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Trends in Neurosciences

NeurAegis and Nanosyn announce partnership agreement

NeurAegis today announced that it has chosen Nanosyn, Inc., a leading US-based contract research provider of drug discovery and development services, to lead its chemistry efforts towards advancing novel and selective calpain-2 inhibitors to clinical candidates.

NeurAegis has identified calpain-2 as a critical target in the pathway leading to neuronal death in a variety of neurological disorders resulting from insults or trauma, including traumatic brain injury and concussion, stroke, glaucoma, and other diseases associated with neuronal damage.

Dr. Baudry, NeurAegis CEO said "Nanosyn has an excellent track record in projects delivery. This partnership, combining NeurAegis' team of biologists, chemists and biotech leaders with a company with a proven record of advancing molecules to the clinic, provides for a unique synergy, which will speed up our efforts to develop the best selective calpain-2 inhibitor for neuroprotection."

"We are excited about this project and look forward to working with NeurAegis' reputable team. Together we are well positioned to develop a new generation of much needed therapies for the patients with neurological disorders", said Olga Issakova, Ph.D., Executive Vice President of Nanosyn, Inc.

NeurAegis also added Drs. Norton Peet and Shujaath Mehdi to its Scientific Advisory Board.

Dr. Norton Peet

Dr. Norton Peet is an International R&D Consultant, and provides guidance and direction to industrial and academic organizations on drug discovery and development strategies. Dr. Peet currently serves as the Chief Scientific Officer for Chicago BioSolutions, a newly formed drug discovery company. In prior positions, Dr. Peet was Head of Medicinal Chemistry at Microbiotix, where he designed the chemistry for all internal and external research proposals. Dr. Peet is an organic chemist by training (UNL, MIT) and has spent much of his career in big pharma, with the string of companies that led to Aventis (now Sanofi). When he left Aventis in 2000 he was Head of Medicinal Chemistry and Distinguished Scientist. He joined the executive team at ArQule as Vice President of Discovery Alliances, where he managed alliances with several companies and also built a multidisciplinary Drug Discovery Group. In 2002, he became the CEO of Aurigene Discovery Technologies, a drug discovery company, and built laboratories in Boston (Lexington) and Bangalore (India). Dr. Peet has authored 175 journal articles and 70 US patents, and has contributed to 25 awarded grant applications. He has organized numerous international symposia and serves on several editorial and scientific advisory boards.

Dr. Shujaath Mehdi

Dr. Shujaath Mehdi is an expert in enzyme mechanisms and kinetics, in molecular aspects of drug design, discovery and development, and in translational medicine. Dr. Mehdi joined Merrell Dow (a predecessor company of Sanofi) in 1985 in Discovery Research after post-doctoral training in enzymology at Harvard University. Over the years he held the positions of Project Team Leader, Lab Head, and Group Leader of the Enzyme Chemistry group. Dr. Mehdi was instrumental in the design and characterization of enzyme inhibitors as drugs in multiple therapeutic areas. Prior to retirement, Dr. Mehdi led a cross-functional Translational Medicine group, whose responsibility was to apply translational principles to ensure the success of preclinical and clinical projects in the Immunoinflammation therapeutic area. After retirement from Sanofi in 2012 as a Distinguished Scientist, Dr. Mehdi has taught courses on ‘Drug Discovery Through Preclinical Development’ and on ‘Ethics of Science and Technology Management’ in the Master of Business and Science program at Rutgers University, and has lectured on Personalized Medicine at Rutgers and at Columbia University. He is the author of 50 publications, and is the co-inventor of 17 US Patents.

About NeurAegis

NeurAegis (neuraegis.com) has been founded to translate fundamental discoveries on the mechanisms of synaptic plasticity and neuronal survival/cell death into clinical applications. NeurAegis has identified neuroprotection as a key focus for research and development, because of the high unmet needs and tremendous research potential in this therapeutic area. Nevertheless, there is still no drug on the market that provides any significant degree of neuroprotection, especially within the crucial minutes to maximum of several hours following any brain insult that results in neuronal loss. NeurAegis company is privately held and self-funding. The company has laboratories in Pomona, CA.

