Apr 5, 2023
Treating Respiratory Diseases & Inflammation w/ Stan Miele of Aqualung Therapeutics
- BRT S04 EP14 (176) 4-2-2023
Things We Learned This Week
- Aqualung Therapeutics is treating inflammation in the lungs, getting people off ventilators (cut down 50%) & saving lives
- ARDS - Acute Respiratory Disease Syndrome - serious lung condition that causes low blood oxygen & fluid in the lungs
- Aqualung's novel therapeutics are also reversing fibrosis / scar tissue in lungs - could be used in future to treat other diseases
Guest:
Stan
Miele
President & CBO
Aqualung Therapeutics Corp
LKIN: HERE
Stan Miele Bio:
A recognized global executive with success in sales, marketing and P&L leadership in the pharmaceutical/medical device and biotech industries. Mr. Miele was formally the Chief Commercial Officer at bioLytical Laboratories and Sucampo Pharmaceuticals Inc. He was also President of Sucampo Pharma Americas for 6 years. He was instrumental on some key licensing agreements for Sucampo, inclusive of the agreement with Abbott Japan, and also Takeda Pharmaceuticals (now Shire). He is actively part of the team ensuring proper execution of clinical development, manufacturing, licensing, capital funding, alliances, and ensuring Aqualung meets all critical milestones. He will be helping the company move toward accelerating the pipeline/platform technology and moving eNamptor™ toward commercialization.
Joe G.N. “Skip” Garcia, MD
FOUNDER & CHIEF
EXECUTIVE OFFICER
Joe G. N. "Skip" Garcia, MD, is an internationally-noted pulmonary
physician-scientist, an endowed professor of medicine at the
University of Arizona College of Medicine – Tucson, and an elected
member of the National Academy of Medicine. A noted academic health
system administrator, scholar and educator, Dr. Garcia is a leading
authority on the genetic basis of lung disease and the prevention
and treatment of inflammatory lung injury. Dr. Garcia is
internationally recognized for development of novel biomarkers and
therapies for critically ill patients with acute inflammatory lung
disease and for addressing health disparities in vulnerable
populations. He has over 575 peer-reviewed publications, an
expansive portfolio of NIH-sponsored research, and continues to
direct large federally-funded programs.
Aqualung Therapeutics
Aqualung Therapeutics (ALT) is developing multi-pronged strategies to address the development of severe lung inflammation which is essential to the severity and outcomes of acute and chronic lung disorders such as acute lung injury, ventilator-induced lung injury (VILI), idiopathic pulmonary fibrosis, and pulmonary hypertension. Effective FDA-approved drugs are either currently unavailable or extraordinarily modest in their ability to modify disease progression. No drug is currently available that is preventive or curative. Aqualung’s strategies, which include deployment of a human monoclonal antibody which targets a novel inflammatory mediator (nicotinamide phosphoribosyltransferase or NAMPT) will address the unmet need for novel, effective therapies for VILI, IPF, and pulmonary hypertension.
Notes:
Seg 1
Cornerstone of health tech comes from biotech & spin offs from incubator universities – an idea with proof of concept becomes a company
NIH investment – National Institute of Health has different divisions & a governing body, they review grant submissions from University level inception of biotech
The idea is then sold to large pharmaceutical co. – the process is very expensive, takes decades of R & D to bring a product to market
Grants – R41 or R42 as examples of investment from NIH
NIH works w/ startups, biotech & universities – helps w/ early funding of $ thousands to millions
Supports basic science & research, to fund an initial scientific thesis, this is pre-clinical and non-dilutive capital from NIH or Government
This is important, because venture capital can be brought to raise more funding, and not be concerned with NIH having an equity position
Aqualung is working on Unchecked or runaway inflammation in the lungs and body
Deals with Fibrosis, scar tissue in lungs for example
ARDS - Acute Respiratory Distress Syndrome - serious lung condition that causes low blood oxygen & fluid in the lungs
Aqualung Founder is Dr. Joseph Garcia, a physician / scientist who worked in ICU
Their treatment can help with Covid 19 or Pneumonia
Mechanical Ventilation (ventilator) – keeps patient alive, but exacerbates inflammation, 30-40% of death w/ ARDS the long one stays on a ventilator
Aqualung – novel therapies to treat ARDS, with a 1X infusion & reduce inflammation, takes 20 mins. to administer, and can lessen days on a ventilator, saving lives less days
Seg. 2
Covid 19 & ARDS – pneumonia & sepsis hypoxia – less oxygen & oxygenated blood flow, not enough, leads to fluid in lungs (edema), have nasal issues, use C pap machine, but if too severe then need ventilator to help w/ breathing
Pulmonary edema is often caused by congestive heart failure. When the heart is not able to pump efficiently, blood can back up into the veins that take blood through the lungs. As the pressure in these blood vessels increases, fluid is pushed into the air spaces (alveoli) in the lungs.
