83 FR 38710 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 152 (August 7, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38710-38711 | |
| FR Document | 2018-16838 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38710-38711] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16838] ----------------------------------------------------------------------- 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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed [[Page 38711]] Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve commercialization of results of federally-funded research and development. Technology description follows. Albumin Binding Prostate Cancer Treating Compositions The invention pertains to a therapeutic agent that includes a chemically conjugated residue derived from (((R-)-1-carboxy-2- mercaptoethyl)carbamoyl)-L-glutamic acid that is further bound to an Evans blue analog (EB). The EB analog reversibly binds to circulating serum albumin to provide a radiopharmaceutical that retains affinity and specificity to prostate specific membrane antigen (PSMA; in this case PSMA-617). PSMA is a surface molecule shown to be specifically expressed by prostate tumor cells. PSMA expression levels correlate with disease stage and with hormone refractory cancers. Although most PSMA expression appears to be restricted to the prostate cancer, low levels of expression can also be detected in the brain, kidneys, salivary glands, and small intestine. The antigen is also shown to be expressed by neovascular tumor vessels of multiple other cancers. Inclusion of the Evans blue analog promotes high internalization and retention rates of the conjugated target ligand, and therefore, higher accumulation in PSMA positive tumors. Labeling EB-PSMA-617 derivatives with the therapeutic beta emitters, e.g., 90Y, 86Y, and 177Lu gives rise to improved tumor response and survival rates. Potential Commercial Applications:Cancer therapeutics Higher stability/Lower toxicity Development Stage: Early stage Inventors: Xiaoyuan Chen and Orit Jacobson Weiss (both of NIBIB). Intellectual Property: HHS Reference No. E-054-2018/0; U.S. Provisional Patent Applications 62/633,648 filed February 22, 2018. Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected]. Dated: July 20, 2018. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2018-16838 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
![38710 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
Planning Grant (R34) and Implementation Clinical and Translational R21 and Omnibus Place: National Cancer Institute, Shady
Cooperative Agreement (U01). R03. Grove, 9609 Medical Center Drive, Room
Date: August 28, 2018. Date: September 27, 2018. 7W634, Rockville, MD 20850 (Telephone
Time: 10:00 a.m. to 12:30 p.m. Time: 7:30 a.m. to 5:00 p.m. Conference Call).
Agenda: To review and evaluate grant Agenda: To review and evaluate grant Contact Person: Yasuko Furumoto, Ph.D.,
applications. applications. Scientific Review Officer, Research
Place: National Institutes of Health, 5601 Place: Bethesda North Marriott Hotel & Technology and Contract Review Branch,
Fishers Lane, Rockville, MD 20892 Conference Center, 5701 Marinelli Road, Division of Extramural Activities, National
(Telephone Conference Call). North Bethesda, MD 20852. Cancer Institute, NIH, 9609 Medical Center
Contact Person: Louis A. Rosenthal, Ph.D., Contact Person: Saejeong J. Kim, Ph.D., Drive, Room 7W634, Bethesda, MD 20892–
Scientific Review Officer Scientific Review Scientific Review Officer, Special Review 9750, 240–276–5287, yasuko.furumoto@
Program, Division of Extramural Activities, Branch, Division of Extramural Activities, nih.gov.
Rm. 3G42B, National Institutes of Health/ National Cancer Institute, NIH, 9609 Medical Name of Committee: National Cancer
NIAID, 5601 Fishers Lane, MSC 9834, Center Drive, Room 7W640, Bethesda, MD Institute Special Emphasis Panel; UH2/UH3
Bethesda, MD 20892–9834, (240) 669–5070, 20892–9750, 240–276–5179, saejeong.kim@ Review.
rosenthalla@niaid.nih.gov. nih.gov. Date: November 7, 2018.
(Catalogue of Federal Domestic Assistance Name of Committee: National Cancer Time: 1:00 p.m. to 4:00 p.m.
Program Nos. 93.855, Allergy, Immunology, Institute Initial Review Group, Subcommittee Agenda: To review and evaluate grant
and Transplantation Research; 93.856, J—Career Development. applications.
