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Humanized EMAP II mAb as a Novel Therapy for Viral-Associated Lung Injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL135945-01A1
Agency Tracking Number: R41HL135945
Amount: $281,155.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-15
Award End Date (Contract End Date): 2020-01-31
Small Business Information
Cleveland, OH 44122-5344
United States
DUNS: 078891800
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (317) 291-4843
Business Contact
Phone: (216) 455-3200
Research Institution
United States

 Nonprofit College or University

Summary Abstract
The ultimate goal of this project is the validation of a humanized endothelial monocyteactivating protein IIEMAP IIneutralizing monoclonal antibodymAbfor progression to
clinical evaluation as a novel treatment for patients with influenza associated lung injuryInfection with influenza virusIAVremains a major world wide health threat to high risk
populations including the young and elderlypregnant womenand people with weakened
immune systemsAccording to CDC datainfluenza accounts for more thandeaths in US
annually due to underlying respiratory and circulatory causesThe efficiency of influenza
vaccination and antiviral drugs is compromised by the constant change in circulating viruses and
the development of resistance in influenza virus strainsAllinaire TherapeuticsLLC is developing
a first in class therapy which will not depend on the suppression of virus replicationand will be
independent of the circulating influenza strainRatherthe EMAP II mAb will target the pathogenic
components of lung injuryincluding vascular endothelium apoptosis and leakageWe
hypothesize that EMAP II is a key underlying factor in IAV induced lung injuryand that a
humanized EMAP II mAb will attenuate the development and serious consequences of lung
damage produced by IAVHere we present preliminary data demonstrating that IAV induced
pathologies are associated with dramatic increases in levels of EMAP II in the lungand that
administration of a rodent EMAP II mAb to influenza AIAVinfected mice ameliorates lung injuryImportantlywe have competed the creation of a fully humanized version of the EMAP II mAba
crucial step towards targeting EMAP II clinically and creating a novel medicineTo evaluate our
hypothesis and meet our drug discovery milestoneswe plan to validate our humanized EMAP II
mAb candidates in vitro in human lung cells exposed to IAV and recombinant EMAP IIAimand select the most potent and efficacious mAb to be tested in vivo in our established murine
model of IAV induced lung injuryAimNarrative
The goal of this project is the validation of a fully humanized EMAP II antibody for progression to
clinical evaluation as a first in class treatment for patients with influenza associated lung injuryAn EMAP II targeted therapy will directly protect the lung from injury regardless of viral strain and
represents a paradigm shift in the treatment of viral respiratory infections

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

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