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Development of CM-IAV1 for Treatment of High-risk Pandemic Influenzas

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI157074-01A1
Agency Tracking Number: R44AI157074
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-259
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-04-25
Award End Date (Contract End Date): 2023-03-31
Small Business Information
16 CAVENDISH CT
Lebanon, NH 03766-1441
United States
DUNS: 828763263
HUBZone Owned: Yes
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

Project Summary
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 is a broadly neutralizing human monoclonal that is cross-reactive for
group 1 and group 2 avian influenza. CM-IAV1 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. To leverage this
outstanding preclinical data, we have assembled a world-class team that is focused on advancing CM-IAV1
into the clinic. The experiments presented in this application will take a promising preclinical agent 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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