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
2024_Process Robustness
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 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Dr. Lior Shaltiel Chief Executive Officer and Director Phone: +972-52-4803034 Email: [email protected]
Thesis Capital Inc. Investment Relation - Canada Phone: +1 905-347-5569 Email: [email protected]
Dr. Eva Reuter Investment Relation - Germany Phone: +49-69-1532-5857 Email: [email protected]
Allele Capital Partners Investment Relation - US Phone: +1 978-857-5075 Email: [email protected]
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.
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