Prospective Grant of Exclusive Patent License: Radiotherapeutics for Nasopharyngeal Cancer, 62866-62867 [2022-22476]

Download as PDF 62866 Federal Register / Vol. 87, No. 199 / Monday, October 17, 2022 / Notices lotter on DSK11XQN23PROD with NOTICES1 Contact Person: Kaushiki Mazumdar, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–1427, kaushiki.mazumdar@ nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Bacterial Pathogenesis. Date: November 9–10, 2022. Time: 10 a.m. to 7 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Diana Maria Ortiz-Garcia, Ph.D., Scientific Review Officer, The Center for Scientific Review, The National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301–594–5614, diana.ortizgarcia@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–NS– 22–034: HEAL Initiative. Date: November 9, 2022. Time: 11 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Roger Janz, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 402–8515, janzr2@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Motivated Behavior, Alcohol and Neurotoxicology. Date: November 9, 2022. Time: 11 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kirk Thompson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301–435– 1242, kgt@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 7, 2022. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–22417 Filed 10–14–22; 8:45 am] BILLING CODE 4140–01–P 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. 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. SUMMARY: 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. DATES: 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 michael.davis4@nih.gov. ADDRESSES: 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: SUPPLEMENTARY INFORMATION: NIH Ref No. Patent No. or patent application No. Issue date Filing date Title E–150–2016–0–US–01 62/333,427 ................. .................................... May 9, 2019 .............. E–150–2016–0–PCT– 02. PCT/US2017/031696 .................................... May 9, 2017 .............. E–150–2016–0–CN– 03. 201780029003X ......... .................................... November 9, 2018 ..... E–150–2016–0–EP–04 3455206 ..................... November 4, 2020 ..... May 9, 2017 .............. E–150–2016–0–JP–05 2018–558662 ............. TBD (Allowed) ........... May 9, 2017 .............. E–150–2016–0–US–06 10,696,637 ................. June 30, 2020 ........... May 9, 2017 .............. E–150–2016–0–SG– 07. 11201809982R .......... November 8, 2021 ..... May 9, 2017 .............. E–150–2016–0–CH– 08. 3455206 ..................... November 4, 2020 ..... May 9, 2017 .............. E–150–2016–0–DE–09 3455206 ..................... (Certificate No. 602017027023.7). 3455206 ..................... November 4, 2020 ..... May 9, 2017 .............. November 4, 2020 .... May 9, 2017 .............. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. E–150–2016–0–FR–10 VerDate Sep<11>2014 17:35 Oct 14, 2022 Jkt 259001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1 62867 Federal Register / Vol. 87, No. 199 / Monday, October 17, 2022 / Notices Patent No. or patent application No. Issue date Filing date Title E–150–2016–0–GB– 11. 3455206 ..................... November 4, 2020 .... May 9, 2017 .............. E–150–2016–0–IE–12 3455206 ..................... November 4, 2020 .... May 9, 2017 .............. E–150–2016–0–IT–13 3455206 ..................... November 4, 2020 ..... May 9, 2017 .............. E–150–2016–1–PCT– 01. PCT/US2017/054863 .................................... October 3, 2017 ........ E–150–2016–1–CN– 02. 201780095506.7 ........ .................................... October 3, 2017 ........ E–150–2016–1–EP–03 17928082.1 ................ .................................... October 3, 2017 ........ E–150–2016–1–JP–04 2020–519137 ............. .................................... October 3, 2017 ........ E–150–2016–1–SG– 05. 112020002882V ......... .................................... October 3, 2017 ........ E–150–2016–1–US–06 10,981,866 ................. April 20, 2021 ............ October 3, 2017 ........ 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. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and Their Use as Radiotherapy and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And Their Use As Radiotherapy And Imaging Agents. lotter on DSK11XQN23PROD with NOTICES1 NIH Ref No. 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 177Lu, 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 VerDate Sep<11>2014 17:35 Oct 14, 2022 Jkt 259001 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 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors of the NIH Clinical Center. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended for the review, discussion, and evaluation of individual grant applications conducted by the Clinical Center, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors of the NIH Clinical Center. Date: November 14, 2022. Time: 10 a.m. to 5:30 p.m. Agenda: To review and evaluate to review and evaluate the Rehabilitation Medicine Department, presentations, interviews and reports. Place: Clinical Center, 10 Center Drive, Bethesda, MD 20892 (Virtual Meeting). Date: November 15, 2022. E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     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


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