[Federal Register Volume 87, Number 199 (Monday, October 17, 2022)]
[Notices]
[Pages 62866-62867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Radiotherapeutics 
for Nasopharyngeal Cancer

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 Molecular 
Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its 
principle place of business in West Chester, Pennsylvania, to practice 
the inventions embodied in the issued patents and 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 
November 1, 2022 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 Davis, JD, Ph.D., Deputy Director, NHLBI 
OTTAD, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, 
phone number 301-451-9032, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to MTTI:

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                                     Patent No. or patent
            NIH Ref No.                application No.                Issue date                        Filing date                      Title
--------------------------------------------------------------------------------------------------------------------------------------------------------
E-150-2016-0-US-01................  62/333,427...........  ................................  May 9, 2019.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-PCT-02...............  PCT/US2017/031696....  ................................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-CN-03................  201780029003X........  ................................  November 9, 2018................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-EP-04................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-JP-05................  2018-558662..........  TBD (Allowed)...................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-US-06................  10,696,637...........  June 30, 2020...................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-SG-07................  11201809982R.........  November 8, 2021................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-CH-08................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-DE-09................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                    (Certificate No.                                                                            Evans Blue Derivatives
                                     602017027023.7).                                                                           and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-FR-10................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.

[[Page 62867]]

 
E-150-2016-0-GB-11................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-IE-12................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-0-IT-13................  3455206..............  November 4, 2020................  May 9, 2017.....................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                and Their Use as
                                                                                                                                Radiotherapy and Imaging
                                                                                                                                Agents.
E-150-2016-1-PCT-01...............  PCT/US2017/054863....  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-CN-02................  201780095506.7.......  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-EP-03................  17928082.1...........  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-JP-04................  2020-519137..........  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-SG-05................  112020002882V........  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-US-06................  10,981,866...........  April 20, 2021..................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
E-150-2016-1-HK-07................  62020015610.2........  ................................  October 3, 2017.................  Chemical Conjugates of
                                                                                                                                Evans Blue Derivatives
                                                                                                                                And Their Use As
                                                                                                                                Radiotherapy And Imaging
                                                                                                                                Agents.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The prospective patent 
license may be granted in a field of use directed to radiotherapeutics 
for nasopharyngeal cancer and the extent of the exclusive license may 
be territorially restricted to the United States, its Territories, 
Commonwealths and Possessions; and Asia.
    The invention pertains to a radiotherapeutics against cancers that 
express somatostatin receptor. Radionuclide therapy directed against 
tumors that express somatostatin receptors (SSTRs) has proven effective 
for the treatment of advanced, low- to intermediate-grade 
neuroendocrine tumors. The subject radiotherapeutic covered by the 
patent estate includes a somatostatin (SST) peptide derivative like 
octreotate (TATE), conjugated to an Evans Blue (EB) analog, and further 
chelated via DOTA to therapeutic radionuclide \177\Lu, a beta emitter. 
The EB analog reversibly binds to circulating serum albumin and 
improves the pharmacokinetics of SST peptide derivatives and reduce 
peptide-receptor radionuclide therapy toxicity. EB analog conjugated to 
octreotate (EB-TATE) has been shown by the inventors to provide 
reversible albumin binding in vivo and extended half-life in 
circulation. When EB-TATE is slowly released into the tumor 
microenvironment, tumor uptake and internalization into SSTR positive 
tumors resulted in delivery of radioactive particles and tumor cell 
killing. EB-TATE displayed significantly more favorable 
pharmacokinetics than TATE alone by achieving higher tumor to non-tumor 
penetration as evidenced by positron emission tomography.
    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.

Michael D. Davis,
Deputy Director, National Heart, Lung, and Blood Institute, Office of 
Technology Transfer and Development.
[FR Doc. 2022-22476 Filed 10-14-22; 8:45 am]
BILLING CODE 4140-01-P