# Development of highly potent human monoclonal for RSV immuno-prophylaxis

> **NIH NIH R44** · MAPP BIOPHARMACEUTICAL, INC. · 2021 · $801,020

## Abstract

PROJECT SUMMARY
Respiratory syncytial virus (RSV) is a leading cause of infant hospitalizations in the U.S., and the disease
burden among the elderly is similar to non-pandemic influenza A. Traditional strategies have failed to generate
an effective RSV vaccine, and in some instances vaccination resulted in enhanced disease, underscoring the
complexity of the human immune response to RSV. Although a prophylactic antibody is available (palivizumab,
a humanized mouse mAb marketed by MedImmune as Synagis®), its high cost and modest efficacy have
restricted its use to high-risk infants. Moreover, due to this high cost, palivizumab is inaccessible to children in
developing nations and is unavailable in 4 of the 5 most populous countries – more than half the world’s
population does not have access to this type of treatment.
The public health benefit and the worldwide accessibility would undoubtedly be improved by lowering the cost
of RSV immunoprophylaxis. In this Phase 2 proposal, the University of Texas at Austin, Adimab (Lebanon,
NH), Einstein College of Medicine (The Bronx, NY) and Mapp Biopharmaceutical, Inc. (San Diego, CA),
teamed to develop a fully human, highly potent mAb that can be administered in a single dose per RSV
season. With a more potent mAb (i.e. lower dose) that can be dosed less frequently (due to extended serum
half-life), the team’s objective is to dramatically lower the price and increase the availability of RSV
immunoprophylaxis. In addition, competition in the marketplace may also help to reduce costs and increase
accessibility globally, especially since palivizumab currently has a monopoly on the RSV market. Our Phase 1
effort identified 3 lead candidates (from a panel of 445 mAbs), all of which are dramatically more potent in vitro
and in vivo than palivizumab. Further, these mAbs have similar neutralization activity to AstraZeneca’s second
generation RSV mAb MEDI8897 (currently in late stage clinical development) against the 5 RSV strains tested
to date. After the success of these Phase 1 efforts, we propose the following Specific Aims for Phase 2: 1)
Select a lead candidate based on breadth and potency of neutralization activity against a panel of clinical
isolates; 2) Generate a CHO cell line appropriate for GMP manufacture; 3) Manufacture for IND-enabling
studies; 4) Conduct IND-enabling studies.

## Key facts

- **NIH application ID:** 10208698
- **Project number:** 5R44AI136272-04
- **Recipient organization:** MAPP BIOPHARMACEUTICAL, INC.
- **Principal Investigator:** Larry Zeitlin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $801,020
- **Award type:** 5
- **Project period:** 2018-01-15 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10208698

## Citation

> US National Institutes of Health, RePORTER application 10208698, Development of highly potent human monoclonal for RSV immuno-prophylaxis (5R44AI136272-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10208698. Licensed CC0.

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