82 FR 31783 - Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of Pancreatic Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 130 (July 10, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 130 (July 10, 2017)
| Page Range | 31783-31784 | |
| FR Document | 2017-14370 |
[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)] [Notices] [Pages 31783-31784] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14370] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of Pancreatic Cancer AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Institute on Aging, 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 Supplementary Information section of this notice to VeriLuce Therapeutics (``VLT'') located in Toronto, ON, Canada. 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 July 25, 2017 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Surekha Vathyam, Ph.D., Senior Technology Transfer 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 PropertyUnited States Provisional Patent Application No. 61/ 045,088, filed April 15, 2008, titled ``Composition and methods for delivering inhibitory oligonucleotides'', [HHS Reference No. E-051- 2008/0-US-01], status: expired; International Patent Application No. PCT/US2009/040607, filed April 15, 2009, titled ``Composition and methods for delivering inhibitory oligonucleotides'', [HHS Reference No. E-051-2008/0-PCT-02], status: converted; Canadian Patent Application No. 2,720,363, filed April 15, 2009, titled ``Composition and methods for delivering inhibitory oligonucleotides'', [HHS Reference No. E-051-2008/0-CA-04], status: pending; United States Patent Application No. 12/988,148, filed March 8, 2011, titled ``Compositions and methods for delivering inhibitory oligonucleotides'' [HHS Reference No. E-051-2008/0-US-07], status: issued as Patent No. 8,703,921; United States Patent Application No. 14/220,726, filed March 20, 2014, titled ``Compositions and Methods for delivering inhibitory oligonucleotides'' [HHS Reference No. E-051-2008/0-US-08], status: issued as Patent No. 9,415,116; and United States Patent Application No. 15,204,789, filed July 7, 2016, titled ``Compositions and Methods for delivering inhibitory oligonucleotides'' [HHS Reference No. E-051-2008/0-US-11], status: pending. The patent rights in these inventions have been assigned 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: ``Treatment of pancreatic cancer by targeting regulatory T cells using complexes or fusion molecules comprising inhibitory nucleic acids, a nucleic acid binding moiety and a targeting polypeptide, wherein the targeting polypeptide contains either the TARC/CCL17 or RANTES/CCL5 cell surface receptor ligand.'' Despite significant attractiveness of anti-sense oligonucleotide technology, its clinical application has been precluded by a lack of methods for targeted delivery and transduction of primary immune cells in vivo. Novel complexes and methods for delivering [[Page 31784]] inhibitory nucleic acids to cells in a targeted and efficient manner are disclosed in this invention. The complexes and methods are based on utilizing a cell surface receptor targeting ligand and a nucleic acid binding domain that binds an inhibitory nucleic acid, to efficiently deliver the inhibitory oligonucleotide to the cell that expresses the cell surface receptor targeting ligand. The compositions can be used to silence gene expression in a cell or to deliver agents to a target cell, thereby treating or preventing a disease or disorder. The invention has broad utility as the cell surface receptor targeting ligand could be any molecule such as, cytokines, chemokines, antibodies or growth factors, that binds to a unique cellular receptor or cell surface antigen. Cytokines are small secreted proteins which mediate and regulate immunity, inflammation, and hematopoiesis. Chemokines are a family of small cytokines that are secreted by cells. They act on their target cells by binding specific membrane receptors. TARC/CCL17 and RANTES/CCL5 are examples of chemokines whose receptors are CCR4 and CCR5, respectively. The complexes of this invention could inactivate immune cells by delivering oligonucleotides. For example, the TARC-nucleic acid binding domain complex referred to as TARC-arp, has been shown to deliver si- FoxP3 oligonucleotide into CCR4-expressing cancer cells that will specifically only inactivate FoxP3 expression. Chemokine-based gene silencing can be therapeutically used to modulate immune cells and improve outcome of diseases, such as by inactivating Tregs to block cancer escape and metastasis. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and 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. 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: June 27, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017-14370 Filed 7-7-17; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices 31783
their presentation on or before July 12, virus outbreak in the Americas. The business mail), Rockville, MD 20850–
2017. Time allotted for each document was published with the 9702 Telephone: (240) 276–5530;
presentation may be limited. If the incorrect docket number. This Facsimile: (240) 276–5504 Email:
number of registrants requesting to document corrects that error. vathyams@mail.nih.gov.
