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

> **NIH NIH R44** · CELDARA MEDICAL, LLC · 2022 · $300,000

## 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.

## Key facts

- **NIH application ID:** 10480298
- **Project number:** 1R44AI157074-01A1
- **Recipient organization:** CELDARA MEDICAL, LLC
- **Principal Investigator:** Colleen Doyle Cooper
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2022-04-25 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10480298

## Citation

> US National Institutes of Health, RePORTER application 10480298, Development of CM-IAV1 for Treatment of High-risk Pandemic Influenzas (1R44AI157074-01A1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10480298. Licensed CC0.

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