Development of a therapeutic monoclonal antibody for the treatment of myocardial infarction and heart failure
Grant Award Details
Grant Type:
Grant Number:
CLIN1-15399
Investigator(s):
Disease Focus:
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
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.