speak is greater than can be reasonably FOR FURTHER INFORMATION CONTACT: Lisa SUPPLEMENTARY INFORMATION:
accommodated during the scheduled Granger, Office of Policy and Planning,
open public hearing session, FDA may Intellectual Property
Food and Drug Administration, 10903
conduct a lottery to determine the New Hampshire Ave., Bldg. 32, Rm. • United States Provisional Patent
speakers for the scheduled open public 3330, Silver Spring, MD 20993–0002, Application No. 61/045,088, filed April
hearing session. The contact person will 301–796–9115. 15, 2008, titled ‘‘Composition and
notify interested persons regarding their SUPPLEMENTARY INFORMATION: In the
methods for delivering inhibitory
request to speak by July 13, 2017. Federal Register of Friday, June 30, oligonucleotides’’, [HHS Reference No.
Persons attending FDA’s advisory 2017, in FR Doc. 2017–13720, on page E–051–2008/0–US–01], status: expired;
committee meetings are advised that the • International Patent Application
29866, the following correction is made:
Agency is not responsible for providing 1. On page 29866, in the first column, No. PCT/US2009/040607, filed April 15,
access to electrical outlets. in the headings section at the beginning 2009, titled ‘‘Composition and methods
FDA welcomes the attendance of the of the document, the docket number is for delivering inhibitory
public at its advisory committee corrected to read ‘‘FDA–2016–N–1486’’. oligonucleotides’’, [HHS Reference No.
meetings and will make every effort to E–051–2008/0–PCT–02], status:
accommodate persons with disabilities. Dated: June 30, 2017. converted;
If you require accommodations due to a Anna K. Abram, • Canadian Patent Application No.
disability, please contact Philip Bautista Deputy Commissioner for Policy, Planning, 2,720,363, filed April 15, 2009, titled
at least 7 days in advance of the Legislation, and Analysis. ‘‘Composition and methods for
meeting. [FR Doc. 2017–14365 Filed 7–7–17; 8:45 am] delivering inhibitory oligonucleotides’’,
FDA is committed to the orderly BILLING CODE 4164–01–P [HHS Reference No. E–051–2008/0–CA–
conduct of its advisory committee 04], status: pending;
meetings. Please visit our Web site at • United States Patent Application
https://www.fda.gov/ DEPARTMENT OF HEALTH AND No. 12/988,148, filed March 8, 2011,
AdvisoryCommittees/ HUMAN SERVICES titled ‘‘Compositions and methods for
AboutAdvisoryCommittees/ delivering inhibitory oligonucleotides’’
ucm111462.htm for procedures on National Institutes of Health [HHS Reference No. E–051–2008/0–US–
public conduct during advisory 07], status: issued as Patent No.
Prospective Grant of Exclusive Patent 8,703,921;
committee meetings.
Notice of this meeting is given under License: Composition and Methods for • United States Patent Application
the Federal Advisory Committee Act (5 Delivering Inhibitory Oligonucleotides No. 14/220,726, filed March 20, 2014,
U.S.C. app. 2). for the Treatment of Pancreatic Cancer titled ‘‘Compositions and Methods for
Dated: June 29, 2017. AGENCY: National Institutes of Health, delivering inhibitory oligonucleotides’’
Anna K. Abram, Department of Health and Human [HHS Reference No. E–051–2008/0–US–
Services. 08], status: issued as Patent No.
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. ACTION: Notice. 9,415,116; and
• United States Patent Application
[FR Doc. 2017–14364 Filed 7–7–17; 8:45 am]
SUMMARY: The National Institute on No. 15,204,789, filed July 7, 2016, titled
BILLING CODE 4164–01–P
Aging, an institute of the National ‘‘Compositions and Methods for
Institutes of Health, Department of delivering inhibitory oligonucleotides’’
Health and Human Services, is [HHS Reference No. E–051–2008/0–US–
DEPARTMENT OF HEALTH AND
contemplating the grant of an Exclusive 11], status: pending.
HUMAN SERVICES The patent rights in these inventions
Patent License to practice the inventions
Food and Drug Administration embodied in the U.S. Patents and Patent have been assigned to the government of
Applications listed in the the United States of America.
