostraron rendimientos consistentes y una distribución de tamaño similar.
NurExone también probó la efectividad de los exosomas en un modelo animal de lesión de médula espinal, demostrando excelentes y comparables capacidades de localización hacia el área lesionada. La empresa comparó los exosomas producidos mediante métodos de cultivo 2D y 3D, encontrando capacidades de localización y direccionamiento similares. Este avance apoya la capacidad de NurExone para aumentar la producción para aplicaciones comerciales potenciales en tratamientos de medicina regenerativa.
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF)는 엑소좀 제조 공정에서 중요한 발전을 발표했습니다. 이는 ExoPTEN 제품 개발에 필수적입니다. 이 회사는 여러 생물학적 출처에서 일관된 엑소좀 생산을 시연하며, 다양한 기증자의 골수 유래 중간체 줄기세포(MSC)에서 추출한 엑소좀을 비교했습니다. 시작 물질의 자연 변동성에도 불구하고, 엑소좀은 일관된 수확량과 비슷한 크기 분포를 보였습니다.
NurExone은 또한 동물 모델에서의 엑소좀의 효과를 테스트하여 부상당한 부위로의 훌륭하고 유사한 위치 지정 능력을 보여주었습니다. 이 회사는 2D 및 3D 배양 방법으로 생산된 엑소좀을 비교하여 유사한 이동 및 표적 지정 기능을 발견했습니다. 이 발전은 NurExone이 생산을 확대할 수 있는 능력을 지원하여 재생 의학 치료의 잠재적 상업적 응용에 기여하고 있습니다.
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) a annoncé des avancées significatives dans leur processus de fabrication d'exosomes, essentiel pour le développement de leur produit ExoPTEN. L'entreprise a démontré une production d'exosomes constante à partir de plusieurs sources biologiques, en comparant les exosomes provenant de cellules souches mésenchymateuses (MSC) dérivées de la moelle osseuse de différents donneurs. Malgré la variabilité naturelle des matériaux de départ, les exosomes ont montré des rendements cohérents et une distribution de taille similaire.
NurExone a également testé l'efficacité des exosomes dans un modèle animal de blessure à la moelle épinière, montrant d'excellentes capacités de localisation comparables à la zone touchée. L'entreprise a comparé les exosomes produits par des méthodes de culture 2D et 3D, trouvant des capacités de localisation et de ciblage similaires. Cette avancée soutient la capacité de NurExone à augmenter la production pour des applications commerciales potentielles dans les traitements de médecine régénérative.
NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) hat bedeutende Fortschritte in ihrem Exosomen-Herstellungsprozess bekannt gegeben, die für die Entwicklung ihres Produkts ExoPTEN wichtig sind. Das Unternehmen hat die konstante Produktion von Exosomen aus mehreren biologischen Quellen demonstriert, indem es Exosome von mesenchymalen Stammzellen (MSCs), die aus dem Knochenmark verschiedener Spender stammen, verglichen hat. Trotz der natürlichen Variabilität der Ausgangsmaterialien zeigten die Exosomen konstante Erträge und eine ähnliche Größenverteilung.
NurExone testete auch die Wirksamkeit von Exosomen in einem Tiermodell für eine Rückenmarksverletzung und zeigte ausgezeichnete und vergleichbare Lokalisierungsfähigkeiten zur verletzten Region. Das Unternehmen verglich Exosomen, die mit 2D- und 3D-Kulturmethoden produziert wurden, und stellte ähnliche Ziel- und Lokalisationseigenschaften fest. Dieser Fortschritt unterstützt die Fähigkeit von NurExone, die Produktion zu erweitern für potenzielle kommerzielle Anwendungen in der regenerativen Medizin.
- Demonstrated consistent exosome production from multiple biological sources
- Exosomes showed excellent homing abilities to injured areas in animal models
- Successful comparison of 2D and 3D culture methods for exosome production
- Advancements support potential for scalable commercial production
- None.
- Company demonstrates reliable production from multiple biological sources
- These manufacturing advancements provide NurExone flexibility in optimizing its exosome production method, ensuring consistency while maintaining efficiency
TORONTO and HAIFA, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”) is pleased to announce significant advancements in their manufacturing process of exosomes. Exosomes, which are naturally released by cells, hold immense promise for regenerative medicine and they are at the heart of the Company’s innovative ExoPTEN product, which is being developed for the treatment of acute spinal cord injury and glaucoma.
