Immuno-modulation based

Prevention and Treatment of Heart Failure

Leveraging recent findings in cardio-immunology, we have developed a first in class immunomodulatory molecule to prevent and treat heart failure.

Heart Failure Death Rate per 100,000 (any mention), All Ages, All Races/Ethnicities, Both Genders, 2014-2016. View interactive map

The problem

We are losing the fight against heart failure

• 6,000,000 Americans have heart failure

• This costs our nation >$30bn/year

• 50% of patients have a form of heart failure for which we have no treatment (HFpEF)

• Despite receiving state of the art care, each year 160,000 Americans develop heart failure after a heart attack

We need new tools to prevent and treat heart failure.

The Opportunity

B-lymphocytes as a therapeutic target

Emerging research suggests that B cell modulation could prevent heart failure after heart attacks and treat HFpEF

The Strategy

Optimize Pirfenidone, a promising B cell targeting drug with poor pharmacokinetics

FDA approved B-lymphocyte targeting drugs

Pirfenidone is an ideal starting point to develop a novel B cell modulating small molecule to prevent and treat heart failure.

The Solution

Optimize Pirfenidone through conjugation

Pirfenidone is limited by:

  1. short half-life

  2. CNS penetration

We eliminate the known shortcomings of Pirfenidone by adding a small PEG chain (<500 kD)

  • Tried and true method to extend half-life, and reduce CNS penetration of suitable small molecules

  • Does not reduce bioavailability after oral administration

Seeing the Light

We have identified a PEGylated Pirfenidone superior to Pirfenidone

Better tolerated

in vivo

More cardioprotective

in vivo

Composition of matter IP and multiple potential applications

Intellectual property

  • Patentability and FTO assessment performed by Global Patent Group, LLC

  • FTO cleared and path identified for broad composition of matter IP protection

  • Patent application filed by WashU in July 2018, key claims upheld by international searching authority

  • i-Cordis, LLC has exclusive option to license IP

Potential applications

  • Prevention of post MI heart failure

  • Treatment of HFpEF (see Pirouette trial)

  • Treatment of Muscular dystrophy associated cardiomyopathy (Orphan indication, see Pirfenidone in mdx mice)

  • Prevention of Post-op Afib (see Pirfenidone studies in dogs)

  • Prevention/treatment of Immunotherapy associated myocarditis

  • Treatment of Idiopathic pulmonary fibrosis (current application of Pirfenidone)

  • Etc.

Fit for the Task

Meet The Team

Douglas Mann, MD

Lewin Distinguished Professor of Cardiovascular Disease;Professor of Medicine, Cell Biology, and Physiology, Washington University School of Medicine

Luigi Adamo, MD, PhD

Heart Failure Specialist and Director for Cardiac Immunology at Johns Hopkins University.Expert in myocardial B cells

Jennifer Riggs, PhD

21 years experience; lead chemist for 2 successful PEG small molecules at Nektar Therapeutics

Bradley Keller, PhD

Drug development expert;30+ years in pharma;7+ years in small/startup biopharma companies

Roland Dolle, PhD

Medicinal Chemist and inventor of Pegydone;25+ years experience, 8 INDs, 1 marketed drug

Jennifer Baltz, PhD

Harvard-trained biochemist;Serial entrepreneur;Phase I SBIR PI