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NovaGo Therapeutics: Developing Human Antibody Therapeutics Targeting Cerebral Stroke and Spinal Cord Injury to Stimulate Nerve Repair and Regeneration

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“A strategic partnership with Neurimmune Holding AG supported the development of a novel class of human-derived anti-Nogo-A antibodies with exceptional therapeutic properties using the Reverse Translational Medicine™ (RTM™) technology platform.”

Stroke the most common causes of disability worldwide, according to the World Health Organization (WHO). Stroke is a leading cause of adult disability and represents a major health problem worldwide, with an estimated 17 million people suffering a first stroke each year. The current standard of care has significant shortcomings, leaving more than 50% of all stroke patients severely and permanently disabled. Stroke often creates life-long functional impairment and burden to the victims, the wider society and healthcare providers. This chronic disease generates tremendous direct as well as indirect costs for the public health system and economy, with per-patient costs running into millions.

In adulthood, we cannot regenerate axons within the central nervous system (CNS), therefore, making any damage to it remains permanent and leads to the loss of sensory and motor neurons function below the site of injury and it can be crippling to person’s health. Spontaneous recovery can occur from plastic changes but it is limited. The absence of regeneration is due to the inhibitory environment and factors of the CNS as well as the inherent inability of CNS axons to form growth cones. Amongst many factors, one crucial factor is the inhibitory signal of the CNS environment is the myelin-associated Nogo proteins. Nogo-A, Nogo-B, and Nogo-C stimulate the Nogo receptor, inhibiting neurite outgrowth by causing growth cones to collapse through activation of Rho Kinase (ROCK). This is where recombinant human monoclonal antibodies can be used to target this signaling pathway by binding to Nogo (especially Nogo-A) and thus promote the outgrowth of neuronal axons in the CNS. This use of anti-Nogo antibodies has been shown to up-regulate CNS regeneration.

NovaGo Therapeutics is one such biotech start-up dedicated to the development of human antibody therapeutics targeting cerebral stroke to stimulate nerve repair and regeneration. The firm partners with Neurimmune to provide access to a unique class of human-derived antibodies with exceptional therapeutic properties generated through their Reverse Translational Medicine™ (RTM™) technology platform. The founding and management team has a proven track record in research and drug development.

Eduardo Vianna: Interview Highlights

Q. What was the reason behind the genesis of NovaGo Therapeutics? What is the reason behind providing dedicated treatments for stroke injuries?

Stroke affects approximately 33 million patients worldwide, with 17 million new cases per year. NovaGo’s anti-Nogo-A regenerative antibody therapy is expected to improve the functionality of severe stroke patients, therefore giving them a higher quality of life and less dependence on expensive assistance and nursing homes. Our anti-Nogo-A therapy represents a novel, regenerative approach that may potentially lead to the recovery of function. The successful commercialization of this therapeutic strategy would not only open up a substantial market opportunity for anti-Nogo-A therapy but also be a real clinical breakthrough.

Q. Can you tell us about your company’s successful journey to date?

Damage to the brain or spinal cord causes a massive, often life-long drop in the quality of life and render affected people dependent on costly aid by society. The restricted repair capacity and lacking regeneration in the central nervous system (i.e. brain and spinal cord) represent a major reason for the low degree of recovery following damage to the brain and spinal cord. The protein-rich myelin present in the CNS actively inhibits nerve fiber growth after injury. This concept was discovered by the company’s co-founder and President, Martin E. Schwab.

We focused on Nogo-A, the most potent and best-studied nerve fiber growth inhibitor to date is a transmembrane protein predominantly expressed by oligodendrocyte myelin in the adult central nervous system. Nogo-A as a highly potent inhibitor of nerve fiber growth has opened up the potential for designing and testing Nogo-targeted intervention strategies in the context of spinal cord and brain injuries. Neutralization of Nogo-A by specifically targeted antibodies blocking its function has been shown to lead to long-distance regeneration of injured nerve fibers as well as compensatory sprouting of intact fibers.

NovaGo Therapeutics AG has closed a Series-A financing round of CHF 10 million early 2019. The proceeds will be used to develop NovaGo’s regenerative therapeutics towards clinical trials and have allowed us to identify and characterize a human monoclonal anti-Nogo-A antibody and is currently finalizing preclinical toxicology studies to initiate clinical trials. The lead indication for this antibody program is stroke, based on the most impressive preclinical animal data for this indication and because of the large unmet medical need.

Q. Can you brief us about your strategic partnership with Neurimmune?

A strategic partnership with Neurimmune Holding AG supported the development of a novel class of human-derived anti-Nogo-A antibodies with exceptional therapeutic properties using the Reverse Translational Medicine™ (RTM™) technology platform. This platform is based upon the finding that selected elderly and healthy subjects produce antibodies against proteins and provide the ability to identify specific immune cell clones harboring the genetic information for target-selective antibodies. The use of fully human monoclonal antibodies for the treatment of human diseases has principal advantages over-engineered antibodies derived from mice or libraries, including human affinity maturation and tolerance selection.

Q. What makes your company standout from the competition?

The approach of NovaGo Therapeutics differs significantly from historical thrombolytic and neuroprotective attempts for stroke therapy. NovaGo’s lead antibody targets the neurite growth inhibitor Nogo-A, the most potent known neurite growth inhibitory factor in the central nervous system. The anti-Nogo-A antibody therapy represents a novel approach that promotes the central nervous system’s regenerative healing process and neurological recovery after stroke.

NovaGo’s anti-Nogo-A therapy represents the first regenerative approach to stroke. Furthermore, based on animal data and early clinical data, NovaGo’s potential regenerative therapy could be the first pharmacological therapy with the potential to address recovery of function in acute ischemic stroke, and even in the chronic phase post-stroke.

Q. What are your plans for the future development of your company?

NovaGo Therapeutics has initiated a series B financing round. The proceeds of this financing round will be used to support the company’s lead anti-Nogo-A antibody clinical development program.

If you are interested in learning more regarding NovaGo Therapeutics and its investment opportunity, please contact : info@novagotherapeutics.com

www.novagotherapeutics.com

The Ingenious Leadership Behind the Triumph of NovaGo Therapeutics

Eduardo Vianna: Eduardo Vianna, Ph.D., MBA, serves as the Chief Executive Officer of NovaGo Therapeutics. He is a neuroscientist with more than 10 years of experience in research, drug development, and portfolio management. Before joining NovaGo, he held global positions of increasing responsibility within Product Development at several major pharmaceutical companies. He has an established network of industry contacts across the pharmaceutical industry from his previous assignments. Mr. Vianna earned his Ph.D. in Neuroscience from the University of Iowa, USA, and an MBA from the Open University, United Kingdom.

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Professor Martin E. Schwab: Professor Martin E. Schwab, Ph.D., hon. MD is the Founder and President of NovaGo Therapeutics. He is a key opinion leader in the field of spinal cord and brain injury and repair and holds faculty positions at both the University of Zurich and ETH Zurich, Switzerland. He discovered the existence of “inhibitors of neurite growth” as a cause of the absent regeneration of injured fiber tracts in the central nervous system. An important breakthrough, honored by numerous international prizes, was the demonstration that blocking the most potent of those nerve fiber growth inhibitors, Nogo-A, led to regeneration and functional repair in animal models of stroke and spinal cord injury. These findings disrupted the dogma that nerve fibers in the brain and spinal cord would be unable to repair and regenerate.

“Our anti-Nogo-A regenerative antibody therapy is expected to improve the functionality of severe stroke patients, therefore giving them a higher quality of life and less dependence on expensive assistance and nursing homes.”