[Docket No. FDA–2016–N–1486] Supplementary Information section of The prospective exclusive license
this notice to VeriLuce Therapeutics territory may be worldwide and the
Authorizations of Emergency Use of In field of use may be limited to the use
Vitro Diagnostic Devices for Detection (‘‘VLT’’) located in Toronto, ON,
Canada. of Licensed Patent Rights for the
of Zika Virus; Availability; Correction following: ‘‘Treatment of pancreatic
DATES: Only written comments and/or
AGENCY: Food and Drug Administration, cancer by targeting regulatory T cells
applications for a license which are using complexes or fusion molecules
HHS. received by the National Cancer
ACTION: Notice; correction. comprising inhibitory nucleic acids, a
Institute’s Technology Transfer Center nucleic acid binding moiety and a
SUMMARY: The Food and Drug on or before July 25, 2017 will be targeting polypeptide, wherein the
Administration is correcting a notice considered. targeting polypeptide contains either the
entitled ‘‘Authorizations of Emergency ADDRESSES: Requests for copies of the TARC/CCL17 or RANTES/CCL5 cell
Use of In Vitro Diagnostic Devices for patent application, inquiries, and
sradovich on DSK3GMQ082PROD with NOTICES
surface receptor ligand.’’
Detection of Zika Virus; Availability’’ comments relating to the contemplated Despite significant attractiveness of
that appeared in the Federal Register of Exclusive Patent License should be anti-sense oligonucleotide technology,
June 30, 2017 (82 FR 29886). The directed to: Surekha Vathyam, Ph.D., its clinical application has been
document announced the issuance of Senior Technology Transfer Manager, precluded by a lack of methods for
two Emergency Use Authorizations for NCI Technology Transfer Center, 9609 targeted delivery and transduction of
in vitro diagnostic devices for detection Medical Center Drive, RM 1E530 MSC primary immune cells in vivo. Novel
of the Zika virus in response to the Zika 9702, Bethesda, MD 20892–9702 (for complexes and methods for delivering
VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\10JYN1.SGM 10JYN1](https://thefederalregister.org/doc/82_FR_31913/page/1.svg)
![31784 Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices
inhibitory nucleic acids to cells in a Dated: June 27, 2017. STATUS: Open to the public.
targeted and efficient manner are Richard U. Rodriguez, MATTERS TO BE CONSIDERED:
disclosed in this invention. The Associate Director, Technology Transfer 1. Agendas for future meetings: none.
complexes and methods are based on Center, National Cancer Institute. 2. Minutes.
utilizing a cell surface receptor targeting [FR Doc. 2017–14370 Filed 7–7–17; 8:45 am] 3. Ratification List.
ligand and a nucleic acid binding BILLING CODE 4140–01–P 4. Vote in Inv. Nos. 701–TA–579–580
domain that binds an inhibitory nucleic and 731–TA–1369–1373
acid, to efficiently deliver the inhibitory (Preliminary)(Fine Denier Polyester
oligonucleotide to the cell that INTERNATIONAL TRADE Staple Fiber from China, India, Korea,
expresses the cell surface receptor COMMISSION Taiwan, and Vietnam). The Commission
targeting ligand. The compositions can is currently scheduled to complete and
be used to silence gene expression in a [USITC SE–17–027]
file its determinations on July 17, 2017;
cell or to deliver agents to a target cell, views of the Commission are currently
thereby treating or preventing a disease Sunshine Act Meeting
scheduled to be completed and filed on
or disorder. AGENCY HOLDING THE MEETING: United July 24, 2017.
The invention has broad utility as the 5. Vote in Inv. Nos. 701–TA–581 and
States International Trade Commission.
cell surface receptor targeting ligand 731–TA–1374–1376 (Preliminary)
could be any molecule such as, TIME AND DATE: July 12, 2017 at 11:00
a.m. (Citric Acid and Certain Citrate Salts
cytokines, chemokines, antibodies or from Belgium, Colombia, and Thailand).
growth factors, that binds to a unique PLACE: Room 101, 500 E Street SW.,
Washington, DC 20436, Telephone: The Commission is currently scheduled
cellular receptor or cell surface antigen.
(202) 205–2000. to complete and file its determinations
Cytokines are small secreted proteins
on July 17, 2017; views of the
which mediate and regulate immunity, STATUS: Open to the public.