In a recent study, NurExone focused on ensuring that the Company’s exosome production process could consistently deliver reliable products. The study compared exosomes produced from bone marrow-derived mesenchymal stem cells (MSCs) from two different donors. Despite a natural variability in the starting material, the exosomes showed consistent yields measured in concentration of exosomes (Fig. A) and similar size distribution (Fig. B), demonstrating the reliability of NurExone's production methods.
"The exosome production process must be stable to ensure the same quality of exosomes every time, even when the stem cell material comes from different donors," notes Dr. Noa Avni, Director of Research and Development at NurExone, and She continues, "our tests and analysis have clearly shown that this is possible using our proprietary technology, which will allow large-scale mass production without genetic manipulation".
To ensure the exosomes are not only consistent but also effective at targeting damaged tissue, NurExone conducted further tests using an advanced animal model of spinal cord injury. Exosomes from the different donors were administered to rats with spinal cord compression injuries and compared with an untreated control group. The newly produced exosomes demonstrated excellent and comparable homing abilities to the injured area (Fig. C).
NurExone also investigated the effectiveness of exosomes produced using different culture methods, comparing 2D culture conditions with NurExone’s scalable 3D culture systems. Testing showed that both methods produced exosomes with similar homing and targeting capabilities (Fig. D). NurExone’s patented 3D culture is expected to facilitate commercial mass production of exosomes.
Dr. Lior Shaltiel, Chief Executive Officer at NurExone, emphasized the importance of these findings stating that "ensuring consistency across different donors and culture systems while maintaining targeting and homing ability is crucial and will allow our exosomes to serve as an excellent, targeted system for drug delivery.” He continued, “NurExone's ongoing achievements in establishing a robust, scalable exosome manufacturing process will pave the way to regenerative medicine treatments for a variety of clinical indications developed by NurExone independently as well as with future collaboration partners.”
Fig. 1: Analysis of Properties and Homing Capability of Exosomes Produced from Different Donors
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in
For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com
Thesis Capital Inc.
Investment Relation - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com
Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Allele Capital Partners
Investment Relation - US
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to advancements in the manufacturing process of exosomes; exosomes holding immense promise for regenerative medicine; the reliability of the Company’s production methods; the Company having flexibility in optimizing its exosome production method; exosomes serving as an excellent, targeted system for drug delivery; the Company paving the way to regenerative medicine treatments for a variety of clinical indications by the Company and with future collaboration partners; and the NurExone platform technology offering novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; partnerships having their intended impact on the Company and its business; patents safeguarding NurExone’s technology; the Company’s drug products having its intended benefits and effects; the Company making progress through new partnerships and technologies to move towards commercialization of their products; the Company’s intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; exosomes becoming an ideal and natural choice for drug delivery; the Company making advancements in the manufacturing process of exosomes; exosomes holding immense promise for regenerative medicine; the Company’s production methods continuing to be reliable; the Company will have flexibility in optimizing its exosome production method; exosomes will serve as an excellent, targeted system for drug delivery; the Company will pave the way to regenerative medicine treatments for a variety of clinical indications by the Company and with future collaboration partners; and the NurExone platform technology offering novel solutions to drug companies.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company’s intellectual property; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the NurExone platform technology being unable to offer novel solutions to drug companies; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to realize upon partnerships; risk that the exosomes will not become an ideal and/or natural choice for drug delivery; risk that the company will be unable to make advancements in the manufacturing process of exosomes; risk that exosomes will not be a viable option in regenerative medicine; risk that the Company’s production methods will become unreliable; risk that the Company will not have flexibility in optimizing its exosome production method; risk that exosomes will not serve as a targeted system for drug delivery; risk that the Company will be unable to pave the way to regenerative medicine treatments for a variety of clinical indications by the Company and/or with future collaboration partners; risk that the NurExone platform technology will be unable to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 29 to 36 of the Company’s Annual Information Form dated March 30, 2023, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f13f2b37-b9f4-4d39-9990-a6d5f7a2f474
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