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An immunotherapeutic IgY formulation against norovirus diarrhea

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI172485-01A1
Agency Tracking Number: R41AI172485
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-11
Award End Date (Contract End Date): 2024-07-31
Small Business Information
Hagerstown, MD 21740-5071
United States
DUNS: 080733930
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (585) 857-9237
Business Contact
Phone: (585) 820-9937
Research Institution
BLACKSBURG, VA 24061-6100
United States

 Nonprofit College or University

Project Summary/Abstract for STTR Phase I Application: An immunotherapeutic IgY formulation
against norovirus diarrhea
Human norovirus (HuNoV) infects millions of people globally each year, causing diarrheal illness
resulting in more than 200,000 deaths annually, particularly in the very young, the very old, and the
immunocompromised. There is currently neither an effective vaccine nor effective treatment for
HuNoV infections. Compounding the problem is the fact that HuNoV strains mutate rapidly and
unpredictably, which can reduce the impact of any targeted therapeutic when faced with novel
emerging strains. This proposal’s long-term objective is to evaluate a novel approach to the
prevention or treatment of HuNoV diarrhea: using anti-HuNoV antibodies, purified from eggs of hens
immunized with nanoparticles representing multiple strains of HuNoV, to provide “passive immunity”
to the intestinal tract. These antibodies are called “IgY” to indicate that they are immunoglobulins from
egg yolks. The applicant has already demonstrated that anti-HuNoV IgY can stop HuNoV viruses
from replicating in a human intestinal cell model, and this project is the natural extension of that work.
The project’s Specific Aim 1 is to produce and thoroughly characterize IgY produced against three
different strains of the predominant HuNoV viral genotype, GII.4. By using so-called “P24”
nanoparticles representing all three strains as the immunizing antigens, the IgY produced will target
all three variants, offering a proof that broad-spectrum protection can be achieved using inexpensive
and readily-produced antigens. Once the antibodies have been characterized and their ability to bind
to and inhibit all three viral strains has been established, the project’s Specific Aim 2 will be to
evaluate the protective effect of the anti-HuNoV antibodies in a gnotobiotic pig model that has been
shown to recapitulate human HuNoV diarrhea. Pigs will be pre-treated for one day with the active
antibodies or control (unimmunized) antibodies, and then will be infected with a large dose of one
HuNoV GII.4 variant. The animals’ signs and symptoms of diarrhea will be monitored for an additional
seven days, to help us understand both how well the treatment prevented diarrhea, and in those
animals that develop diarrhea, how well it minimizes the disease severity or duration. If the project
successfully demonstrates significant protection against HuNoV in this model, human safety,
tolerability, and effectiveness studies will be performed, ultimately resulting in regulatory approval to
use anti-HuNoV IgY to prevent and/or treat HuNoV diarrhea. Such a readily available treatment is
expected to significantly reduce human suffering and provide substantial societal benefit, especially
among the most vulnerable populations in the US and around the world.

* Information listed above is at the time of submission. *

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