Commission are currently scheduled to
inflammation, and hematopoiesis. MATTERS TO BE CONSIDERED: be completed and filed on July 24, 2017.
Chemokines are a family of small 1. Agendas for future meetings: None. 6. Outstanding action jackets: None.
cytokines that are secreted by cells. 2. Minutes.
In accordance with Commission
They act on their target cells by binding 3. Ratification List.
4. Vote in Inv. No. 731–TA–410 policy, subject matter listed above, not
specific membrane receptors. TARC/
(Fourth Review) (Light-Walled disposed of at the scheduled meeting,
CCL17 and RANTES/CCL5 are examples
of chemokines whose receptors are Rectangular Pipe from Taiwan). The may be carried over to the agenda of the
CCR4 and CCR5, respectively. Commission is currently scheduled to following meeting.
The complexes of this invention complete and file its determination and By order of the Commission.
could inactivate immune cells by views of the Commission by July 25, Issued: July 5, 2017.
delivering oligonucleotides. For 2017. William R. Bishop,
example, the TARC-nucleic acid 5. Vote in Inv. No. 731–TA–703 Supervisory Hearings and Information
binding domain complex referred to as (Fourth Review) (Furfuryl Alcohol from Officer.
TARC-arp, has been shown to deliver si- China). The Commission is currently [FR Doc. 2017–14449 Filed 7–6–17; 11:15 am]
FoxP3 oligonucleotide into CCR4- scheduled to complete and file its BILLING CODE 7020–02–P
expressing cancer cells that will determination and views of the
specifically only inactivate FoxP3 Commission by July 28, 2017.
expression. Chemokine-based gene 6. Outstanding action jackets: None.
silencing can be therapeutically used to In accordance with Commission DEPARTMENT OF JUSTICE
modulate immune cells and improve policy, subject matter listed above, not [OMB Number 1122–0029]
outcome of diseases, such as by disposed of at the scheduled meeting,
inactivating Tregs to block cancer may be carried over to the agenda of the Agency Information Collection
escape and metastasis. following meeting. Activities; Proposed eCollection
This notice is made in accordance By order of the Commission.
eComments Requested; Extension of a
with 35 U.S.C. 209 and 37 CFR part 404. Currently Approved Collection
Issued: July 5, 2017.
The prospective Exclusive Patent
License will be royalty bearing and may William R. Bishop, AGENCY: Office on Violence Against
be granted unless within fifteen (15) Supervisory Hearings and Information Women, Department of Justice.
days from the date of this published Officer. ACTION: 30-day notice.
notice, the National Cancer Institute [FR Doc. 2017–14450 Filed 7–6–17; 11:15 am]
SUMMARY: The Department of Justice,
receives written evidence and argument BILLING CODE 7020–02–P
Office on Violence Against Women
that establishes that the grant of the
(OVW) will be submitting the following
license would not be consistent with the
UNITED STATES INTERNATIONAL information collection request to the
requirements of 35 U.S.C. 209 and 37
TRADE COMMISSION Office of Management and Budget
CFR part 404.
Complete applications for a license in (OMB) for review and approval in
[USITC SE–17–028]
the prospective field of use that are filed accordance with the Paperwork
in response to this notice will be treated Sunshine Act Meeting Reduction Act of 1995. The proposed
as objections to the grant of the information collection was previously
sradovich on DSK3GMQ082PROD with NOTICES
contemplated Exclusive Patent License AGENCY HOLDING THE MEETING: United published on May 18, 2017, allowing for
Agreement. Comments and objections States International Trade Commission. a 60 day comment period.
submitted to this notice will not be TIME AND DATE: July 14, 2017 at 11:00 DATES: Comments are encouraged and
made available for public inspection a.m. will be accepted for 30 days until
and, to the extent permitted by law, will PLACE: Room 101, 500 E Street SW., August 9, 2017.
not be released under the Freedom of Washington, DC 20436, Telephone: FOR FURTHER INFORMATION CONTACT:
Information Act, 5 U.S.C. 552. (202) 205–2000. Written comments and/or suggestion
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Document Created: 2017-07-08 00:55:28
Document Modified: 2017-07-08 00:55:28
| 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 July 25, 2017 will be considered. | |
| FR Citation | 82 FR 31783 |
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