Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of Pancreatic Cancer, 31783-31784 [2017-14370]

Download as PDF Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices their presentation on or before July 12, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 13, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Philip Bautista at least 7 days in advance of the meeting. 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Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. AGENCY: [FR Doc. 2017–14364 Filed 7–7–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1486] Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability; Correction Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus; Availability’’ that appeared in the Federal Register of June 30, 2017 (82 FR 29886). The document announced the issuance of two Emergency Use Authorizations for in vitro diagnostic devices for detection of the Zika virus in response to the Zika sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 [FR Doc. 2017–14365 Filed 7–7–17; 8:45 am] BILLING CODE 4164–01–P 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 National Institutes of Health, Department of Health and Human Services. ACTION: Notice. 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 SUMMARY: BILLING CODE 4164–01–P AGENCY: Dated: June 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 31783 business mail), Rockville, MD 20850– 9702 Telephone: (240) 276–5530; Facsimile: (240) 276–5504 Email: vathyams@mail.nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property • United 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 E:\FR\FM\10JYN1.SGM 10JYN1 sradovich on DSK3GMQ082PROD with NOTICES 31784 Federal Register / Vol. 82, No. 130 / Monday, July 10, 2017 / Notices 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 siFoxP3 oligonucleotide into CCR4expressing 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. VerDate Sep<11>2014 16:08 Jul 07, 2017 Jkt 241001 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 INTERNATIONAL TRADE COMMISSION [USITC SE–17–027] Sunshine Act Meeting United States International Trade Commission. TIME AND DATE: July 12, 2017 at 11:00 a.m. PLACE: Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205–2000. STATUS: Open to the public. MATTERS TO BE CONSIDERED: 1. Agendas for future meetings: None. 2. Minutes. 3. Ratification List. 4. Vote in Inv. No. 731–TA–410 (Fourth Review) (Light-Walled Rectangular Pipe from Taiwan). The Commission is currently scheduled to complete and file its determination and views of the Commission by July 25, 2017. 5. Vote in Inv. No. 731–TA–703 (Fourth Review) (Furfuryl Alcohol from China). The Commission is currently scheduled to complete and file its determination and views of the Commission by July 28, 2017. 6. Outstanding action jackets: None. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. AGENCY HOLDING THE MEETING: By order of the Commission. Issued: July 5, 2017. William R. Bishop, Supervisory Hearings and Information Officer. [FR Doc. 2017–14450 Filed 7–6–17; 11:15 am] BILLING CODE 7020–02–P UNITED STATES INTERNATIONAL TRADE COMMISSION [USITC SE–17–028] Sunshine Act Meeting United States International Trade Commission. TIME AND DATE: July 14, 2017 at 11:00 a.m. PLACE: Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205–2000. AGENCY HOLDING THE MEETING: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 STATUS: Open to the public. MATTERS TO BE CONSIDERED: 1. Agendas for future meetings: none. 2. Minutes. 3. Ratification List. 4. Vote in Inv. Nos. 701–TA–579–580 and 731–TA–1369–1373 (Preliminary)(Fine Denier Polyester Staple Fiber from China, India, Korea, Taiwan, and Vietnam). The Commission is currently scheduled to complete and file its determinations on July 17, 2017; views of the Commission are currently scheduled to be completed and filed on July 24, 2017. 5. Vote in Inv. Nos. 701–TA–581 and 731–TA–1374–1376 (Preliminary) (Citric Acid and Certain Citrate Salts from Belgium, Colombia, and Thailand). The Commission is currently scheduled to complete and file its determinations on July 17, 2017; views of the Commission are currently scheduled to be completed and filed on July 24, 2017. 6. Outstanding action jackets: None. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. By order of the Commission. Issued: July 5, 2017. William R. Bishop, Supervisory Hearings and Information Officer. [FR Doc. 2017–14449 Filed 7–6–17; 11:15 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE [OMB Number 1122–0029] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection Office on Violence Against Women, Department of Justice. ACTION: 30-day notice. AGENCY: The Department of Justice, Office on Violence Against Women (OVW) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published on May 18, 2017, allowing for a 60 day comment period. DATES: Comments are encouraged and will be accepted for 30 days until August 9, 2017. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestion SUMMARY: E:\FR\FM\10JYN1.SGM 10JYN1

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[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Notices]
[Pages 31783-31784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14370]


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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: vathyams@mail.nih.gov.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

     United 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

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