Contact information: Michel Baudry, CEO, NeurAegis: m.baudry@neuraegis.com; tel: +19494687310.

About Nanosyn

Nanosyn (nanosyn.com) is a Contract Research and Manufacturing Organization providing integrated drug discovery and development services, medicinal chemistry, process chemistry, cGMP manufacturing, assay development, screening and profiling services, and other innovative solutions to meet our partners' drug discovery needs. Founded in 1998, Nanosyn is privately held and self-funding. The company is headquartered in San Francisco Bay Area, California with discovery site in Santa Clara, CA and cGMP kilo lab in Santa Rosa, CA.

Contact information: Olga Issakova, Executive VP, Nanosyn: oissakova@nanosyn.com; tel: +1 (650) 269-3528

WesternU team seeks 'magic molecule' to treat traumatic brain injuries, strokes

Following a series of outstanding discoveries, five Western University of Health Sciences faculty are developing a "magic molecule" with the potential to treat traumatic brain injury, stroke, glaucoma, and disorders associated with learning impairment.

Graduate College of Biomedical Sciences (GCBS) Dean Michel Baudry, PhD is leading a team that includes College of Osteopathic Medicine of the Pacific (COMP) Professor Xiaoning Bi, PhD, MD, GCBS Assistant Professor Steve Standley, PhD, GCBS Research Assistant Professor Yubin Wang, PhD, and College of Pharmacy Assistant Professor Lyna Luo, PhD.

"In the brain there are two major isoforms of this enzyme, calpain-1 and calpain-2," Baudry said. "Calpain-1 and calpain-2 play opposite functions in both synaptic plasticity and learning and neurodegeneration. Calpain-1 is required for triggering synaptic plasticity and learning and memory. Calpain-2 limits the extent of synaptic plasticity and learning and memory. Calpain-1 is neuroprotective and calpain-2 is neurodegenerative."

Baudry and his team have identified a selective calpain-2 inhibitor, named NA 101, which is both neuroprotective and a cognitive enhancer when injected into mice. They tested NA 101's neuroprotective effects in two models - acute glaucoma produced by a transient increase in intraocular pressure, and traumatic brain injury. When injecting this molecule two hours after increasing intraocular pressure, it protected retinal ganglion cells from dying and protects vision. They had similar positive results with traumatic brain injury.

"We gave this magic molecule one hour after this insult, and we protected about 75 percent of neurons, which will die otherwise, and decreased brain lesion by 75 percent," Baudry said. "This is a degree of protection that I've never seen in the literature. We have really strong data showing that by blocking this calpain-2 enzyme we prevent the death of neurons."

Baudry and his WesternU team have joined forces with two business people, Dr. Bernard Malfroy-Camine (CEO, MindSetRx, MA) and Greg DiRienzo (CEO, ProgenaCell, CA), to form NeurAegis, a company that will develop the molecule. Baudry and his team filed a patent through WesternU claiming that selective calpain-2 inhibitors can enhance learning, be neuroprotective, and can be a useful treatment of a large number of diseases. NeurAegis and WesternU have agreed on the terms of an exclusive licensing agreement allowing NeurAegis to develop these molecules for the many possible indications. Under this agreement, WesternU becomes a shareholder of the company and is entitled to royalties generated from direct or indirect sales of NeurAegis products.

Aegis is the shield of the Greek god Zeus, so NeurAegis is focusing on neuroprotection. The company is the result of 35 years of research on the calcium-dependent protease calpain by Dr. Baudry and his collaborators.

"All of us are very excited about this, because creating NeurAegis not only crowns 35 years of basic research, but also fits perfectly with the translational strategy Western University of Health Sciences has been embarking on in recent years," Baudry said.

http://news.westernu.edu/westernu-team-seeks-magic-molecule-to-treat-traumatic-brain-injuries-strokes/

NeurAegis Presents Exciting Results for Treating Traumatic Brain Injury

Possible Treatment for Traumatic Brain Injury within 4 Hours of Insult

POMONA, CA / ACCESSWIRE / May 3, 2016 / Traumatic Brain Injury is a significant public health problem globally, affecting 10 million people annually and primary cause of injury-related deaths among young and older individuals. While there has been significant progress made in the understanding of the mechanisms underlying brain injury, most drug trials fail to demonstrate clinical efficacy.

