[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Page 14689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05146]


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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unpublished patent applications.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.

Genomic Sequence of Avian Paramyxovirus Type 2 and Uses Thereof

Description of Technology

    As a first step towards characterizing the molecular genetics and 
pathogenesis of avian paramyxovirus type 2 (APMV-2), the biological 
activities and growth characteristics of APMV-2 were investigated. The 
present inventors found that APMV-2 is different than Newcastle Disease 
Virus (NDV, AMPV-1) in several characteristics: (I) APMV-2 does not 
require trypsin or allantoic fluid to grow in cell culture; (II) 
previous RNA-RNA hybridization studies showed APMV-2 is genetically 
different than NDV; (III) APMV-2 is the only paramyxovirus serotype 
which causes single-cell infection foci in cell culture, and does not 
induce cell fusion, which is a hallmark of paramyxovirus infection; 
(IV) APMV-2 does not kill chicken embryos; and (V) APMV-2 does not grow 
in the brain of chickens.
    These results suggested that APMV-2 is significantly different 
biologically and genetically from NDV. These differences provide 
certain advantages over other viruses considered for use as a vaccine, 
as a virus vector, or as a therapeutic. For example, unlike the current 
NDV vaccine such as LaSota and Hitchner B1 that can cause disease due 
to reversion to virulence, since AMPV-2 is not an agricultural 
pathogen, it is not a concern for the poultry industry. Unlike many 
strains of NDV, APMV-2 is not a Select Agent.
    However, in order to develop a recombinant APMV-2 virus for use as 
a vector, vaccine, or cancer therapy, the complete genome sequence was 
needed, and a reverse genetic system needed to be developed. Sequence 
analysis proved to be difficult since primers based on NDV were not 
useful because the two viruses are genetically different. Therefore, 
different strategies had to be used for primer design, including the 
design and testing of consensus primers from other paramyxoviruses, 
primers based on gene start and gene end sequences of other 
paramyxoviruses, and primer walking.
    This invention covers the complete genomic sequence of avian 
paramyxovirus type 2, strains Yucaipa, England, Kenya and Bangor. The 
genomic sequence of strain Yucaipa was used to develop a reverse 
genetic system for AMPV-2. This produced cDNA-derived AMPV-2 with the 
same properties as biologically-derived AMPV-2, confirming the 
authenticity of the genomic sequence. The sequence and reverse genetic 
system are useful for production of recombinant infective virus, a 
virus vector, for vaccine development and for therapeutic compositions. 
The sequences are also useful for development of viral diagnostics. The 
recombinant APMV-2 was used to express a foreign antigen, the green 
fluorescent protein (GFP), and can be used as a vaccine vector. 
Recombinant APMV-2 can also be used in cancer treatment, similar to 
NDV.
    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 therapeutics
 Viral diagnostics
 Vaccine research

Competitive Advantages

 Ease of manufacture
 Low-cost vaccine
 Adjuvants unnecessary

Development Stage

 In vivo data assessment (animal)

    Inventors: Siba Samal (EM), Peter Collins (NIAID).
    Intellectual Property: HHS Reference No. E-019-2018-0--U.S. 
Provisional Application No. 61/218,851, filed June 19, 2009, HHS 
Reference No. E-019-2018-1--U.S. Patent Application No. 12/803165, 
filed June 21, 2010, now U.S. Patent No. 9,937,196.
    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: March 2, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-05146 Filed 3-12-20; 8:45 am]
 BILLING CODE 4140-01-P