83 FR 50666 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 195 (October 9, 2018)

Page Range		50666-50666
FR Document		2018-21768

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.

Federal Register, Volume 83 Issue 195 (Tuesday, October 9, 2018)

[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Page 50666]
From the Federal Register Online  [www.thefederalregister.org]
[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unpublished patent applications.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

50666 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices

interpretation or other reasonable of the most lethal viral infections and Inventors: Shirin Munir (NIAID),
accommodations, should indicate the lacks a licensed vaccine. EBOV is Matthias Lingemann (NIAID), Ursula
special accommodation when transmitted by contact with body fluids Buchholz (NIAID), Peter Collins
registering online or by notifying from infected individuals including (NIAID).
Jennifer Gillissen at jennifer.gillissen@ droplets or aerosols. Aerosolized EBOV Publications: ‘‘Attenuated Human
kauffmaninc.com by October 25. could also be exploited for intentional Parainfluenza Virus Type 1 Expressing
Authority: The National Clinical Care virus spread. Therefore, vaccines that Ebola Virus Glycoprotein GP
Commission is required under the National protect against mucosal and systemic Administered Intranasally Is
Clinical Care Commission Act (Pub. L. 115– exposure are needed. Immunogenic in African Green
80). The Commission is governed by The NIH/NIAID has developed Monkeys,’’ Lingemann M, Liu X,
provisions of the Federal Advisory recombinant human parainfluenza virus Surman S, Liang B, Herbert R,
Committee Act (FACA), Public Law 92–463, type 1 (rHPIV1) bearing a stabilized Hackenberg AD, Buchholz UJ, Collins
as amended (5 U.S.C., App.) which sets forth
attenuating mutation in the P/C gene to PL, Munir S. J Virol. 2017 Apr
standards for the formation and use of federal
advisory committees. express the membrane-anchored form of 28;91(10). pii: e02469–16. doi: 10.1128/
EBOV glycoprotein GP as an intranasal JVI.02469–16. Print 2017 May 15. PMID:
Dated: October 1, 2018. 28250127.
(IN) EBOV vaccine. GP was codon
Don Wright, optimized and expressed either as a full- Intellectual Property: HHS Reference
Deputy Assistant Secretary for Health length protein or a chimeric form in No. E–142–2018/0.
(Disease Prevention and Health Promotion). which its transmembrane and Licensing Contact: Peter Soukas, J.D.,
[FR Doc. 2018–21854 Filed 10–5–18; 8:45 am] cytoplasmic tail (TMCT) domains were 301–594–8730; peter.soukas@nih.gov.
BILLING CODE 4150–32–P substituted with those of the HPIV1 F Collaborative Research Opportunity:
protein in an effort to increase The National Institute of Allergy and
packaging into the vector particle and Infectious Diseases is seeking statements
DEPARTMENT OF HEALTH AND enhance immunogenicity. GP was of capability or interest from parties
HUMAN SERVICES inserted either preceding the N gene interested in collaborative research to
(pre-N) or between the N and P genes further develop, evaluate or
National Institutes of Health commercialize for development of a
(N-P) of rHPIV1. All vectors replicated
Government-Owned Inventions; to high titers in vitro and had stable GP vaccine for respiratory or other
Availability for Licensing expression. Viruses were attenuated and infections. For collaboration
replicated at low titers in the respiratory opportunities, please contact Peter
AGENCY: National Institutes of Health, tract of African green monkeys. Two Soukas, J.D., 301–594–8730;
HHS. doses of candidates expressing GP from peter.soukas@nih.gov.
ACTION: Notice. the pre-N position elicited higher GP Dated: September 25, 2018.
SUMMARY: The invention listed below is neutralizing serum antibody titers than Suzanne M. Frisbie,
owned by an agency of the U.S. the N-P viruses, and unmodified GP Deputy Director, Technology Transfer and
Government and is available for induced higher levels than its TMCT Intellectual Property Office, National Institute
licensing to achieve expeditious counterpart. Unmodified EBOV GP was of Allergy and Infectious Diseases.
commercialization of results of packaged into the HPIV1 particle, and [FR Doc. 2018–21768 Filed 10–5–18; 8:45 am]
federally-funded research and the TMCT modification did not increase BILLING CODE 4140–01–P
development. Foreign patent packaging or immunogenicity. Overall,
applications are filed on selected the candidate expressing full-length GP
inventions to extend market coverage from the Pre-N position was the most DEPARTMENT OF HEALTH AND
for companies and may also be available immunogenic. HUMAN SERVICES
for licensing. This invention relates to an
attenuated and immunogenic IN vaccine National Institutes of Health
FOR FURTHER INFORMATION CONTACT:
Peter Soukas, J.D., 301–594–8730; candidate expected to be well tolerated
in humans and is available for clinical Government-Owned Inventions;
peter.soukas@nih.gov. Licensing Availability for Licensing
information and copies of the patent evaluation.
applications listed below may be This technology is available for AGENCY: National Institutes of Health,
obtained by communicating with the licensing for commercial development HHS.
indicated licensing contact at the in accordance with 35 U.S.C. 209 and 37 ACTION: Notice.
Technology Transfer and Intellectual CFR part 404, as well as for further
Property Office, National Institute of development and evaluation under a SUMMARY: The invention listed below is
Allergy and Infectious Diseases, 5601 research collaboration. owned by an agency of the U.S.
Fishers Lane, Rockville, MD 20852; tel. Potential Commercial Applications: Government and is available for
301–496–2644. A signed Confidential • Viral diagnostics licensing to achieve expeditious
Disclosure Agreement will be required • Vaccine research commercialization of results of
to receive copies of unpublished patent Competitive Advantages: federally-funded research and
applications. development. Foreign patent
• Ease of manufacture
applications are filed on selected
SUPPLEMENTARY INFORMATION: • Bivalent or Multivalent live
Technology description follows. inventions to extend market coverage
amozie on DSK3GDR082PROD with NOTICES1

attenuated vaccines
for companies and may also be available
Attenuated Human Parainfluenza Virus • B cell and T cell activation
for licensing.
Type 1 Expressing Ebola Virus • Low-cost vaccines
FOR FURTHER INFORMATION CONTACT:
Glycoprotein GP as an Intranasal Ebola • Intranasal administration/needle-free
delivery Peter Soukas, J.D., 301–594–8730;
Vaccine peter.soukas@nih.gov. Licensing
Description of Technology: Ebola Development Stage: information and copies of the patent
virus (EBOV) hemorrhagic fever is one • In vivo data assessment (animal) applications listed below may be

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Document Created: 2018-10-06 00:59:25
Document Modified: 2018-10-06 00:59:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		83 FR 50666

83 FR 50666 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 195 (October 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health