NeurAegis is presenting results using its selective calpain-2 inhibitor, NA 101, on a mouse model of traumatic brain injury ("TBI") at the 6th Annual Traumatic Brain Injury Conference to be held in Washington, DC, May 11-12, 2016.

This conference brings together researchers and clinicians from industry, academia, military and government to discuss recent advances in diagnosis, treatment and long-term care of TBI patients. NeurAegis scientists have identified a critical enzyme, calpain-2, which activates early following brain trauma and is a major contributor to neuronal death. Moreover, NeurAegis scientists have also identified a selective calpain-2 inhibitor, NA 101, and NeurAegis CEO, Dr. Michel Baudry, will present the results obtained with NA 101 in a mouse model of TBI. NeurAegis NA 101 provides an unprecedented degree of neuroprotection when administered within one hour of brain trauma, and is still significantly neuroprotective if given within 4 hours of the trauma.

These results suggest it might be possible to protect soldiers, trauma patients and athletes from the debilitative effects of traumatic brain injury, if NA 101 or a similar molecule can be administered shortly after the injury. The company is currently pursuing the preclinical studies to bring a selective calpain-2 inhibitor to the clinic for the treatment of TBI or related acute trauma in the next 2-3 years.

NeurAegis was founded to translate fundamental discoveries on the mechanisms of synaptic plasticity and neuronal survival/cell death into clinical applications. These discoveries are the results of over 30 years of research by the scientific co-founders, Michel Baudry, PhD, Dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences and Xiaoning Bi, MD, PhD, Professor, College of Medicine, Western University of Health Sciences, directed at understanding the roles of selective biochemical cascades in both synaptic plasticity and neuroprotection/neurodegeneration.

NeurAegis has identified neuroprotection as a key focus for research and development, because of the high unmet needs and tremendous research potential in this therapeutic area. Much work has been conducted to identify the mechanisms underlying neuronal death and significant progress has been made over the last 10-20 years. Nevertheless, there is still no drug on the market that provides any significant degree of neuroprotection, especially within the crucial minutes to maximum of several hours following any brain insult that results in neuronal loss.

http://finance.yahoo.com/news/neuraegis-presents-exciting-results-treating-080000297.html

NeurAegis Presents New Results with NA 101 as Potential Treatment for Acute Glaucoma

NeurAegis recently reported results with its selective calpain-2 inhibitor, NA 101, on a mouse model of acute glaucoma in a publication in Neurobiology of Disease. NeurAegis scientists have identified a critical enzyme, calpain-2, which is activated early following increased IOP and is responsible for producing neuronal death. The company also found that a single systemic or intraocular injection of a selective calpain-2 inhibitor given 2 hours following increased IOP, prevented RGC death and loss of vision in mice. These results suggest the possibility of developing selective calpain-2 inhibitors for the treatment of acute glaucoma, according to a company news release.

The company is currently pursuing the preclinical studies required to bring a selective calpain-2 inhibitor to the clinic for the treatment of acute glaucoma within the next 2-3 years.

The study can be found here: http://www.sciencedirect.com/science/article/pii/S0969996116301012.

http://eyewiretoday.com/2016/05/19/neuraegis-presents-new-results-with-na-101-as-potential-treatment-for-acute-glaucoma

NeurAegis Presents Novel Technology at Defense Innovation Technology Acceleration Challenge in Austin, TX

POMONA, CA / ACCESSWIRE / December 5, 2016 / Leaders of the global innovation business and defense organizations and related industries met in Austin to accelerate technology solutions in all areas of defense, including energy, cyber, medical, materials and systems. NeurAegis was invited to present its technologies directed at diagnosing and treating various forms of acute neurodegeneration, including traumatic brain injury (TBI). NeurAgis is developing "Neuritus" and "NeuroP13BP" for the treatment and diagnosis of TBI and other neurodegenerative conditions.

