NRX:CC - 24 Cent Micro Cap May Hold The Key To Potential Breakthrough In Acute Spinal Cord Injury
2023-10-04 16:06:31 ET
An estimated 250,000-500,000 people experience a %SpinalCordInjury (SCI) annually, with roughly 17,000 new cases in the US and 27,000 in Europe each year, leaving many of those people permanently confined to a wheelchair. What if there were a way to repair the damaged tissue and allow those people to once again have feeling and regain use of their limbs? Thanks to tiny particles known as %Exosomes , such a miracle may be on the horizon.
Exosomes are small extracellular vesicles that are secreted by all Stem Cell types. They are thought to play a role in cell-to-cell communication.
Exosomes contain a variety of proteins, lipids, and nucleic acids, and have diverse potential in emerging technologies to address areas of unmet medical need. Exosomes can be used to deliver drugs, genes, and other molecules to target cells, making them ideal for new therapeutics and improving existing drugs. Plus, they also can function as potential biomarkers, giving them unique value in diagnostics applications. It’s not hyperbole that exosomes may revolutionize many standards of care and provide people hope in diseases fraught with desperation.
Every year, thousands of people are relegated to wheelchairs because of irreparable spinal cord injuries. Research suggests that exosomes can be used to regenerate damaged tissue and organs.
Further, in addition to being used to deliver drugs to diseased cells, exosomes have also been shown to be effective in reducing inflammation and stimulating the immune system. To wit, it should be unsurprising that exosomes are a rapidly growing field of research.
The buzz around exosomes and their ability to carry payloads from one cell to another has been steadily growing, evidenced by Bio-Techne Corporation (NASDAQ: ) in 2018 agreeing to pay $250 million in cash (and up to $325 million for achieving certain milestones) to acquire Exosome Diagnostics. In 2020, Eli Lilly (NYSE: ) made a $20 million upfront payment to launch a deal that could be worth up to $1.2 billion for Evox Therapeutics pursuant to which Evox agreed to provide DeliverEX™, its exosome-based drug delivery platform, to allow targeted drug delivery across the blood-brain barrier. Others that have compelling exosome technology in development include Capricor Therapeutics, Inc. (NASDAQ: ) and %NurExoneBiologic (TSX-Venture: ).
Capricor’s StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted therapies to treat or prevent a variety of diseases.
NurExone Biologic Inc. (TSX-Venture: NRX) has assembled an expert team in its mission to revolutionize recovery from nervous system injuries by regenerating and rewiring neurons. The Israel-based company is at the forefront of exosome-based therapeutics R&D, developing and commercializing exosome-based therapies and a production platform for a global market projected at $5.2 billion.
With operations launched in 2020, NurExone possesses a lot more fundamental strength than is typically found in such a young company. The company obtained an exclusive worldwide license from the Technion and Tel Aviv University to develop and commercialize an exosome technology that has been under development for 10+ years. NurExone has a global vision and has submitted patent applications in the U.S. and other key markets under the Patent Cooperation Treaty (PCT), with a first U.S. patent awarded in January. The rest of the IP portfolio includes 2 PCTs on Production and Composition of Matter of its exosomes and 4 provisional patents on loading technique and siRNA target sequences.
NurExone operates according to two business lines – Development of a first exosome-based
therapy for acute SCI (spinal cord injuries). In parallel, the company plans to soon monetize its proprietary exosome technology and production platform through licensing to the global biopharmaceutical industry for other diseases and indications.
Get to Know ExoTherapy and ExoPTEN
One of the key assets of NurExone's technology is its drug delivery system, branded %ExoTherapy . ExoTherapy is a play on the combination of exosomes with therapeutic compounds. The first ExoTherapy product, which uses modified siRNA as its therapeutic molecule, is called %ExoPTEN , which is designed to treat acute spinal cord injuries and has shown promising initial results in preclinical studies for neuron regeneration in rat models.
While very early in development, the data from an internal preclinical study of ExoPTEN were very positive and inspiring. In short, the company used the ExoTherapy platform to produce and load exosomes with pharmaceutical cargo targeting damaged tissue at the core of SCI. Healthy rats with full mobility underwent a complete transection of the spinal cord, rendering their rear legs paralyzed. The rats were then treated with exosomes only (control group) or with intranasal administration of ExoPTEN. NurExone reported positive imaging results visualizing successful nerve regeneration following traumatic full transection of the spinal cord in rats.
These imaging results align with previous functional results showing a remarkable recovery of motor function in 75% of paralyzed rats suffering from spinal cord injuries that were treated with the new therapy. In other words, rats treated with ExoPTEN experienced restored functionality of their legs including sensorial recovery. These results align with previous Proof of Concept experiments (see video here: https://nurexone.com/study-results/ )
The study indicates that ExoPTEN therapy enables new nerve-connections to be made, effectively repairing the transected spinal cord, at least partially. For humans, the research suggests that ExoTherapy may facilitate even a partial recovery, providing patients with a better outcome than had been possible to date. NurExone is aiming for filing an investigational new drug (IND) application during 2024 to initiate clinical trials.
ExoPTEN is differentiated with some competitive advantages. First, it can be administered non-invasively (intranasal). Next, the treatment is off-the-shelf and not personalized, which conquers some of the logistic headaches involved with autologous (derived from patient) therapies. Further, being a novel therapeutic targeting a patient population under 200,000 people, ExoPTEN may be an ideal candidate for an Orphan Drug designation, which expedites development and provides financial incentives to develop a new drug.
According to Grand View Research, the global market for acute spinal cord injury will reach $2.9 billion by 2027.
As for the other business silo, licensing the proprietary exosome production and loading platform to biopharmaceutical companies for a litany of diseases and conditions, Grand View Research estimates the global market for exosome-based diagnostics and therapeutics to reach $2.3 billion by 2030. Broadly, Grand View’s analysts see the global exosomes market size as valued at $112.25 million in 2022 and anticipate it to expand at a compound annual growth rate (CAGR) of 32.75% by 2030.
A Quick Word on an Amazing Team
NurExone management is led by CEO, Dr. Lior Shaltiel, an awarded scientist with extensive multidisciplinary international experience. The company’s team includes experts in biological research and a scientific advisory board led by world renowned Prof. Shulamit Levenberg, and Prof. Nahshon Knoller, the former head of the neurosurgery department in the largest hospital in Israel, that led 3 clinical SCI studies.
The team was further strengthened during the second quarter with the appointment of Dr. Gadi Riesenfeld to the Board of Directors. Dr. Riesenfeld was previously the president of Pharmos Corporation (formerly NASDAQ: PARS) and president of several biopharmaceutical companies, including Kamapharm Ltd., Galisar Ltd., and OticPharma.
This team is skilled clinically and at the negotiating table too. Not only did they secure the licensing rights, but they also recently inked a deal to make their lab better. In June, the company announced a collaboration with Particle Metrix, a leading provider of particle analysis devices. In connection with the collaboration, a highly advanced Nanoparticle Tracking Analysis instrument (NTA) has been placed at the company’s laboratory. Management plans to leverage the capabilities of the advanced NTA to validate its methodology for analysis of loaded exosomes, a vital part of the development process of its ExoPTEN drug.
The company has the cash to keep moving forward following the closing of a second tranche of a non-brokered private placement this month. The financing raised about CAD$1.5 million, enough cash runway to get through the year and into 2024, a time when things will get very interesting as it nears the clinical stage.
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