Heartland Virus Humanized Monoclonal Antibodies for Diagnostic and Therapeutic Development

Heartland virus (HRTV) is a novel tick-borne virus first discovered in 2009 that causes flu-like symptoms such as fever, headaches, fatigue, muscle aches, and diarrhea. Patients with HRTV often have low white blood cell counts, low platelet counts, and abnormal liver function tests which can become severe. Cases of Heartland virus disease have been identified in the Midwestern and southern United States. There are no vaccines to prevent or medications to treat Heartland virus infections. HRTV presents symptoms and generates a similar immune response to other tick-borne viruses, making diagnosis difficult. In order to develop a diagnostic assay that can detect HRTV and distinguish it from other infections, CDC scientists developed and characterized anti-HRTV murine monoclonal antibodies. These monoclonal antibodies (mAbs) react to the viral nucleocapsid (N) protein. The mouse monoclonal antibodies can detect both recent and past infections with specificity to HRTV in diagnostic assays developed by the CDC. These monoclonal antibodies can be engineered to have the murine variable regions reactive with the viral antigen cloned for use as positive controls in assays to detect recent and past infections in humans. These mAbs have been integrated by CDC’s diagnostic lab into a multi-bead array assay, IgM antibody capture ELISA (MAC-ELISA) and IgG ELISA for the detection of recent and past HRTV infections for diagnostic purposes. In addition, research with the humanized antibodies can be done to determine their usefulness as a therapeutic in humans for HRTV infection.

Potential Commercial Applications:		Competitive Advantages:
Development of immunoassay diagnostics in IgG and IgM ELISA formats and other serological diagnostics (e.g., immunofluorescence, multi-bead array, and lateral flow assays for point of care diagnostics) for Heartland virus infections Development of immunoassay diagnostics for the detection of severe fever with thrombocytopenia syndrome virus (SFTSV), another tick-borne virus similar to HRTV Research tools to characterize this newly discovered virus which causes severe diseases in humans Tick-borne virus monitoring programs Development of therapeutics to treat Heartland virus infections in humans		The only characterized antibodies against HRTV Potential use as a diagnostic, therapeutic, or research tool Differentiation between recent and past infections Ability to perform diagnostic assay without biosafety level 3 containment Currently, no diagnostic tests exist for HRTV except for plaque reduction neutralization tests MAb 2AF11 is the only mAb available in the U.S. that recognizes both HRTV and SFTSV, the latter which has caused several thousand cases of severe disease throughout China, Korea and Japan

Related Invention(s):
E-269-2013-0


Inventors:

Amanda Calvert (CDC)  ➽ more inventions...

Aaron Brault (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 10,584,161 issued 2020-03-10
PCT Application No. PCT/US2016/013073
US Application No. 15/761,789

Publications:
CDC FAQs cdc.gov/heartland-virus/index.html
Calvert, A., et al. PMID 26503274

Collaboration Opportunity:
The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Heartland Virus Humanized Monoclonal Antibodies for Diagnostic and Therapeutic Development. For collaboration opportunities, please contact CDC Technology Transfer Office at tto@cdc.gov or 1-404-639-1330.


Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-293-2014-1
Updated: Feb 14, 2018