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Preclinical development of an important, broad-spectrum antibody for pandemic influenza

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI157074-02
Agency Tracking Number: R44AI157074
Amount: $999,635.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-259
Timeline
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-06-12
Award End Date (Contract End Date): 2025-05-30
Small Business Information
CELDARA MEDICAL, LLC
Lebanon, NH 03766-1441
United States
DUNS: 828763263
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 COLLEEN COOPER
 (617) 320-8521
 cdc@celdaramedical.com
Business Contact
 JAKE REDER
Phone: (617) 320-8521
Email: jr@celdaramedical.com
Research Institution
N/A
Abstract

Health and human services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA) have suggested a severe pandemic influenza outbreak is the greatest current threat to national and global security. The Center for Disease Control rates H7N9 as the most threatening of the Influenza A viruses as it, along with H5N1, have fatality rates of ~40% and ~60%, respectively. Models have predicted that an H7N9 pandemic could result in infection of one third of the world population and death of ~40% of those infected, making it the deadliest virus in recorded history (the 1918 flu had a fatality rate of ~2.5%). There is currently no approved therapeutic for severe influenza infection, and in the case of H7N9 ~98% of those infected develop severe infection and require hospitalization. This project seeks to provide some hope of protection in such an outbreak by advancing the most effective broad-spectrum human antibody therapeutic currently available, CM-IAV1. CM-IAV1 has great promise since it has already been shown to protect mice against lethal (non-laboratory strain) H7N9 and H5N1 when given in a single dose 72 hours post-infection. We have assembled a world-class team with outstanding preclinical data and are now focused on advancing CM-IAV1 into the clinic. The experiments presented in this application will take a promising laboratory product and, together with our continued and parallel investments, create a clinical asset with enormous potential to reduce morbidity and mortality associated influenza infection from the most relevant CDC- prioritized pandemic strains. We believe that development of this antibody, at this time, and by this team represents the best hope of offering meaningful lifesaving protection against the terrifying possibility of a global Influenza A outbreak. The overarching goal of this project is to advance a novel broad-spectrum, lifesaving therapeutic for pandemic influenza A infection from promising preclinical candidate through investigational new drug (IND)-enabling studies to IND filing.

* Information listed above is at the time of submission. *

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