[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36809-36810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: MicroRNA
Therapeutics for Treating Squamous Cell Carcinomas
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an Exclusive Patent License to MiRecule,
Inc., located in Rockville, Maryland, to practice the inventions
embodied in the patent applications listed in the SUPPLEMENTARY
INFORMATION section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the NHLBI Office of Technology Transfer and Development
August 22, 2017 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Michael Shmilovich, Esq., Senior Licensing and
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD
20892-2479, phone number 301-435-5019, or [email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement: HHS Ref. No.
E-043-2016/0, including provisional patent application 62/304,844 filed
March 7, 2016 and International Patent Application PCT/US2017/021178
filed March 7, 2017 both entitled ``MicroRNAs And Methods Of Their
Use,'' and all continuing U.S. and foreign patents/patent applications
for the technology family, to MiRecule. The patent rights in these
inventions have been assigned to and/or exclusively licensed to the
Government of the United States of America.
With respect to persons who have an obligation to assign their
right, title and interest to the Government of the United States of
America, the patent rights in these inventions have been assigned to
the Government of the United States of America.
The prospective Exclusive Patent License territory may be worldwide
for the following field of use: MicroRNA therapeutics for squamous cell
carcinomas.
The invention relates to the use of microRNAs (miRs), miR mimics,
miR mimetics, and a combination thereof as anti-proliferative cancer
therapeutics. In this case, miRs will be administered in a form
complexed with nanoparticles in the form of liposomes decorated with
anti-transferrin receptor (TfR) scFv fragments. Generally, miRs are a
highly conserved class of small RNA molecules (about 18-24bp) that
primarily bind the 3'-UTR region of mRNA molecules and either block
translation or promote nuclease mediated degradation. The inventors
found that mimics or mimetics derived from several members of the miR-
30-5p family; and miR-30a-5p and miR-30e-5p, have potential as anti-
proliferative therapeutics in cancers including but not limited to
squamous cell carcinomas and currently have a CRADA with NIDCD
exploring their uses in treating head and neck squamous cell carcinoma
(HNSSC). In an in vivo proof-of-concept using a murine xenograft tumor
model for HNSSC, the inventors demonstrated that intraperitoneal
administration of a nanoliposome formulated with an anti-transferrin
receptor antibody fragment and a synthetic miR-30a-5p mimic strongly
delayed tumor growth. Other anti-cancer miR therapeutic mimics can be
combines with miR-30 including miR-145-5p, miR-26a-5p, miR-26b-5p, miR-
375-5p, miR-30b-5p, miR-30d-5p, or miR-338-3p. Modes of administration
can be by intravenous injection, intraperitoneal injection,
subcutaneous injection, or intratumoral injection. Therapeutic design
employing miR mimicry focuses on nucleic acid modifications that
exhibit better cytotoxicity than unmodified miRs or commercially
available mimics. For example, it is accepted that modification of the
2' position of individual nucleic acids in an oligonucleotide can
improve affinity to complementary strands and confer resistance to
nucleases and reduce adverse immunogenic reactions. By way of another
example, bases 1, 6, and 20 of a passenger strand miR can be mutated to
increase the stability of the resulting duplex; however, these mutation
sites may differ from one
[[Page 36810]]
therapeutic miR to another. Tumor suppressing miR mimics can be
synergistically combined with standard chemo- and radiation therapies
in an anti-cancer regimen.
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 NHLBI 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 timely filed in response to this notice will be treated as
objections to the grant of the contemplated Exclusive Patent License.
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: July 25, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, NHLBI Office of Technology
Transfer and Development.
[FR Doc. 2017-16524 Filed 8-4-17; 8:45 am]
BILLING CODE 4140-01-P