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  1. FDA Technology Transfer Program

Therapeutic Hepatitis C Virus Antibodies

Therapeutic Hepatitis C Virus Antibodies

Therapeutic antibodies against Hepatitis C Virus (HCV) have not been very effective in the past and there is evidence that this may result in part from interfering antibodies generated during infection that block the action of neutralizing antibodies. These neutralizing antibodies prevent HCV infection of a host cell.

The subject technologies are monoclonal antibodies against HCV that can neutralize different genotypes of HCV. Both antibodies bind to the envelope (E2) protein of HCV found on the surface of the virus. One of the monoclonal antibodies neutralizes HCV genotype 1a, the most prevalent HCV strain in the U.S., infection and in vitro data show that it is not blocked by interfering antibodies. The second antibody binds a conserved region of E2 and can cross neutralize a number of genotypes including genotypes 1a and 2a. The monoclonal antibodies have the potential to be developed either alone or in combination into therapeutic antibodies that prevent or treat HCV infection. These antibodies may be particularly suited for preventing HCV re-infection in HCV patients who undergo liver transplants; a population of patients that is especially vulnerable to the side effects of current treatments for HCV infection.

Potential Commercial Applications:

  • Therapeutic antibodies for the prevention and/or treatment of HCV infection.

Competitive Advantages:

  • Therapeutic antibodies have generally fewer side effects than current treatments for HCV infection.
  • Potential to be developed into an alternative treatment for HCV infected liver transplant patients, who often cannot tolerate the side effects of current drug treatments.

Stephen Feinstone
Hongying Duan
Marian Major
Pei Zhang
Alla Kachko

Intellectual Property:
US Application No. 14/401,648
PCT Application No. PCT/US12/62197
PCT Application No. PCT/US13/41352

Kachko A, et al. PMID 22041300
Duan H, et al. PMID 22973024

Licensing Contact:
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-002-2012/0
Updated: August 5, 2015