To further its mission, NeurAegis has started the formation of a Board of Scientific Advisors (SAB) with the appointment of several distinguished academic and pharmaceutical scientists.

Philippe Bey, PhD

Dr. Bey has 45 years of experience in the biotechnology and pharmaceutical industry where he has participated in and led teams responsible for over 30 Investigational New Drug applications (INDs) in many therapeutic areas, including oncology, respiratory diseases, infectious diseases, inflammation, metabolic and central nervous system diseases. Dr. Bey served until October 2016 as Senior Vice President of R&D at Thrasos Therapeutics. Prior to joining Thrasos, Dr. Bey was the Chief Scientific Officer and Senior Vice President of R&D at ArQule. He also previously served as U.S. Senior Vice President of R&D at Hoechst Marion Roussel (HMR), now Sanofi.

Michael Palfreyman, PhD

Michael is a seasoned leader in the biotechnology and pharmaceutical industries with over 40 years' experience in leadership positions He currently serves as Director of Oculogics, Inc and is a Member of the Patent Review Board, Forsyth Dental Institute. In addition to these positions, he is the Head of R&D Diligence at Torrey Pines Investment and Senior R&D Diligence at ChemRar; Chief Scientific Officer at Amorsa Therapeutics, Inc., and the Chairman of the SAB and SVP Drug Development at Aminex Therapeutics, Inc. He also serves as Scientific Advisor for Avineuro, Inc., NeuroNascent, Inc., and Jasco Pharmaceuticals, Inc. Prior to entering the biotechnology industry in 1994 he was VP Research (North America) at the Marion Merrell Dow Research Institute.

Serge Bischoff, PhD

Dr. Serge Bischoff spent over 43 years in medical and pharmaceutical research in neurosciences. He spent most of his professional life in the large pharma industry (Synthélabo-Sanofi, Ciba-Geigy, Novartis), where he was Head of various research programs for psychiatric, neurological and neurodegenerative diseases. Author of several patents and over a hundred scientific publications and analysis articles, he is laureate of numerous awards including the Young Psychiatry Scientist Award by the Swiss Society of Psychiatry, the Leading Scientist Award at Novartis, the French National Contest of Creation of Innovative Enterprises, and very recently the World Contest of Innovation and the Valori Prize of the French Academy of Sciences.

Gary Lynch, PhD

Dr. Gary Lynch received his PhD at Princeton University and started his academic career at UC Irvine, where he contributed to making the Psychobiology Dept a world leader in neurosciences. For almost 50 years, his work has contributed to our understanding of the mechanisms of learning and memory, and more generally on how the brain processes information. He has published over 600 publications in top journals, has been invited to numerous Symposia and meetings all over the world, and is the inventor on numerous patents. He was the co-founder of several companies, including Synaptics, Inc., Cortex Pharmaceuticals, Thorus, Inc, and Tensor, Inc. His vast knowledge in neurosciences and his experience in translating basic findings into therapeutic applications make him a terrific asset for NeurAegis.

http://finance.yahoo.com/news/neuraegis-presents-novel-technology-defense-134000685.html

Publications

Wang, Y., Zhu, G., Briz, V., Hsu, Y.-T., Bi, X. and Baudry, M. A molecular brake controls the magnitude of long-term potentiation. Nature Communications 5, Article number: 3051; doi: 10.1038/ ncomms4051, 2014.

Wang, Y., Lopez, D., Davey, P., Cameron D.J., Nguyen, K., Tran, J., Marquez, E., Liu, Y., Bi, X. and Baudry, M. Calpain-1 and calpain-2 play opposite roles in retinal ganglion cell degeneration induced by retinal ischemia/reperfusion injury. Neurobiology of Disease 93: 121-128. 2016.

Baudry, M. and Bi, X. Calpain-1 and calpain-2: the yin and yang of synaptic plasticity and neurodegeneration. Trends in Neurosciences 2016 Feb 10. 39: 235-245. pii: S0166-2236(16)00020-5. doi: 10.1016/j.tins.2016.01.007, 2016.

