81 FR 65364 - Prospective Grant of Exclusive Patent License: Development of an Antibody-Drug Conjugate for Use in PhotoImmunoTherapy
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 184 (September 22, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 184 (September 22, 2016)
| Page Range | 65364-65365 | |
| FR Document | 2016-22820 |
[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)] [Notices] [Pages 65364-65365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22820] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Development of an Antibody-Drug Conjugate for Use in PhotoImmunoTherapy AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Summary Information section of this notice to Aspyrian Therapeutics, Inc. (``Aspyrian'') located in San Diego, California USA. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before October 7, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Thomas Clouse, J.D., Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 Telephone: (240)-276-5530; Facsimile: (240)-276-5504 Email: [email protected]. SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 62/202,252, filed August 7, 2015 ``Near Infrared PhotoImmunoTherapy (NIR-PIT) of Suppressor Cells to Treat Cancer'' [HHS Reference No. E-231-2015/0-US- 01]; and PCT Patent Application PCT/US2016/045090, filed August 2, 2016 ``Near Infrared PhotoImmunoTherapy (NIR-PIT) of Suppressor Cells to Treat Cancer'' [HHS Reference No. E-231-2015/0-PCT-02]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: ``Use of photosensitizing antibody-fluorophore conjugate defined by the Licensed Patent Rights by itself for PhotoImmunoTherapy (PIT), or in combination with cancer therapeutic agents, to treat cancer or hyperplasia.'' This technology discloses the concept of binding an anti-foxp3+ antibody to IR700 to bind to foxp3+ T-cells. When irradiated with near infrared light localized at the site of the solid tumor, controlled local knockdown of foxp3+ negative regulatory T-cells in tumors results in rapid tumor death without the severe autoimmune response that is induced by systemic knock-down of foxp3+ T-cells. Theoretically, this technology can be used in a broad spectrum of patients with a variety of solid cancers including those with [[Page 65365]] multiple distant metastasis as foxp3+ T-cells are generally believed to be critical to immunotolerance found in cancers. By treating a single local site with this technology, systemic host immunity against in situ cancers can be dramatically activated, leading to rapid tumor regression at the treated lesion as well as distant metastatic lesions untreated with the near infrared light while inducing minimal side effects. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404.7. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7. Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: September 16, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2016-22820 Filed 9-21-16; 8:45 am] BILLING CODE 4140-01-P
![65364 Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices
Name of Committee: Center for Scientific Name of Committee: Board of Scientific practice the inventions embodied in the
Review Special Emphasis Panel; Drug Advisors. U.S. Patents and Patent Applications
Discovery and Mechanisms of Antimicrobial Open: October 31, 2016, 1:00 p.m. to 4:00 listed in the Summary Information
Resistance. p.m. section of this notice to Aspyrian
Date: October 20, 2016. Agenda: RFA and RFP Concept Reviews.
Time: 1:00 p.m. to 2:00 p.m. Place: National Cancer Institute Shady
Therapeutics, Inc. (‘‘Aspyrian’’) located
Agenda: To review and evaluate grant Grove, 9609 Medical Center Drive, Room in San Diego, California USA.
applications. TE406, Rockville, MD 20850 (Virtual DATES: Only written comments and/or
Place: St. Gregory Hotel, 2033 M Street Meeting). applications for a license which are
NW., Washington, DC 20036. Contact Person: Paulette S. Gray, Ph.D., received by the National Cancer
Contact Person: John C. Pugh, Ph.D., Executive Secretary, Division of Extramural Institute’s Technology Transfer Center
Scientific Review Officer, Center for Activities, National Cancer Institute—Shady on or before October 7, 2016 will be
Scientific Review, National Institutes of Grove, National Institutes of Health, 9609
considered.
