[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Page 50666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21768]


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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 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.

FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301-594-8730; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Attenuated Human Parainfluenza Virus Type 1 Expressing Ebola Virus 
Glycoprotein GP as an Intranasal Ebola Vaccine

    Description of Technology: Ebola virus (EBOV) hemorrhagic fever is 
one of the most lethal viral infections and lacks a licensed vaccine. 
EBOV is transmitted by contact with body fluids from infected 
individuals including droplets or aerosols. Aerosolized EBOV could also 
be exploited for intentional virus spread. Therefore, vaccines that 
protect against mucosal and systemic exposure are needed.
    The NIH/NIAID has developed recombinant human parainfluenza virus 
type 1 (rHPIV1) bearing a stabilized attenuating mutation in the P/C 
gene to express the membrane-anchored form of EBOV glycoprotein GP as 
an intranasal (IN) EBOV vaccine. GP was codon optimized and expressed 
either as a full-length protein or a chimeric form in which its 
transmembrane and cytoplasmic tail (TMCT) domains were substituted with 
those of the HPIV1 F protein in an effort to increase packaging into 
the vector particle and enhance immunogenicity. GP was inserted either 
preceding the N gene (pre-N) or between the N and P genes (N-P) of 
rHPIV1. All vectors replicated to high titers in vitro and had stable 
GP expression. Viruses were attenuated and replicated at low titers in 
the respiratory tract of African green monkeys. Two doses of candidates 
expressing GP from the pre-N position elicited higher GP neutralizing 
serum antibody titers than the N-P viruses, and unmodified GP induced 
higher levels than its TMCT counterpart. Unmodified EBOV GP was 
packaged into the HPIV1 particle, and the TMCT modification did not 
increase packaging or immunogenicity. Overall, the candidate expressing 
full-length GP from the Pre-N position was the most immunogenic.
    This invention relates to an attenuated and immunogenic IN vaccine 
candidate expected to be well tolerated in humans and is available for 
clinical evaluation.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.
    Potential Commercial Applications:

 Viral diagnostics
 Vaccine research

    Competitive Advantages:

 Ease of manufacture
 Bivalent or Multivalent live attenuated vaccines
 B cell and T cell activation
 Low-cost vaccines
 Intranasal administration/needle-free delivery

    Development Stage:

 In vivo data assessment (animal)

    Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Ursula 
Buchholz (NIAID), Peter Collins (NIAID).
    Publications: ``Attenuated Human Parainfluenza Virus Type 1 
Expressing Ebola Virus Glycoprotein GP Administered Intranasally Is 
Immunogenic in African Green Monkeys,'' Lingemann M, Liu X, Surman S, 
Liang B, Herbert R, Hackenberg AD, Buchholz UJ, Collins PL, Munir S. J 
Virol. 2017 Apr 28;91(10). pii: e02469-16. doi: 10.1128/JVI.02469-16. 
Print 2017 May 15. PMID: 28250127.
    Intellectual Property: HHS Reference No. E-142-2018/0.
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; [email protected].

    Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-21768 Filed 10-5-18; 8:45 am]
 BILLING CODE 4140-01-P