2022 AZBio Fast Lane Award: Aqualung Therapeutics
Channel: AZ Bio
Date: 2022-10-03

When Every Breath Matters

Acute Respiratory Distress Syndrome (ARDS) occurs when severe inflammation causes fluid to leak from the bloodstream into the tiny air sacs in your lungs. This impedes your lungs from adequately filling with air thereby limiting oxygen from reaching the blood and vital organs seriously impairing their function. 

ARDS affects approximately 500,000 patients a year, numbers that have dramatically increased during the COVID-19 pandemic. ARDS carries a staggering mortality rate of 30-40% and the majority of COVID-related deaths are due to ARDS. Sadly, today there are no FDA-approved therapies for ARDS other than supportive care and the use of mechanical ventilation when the fluid-filled lungs completely fail.

Aqualung Therapeutics is an early stage immunotherapeutics biotech company that has developed an anti-inflammatory therapeutic platform whose centerpiece is a humanized monoclonal antibody (ALT- 100 mAb) that targets a potent inflammation-inducing protein, eNAMPT, a master regulator of runaway inflammation. This novel ALT- 100 mAb therapeutic is effective for multiple serious inflammatory disorders, however, Aqualung’s lead indication for ALT-100 mAb is ARDS. ALT-100 carries the promise of reducing inflammation, reducing patient days on mechanical ventilation, and ultimately improving ARDS survival. While other ARDS therapies have been explored (stem cells, anti-IL-6 and anti-GMCSF mAbs), these have largely failed in clinical trials. ALT-100 mAb has proven efficacy in a large animal ARDS model that reflects human ARDS with dramatic improvement in multiple indices of lung and systemic inflammation.

Aqualung’s CEO and Founder, Joe GN Garcia MD, is a physician-scientist with a career-long research focus on inflammation and ARDS that led to his identification of eNAMPT as a novel ARDS target. Aqualung is the world’s leader in developing eNAMPT-targeted therapies and has completed cGMP ALT-100 manufacturing allowing initiation a “First-In-Human” Phase 1A clinical trial in Australia. In this trial, ALT-100 mAb dosing of the first cohort is complete, a highly significant milestone and value inflection point. 

Aqualung’s enjoys strong collaboration with the University of Arizona College of Medicine and Tech Launch Arizona. The company has a strong patent portfolio with 4 patents issued covering ALT-100 mAb composition of matter and method of use patents issued for ARDS, lung fibrosis and pulmonary hypertension with multiple patents pending. Aqualung recently closed a $3.1M convertible note and is expected to close the first tranche of a $10M Series A raise in mid-September.

Aqualung has received ~$28M dollars in non-dilutive NIH grant awards, highlighting the superior scientific thesis of targeting eNAMPT and the utility of ALT-100 mAb. Multiple peer-reviewed reports (published or pending publication) detail the effectiveness of ALT-100 mAb treatment in preclinical models of ARDS, pulmonary hypertension, prostate cancer, and diseases characterized by organ fibrosis (lung, liver, heart) such autoimmune diseases and NASH.

“Our physicians need more effective medicines to help patients who are struggling for breath due to ARDS,” stated Joan Koerber-Walker, President & CEO of AZBio. “Aqualung Therapeutics is being honored with a 2022 AZBio Fast Lane Award for their work to develop new health solutions that can help patients and their care teams when every breath matters.”

SOURCE: AZBio