Health, 6701 Rockledge Drive, Room 1206, Medical Center Drive, Room 7W444,
MSC 7808, Bethesda, MD 20892, (301) 435– Bethesda, MD 20892, 240–276–6340, grayp@ ADDRESSES: Requests for copies of the
2398, pughjohn@csr.nih.gov. mail.nih.gov. patent application, inquiries, and
Name of Committee: Center for Scientific Any interested person may file written comments relating to the contemplated
Review Special Emphasis Panel; Language comments with the committee by forwarding exclusive license should be directed to:
and Communication. the statement to the Contact Person listed on Thomas Clouse, J.D., Senior Licensing
Date: October 20, 2016. this notice. The statement should include the and Patenting Manager, NCI Technology
Time: 1:00 p.m. to 2:00 p.m. name, address, telephone number and when Transfer Center, 9609 Medical Center
Agenda: To review and evaluate grant applicable, the business or professional
applications. affiliation of the interested person.
Drive, RM 1E530 MSC 9702, Bethesda,
Place: Palomar Hotel, 2121 P Street NW., In the interest of security, NCI Shady Grove MD 20892–9702 (for business mail),
Washington, DC 20037. has instituted stringent procedures for Rockville, MD 20850–9702 Telephone:
Contact Person: Maribeth Champoux, entrance into the NCI Shady Grove building. (240)–276–5530; Facsimile: (240)–276–
Ph.D., Scientific Review Officer, Center for Visitors will be asked to show one form of 5504 Email: thomas.clouse@nih.gov.
Scientific Review, National Institutes of identification (for example, a government- SUPPLEMENTARY INFORMATION:
Health, 6701 Rockledge Drive, Room 3182, issued photo ID, driver’s license, or passport)
MSC 7759, Bethesda, MD 20892, 301–594– and to state the purpose of their visit. Intellectual Property
3163, champoum@csr.nih.gov. Information is also available on the United States Provisional Patent
(Catalogue of Federal Domestic Assistance Institute’s/Center’s home page: http://
Application No. 62/202,252, filed
Program Nos. 93.306, Comparative Medicine; deainfo.nci.nih.gov/advisory/bsa/bsa.htm,
where an agenda and any additional August 7, 2015 ‘‘Near Infrared
93.333, Clinical Research, 93.306, 93.333,
information for the meeting will be posted PhotoImmunoTherapy (NIR–PIT) of
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National when available. Suppressor Cells to Treat Cancer’’ [HHS
Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance Reference No. E–231–2015/0–US–01];
Program Nos. 93.392, Cancer Construction; and
Dated: September 16, 2016. PCT Patent Application PCT/US2016/
93.393, Cancer Cause and Prevention
Anna Snouffer, Research; 93.394, Cancer Detection and 045090, filed August 2, 2016 ‘‘Near
Deputy Director, Office of Federal Advisory Diagnosis Research; 93.395, Cancer Infrared PhotoImmunoTherapy (NIR–
Committee Policy. Treatment Research; 93.396, Cancer Biology PIT) of Suppressor Cells to Treat
[FR Doc. 2016–22815 Filed 9–21–16; 8:45 am] Research; 93.397, Cancer Centers Support; Cancer’’ [HHS Reference No. E–231–
BILLING CODE 4140–01–P 93.398, Cancer Research Manpower; 93.399, 2015/0–PCT–02].
Cancer Control, National Institutes of Health,
The patent rights in these inventions
HHS)
have been assigned and/or exclusively
DEPARTMENT OF HEALTH AND Dated: September 16, 2016. licensed to the government of the
HUMAN SERVICES Melanie J. Gray, United States of America.
Program Analyst, Office of Federal Advisory The prospective exclusive license
National Institutes of Health Committee Policy. territory may be worldwide and the
[FR Doc. 2016–22817 Filed 9–21–16; 8:45 am] field of use may be limited to the use
National Cancer Institute; Notice of
BILLING CODE 4140–01–P of Licensed Patent Rights for the
Meeting
following: ‘‘Use of photosensitizing
Pursuant to section 10(a) of the antibody-fluorophore conjugate defined
Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND by the Licensed Patent Rights by itself
amended (5 U.S.C. App.), notice is HUMAN SERVICES for PhotoImmunoTherapy (PIT), or in
hereby given of a meeting of the combination with cancer therapeutic
National Cancer Institute Board of National Institutes of Health agents, to treat cancer or hyperplasia.’’
