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ArunA Biomedical Launches New Class of Exosome Biologics to Treat Central Nervous System and Neurodegenerative Disorders; Company Rapidly Moving Toward Clinical Development of Cell-Free Biologic Therapy, Plans to Initiate First-in-Human Studies in 2019

On January 3, 2018, ArunA Biomedical announced the official launch of a new class of cell-free exosome biologics to treat central nervous system and neurodegenerative disorders. With an initial focus on an exosome therapeutic for stroke, the company published, on January 3, 2018, results of a study in Translational Stroke Research that found that extracellular vesicles (EVs) derived from human neural stem cells improved tissue and functional recovery in murine thromboembolic stroke models. The open-access article is titled “Human Neural Stem Cell Extracellular Vesicles Improve Tissue and Functional Recovery in the Murine Thromboembolic Stroke Model.” The study was led by Dr. Steven Stice, a Georgia Research Alliance Eminent Scholar endowed chair, Professor and Director of the Regenerative Bioscience Center at The University of Georgia, and who serves as Co-Founder, Chief Executive, and Chief Scientific Officer for ArunA Biomedical. The study was conducted in collaboration with Dr. Nasrul Hoda at Augusta University in Augusta, Georgia. Neural stem cells (NSCs) and mesenchymal stem cells (MSCs) were evaluated for changes in infarct volume as well as sensorimotor function. Results showed that the NSC EVs improved cellular, tissue, and functional outcomes in middle-aged rodents, whereas MSC EVs were less effective. Acute differences in lesion volume following NSC EV treatment were corroborated by MRI in aged rodents. NSC EVs mechanistically increased circulating regulatory T cell numbers, which are known to enhance remyelination in the injured brain. Specifically, neural stem cell EV treatment has a positive effect on motor function as indicated by beam walk, instances of foot faults, and strength evaluated by a hanging wire test. Increased time with a novel object supports improved episodic memory formation in the rodent.Notably, investigators have been able to duplicate many of these results in a unique large animal model of stroke developed at the University of Georgia, and results will be published in a peer-reviewed journal in the next few months.

“With more than twelve years of expertise in developing and providing neural stem cells to the world’s leading research organizations, it was a natural progression to focus efforts on developing a new cell-free class of biologics—exosome therapeutics—for central nervous system and neurodegenerative disorders that have few treatment options today,” said Dr. Stice. “Buoyed by the results of this study and our additional pre-clinical models and internal in vitro studies, we will rapidly move toward the clinic with a plan to initiate first-in-human studies in 2019.”

Dr. Stice is an expert in stem cell technologies and regenerative medicine, and is world-renowned for developing the first human pluripotent stem cell (hPSC)-derived neural cell product for research and enabled its use throughout the biotechnology and pharmaceutical industries. This expertise has led to the development of an unmodified, stable, and proprietary neural cell line that enables scale-up technologies for use in exosome product manufacturing. This proprietary offering, coupled with the company’s exosome separation methods, enables ArunA to produce billions of cells and up to trillions of exosomes per manufacturing lot.

In addition to the stroke study, ArunA Biomedical plans to initiate a drug delivery platform, as well as preclinical studies in epilepsy, traumatic brain, and spinal cord injuries in 2018.

EXOSOMES AS A THERAPEUTIC

Since their discovery more than 30 years ago, extracellular vesicles—nanometer-sized cell-signaling particles— have increasingly been found to play a role in intercellular communication, capable of delivering functional proteins, mRNA transcripts, and miRNA to cells throughout the body. Exosomes have the potential to target any cell in the body and, as proved in ArunA’s study published in Translational Stroke Research, are capable of crossing the blood-brain barrier non-invasively to reach the site of injury. Exosomes have shown great promise as potential therapeutics and as vehicles to carry drug payloads to the site of injury or disease.

ARUNA BIOMEDICAL

Scientists at ArunA Biomedical are experts in the design, loading, and scaling of neural-derived exosomes, developing a new class of cell-free biologics and cell-mediated drug delivery systems to treat CNS and neurodegenerative disorders. Through its lead program in stroke, ArunA Biomedical has demonstrated the unique ability of exosomes to enhance the nervous system’s self-repair mechanisms, leading to both structural and functional benefits in multiple preclinical models.

[Press release] [Translational Stroke Research article]