Microbiology and Infectious Diseases Date: October 11–12, 2018. Place: National Cancer Institute, Shady
Research, National Institutes of Health, HHS) Time: 5:00 p.m. to 4:00 p.m. Grove, 9609 Medical Center Drive, Room
Agenda: To review and evaluate grant 7W110, Rockville, MD 20850 (Telephone
Dated: August 1, 2018.
applications. Conference Call).
Sylvia L. Neal, Place: Bethesda Marriott Suites, 6711 Contact Person: Robert E. Bird, Ph.D.,
Program Analyst, Office of Federal Advisory Democracy Boulevard Bethesda, MD 20817. Scientific Review Officer, Resources and
Committee Policy. Contact Person: Tushar Deb, Ph.D., Training Review Branch, Division of
[FR Doc. 2018–16789 Filed 8–6–18; 8:45 am] Scientific Review Officer, Resources and Extramural Activities, National Cancer
BILLING CODE 4140–01–P
Training Review Branch, Division of Institute, NIH, 9609 Medical Center Drive,
Extramural Activities, National Cancer Room 7W110, Bethesda, MD 20892–9750,
Institute, NIH, 9609 Medical Center Drive, 240–276–6344, birdr@mail.nih.gov.
Room 7W624, Bethesda, MD 20892–9750, (Catalogue of Federal Domestic Assistance
DEPARTMENT OF HEALTH AND 240–276–6132, tushar.deb@nih.gov.
HUMAN SERVICES Program Nos. 93.392, Cancer Construction;
Name of Committee: National Cancer 93.393, Cancer Cause and Prevention
National Institutes of Health Institute Special Emphasis Panel; Innovative Research; 93.394, Cancer Detection and
Molecular and Cellular Analysis Diagnosis Research; 93.395, Cancer
National Cancer Institute; Notice of Technologies (IMAT). Treatment Research; 93.396, Cancer Biology
Date: October 19, 2018. Research; 93.397, Cancer Centers Support;
Closed Meetings Time: 8:30 a.m. to 5:30 p.m. 93.398, Cancer Research Manpower; 93.399,
Pursuant to section 10(d) of the Agenda: To review and evaluate grant Cancer Control, National Institutes of Health,
Federal Advisory Committee Act, as applications. HHS)
Place: National Cancer Institute, Shady
amended, notice is hereby given of the Dated: August 1, 2018.
Grove, 9609 Medical Center Drive, Room
following meetings. 2E908, Rockville, MD 20850. Melanie J. Pantoja,
The meetings will be closed to the Contact Person: Yasuko Furumoto, Ph.D., Program Analyst, Office of Federal Advisory
public in accordance with the Scientific Review Officer, Research Committee Policy.
provisions set forth in sections Technology and Contract Review Branch, [FR Doc. 2018–16784 Filed 8–6–18; 8:45 am]
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Division of Extramural Activities, National
BILLING CODE 4140–01–P
as amended. The grant applications and Cancer Institute, NIH, 9609 Medical Center
the discussions could disclose Drive, Room 7W634, Bethesda, MD 20892–
confidential trade secrets or commercial 9750, 240–276–5287, yasuko.furumoto@
nih.gov. DEPARTMENT OF HEALTH AND
property such as patentable material, HUMAN SERVICES
and personal information concerning Name of Committee: National Cancer
individuals associated with grant Institute Special Emphasis Panel; R25
Review. National Institutes of Health
applications, the disclosure of which Date: October 24, 2018.
would constitute a clearly unwarranted Time: 1:00 p.m. to 5:00 p.m. Government-Owned Inventions;
invasion of personal privacy. Agenda: To review and evaluate grant Availability for Licensing
Name of Committee: National Cancer applications. AGENCY: National Institutes of Health,
Institute Special Emphasis Panel; NCI Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
HHS.
Clinical and Translational Exploratory/
Developmental Studies. 7W110, Rockville, MD 20850 (Telephone ACTION: Notice.
