[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