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    Date submitted
  • 13-Nov-2017

Lung Injury Therapeutic Antibody

Abstract

Aqualung Therapeutics (ALT) is an Arizona-based startup company developing a human therapeutic monoclonal antibody (mAb) to treat ventilator-induced lung injury (VILI). The company seeks exit prior to Phase III clinical trials (late 2021), through licensing or acquisition by a large biopharmaceutical company.

Additional Questions

Who is your customer?

Hospital/ICU: Mechanical Ventilation (MV) is routinely used in hospitals and intensive care units (ICU) for both simple and highly complex surgeries (over 20M cases in US/year, 0.01-6% mortality) and in the ICU (1.1M cases in US/year, 5-30% mortality). VXB is an innovative mAb therapy that will create a new market and overtake existing, ineffective symptom-oriented therapies.

What problem does this idea/product solve or what market need does it serve?

Mechanical ventilation (MV) is routinely used in hospitals for both simple and highly complex surgeries and is a life-saving supportive therapy for ICU patients with respiratory failure who are unable to maintain adequate breathing on their own. Although a necessary form of life support, MV can worsen lung injury contributing to the unacceptably high 30% mortality rates in critically ill patients. MV use also results in extended ICU days and extraordinary healthcare costs (12% of all hospital costs, $29.6 billion/year). Currently, there are no FDA-approved drugs to limit or prevent VILI.

What attributes will make this idea/product successful? Why do you believe that those features will create success?

ALT has identified a novel therapeutic target, NAMPT, that is critical to the development of VILI. NAMPT is a protein that is secreted into the bloodstream in response to exposure to mechanical ventilation and potently induces lung inflammation. ALT has developed a human monoclonal antibody (Enamptcumab, ENB) that neutralizes circulating NAMPT, thus reducing the incidence of VILI and potentially improving survival in the critically ill and in patients undergoing complicated surgeries. ENB is an innovative, prophylactically-administered mAb therapy given at the time the patient is intubated and placed on MV. ENB is a novel therapy to address a serious unmet medical need, reduce ICU mortality, and reduce healthcare costs.

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

ALTʼs CEO, Dr. Garcia is a pulmonary and critical care physician-scientist and a leading authority on the genetics, prevention and treatment of inflammatory lung injury. His laboratory first identified NAMPT as a viable target in VILI and in critical care illnesses. He is the inventor of an issued U.S. Patent on "Methods and Compositions involving NAMPT/PBEF inhibitors for lung inflammation" and Aqualung has an exclusive license from University of Arizona/TechLaunch Arizona and has several jointly-owned antibody composition patents with Gennova Biopharmaceuticals to be filed Q4-2017.