Scientific Advisors. This technology discloses the concept
The meeting will be open to the Prospective Grant of Exclusive Patent of binding an anti-foxp3+ antibody to
public as indicated below, with License: Development of an Antibody- IR700 to bind to foxp3+ T-cells. When
attendance limited to space available. Drug Conjugate for Use in irradiated with near infrared light
Individuals who plan to attend and PhotoImmunoTherapy localized at the site of the solid tumor,
need special assistance, such as sign controlled local knockdown of foxp3+
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: National Institutes of Health,
language interpretation or other HHS. negative regulatory T-cells in tumors
reasonable accommodations, should ACTION: Notice. results in rapid tumor death without the
notify the Contact Person listed below severe autoimmune response that is
in advance of the meeting. The meeting SUMMARY: The National Cancer Institute, induced by systemic knock-down of
will also be videocast and can be an institute of the National Institutes of foxp3+ T-cells. Theoretically, this
accessed from the NIH Videocasting and Health, Department of Health and technology can be used in a broad
Podcasting Web site (http:// Human Services, is contemplating the spectrum of patients with a variety of
videocast.nih.gov). grant of an exclusive patent license to solid cancers including those with
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![Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices 65365
multiple distant metastasis as foxp3+ T- Dated: September 16, 2016. DEPARTMENT OF HEALTH AND
cells are generally believed to be critical Carolyn A. Baum, HUMAN SERVICES
to immunotolerance found in cancers. Program Analyst, Office of Federal Advisory
By treating a single local site with this Committee Policy. National Institutes of Health
technology, systemic host immunity [FR Doc. 2016–22812 Filed 9–21–16; 8:45 am]
National Institute of Allergy and
against in situ cancers can be BILLING CODE 4140–01–P Infectious Diseases; Notice of Closed
dramatically activated, leading to rapid
Meeting
tumor regression at the treated lesion as
well as distant metastatic lesions DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the
untreated with the near infrared light HUMAN SERVICES Federal Advisory Committee Act, as
while inducing minimal side effects. amended (5 U.S.C. App.), notice is
National Institutes of Health hereby given of the following meeting.
The prospective exclusive license will
The meeting will be closed to the
be royalty bearing and will comply with National Institute of Allergy And public in accordance with the
the terms and conditions of 35 U.S.C. Infectious Diseases; Notice of Closed provisions set forth in sections
209 and 37 CFR part 404.7. The Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
prospective exclusive license may be as amended. The contract proposals and
granted unless within fifteen (15) days Pursuant to section 10(d) of the the discussions could disclose
from the date of this published notice, Federal Advisory Committee Act, as confidential trade secrets or commercial
the National Cancer Institute receives amended (5 U.S.C. App.), notice is property such as patentable material,
written evidence and argument that hereby given of the following meeting. and personal information concerning
establishes that the grant of the license individuals associated with the contract
The meeting will be closed to the
would not be consistent with the proposals, the disclosure of which
public in accordance with the
requirements of 35 U.S.C. 209 and 37 would constitute a clearly unwarranted
provisions set forth in sections
CFR part 404.7. invasion of personal privacy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Complete applications for a license in as amended. The contract proposals and Name of Committee: National Institute of
the prospective field of use that are filed Allergy and Infectious Diseases Special
the discussions could disclose
in response to this notice will be treated Emphasis Panel; NIAID Peer Review Meeting.
confidential trade secrets or commercial Date: October 13, 2016.
as objections to the grant of the property such as patentable material, Time: 8:00 a.m. to 5:00 p.m.
