Development of a therapeutic monoclonal antibody for the treatment of myocardial infarction and heart failure

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Grant Award Details

Grant Number:
CLIN1-15399
Investigator(s):
Award Value:
$5,999,998
Status:
Pre-Active

Grant Application Details

Application Title:

Development of a therapeutic monoclonal antibody for the treatment of myocardial infarction and heart failure

Public Abstract:
Therapeutic Candidate or Device

Fully Humanized monoclonal antibody targeting human ectonucleotide pyrophosphatase/phosphodiesterase (ENPP1)

Indication

Heart Disease: To prevent the development of heart failure after heart attacks

Therapeutic Mechanism

After myocardial infarction, myofibroblast progenitors express ENPP1. ENPP1 is a type II transmembrane protein that hydrolyzes extracellular ATP and hydrolytic products generated by ENPP1 initiate an inflammatory cascade that worsens cardiac repair. The monoclonal antibody would bind to and inhibit ENPP1 on myofibroblast progenitors to decrease inflammation and scarring and augment heart repair and post injury heart function after myocardial infarction.

Unmet Medical Need

Approximately 7 million people in the United States have heart failure (HF) and once a diagnosis of HF is made, approximately 50% survive 5 years. Heart attacks contribute between 40-70% of all cases of HF. The agent being developed will prevent the development of HF after heart attacks.

Project Objective

IND filing

Major Proposed Activities

  • Manufacturing of biologic to support IND enabling studies
  • IND enabling GLP toxicity studies
  • GMP preparation and production of drug substance and product
Statement of Benefit to California:
Cardiovascular disease remains a leading cause of death in California and accounts for nearly one third of all deaths. The prevalence of heart disease is close to 25% in individuals above the age of 75 and 7% of individuals above the age of 65 suffer from heart failure. Heart attacks are the leading cause of heart failure and the therapeutic agent developed here will prevent the development of heart failure after heart attacks and of immense benefit to Californians.