Study validates siRNA produced by new GMP-compliant manufacturer and company’s exosomes for drug delivery
On August 9, 2024, NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) said it was pleased to announce new data for its ExoPTEN nanodrug, marking a significant step towards commercial-grade manufacturing. Building on the announcement of a new Good Manufacturing Practice (“GMP”) compliant Contract Research Organization (“CRO”) partner, this study assessed the performance of ExoPTEN loaded with small interfering RNA (“siRNA”) produced by the new manufacturer (the “GMP Partner”). This study focused on the capability of ExoPTEN to biologically target sites of inflammation and injury as evidenced by a high concentration of the drug in damaged tissue. ExoPTEN, loaded with siRNA either from the GMP Partner or from a research grade CRO, was minimally-invasively administered to rats after spinal cord compression injury. The treated rats were compared to each other and to an untreated control group. The homing capacity of ExoPTEN was assessed by evaluating biodistribution of the ExoPTEN three days post-injury and injection.
As shown in the figure below, ExoPTEN loaded with siRNA from both sources (A and C) demonstrated exceptional homing capacity to the injured spinal cord, targeting the site of inflammation with precision. This resulted in a high concentration of the drug in damaged tissue, further validating the quality of the siRNA produced by the Company’s GMP Partner and the use of NurExone’s exosomes as a drug delivery system.
“We are excited by the successful results of the highly complex transfer to a commercial manufacturer,” commented Dr. Noa Avni, Director of Research and Development at NurExone. “These positive results reinforce our confidence in our ability to produce and scale up our siRNA to meet the quality and regulatory standards needed for commercial manufacturing. It also shows the scalability and reliability of our therapies as we advance towards clinical trials,” Dr. Avni added.
Dr. Lior Shaltiel, CEO of NurExone, also noted, “The ability of our loaded exosomes to precisely target sites of inflammation underscores their potential as an ideal and natural choice for drug delivery. We continue to be enthused by the progress we are observing.”
Figure 1: Homing ability of ExoPTEN using exosomes loaded with siRNA manufactured from a GMP-Compliant Manufacturer
