83 FR 53886 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 207 (October 25, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 207 (October 25, 2018)
| Page Range | 53886-53886 | |
| FR Document | 2018-23311 |
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)] [Notices] [Page 53886] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23311] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. Recombinant Respiratory Syncytial Virus Challenge Strain Description of Technology RSV is the most important viral agent of severe respiratory tract disease worldwide, especially in infants and young children, and it also causes severe disease in the elderly and in immunocompromised individuals. There are no licensed vaccines or antivirals suitable for routine use. This invention relates to a reverse genetics system and cDNA- derived virus for a contemporary wild-type clinical isolate of RSV of antigenic subgroup A, termed RSV strain A/Maryland/001/11, that was isolated in 2011 from an adult with respiratory illness. The genomic sequence was determined. A reverse genetics system was created encoding a recombinant, replication competent RSV that contains a codon- optimized G ORF, which was done to stabilize the cDNA for replication in bacteria. Because this virus was generated by reverse genetics, it is a ``clean'' virus with a well-defined passage history. Clinical study material of this challenge virus has been manufactured and is available for use as an U.S. Food and Drug Administration (FDA) regulated Investigational New Drug (IND) in clinical studies in adult volunteers within and outside of the United States. Preliminary clinical data confirmed that this virus efficiently infects and replicates in 95% of study participants pre-selected for pre-existing RSV antibody titers in the bottom 50% of the range. The challenge virus causes mild upper respiratory illness in the majority of infected participants, typical for RSV illness in otherwise healthy adults. This provides a suitable challenge system for evaluating antivirals, as well as vaccines for older children and adults. This also could be used for developing live-attenuated RSV vaccine candidates based on this contemporary strain, using the stabilized point mutations, stabilized codon-deletions, and gene-deletions that were previously used in RSV strain A2. This invention relates to a reverse genetics system and the encoded RSV vaccine challenge strain that infects and causes disease in RSV- experienced adults and is available for antiviral and vaccine research. 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 ApplicationsVaccine development Viral diagnostics Vaccine research Competitive Advantages Ease of manufacture Clinical trial material Low-cost vaccines Intranasal administration/needle-free delivery Development Stage In vivo data assessment (human) Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID). Intellectual Property: HHS Reference No. E-235-2018-0. 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: October 12, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018-23311 Filed 10-24-18; 8:45 am] BILLING CODE 4140-01-P
![53886 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Average time
Number of Total annual
Category of respondent responses per per response
respondents burden hours
respondent (in hours)
Individuals (DARF-Oral) ................................................................................... 711 16 4/60 758
Total .......................................................................................................... 2,844 45,504 ........................ 3,033
Patricia M. Busche, This invention relates to a reverse • Vaccine research
Project Clearance Liaison, National Cancer genetics system and cDNA-derived virus
Institute, National Institutes of Health. Competitive Advantages
for a contemporary wild-type clinical
[FR Doc. 2018–23313 Filed 10–24–18; 8:45 am] isolate of RSV of antigenic subgroup A, • Ease of manufacture
BILLING CODE 4140–01–P termed RSV strain A/Maryland/001/11, • Clinical trial material
that was isolated in 2011 from an adult • Low-cost vaccines
with respiratory illness. The genomic • Intranasal administration/needle-
DEPARTMENT OF HEALTH AND sequence was determined. A reverse free delivery
HUMAN SERVICES genetics system was created encoding a Development Stage
recombinant, replication competent
National Institutes of Health • In vivo data assessment (human)
RSV that contains a codon-optimized G
Inventors: Ursula Buchholz (NIAID),
Government-Owned Inventions; ORF, which was done to stabilize the
Peter Collins (NIAID).
Availability for Licensing cDNA for replication in bacteria.
Intellectual Property: HHS Reference
Because this virus was generated by
No. E–235–2018–0.
AGENCY: National Institutes of Health, reverse genetics, it is a ‘‘clean’’ virus Licensing Contact: Peter Soukas, J.D.,
HHS. with a well-defined passage history. 301–594–8730; peter.soukas@nih.gov.
ACTION: Notice. Clinical study material of this challenge Collaborative Research Opportunity:
virus has been manufactured and is The National Institute of Allergy and
SUMMARY: The invention listed below is available for use as an U.S. Food and
owned by an agency of the U.S. Infectious Diseases is seeking statements
Drug Administration (FDA) regulated of capability or interest from parties
Government and is available for Investigational New Drug (IND) in
licensing to achieve expeditious interested in collaborative research to
clinical studies in adult volunteers further develop, evaluate or
commercialization of results of within and outside of the United States.
federally-funded research and commercialize for development of a
Preliminary clinical data confirmed that vaccine for respiratory or other
development. Foreign patent this virus efficiently infects and
applications are filed on selected infections. For collaboration
replicates in 95% of study participants opportunities, please contact Peter
inventions to extend market coverage pre-selected for pre-existing RSV
for companies and may also be available Soukas, J.D., 301–594–8730;
antibody titers in the bottom 50% of the peter.soukas@nih.gov.
for licensing. range. The challenge virus causes mild
FOR FURTHER INFORMATION CONTACT: upper respiratory illness in the majority Dated: October 12, 2018.
Peter Soukas, J.D., 301–594–8730; of infected participants, typical for RSV Suzanne M. Frisbie,
peter.soukas@nih.gov. Licensing illness in otherwise healthy adults. This Deputy Director, Technology Transfer and
information and copies of the patent provides a suitable challenge system for Intellectual Property Office, National Institute
applications listed below may be evaluating antivirals, as well as vaccines of Allergy and Infectious Diseases.
obtained by communicating with the for older children and adults. This also [FR Doc. 2018–23311 Filed 10–24–18; 8:45 am]
indicated licensing contact at the could be used for developing live- BILLING CODE 4140–01–P
Technology Transfer and Intellectual attenuated RSV vaccine candidates
Property Office, National Institute of based on this contemporary strain, using
Allergy and Infectious Diseases, 5601 the stabilized point mutations, DEPARTMENT OF HEALTH AND
Fishers Lane, Rockville, MD 20852; tel. stabilized codon-deletions, and gene- HUMAN SERVICES
301–496–2644. A signed Confidential deletions that were previously used in
Disclosure Agreement will be required National Institutes of Health
RSV strain A2.
to receive copies of unpublished patent This invention relates to a reverse
applications. Center for Scientific Review; Notice of
genetics system and the encoded RSV Closed Meetings
SUPPLEMENTARY INFORMATION: vaccine challenge strain that infects and
Technology description follows. causes disease in RSV-experienced Pursuant to section 10(d) of the
Recombinant Respiratory Syncytial adults and is available for antiviral and Federal Advisory Committee Act, as
Virus Challenge Strain vaccine research. amended, notice is hereby given of the
This technology is available for following meetings.
Description of Technology licensing for commercial development The meetings will be closed to the
RSV is the most important viral agent in accordance with 35 U.S.C. 209 and 37 public in accordance with the
daltland on DSKBBV9HB2PROD with NOTICES
of severe respiratory tract disease CFR part 404, as well as for further provisions set forth in sections
worldwide, especially in infants and development and evaluation under a 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
young children, and it also causes research collaboration. as amended. The grant applications and
severe disease in the elderly and in the discussions could disclose
immunocompromised individuals. Potential Commercial Applications confidential trade secrets or commercial
There are no licensed vaccines or • Vaccine development property such as patentable material,
antivirals suitable for routine use. • Viral diagnostics and personal information concerning
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Document Created: 2018-10-25 01:44:58
Document Modified: 2018-10-25 01:44:58
| 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 53886 |
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