# IND-enabling development for IN-002, an inhaled muco-trapping mAb against respiratory syncytial virus

> **NIH NIH R44** · INHALON BIOPHARMA, INC. · 2022 · $1,023,232

## Abstract

Project Summary
Respiratory Syncytial Virus (RSV) is the leading cause of viral death in infants and young children, and is
also a major cause of respiratory illness in immune compromised adults and the elderly. Unfortunately, there is
currently no vaccine or effective therapy available for RSV. Synagis, a monthly intramuscular injection of the
monoclonal antibody (mAb) palivizumab, is the only FDA-approved intervention, but can only be used for
prevention and is given only to a very small subset of high-risk infants. Synagis is not effective at treating RSV
after infection has begun. Thus, for the tens of thousands hospitalized with RSV, only supportive therapy is
available; the resulting morbidity and mortality are substantial, particularly among the immunocompromised.
Interestingly, RSV spreads in the lung via shedding of virus exclusively into the airway; thus, RSV must
traverse the airway mucus (AM) before infecting other neighboring cells, and remains restricted to the airways
with little-to-no systemic viremia. This unique pathophysiology makes RSV difficult to target by systemically
dosed therapies. We believe an RSV-specific, safe and effective antiviral therapy that can be inhaled directly
into the respiratory tract would provide a powerful option addressing the current gap in pharmacological
interventions. To meet this goal, Inhalon has been advancing IN-002, developed using its proprietary and
patented “muco-trapping” mAb technology platform. IN-002 is a potent anti-F mAb with picomolar binding
affinity and neutralization potency, has minimal risk of viral escape, and possess suitable Fc N-glycosylation for
trapping RSV in AM. In turn, trapped RSV are quickly purged from the airways via natural mucociliary
clearance mechanisms. We have further formulated IN-002 to be stably nebulized using a vibrating mesh
nebulizer. By concentrating IN-002 directly at the site of infection, rather than delivering the mAb systemically,
we expect to enable efficacious and cost-effective treatment of RSV, with little risk of adverse side effects due
to limited systemic adsorption from pulmonary delivery. In a neonatal lamb model of RSV infection, daily
nebulized therapy with IN-002 initiated even at near peak viral titers in the lung was able to reduce infectious
RSV viral load in the lungs and BALF to almost non-detectible levels within 3 days. Inhalon is currently actively
engaging in cell line development for IN-002. To enable rapid translation into the clinic, we seek to complete
the cell line development in this proposal, and produce tox materials suitable for IND-enabling activities such
as Tissue Cross Reactivity studies, GLP pulmonary tox studies, and GLP nebulization characterization studies.
Together, the proposed work will support rapid advancement of IN-002 into clinical testing. Our work here with
RSV will also help pave the way for improved, molecularly-targeted, inhaled therapies for other respiratory
pathogens.

## Key facts

- **NIH application ID:** 10385558
- **Project number:** 1R44AI167461-01
- **Recipient organization:** INHALON BIOPHARMA, INC.
- **Principal Investigator:** JEFF T HUTCHINS
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,023,232
- **Award type:** 1
- **Project period:** 2022-07-12 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10385558

## Citation

> US National Institutes of Health, RePORTER application 10385558, IND-enabling development for IN-002, an inhaled muco-trapping mAb against respiratory syncytial virus (1R44AI167461-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10385558. Licensed CC0.

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