Treating Respiratory Diseases & Inflammation w/ Stan Miele of Aqualung Therapeutics - BRT S04 EP14 (176) 4-2-2023

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

www.aqualungtherapeutics.com

 

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

 

 

 

AZ Tech Council Shows: HERE

*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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