Covid – when people have severe Covid, lungs have too much fluid, do not work
Ventilator increases significant inflammation – too much, storm of bad events, organs fail. Bottome line: Longer on ventilator, the worse things go
Average ICU stay is 11-15 days for ARDS
Aqualung tamps down inflammation, ‘turn dial down’ w/drug, within 6hrs. of diagnosis, Aqualung should be given to a patient
Reduce inflammation 50% & then reduce time 50% on vent.
Life & Money saving as 1 day on ventilator = $30k
Other areas Aqualung can help – fibrosis / Scar tissue in lungs, Covid long syndrome & could be a Radial therapy for cancer treatment
Aqualung – tamp down inflammation to Reverse fibrosis, reverse course of diseases
Also can assist with - Lupis, inflamed organs, Bowel diseases
Aqualung has been funded by Funded by NIH
Seg. 3
Aqualung produces Novel therapeutics, that can save lives, and help with breathing disorders or illnesses related to Covid or asthma, or Fibrosis in the lungs, kidney, or cardiac issues
Aqualung Therapeutics is agnostic, process can treat all fibrosis as well as help prevent Organ failure. If inflammation or breathing issues persist can lead to failure of liver, kidney, then heart & brain
Aqualung eliminated fibrosis in kidneys with testing on animals
Improve functions of other organs in pre-clinical models in small & large animals
Currently doing doses on human volunteers, and will soon be in 8 hospitals in U.S. & 2 in Australia
Aqualung needs more funding for research, and is doing a Capital raise
Future versions of their treatment could be in different formats, using IV version now in ICU & ER
Other companies working on this type of research and care are Humira, treatment is a simple injection monthly
Aqualung could be additional therapy for Pulmonary issues, or even a Radial therapy for cancer
Multiple forms of delivery are possible like an in home injection
Seg. 4
Received $25 million of non dilutive from NIH
Had to validate their thesis, and was published in 10 publications
Aqualung considered an IND (investigative new drug)
Studies –
Phase 1 – healthy
Phase 2 – ARDS patients
Phase 3 - 2 – 300 patients – large trial
Need funding of $ hundreds millions – for testing IPO or series A-B & C fund raise
Current trials will be a 5 year process thru 2026
Overall a 8-10 year process w/ 2-3 year studies, stats (genomics & priobiomics)
MRNA work done years before to create the vaccine for COVID so luckily it was ready to go in 2020
Alignment on big pharma with this research and application, working in Oncology, immunology, cancer
Fibrosis & immunology – Co’s that can come in are Regeneron, Eli Lilly or Merch
Big Pharma – equity investment has a venture arm within a corporation, to invest in thesis and then pre-human clinical round
Called the ‘Creeping Acquisition Strategy’ of a smaller company, with incremental investments until own the whole business
ARDS – 500k patients in US dealing with ARDS & $2 mil globally, of which 30-40% will die. ARDS is a multi billion $ year market. ARDS grows 3-5% per year, with funding being a problem, plus other issues like limited therapies
Companies working on the disease, must collaborate with the FDA
Aqualung – raising funds, $10 mil series A, has $4 mil committed end of phase 1 with FDA meeting.
Phase 2 study – get rolling & crucial long term, need clinical tests w/ humans
Phase 1 study w/ animals very successful
** Thanks to Joan Kerber-Walker of AZ Bio for the intro to Stan.
AZ Bio & Life Sciences Innovation w/ Joan Koerber-Walker
- BRT S04 EP10 (172) 3-5-2023
FULL Show w/ Joan of AZ Bio: Click HERE
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*Includes Best of AZ Tech Council show from 2/12/2023
Tech Topic: HERE
Best of Tech: HERE
‘Best Of’ Topic: https://brt-show.libsyn.com/category/Best+of+BRT
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