contemplated Exclusive Patent License and personal information concerning Agenda: To review and evaluate contract
Agreement. Comments and objections individuals associated with the contract proposals.
submitted to this notice will not be proposals, the disclosure of which Place: National Institutes of Health, 5601
made available for public inspection would constitute a clearly unwarranted Fishers Lane, Rockville, MD 20892
and, to the extent permitted by law, will (Telephone Conference Call).
invasion of personal privacy. Contact Person: Jay Bruce Sundstrom,
not be released under the Freedom of
Name of Committee: National Institute of Ph.D., Scientific Review Officer, Scientific
Information Act, 5 U.S.C. 552. Review Program, Division of Extramural
Allergy and Infectious Diseases Special
Dated: September 16, 2016. Emphasis Panel; NIAID Peer Review Meeting. Activities, Room 3G11A, National Institutes
Richard U. Rodriguez, Date: October 26, 2016. of Health/NIAID, 5601 Fishers Lane, MSC
Time: 9:30 a.m. to 12:30 p.m. 9823, Bethesda, MD 20892–9823, 240–669–
Associate Director, Technology Transfer 5045, sundstromj@niaid.nih.gov.
Center, National Cancer Institute. Agenda: To review and evaluate contract
proposals. (Catalogue of Federal Domestic Assistance
[FR Doc. 2016–22820 Filed 9–21–16; 8:45 am] Program Nos. 93.855, Allergy, Immunology,
Place: National Institutes of Health, 5601
BILLING CODE 4140–01–P and Transplantation Research; 93.856,
Fishers Lane, Rockville, MD 20892
Microbiology and Infectious Diseases
(Telephone Conference Call). Research, National Institutes of Health, HHS)
Contact Person: Dharmendar Rathore,
DEPARTMENT OF HEALTH AND Dated: September 15, 2016.
Ph.D., Senior Scientific Review Officer,
HUMAN SERVICES Scientific Review Program, Division of Natasha M. Copeland,
Extramural Activities, Room 3G30, National Program Analyst, Office of Federal Advisory
National Institutes of Health Committee Policy.
Institutes of Health/NIAID, 5601 Fishers
Lane, Drive, MSC 9823, Bethesda, MD [FR Doc. 2016–22818 Filed 9–21–16; 8:45 am]
National Institute of Mental Health;
20892–9823, 240–669–5058, rathored@ BILLING CODE 4140–01–P
Cancellation of Meeting
mail.nih.gov.
Notice is hereby given of the (Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology, DEPARTMENT OF HEALTH AND
cancellation of the National Institute of
and Transplantation Research; 93.856, HUMAN SERVICES
Mental Health Special Emphasis Panel,
Microbiology and Infectious Diseases
September 14, 2016, 10:00 a.m. to National Institutes of Health
Research, National Institutes of Health, HHS)
September 14, 2016, 11:00 a.m.,
National Institutes of Health, NSC, 6001 Dated: September 16, 2016. National Institute of Neurological
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Executive Boulevard, Bethesda, MD Natasha M. Copeland, Disorders and Stroke; Notice of Closed
20892 which was published in the Program Analyst, Office of Federal Advisory Meeting
Federal Register on August 30, 2016, 81 Committee Policy. Pursuant to section 10(d) of the
FR 59643. [FR Doc. 2016–22819 Filed 9–21–16; 8:45 am] Federal Advisory Committee Act, as
The meeting notice is being cancelled BILLING CODE 4140–01–P amended (5 U.S.C. App.), notice is
due to reviewer conflicts. The review hereby given of the following meeting.
will be rescheduled. The meeting will be closed to the
public in accordance with the
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Document Created: 2016-09-22 01:04:00
Document Modified: 2016-09-22 01:04:00
| 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. | |
| Dates | Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before October 7, 2016 will be considered. | |
| FR Citation | 81 FR 65364 |
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