Date: September 14, 2018. Conference Call).
Contact Person: Robert E. Bird, Ph.D., SUMMARY: The inventions listed below
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Scientific Review Officer, Resources and are owned by an agency of the U.S.
applications. Training Review Branch, Division of Government and are available for
Place: The Westin Arlington Gateway, 801 Extramural Activities, National Cancer licensing in the U.S.
North Glebe Road, Arlington, VA 22203. Institute, NIH, 9609 Medical Center Drive, FOR FURTHER INFORMATION CONTACT:
Contact Person: Robert S. Coyne, Ph.D., Room 7W110, Bethesda, MD 20892–9750, Licensing information may be obtained
daltland on DSKBBV9HB2PROD with NOTICES
Scientific Review Officer, Special Review 240–276–6344, birdr@mail.nih.gov.
by emailing the indicated licensing
Branch, Division of Extramural Activities, Name of Committee: National Cancer
National Cancer Institute, NIH, 9609 Medical
contact at the National Heart, Lung, and
Institute Special Emphasis Panel; Innovative
Center Drive, Room 7W236, Bethesda, MD Molecular Analysis Technologies (IMAT).
Blood, Office of Technology Transfer
20892–9750, 240–276–7684, coyners@ Date: November 1, 2018. and Development Office of Technology
mail.nih.gov. Time: 11:00 a.m. to 2:00 p.m. Transfer, 31 Center Drive, Room 4A29,
Name of Committee: National Cancer Agenda: To review and evaluate grant MSC2479, Bethesda, MD 20892–2479;
Institute Special Emphasis Panel; SEP–7: NCI applications. telephone: 301–402–5579. A signed
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38711
Confidential Disclosure Agreement may Dated: July 20, 2018. random co-assembly of diverse trimeric
be required to receive any unpublished Michael Shmilovich, antigens, and therefore cannot guarantee
information. Senior Licensing and Patenting Manager, the pattern and ratio of diverse trimeric
National Heart, Lung, and Blood Institute, antigens on a single ferritin
SUPPLEMENTARY INFORMATION: This Office of Technology Transfer and nanoparticle.
notice is in accordance with 35 U.S.C. Development. Researchers at the Vaccine Research
209 and 37 CFR part 404 to achieve [FR Doc. 2018–16838 Filed 8–6–18; 8:45 am] Center (VRC) of the National Institute of
commercialization of results of BILLING CODE 4140–01–P Allergy and Infectious Diseases are
federally-funded research and developing novel recombinant ferritin
development. nanoparticles that are based on insect
Technology description follows. DEPARTMENT OF HEALTH AND ferritin proteins, and that have been
HUMAN SERVICES engineered to display two different
Albumin Binding Prostate Cancer trimeric antigens in a defined ratio and
Treating Compositions National Institutes of Health geometric pattern. This system has been
tested with antigens derived from HIV–
The invention pertains to a Government-Owned Inventions;
1 envelope (Env) and influenza
therapeutic agent that includes a Availability for Licensing
hemagglutinin (HA). Interestingly, when
chemically conjugated residue derived guinea pigs are immunized with ferritin
AGENCY: National Institutes of Health,
from (((R-)-1-carboxy-2- HHS. nanoparticles displaying two different
mercaptoethyl)carbamoyl)-L-glutamic trimeric antigens, induced B cells could
ACTION: Notice.
acid that is further bound to an Evans simultaneously recognize both trimeric
blue analog (EB). The EB analog SUMMARY: The invention listed below is antigens, thus leading to an immune
reversibly binds to circulating serum owned by an agency of the U.S. response with improved neutralization
albumin to provide a Government and is available for breadth.
radiopharmaceutical that retains affinity licensing to achieve expeditious This technology can be used as a
and specificity to prostate specific commercialization of results of platform for multimerized display of
membrane antigen (PSMA; in this case federally-funded research and trimeric antigens such as viral type I
PSMA–617). PSMA is a surface development. Foreign patent fusion glycoproteins, and may be
molecule shown to be specifically applications are filed on selected applied to many high-priority vaccine
expressed by prostate tumor cells. inventions to extend market coverage targets, such as HIV–1, influenza,
PSMA expression levels correlate with for companies and may also be available respiratory syncytial virus,
disease stage and with hormone for licensing. parainfluenza viruses, and
refractory cancers. Although most FOR FURTHER INFORMATION CONTACT: coronaviruses.
