# SBIR: In vivo validation and IND-enabling development of MM004, a bispecific inhaled immunotherapy for RSV and MPV

> **NIH NIH R44** · MUCOMMUNE, LLC · 2021 · $306,500

## Abstract

Project Summary
Respiratory syncytial virus (RSV) and metapneumovirus (MPV) are the two leading viral causes of death in
infants and young children, and are major causes of respiratory illness in immunocompromised adults and the
elderly. Unfortunately, there is currently no vaccine or effective therapy available for either infection. Synagis, a
monthly intramuscular injection of the monoclonal antibody (mAb) palivizumab, is the only FDA-approved
intervention given to a very small subset of high-risk infants as immunoprophylaxis. However, it is not effective
at treating RSV infections. There are no MPV treatments currently in any stage of clinical development. Thus,
for the tens of thousands of patients hospitalized for either RSV or MPV, only supportive therapy is available,
and morbidity and mortality are substantial. Interestingly, both viruses spread in the lung by shedding daughter
viruses exclusively into the airway lumen; shed viruses must then traverse airway mucus (AM) before
infecting neighboring cells, and infections remain primarily restricted to the airways with little to no systemic
viremia. We believe a virus-specific, safe, effective and topically-delivered antiviral would provide a powerful
option to address the current gap in pharmacological interventions. Mucommune is developing MM004 to meet
the urgent need for a bronchiolitis treatment, based on our “muco-trapping” mAb platform. MM-004 is a topical
mAb treatment based on (i) bispecific mAb possessing “muco-trapping” Fc and binding domains that
neutralizes both RSV and MPV, and (ii) direct delivery to the lung airways using a vibrating mesh nebulizer. By
concentrating MM004 at the site of infection rather than delivering it systemically, we expect to enable
efficacious and cost-effective treatment for both RSV and MPV, with little risk of adverse side effects, due to
limited systemic adsorption after pulmonary delivery. In RSV-infected neonatal lambs, a highly relevant model
for pediatric RSV, our muco-trapping mAb against RSV greatly reduced infectious RSV viral load in infected
neonatal lambs in lung tissues to non-detectible levels, and reduced bronchiolitis, neutrophil infiltration and
inflammation to levels that were often indistinguishable compared to uninfected animals. Building off this
promising result, we have now engineered a bispecific mAb (MM-004) that potently traps both RSV and MPV
in human AM and facilitates rapid clearance from the mouse lung. In this proposal, we seek to validate in
Phase 1 whether MM004 can effectively treat MPV infections in hamsters, the best available model for MPV. If
successful, we will advance to Phase 2, where we will develop a Master Cell Bank cell line for high yield
production of MM-004 (Aim 1), and conduct a number of IND-enabling studies including, GLP tox studies in
rats, tissue cross reactivity studies, and pre-IND filing (Aim 2). Both Phase 2 Aims are part of the critical path
to quickly advance MM-004 into clinical development...

## Key facts

- **NIH application ID:** 10157638
- **Project number:** 1R44AI157661-01
- **Recipient organization:** MUCOMMUNE, LLC
- **Principal Investigator:** RICHARD CONE
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $306,500
- **Award type:** 1
- **Project period:** 2021-03-04 → 2022-09-03

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157638

## Citation

> US National Institutes of Health, RePORTER application 10157638, SBIR: In vivo validation and IND-enabling development of MM004, a bispecific inhaled immunotherapy for RSV and MPV (1R44AI157661-01). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10157638. Licensed CC0.

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