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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: 1R44AI140932-01A1
Agency Tracking Number: R44AI140932
Amount: $290,038.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-14
Award End Date (Contract End Date): 2020-08-31
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: (240) 454-8940
Research Institution

Project Summary Influenza virusINFVresults in global seasonal and pandemic outbreaks estimated to cause severe illness intomillion people annually resulting in significant morbidity and up todeathsThe influenza burden also results in substantial economic lossThe goal of this program is to develop a therapeutic antibody offering effective treatment with broad heterosubtypic specificity for influenza viruses without inducing resistanceOur therapeutic antibodyIhas shown broad neutralizing activity againststrains of INFV A Groupsandand both prophylactic and therapeutic protection in BALB c mouse models of HHHand HserotypesThis Fast track proposal is intended to establish a stable expressing cell line for manufacturingidentify an optimal product formulationcharacterize the dose response and tolerability of the product in nonclinical studiesand complete the mouse efficacy data packageCompletion of these milestones are critical for advancement to IND enabling studies and clinical developmentIbinds the stem of both the uncleaved HA precursor and two mature forms of HAeither after trypsin activation alone or when followed by low pH triggerIprevents both the dissociation of HAHAand the pH dependent HA rearrangement necessary for membrane fusionTargeting the highly conserved HA stem epitope is also expected to drastically reduce the likelihood of viral resistancea significant barrier to developing effective therapeutics for influenzaIntegrated BiotherapeuticsIBThas extensive experience in preclinical model and antibody product development for infectious diseasesDrHoltsberg and his team have extensive experience in providing services to pharma companies over the pastyears in the development and use of in vitro assays and animal models for testing influenza therapiesThis expertise is complimented by a strong strategic partnership with AbViro LLC with subject matter expertise specific to influenza and focus on integrated program management skillsetsextensive knowledge of preclinical product development and clinical scienceregulatory expertiseand business and commercialization strategy for broad spectrum antibodies capable of advancingIinto clinical studiesIBT will also collaborate with MassBiologicsIIT Research InstituteIITRIand La Jolla Institute for Allergy and ImmunologyLJIMassBiologics offers strong competency in stable cell line and manufacturing process developmentIIT Research InstituteIITRIprovides relevant highly pathogenic influenza strains and animal models essential for rigorous evaluation of product efficacyLJI provides core research functionality with next generation sequencing capabilitiesThis development team has successfully advanced another broad spectrum human monoclonal antibody targeting dengue virus to IND enabling studies Project Narrative Influenza virusINFVresults in global seasonal and pandemic outbreaks estimated to cause severe illness intomillion people annually and risk of mortalityparticularly in youngelderly and immunocompromised populationsAnnual vaccination efficacycurrently the most effective control measureis limited by the requirement for annual reformulation and re administration with variable efficacyPotency of existing therapeutic drugs is limited by virus adaptation and emergence of new strains with limited susceptibility to existing drugsThe goal of this program is to develop our lead therapeutic antibodyIoffering broad heterosubtypic effective treatment for both Groupandinfluenza A viruses regardless of group specificitywithout inducing virus resistanceCompletion of the proposed work will positionIfor advancement into IND directed studies

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

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