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NurExone Biologic Successfully Demonstrates its Patent-Pending Platform Technology for Loading Exosomes with Therapeutic Molecules

November 30, 2022 8:32 AM EST

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Company's analysis indicates the successful achievement of its proprietary loading technology for producing exosome-based therapies

Calgary, Alberta--(Newsfile Corp. - November 30, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy ("ExoTherapy") for patients with traumatic spinal cord injuries, reported today results of a pre-clinical loading efficiency study that was completed by the Company showing that its innovative and proprietary loading technology has the potential to serve as an efficient process for loading of therapeutic molecular cargo into exosomes. In exosome-based therapies, loaded exosomes are biologically guided to target inflamed tissues to "dock" and unload their therapeutic cargo, creating a healing environment.

The Company's platform for exosome-based therapy production is planned to include: (i) a large-scale exosome production, (ii) a therapeutic cargo and (iii) a unique technology to load the therapeutic cargo. Previous scientific research results and initiatives have demonstrated the efficiency of the Company's large-scale exosome production process and the effectiveness of the Company's proprietary small-interfering RNA ("siRNA") sequences as a therapeutic cargo. This recent study analyzes the Company's technology for loading therapeutic cargo into exosomes.

The study results indicated that NurExone's proprietary loading technology achieved the desired loading efficiency without compromising the functionality of the loaded molecular cargo. Figure 1 shows a visual inspection of using gold-standard hydrophobic loading moiety as the positive control group versus NurExone's loading technology, which uses a proprietary hydrophilic moiety linked to its molecular cargo. Figure 2 demonstrates the loading percentage equivalency, measured by co-localization of the exosome and its therapeutic cargo, which is a standard metric, allowing the company to have its own proprietary patent-pending technology. Functionality was also assessed by measuring PTEN inhibition of the siRNA cargo after loading into the exosomes as highlighted in Figure 3. Inhibition of the protein PTEN promotes axon regeneration and neural repair[1], key elements for regeneration of neurons after a traumatic spinal cord injury.

NurExone intends to monetize its proprietary technology platform and will explore potential licensing opportunities for this loading technique once it is finalized.

Dr. Lior Shaltiel, CEO of NurExone, commented, "Realizing the promise of exosome-based therapies requires efficient technology for loading therapeutic molecules into the exosome nanocarriers. We believe that our innovative and exclusive loading technology overcomes this industry hurdle, which enables us to capitalize on potential technology platform licensing opportunities and the commercialization of our ExoTherapy products produced thereby."

For the potential treatment of patients with traumatic spinal cord injury patients, NurExone intends to use its ExoTherapy's proprietary exosomes as biologically-guided nanocarriers to deliver specialized siRNA therapeutic compounds to target areas. The delivered molecules promote an environment that induces a healing process at the target location.

Cannot view this image? Visit: https://images.newsfilecorp.com/files/3274/146207_fig1nex_550.jpg

Figure 1: Loading Efficiency Analysis (Visual Inspection)
Comparison of NurExone loading process with a control process

To view an enhanced version of Figure 1, please visit:
https://images.newsfilecorp.com/files/3274/146207_fig1nex.jpg.

The study used EVs (exosomes) isolated from bone marrow-derived Mesenchymal Stem Cells MSCs (violet) loaded with Cy3-labeled siRNA (green) for both processes. The siRNA-loaded exosomes are observed using super-resolution microscopy (Light Sheet, Zeiss Z7). Analysis of colocalization (white) shows ~60% loading efficiency with the NurExone loading process, similar to the results achieved by the control group.

Cannot view this image? Visit: https://images.newsfilecorp.com/files/3274/146207_fig2nex_505.jpg

Figure 2: Loading Efficiency Analysis (Statistical Analysis) -
Comparison of NurExone loading process with a control process

To view an enhanced version of Figure 2, please visit:
https://images.newsfilecorp.com/files/3274/146207_fig2nex.jpg.

The above figure compares the loading percentage of conjugated si-PTEN using NurExone's proprietary technology compared to a control. NurExone's technology achieves 62.3% loading efficiency, showing substantial equivalence to the control process (59.5%).

Cannot view this image? Visit: https://images.newsfilecorp.com/files/3274/146207_fig3nex_550.jpg

Figure 3: Functionality of exosomes produced and loaded with
siRNA using NurExone's proprietary loading moiety

To view an enhanced version of Figure 3, please visit:
https://images.newsfilecorp.com/files/3274/146207_fig3nex.jpg.

The graph above indicates that NurExone's proprietary loading moiety conjugated to siRNA does not affect the efficiency of NUR001 siRNA to knock down PTEN expression (RNA) following transfection in HEK293 cells. There is no statistical difference between the processes - NUR001, NUR001 + hydrophobic loading moiety as standard and NUR001 +NureExo-Load (proprietary loading technology) in terms of PTEN inhibition in HEK293 cells

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is, through its wholly-owned subsidiary, Nurexone Biologic Ltd., developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. NurExone intends to translate the treatment to humans, and the company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.

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: [email protected]

For investors:
Investor Relations
[email protected]
+1 905-347-5569

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company's future plans and intellectual property, the scientific and development activities to be carried out by the company, the efficient loading of exosomes, future potential manufacturing, clinical and marketing activities and the treatment of certain conditions. 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. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. 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 and dependence on the Company's strategic partners. 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 TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

[1] Yosuke Ohtake, Umar Hayat, and Shuxin Li, M.D., Ph.D., PTEN Inhibition and Axon Regeneration and Neural Repair, Neural Regen Res. 2015 Sep; 10(9): 1363-1368,NIH Library of Medicine.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/146207



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