[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Page 7821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02971]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve 
expeditious commercialization of results of federally-funded research 
and development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing and/or co-development.

ADDRESSES: Information on licensing, co-development research 
collaborations, and/or copies of the U.S. patent applications listed 
below may be obtained by contacting: Attn. Invention Development and 
Marketing Unit, Technology Transfer Center, National Cancer Institute, 
9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, 
Tel. 240-276-5515 or email [email protected]. A signed 
Confidential Disclosure Agreement may be required to receive copies of 
the patent applications.

FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent 
application or inquiries about licensing and/or co-development should 
be sent to John D. Hewes, Ph.D., email: [email protected].

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Modified griffithsin tandemers for enhanced 
activity and reduced viral aggregation.
    Description of Technology: Griffithsin (GRFT) is a lectin with 
potent antiviral properties that is capable of preventing and treating 
infections caused by a number of enveloped viruses (including HIV, 
SARS, HCV, HSV, and Japanese encephalitis) and is currently in clinical 
development as an anti-HIV microbicide. In addition to its broad 
antiviral activity, GRFT is stable at high temperature and at a broad 
pH range, displays low toxicity and immunogenicity, and is amenable to 
large-scale manufacturing. Native GRFT is a domain-swapped homodimer 
that binds to viral envelope glycoproteins and has displayed mid-
picomolar activity in cell-based anti-HIV assays. This invention is 
directed to synthetic proteins that comprise two (or more) obligate 
monomers (``mGRFT'') joined by an amino acid linker to form tandemers 
(``mGRFT tandemers''). Each obligate monomer is generated by the 
addition of Gly-Ser residues in the hinge region of wild-type GRFT. Two 
or more obligate monomers are joined by an amino acid linker to form 
the mGRFT tandamers. The properties of the mGRFT tandemers can be 
modulated by the length of the amino acid linker and the number of 
obligate monomers co-joined. mGRFT tandemers exhibit gore potent anti-
viral properties when compared against native GRFT and are equipotent 
against viruses that are both sensitive and resistant to naive GRFT. As 
such, potential uses of the invention tandemers include topical and 
intravenous therapy to treat HIV infection, particularly to treat HIV 
infections that are resistant to native GRFT.

Potential Commercial Applications

 Broad-spectrum antiviral agent similar to wild type GRFT
 Potential activity against SARS CoV, MERS, Ebola, HCV and 
influenza

Value Proposition

 Broad antiviral activity
 Stable at high temperature and at a broad pH range
 Displays low toxicity and immunogenicity.

    Development Stage: In vivo/Lead Validation.
    Inventor(s): Barry R. O'Keefe (NCI), A. Wlodawer (NCI), T. Moulaei 
(NCI).

Publication(s)

--Moulaei T. et al., Griffithsin tandemers: flexible and potent 
lectin inhibitors of the human immunodeficiency virus. 
Retrovirology. 2015 Jan 23;12:6.
--A. Chatterjee et al.,Griffithsin and Carrageenan Combination To 
Target Herpes Simplex Virus 2 and Human Papillomavirus, Antimicrob 
Agents Chemother. 2015 Dec; 59(12): 7290-7298.

Intellectual Property

    HHS Reference No. E-034-2013/0-US-01.
    PCT Application No. PCT/US2014/040992 (HHS Reference No. E-034-
2013/0- US-01) filed June 5, 2013 entitled ``Modified griffithsin 
tandemers for enhanced activity and reduced viral aggregation''.
    Licensing and Collaborative/Co-Development Research Opportunity: 
Researchers at the NCI seek licensees and/or co-development partners 
for the commercialization of Griffithsin and Griffithsin tandemers, 
specifically, additional studies on stability, toxicity, 
immunogenicity, and large-scale production.

    Dated: February 1, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-02971 Filed 2-12-16; 8:45 am]
 BILLING CODE 4140-01-P