[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.

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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 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