Liu, Y., Wang, Y., Zhu, G., Sun, J., Bi, X. and Baudry, M. A calpain-2 selective inhibitor enhances learning and memory by prolonging ERK activation. Neuropharmacol. 105: 471-477, 2016.

Wang Y, Hersheson J, Lopez D, Ben Hamad M, Liu Y, Lee K-H, Pinto V, Seinfeld J, Wiethoff S, Sun J, Amouri R, Hentati F, Baudry N, Tran J, Singleton AB, Coutelier M, Brice A, Stevanin G, Durr A, Bi X, Houlden H and Michel Baudry M. Defects in the CAPN1 gene result in alterations in cerebellar development and in cerebellar ataxia in mice and humans. Cell Reports 16: 79-91, 2016.

Seinfeld, J., Baudry, N., Xu, X., Bi, X. and Baudry, M. Differential activation of calpain-1 and calpain-2 following kainate-induced seizure activity in rats and mice. eNeuro Sep 6;3(4). pii: ENEURO.0088-15.2016. doi: 10.1523/ENEURO.0088-15, 2016.

WesternU team seeks 'magic molecule' to treat traumatic brain injuries, strokes

Following a series of outstanding discoveries, five Western University of Health Sciences faculty are developing a "magic molecule" with the potential to treat traumatic brain injury, stroke, glaucoma, and disorders associated with learning impairment.

Graduate College of Biomedical Sciences (GCBS) Dean Michel Baudry, PhD is leading a team that includes College of Osteopathic Medicine of the Pacific (COMP) Professor Xiaoning Bi, PhD, MD, GCBS Assistant Professor Steve Standley, PhD, GCBS Research Assistant Professor Yubin Wang, PhD, and College of Pharmacy Assistant Professor Lyna Luo, PhD.

"In the brain there are two major isoforms of this enzyme, calpain-1 and calpain-2," Baudry said. "Calpain-1 and calpain-2 play opposite functions in both synaptic plasticity and learning and neurodegeneration. Calpain-1 is required for triggering synaptic plasticity and learning and memory. Calpain-2 limits the extent of synaptic plasticity and learning and memory. Calpain-1 is neuroprotective and calpain-2 is neurodegenerative."

Baudry and his team have identified a selective calpain-2 inhibitor, named NA 101, which is both neuroprotective and a cognitive enhancer when injected into mice. They tested NA 101's neuroprotective effects in two models - acute glaucoma produced by a transient increase in intraocular pressure, and traumatic brain injury. When injecting this molecule two hours after increasing intraocular pressure, it protected retinal ganglion cells from dying and protects vision. They had similar positive results with traumatic brain injury.

"We gave this magic molecule one hour after this insult, and we protected about 75 percent of neurons, which will die otherwise, and decreased brain lesion by 75 percent," Baudry said. "This is a degree of protection that I've never seen in the literature. We have really strong data showing that by blocking this calpain-2 enzyme we prevent the death of neurons."

Baudry and his WesternU team have joined forces with two business people, Dr. Bernard Malfroy-Camine (CEO, MindSetRx, MA) and Greg DiRienzo (CEO, ProgenaCell, CA), to form NeurAegis, a company that will develop the molecule. Baudry and his team filed a patent through WesternU claiming that selective calpain-2 inhibitors can enhance learning, be neuroprotective, and can be a useful treatment of a large number of diseases. NeurAegis and WesternU have agreed on the terms of an exclusive licensing agreement allowing NeurAegis to develop these molecules for the many possible indications. Under this agreement, WesternU becomes a shareholder of the company and is entitled to royalties generated from direct or indirect sales of NeurAegis products.

Aegis is the shield of the Greek god Zeus, so NeurAegis is focusing on neuroprotection. The company is the result of 35 years of research on the calcium-dependent protease calpain by Dr. Baudry and his collaborators.

"All of us are very excited about this, because creating NeurAegis not only crowns 35 years of basic research, but also fits perfectly with the translational strategy Western University of Health Sciences has been embarking on in recent years," Baudry said.

http://news.westernu.edu/westernu-team-seeks-magic-molecule-to-treat-traumatic-brain-injuries-strokes/