[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65364-65365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of an 
Antibody-Drug Conjugate for Use in PhotoImmunoTherapy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, 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 Summary Information section of this notice to Aspyrian 
Therapeutics, Inc. (``Aspyrian'') located in San Diego, California USA.

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 October 7, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Thomas Clouse, J.D., Senior Licensing and Patenting 
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. 62/202,252, filed 
August 7, 2015 ``Near Infrared PhotoImmunoTherapy (NIR-PIT) of 
Suppressor Cells to Treat Cancer'' [HHS Reference No. E-231-2015/0-US-
01]; and
    PCT Patent Application PCT/US2016/045090, filed August 2, 2016 
``Near Infrared PhotoImmunoTherapy (NIR-PIT) of Suppressor Cells to 
Treat Cancer'' [HHS Reference No. E-231-2015/0-PCT-02].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed 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: ``Use of photosensitizing antibody-fluorophore 
conjugate defined by the Licensed Patent Rights by itself for 
PhotoImmunoTherapy (PIT), or in combination with cancer therapeutic 
agents, to treat cancer or hyperplasia.''
    This technology discloses the concept of binding an anti-foxp3+ 
antibody to IR700 to bind to foxp3+ T-cells. When irradiated with near 
infrared light localized at the site of the solid tumor, controlled 
local knockdown of foxp3+ negative regulatory T-cells in tumors results 
in rapid tumor death without the severe autoimmune response that is 
induced by systemic knock-down of foxp3+ T-cells. Theoretically, this 
technology can be used in a broad spectrum of patients with a variety 
of solid cancers including those with

[[Page 65365]]

multiple distant metastasis as foxp3+ T-cells are generally believed to 
be critical to immunotolerance found in cancers. By treating a single 
local site with this technology, systemic host immunity against in situ 
cancers can be dramatically activated, leading to rapid tumor 
regression at the treated lesion as well as distant metastatic lesions 
untreated with the near infrared light while inducing minimal side 
effects.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404.7. The prospective exclusive license 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 404.7.
    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: September 16, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-22820 Filed 9-21-16; 8:45 am]
 BILLING CODE 4140-01-P