[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52697-52698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18861]


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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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[[Page 52698]]

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: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and 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.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Vaccines for HIV.
    Description of Technology: Although the development of an effective 
HIV vaccine has been an ongoing area of research, the high variability 
in HIV-1 virus strains has represented a major challenge in successful 
development. Ideally, an effective candidate vaccine would provide 
protection against the majority of clades of HIV. Two major challenges 
are immunodominance and sequence diversity. One strategy for overcoming 
these two issues is to identify the conserved regions of the virus and 
exploit them for use in a targeted therapy.
    Researchers at the National Cancer Institute's Vaccine Branch used 
conserved elements (CEs) of the polypeptides Gag and Env as immunogenic 
compositions to induce an immune response to HIV-1 envelope 
polypeptides and Gag polypeptides. conserved elements (CEs) of the 
polypeptides Gag and Env as immunogenic compositions to induce an 
immune response to HIV-1 envelope polypeptides and Gag polypeptides. 
This invention is based, in part, on the discovery that administration 
of one or more polypeptides comprising CEs, separated by linkers and 
collinearly arranged, of HIV Env or Gag CE proteins can provide a 
robust immune response compared to administration of a full-length Env 
or Gag protein. The Env-CE DNA vaccines were tested in a rhesus macaque 
model and were able to induce a cellular and humoral immune response in 
this model whereas vaccination with the full length DNA did not produce 
the same effect.
    A robust increase in immunity was observed when rhesus macaques 
were subjected to a prime-boost protocol. First, rhesus macaques were 
primed with Env-CE DNA and boosted with full length Env resulting in an 
observed increase in both the cellular and humoral responses. A further 
increase in immune response was observed from priming with CE and 
boosting with a combination of CE and full length DNA resulting in a 
significantly improved breadth of immune responses. These improved 
protocols may help solve the immunodominance problem observed in 
current protocols. This is considered a major obstacle for HIV vaccine 
development. The CE vaccines described by this invention have potential 
for use as prophylactic and therapeutic HIV vaccines.
    Potential Commercial Applications:
     HIV vaccines
    Value Proposition:
     Addresses two key hurdles faced by current HIV vaccines: 
sequence diversity of HIV and immunodominance.
     Induces cross-clade specific immune response.
     The prime-boost immunization regimen is not limited to 
HIV, but can be employed to improve the induction of immune responses 
to any subdominant epitopes (cellular or humoral) to increase breadth, 
magnitude and quality of the immune response.
    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): George Pavlakis, Barbara Felber, Antonio Valentin, 
James Mullins.
    Intellectual Property: HHS Reference #E-087-2015/0-US-01, 
corresponding to U.S. Provisional Patent App. #62/161,123, filed on May 
13, 2015, entitled: HIV Env Conserved Element DNA Vaccine.
    HHS Reference #E-009-2016/0-US-01, corresponding to U.S. 
Provisional Patent App. #62/241,599, filed on October 14, 2015, 
entitled: Prime-Boost combination vaccine to Expand Breadth of 
Immunological Response.
    HHS Reference #E-087-2015/0-PCT-02; corresponding to International 
Patent App. #PCT/US2016/032317; filed on May 13, 2016, entitled: 
Methods and Compositions for inducing an immune response using 
Conserved Element Constructs.

Publications

 Kulkarni, V. et al. PLoS One;9:e86254. 2014. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0086254
 Kulkarni, V. et al. PLos One Oct 22;9(10):e111085. doi: 
10.1371/journal.pone.0111085. eCollection, 2014. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111085

    Related Technologies: HHS Reference #E-132-2012/0 Method of 
Altering the Immunodominance Hierarchy of HIV Gag by DNA Vaccine 
Expressing Conserved Regions.
    Contact Information: Requests for copies of the patent application 
or inquiries about licensing, research collaborations, and co-
development opportunities should be sent to John D. Hewes, Ph.D., 
email: [email protected].

    Dated: August 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-18861 Filed 8-8-16; 8:45 am]
 BILLING CODE 4140-01-P