[Federal Register Volume 84, Number 100 (Thursday, May 23, 2019)]
[Notices]
[Pages 23798-23799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: The Development 
and Use of a Therapeutic STAT3 Inhibitor, GLG-302, in All Proliferative 
Diseases, Where STAT3 Is Present

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 Supplementary Information section of this notice to GLG 
Pharma LLC located in Jupiter, Florida, 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 June 7, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Sidra Ahsan, 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. 62/481,960, filed 
April 5, 2017 and entitled ``Improved STAT3 Inhibitor Formulation'' 
[HHS Reference No. E-035-2017/0-US-01]; PCT Patent Application No. PCT/
US2018/026228, filed April 5, 2018 and entitled ``STAT3 Inhibitor 
Formulation'' [HHS Reference No. E-035-2017/0-PCT-02]; and U.S. and 
foreign patent applications claiming priority to the aforementioned 
applications.
    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 development and 
commercialization of a therapeutic STAT3 inhibitor, GLG-302, in all 
proliferative diseases, where STAT3 is present.''
    This technology discloses the use of the STAT3 inhibitor GLG-302 
with Trizma salts for preclinical anti-cancer and cancer preventive 
activity. GLG-302 is a proprietary compound developed by GLG Pharma 
LLC. Trizma salts allow GLG-302 to remain in solution for oral 
administration. This formulation has been demonstrated to be effective 
in the modulation of STAT3 signaling and proliferation in normal 
mammary ductal epithelium, and this formulation has demonstrated 
mammary cancer preventive efficacy in rat (ER+) and mouse (ER-) models. 
The technology provides improved sample handing and oral 
bioavailability suggesting that a therapeutic product derived from this 
technology would be applicable for the treatment of cancer where STAT3 
is present.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the

[[Page 23799]]

Freedom of Information Act, 5 U.S.C. 552.

    Dated: May 15, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-10779 Filed 5-22-19; 8:45 am]
 BILLING CODE 4140-01-P