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Development of a Universal Immunotherapeutic for Influenza Viruses

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI140932-02
Agency Tracking Number: R44AI140932
Amount: $1,535,553.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-04-08
Award End Date (Contract End Date): 2023-03-31
Small Business Information
Gaithersburg, MD 20878-1757
United States
DUNS: 601000750
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (240) 778-6523
Business Contact
Phone: (301) 644-3910
Research Institution

Project Summary
Influenza virus (INFV) results in global seasonal and pandemic outbreaks estimated to cause
severe illness in 3 to 5 million people annually resulting in significant morbidity and up to 650,000
deaths. The influenza burden also results in substantial economic loss. The goal of this program
is to develop a therapeutic antibody offering effective treatment with broad heterosubtypic
specificity for influenza viruses without inducing resistance. Our therapeutic antibody (3I14) has
shown broad neutralizing activity against 14 strains of INFV A Groups 1 and 2 and both
prophylactic and therapeutic protection in BALB/c mouse models of H1, H3, H5 and H7 serotypes.
This Fast-track proposal is intended to establish a stable expressing cell line for manufacturing,
identify an optimal product formulation, characterize the dose response and tolerability of the
product in nonclinical studies, and complete the mouse efficacy data package. Completion of
these milestones are critical for advancement to IND-enabling studies and clinical development.
3I14 binds the stem of both the uncleaved HA precursor and two mature forms of HA, either after
trypsin activation alone or when followed by low-pH trigger. 3I14 prevents both the dissociation of
HA1-HA2 and the pH-dependent HA rearrangement necessary for membrane fusion. Targeting
the highly conserved HA stem epitope is also expected to drastically reduce the likelihood of viral
resistance, a significant barrier to developing effective therapeutics for influenza.
Integrated Biotherapeutics (IBT) has extensive experience in preclinical model and antibody
product development for infectious diseases. Dr. Holtsberg and his team have extensive
experience in providing services to pharma companies over the past 8 years in the development
and use of in vitro assays and animal models for testing influenza therapies. This expertise is
complimented by a strong strategic partnership with AbViro LLC with subject matter expertise
specific to influenza and focus on integrated program management skillsets, extensive knowledge
of preclinical product development and clinical science, regulatory expertise, and business and
commercialization strategy for broad-spectrum antibodies capable of advancing 3I14 into clinical
studies. IBT will also collaborate with MassBiologics, IIT Research Institute (IITRI) and La Jolla
Institute for Allergy and Immunology (LJI). MassBiologics offers strong competency in stable cell
line and manufacturing process development. IIT Research Institute (IITRI) provides relevant
highly pathogenic influenza strains and animal models essential for rigorous evaluation of product
efficacy. LJI provides core research functionality with next-generation sequencing capabilities.
This development team has successfully advanced another broad-spectrum human monoclonal
antibody targeting dengue virus to IND-enabling studies.

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

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