NurExone Announces the Transfer of Manufacturing of the Active Element in ExoPTEN Drug to a Commercial GMP Manufacturer

Rhea-AI Summary

NurExone Biologic Inc. (TSXV: NRX, OTCQB: NRXBF) has announced a significant milestone in its regenerative medicine efforts. The company has successfully transferred the manufacturing of the siRNA sequence for its ExoPTEN nanodrug to a German GMP-capable producer. This move is important for producing drugs for clinical trials and commercial sale.

The siRNA from the new vendor achieved an approximately 80% reduction in PTEN expression, demonstrating comparable potency to the previous research-grade producer. This transfer establishes the foundation for future GMP manufacture of NurExone's patented product, which uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage.

Dr. Lior Shaltiel, CEO of NurExone, emphasized the importance of this achievement in meeting the strict quality and regulatory standards necessary for clinical trials, marking a critical step in the development of the ExoPTEN nanodrug.

Positive

• Successful transfer of siRNA manufacturing to a GMP-capable producer
• New siRNA achieved ~80% reduction in PTEN expression, comparable to previous research-grade product
• Establishes foundation for future GMP manufacture of patented ExoPTEN nanodrug
• Critical step towards meeting regulatory standards for clinical trials

Negative

• None.

TORONTO and HAIFA, Israel, Aug. 01, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is thrilled to announce an important milestone in its regenerative medicine efforts. The Company has successfully transferred the manufacturing of the small interfering RNA (“siRNA”) sequence for its flagship ExoPTEN nanodrug to a German producer with Good Manufacturing Practice (“GMP”) capabilities. A move to a GMP-grade manufacturer is essential for producing a drug for clinical trials and commercial sale.

The siRNA sequence was validated at the new GMP partner, solidifying the Company’s commitment to advancing regenerative medicine therapies and strengthening its confidence in meeting future clinical manufacturing demands.

NurExone reports that the siRNA from the new vendor achieved an approximately 80% reduction in expression of PTEN (Phosphatase and Tensin Homolog), demonstrating potency and effectiveness that is comparable to the siRNA from the Company’s previous, research-grade producer. NurExone’s ExoPTEN nanodrug, that is still under development, uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage. Figure 1 below shows that both the research-grade and the new GMP vendor’s siRNA effectively downregulate PTEN mRNA in a neuroblastoma cell line with comparable efficacy.

Dr. Lior Shaltiel, CEO of NurExone, stated: “The tech transfer to a new GMP-compliant vendor for our siRNA sequence is a significant achievement, establishing the foundation for future GMP manufacture of a potent and patented product. Achieving production that meets the strict quality and regulatory standards necessary for clinical trials is a critical step in the development of our ExoPTEN nanodrug."

GMP is a system of regulations, guidelines, and procedures intended to ensure that products are produced and controlled according to quality standards.

Figure 1 illustrates the downregulation of PTEN mRNA in a neuroblastoma cell line following transfection with siRNA targeting PTEN from two different manufacturers: a research-grade producer and a new GMP-grade producer. The relative expression levels of PTEN mRNA are shown on the y-axis, with three experimental conditions depicted on the x-axis: control (untreated cells), research-grade producer, and new GMP-grade producer.

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.

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

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 the success of the partnership with the GMP partner in Germany; the Company making progress with the new GMP partner’s latest tests achieving a reduction in expression of PTEN; the technology transfer to the new GMP compliant partner establishing the foundation for future GMP manufacture of a potent and patented product; and the partnership with the GMP partner helping NurExone to continue its development of its ExoPTEN nanodrug, which it hopes to use to treat central nervous system injuries.

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; the partnership with the GMP manufacturer having the intended impact on the Company and its business; the patents safeguarding NurExone’s technology; the Company’s drug products will have their intended benefits and effects; the Company will make progress using its new partnerships and technologies to move to 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; and the NurExone platform technology will offer 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; risk that the Company will not pay the registration fees prior to the deadline or at all; 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 with the new GMP partner in Germany; 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/2f76c58d-0f8c-4dcc-b83e-2343fcc2f9f9

FAQ

What is the significance of NurExone's transfer to a GMP manufacturer for its ExoPTEN drug?

The transfer to a GMP manufacturer is important for NurExone (NRXBF) as it enables the production of the ExoPTEN drug for clinical trials and potential commercial sale, meeting strict quality and regulatory standards required for pharmaceutical development.

How effective is the new GMP-produced siRNA for NurExone's ExoPTEN drug?

The new GMP-produced siRNA for NurExone's (NRXBF) ExoPTEN drug demonstrated approximately 80% reduction in PTEN expression, showing comparable potency and effectiveness to the previous research-grade siRNA.

What is the mechanism of action for NurExone's ExoPTEN nanodrug?

NurExone's (NRXBF) ExoPTEN nanodrug, currently under development, uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage.

Who is the new manufacturer for NurExone's siRNA sequence?

NurExone (NRXBF) has transferred the manufacturing of its siRNA sequence to a German producer with Good Manufacturing Practice (GMP) capabilities, though the specific name of the manufacturer is not disclosed in the press release.