PSMA expression appears to be Barry Buchbinder, Ph.D., 240–627– Potential Commercial Applications:
3678; barry.buchbinder@nih.gov. • Platform for multimerized
restricted to the prostate cancer, low
Licensing information and copies of the immunogen presentation and vaccine
levels of expression can also be detected
U.S. patent application listed below design.
in the brain, kidneys, salivary glands, • Vaccines for pathogens that use
and small intestine. The antigen is also may be obtained by communicating
with the indicated licensing contact at genetic diversity to escape the immune
shown to be expressed by neovascular response.
tumor vessels of multiple other cancers. the Technology Transfer and
Competitive Advantages:
Inclusion of the Evans blue analog Intellectual Property Office, National • Particles have equal fractions of two
promotes high internalization and Institute of Allergy and Infectious different antigens in a specific
retention rates of the conjugated target Diseases, 5601 Fishers Lane, Rockville, configuration on the nanoparticle
ligand, and therefore, higher MD 20852; tel. 301–496–2644. A signed surface (unlike regular ferritin used
accumulation in PSMA positive tumors. Confidential Disclosure Agreement will previously)
Labeling EB–PSMA–617 derivatives be required to receive copies of • Designed particles have a geometry
unpublished patent applications. that allows for attachment of trimeric
with the therapeutic beta emitters, e.g.,
90Y, 86Y, and 177Lu gives rise to SUPPLEMENTARY INFORMATION: antigens (unlike the native insect
improved tumor response and survival Technology description follows. ferritin).
rates. Self-Assembling Insect Ferritin Development Stage:
Nanoparticles for Display of Co- • In vivo testing (rodents).
Potential Commercial Applications: Inventors: Peter Kwong (NIAID),
assembled Trimeric Antigens
• Cancer therapeutics Description of Technology
Ivelin Georgiev (NIAID), Michael
Gordon Joyce (NIAID), Masaru Kanekiyo
• Higher stability/Lower toxicity Antigens on the surface of virus (NIAID), Aliaksandr Druz (NIAID),
Development Stage: particles are displayed in a regular, Ulrich Baxa (NIAID), Joseph Van Galen
repetitive pattern which facilitates B (NIAID), Rita Chen (NIAID), Cheng
• Early stage cell activation. Presenting trimeric Cheng (NIAID), John Mascola (NIAID),
Inventors: Xiaoyuan Chen and Orit antigens on engineered particles that Yaroslav Tsybovsky (Leidos Biomedical
Jacobson Weiss (both of NIBIB). mimic the geometric patterns observed Research, Inc), Yongping Yang (NIAID),
for native viral proteins can lead to an Paul Thomas (NIAID), Barney Graham
daltland on DSKBBV9HB2PROD with NOTICES
Intellectual Property: HHS Reference
improved host antibody response. (NIAID).
No. E–054–2018/0; U.S. Provisional Self-assembling globular ferritin Publications: Georgiev, Ivelin S., et
Patent Applications 62/633,648 filed nanoparticles have previously been al., ACS Infectious Diseases (2018) 4 (5),
February 22, 2018. used to display multiple copies of a co- 788–796.
Licensing Contact: Michael assembled trimeric antigen to the Intellectual Property: HHS Reference
Shmilovich, Esq, CLP; 301–435–5019; immune system. However, prior ferritin Number E–270–2015: U.S. Patent
shmilovm@mail.nih.gov. nanoparticle technologies only permit a Application No. 62/355,212 filed 06/27/
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Document Created: 2018-11-06 10:38:52
Document Modified: 2018-11-06 10:38:52
| 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 | Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. | |
| FR Citation | 83 FR 38710 |
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