Prospective Grant of an Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer, 75296-75297 [2023-24229]

Download as PDF 75296 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. (National Center for Advancing Translational Sciences, National Institutes of Health, HHS Assistance Listing Number (formerly Catalog of Federal Domestic Assistance (CFDA) numbers) No. 93.350.) Dated: October 30, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–24224 Filed 11–1–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Center for Advancing Translational Sciences, 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 Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Platform Pharmaceuticals, Inc. (‘‘Platform Pharma’’), headquartered in New York, NY. DATES: Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences’ Office of Strategic Alliances on or before November 17, 2023 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: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, Office of Strategic Alliances, Telephone: (301)–642–0460; Email: sury.vepa@nih.gov. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: Intellectual Property 1. U.S. Provisional Patent Application No. 62/095,322 filed on 12/22/2014 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E– 243–2014–0–US–01); 2. International Patent Application No. PCT/ VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 US2015/067406 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E–243–2014–0–PCT–02); 3. Australian Patent Application No. 2015369712 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 2015369712 on 8/ 20/2020 (HHS Ref. No. E–243–2014–0– AU–03); 4. Canadian Patent Application No. 2971872 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E–243– 2014–0–CA–04); 5. Chinese Patent Application No. 2015800763284 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. ZL2015800763284 on 4/13/2021’’ (HHS Ref. No. E–243–2014–0–CN–05); 6. European Patent Application No. 15823901.2 filed on 12/22/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which issued as Patent No. 3237385 on 11/24/2021 and validated in Germany, Spain, France, Great Britain, and Italy (HHS Ref. No. E– 243–2014–0–EP–06); 7. Japanese Patent Application No. 2017534314 filed on 6/22/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 6901394 on 6/21/2021 (HHS Ref. No. E–243–2014–0–JP–07); 8. U.S. Patent Application No. 15/538,570 filed on 12/12/2015 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which issued as Patent No. 10,703,746 on 7/7/2020 (HHS Ref. No. E–243–2014–0–US–08); 9. U.S. Provisional Patent Application No. 62/353,298 filed on 6/22/2016 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E– 189–2016–0–US–01); 10. International Patent Application No. PCT/US2017/038549 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E–189–2016–0–PCT–02); 11. Australian Patent Application No. 2017281088 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 2017281088 on 9/9/2021 (HHS Ref. No. E–189–2016–0–AU–04); 12. Canadian Patent Application No. 3028999 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ (HHS Ref. No. E–189– 2016–0–CA–05); 13. Chinese Patent Application No. 2017800514100 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 201780051410.0 on 9/20/2022 (HHS Ref. No. E–189–2016–0–CN–06); 14. European Patent Application No. 17735296.0 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which issued as Patent No. 3475276 on 3/31/2021 and PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 validated in Germany, Spain, France, Great Britain, and Italy (HHS Ref. No. E– 189–2016–0–EP–07); 15. Japanese Patent Application No. 2018– 567108 filed on 6/21/2017 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 6987798 on 12/3/ 2021(HHS Ref. No. E–189–2016–0–JP– 08); and 16. U.S. Patent Application No. 16/312,206 filed on 12/20/2018 which is entitled ‘‘Mutant IDH1 Inhibitors Useful for Treating Cancer’’ which was issued as Patent No. 10,836,759 on 11/17/2020 (HHS Ref. No. E–189–2016–0–US–03). The patent rights in these inventions have been either assigned and/or exclusively licensed to the government of the United States of America and the University of North Carolina at Chapel Hill. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following: ‘‘Use of mutant isocitrate dehydrogenase 1 (mIDH1) inhibitors, as claimed in the licensed patent rights, for the treatment of cancers (such as acute myeloid leukemia, glioma, cholangiocarcinoma, glioblastoma multiforme (GBM) and other solid tumors) and rare diseases.’’ The inventions relate to a series of novel compounds that potently and selectively inhibit mIDH1. These compounds reduce 2–HG levels in cell lines in vitro as well as in human cancer cells grown in mouse xenografts in vivo. These compounds show greater than 250-fold selectivity for the mutant enzyme over the wild-type, show favorable in vitro stability (in mouse, rat, dog and human hepatocyte exposure studies), are AMES negative, and exhibit no significant metabolic CYP liabilities. These compounds possess very favorable in vivo rodent pharmacokinetics and bioavailability and are well tolerated in rodents, even when dosed at high levels. Thus, the compounds of the subject inventions can be used individually or in combination to develop new therapies to treat diseases which result from mutant IDH1 activity. The diseases caused by mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, glioma, cholangiocarcinoma and potentially other solid tumors) and selected rare diseases, such as Ollier Disease. 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 E:\FR\FM\02NON1.SGM 02NON1 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices Center for Advancing Translational Sciences 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 from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Joni L. Rutter, Director, Office of the Director, National Center for Advancing Translational Sciences. [FR Doc. 2023–24229 Filed 11–1–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES National Eye Institute; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Eye Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov/watch=52746). The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or proposals, the disclosure of which would constitute a VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Eye Council. Date: February 16, 2024. Open: 8:00 a.m. to 3:00 p.m. Agenda: Presentation of the NEI Director’s report, discussion of NEI programs, and concept clearances. Place: National Eye Institute, 1st Floor, Room A/B/C, 6700B Rockledge Drive, Bethesda, MD 20892. Closed: 3:15 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Eye Institute, 1st Floor, Room A/B/C, 6700B Rockledge Drive, Bethesda, MD 20892. Contact Person: Kathleen C. Anderson, Ph.D. Director, Division of Extramural Activities 6700B Rockledge Drive, Room 3440 Bethesda, MD 20892 (301) 451–2020 kanders1@nei.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the contact person listed above before the meeting or within 15 days after the meeting. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nei.nih.gov/about/advisory-committees/ national-advisory-eye-council-naec, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: October 27, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–24133 Filed 11–1–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 75297 The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Aging National Advisory Council on Aging. Date: September 18–19, 2024. Closed: September 18, 2024, 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate review of Applications. Place: National Institutes of Health Natcher Building 45 Natcher Drive Bethesda, MD 20892. Open: September 19, 2024, 9:00 a.m. to 1:10 p.m. Agenda: Call to Order and Director’s Status Report; Staff Introduction; Future Meeting Dates, Consideration of Minutes from Last Meeting; Task Force on Minority Aging Research; Working Group on Program and NOFO Concept Clearances; A Word from Retiring Members, Dr. Manly and Weir; Program Highlights; Council Speaker, Dr. Matthew Gillman, M.D., SM.; Meeting Adjourned. Place: National Institutes of Health, Natcher Building 45, Natcher Drive, Bethesda, MD 20892. Contact Person: Kenneth Santora, Director, Office of Extramural Activities, National Institute on Aging, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20814, (301) 496– 9322, ksantora@nih.gov. Information is also available on the Institute’s/Center’s home page: www.nia.nih.gov/about/naca, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: October 27, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–24134 Filed 11–1–23; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75296-75297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Mutant IDH1 
Inhibitors Useful for Treating Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Center for Advancing Translational Sciences, 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 Patents and Patent 
Applications listed in the SUPPLEMENTARY INFORMATION section of this 
Notice to Platform Pharmaceuticals, Inc. (``Platform Pharma''), 
headquartered in New York, NY.

DATES: Only written comments and/or applications for a license which 
are received by the National Center for Advancing Translational 
Sciences' Office of Strategic Alliances on or before November 17, 2023 
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: Sury Vepa, Ph.D., J.D., Senior Licensing and 
Patenting Manager, Office of Strategic Alliances, Telephone: (301)-642-
0460; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

1. U.S. Provisional Patent Application No. 62/095,322 filed on 12/
22/2014 which is entitled ``Mutant IDH1 Inhibitors Useful for 
Treating Cancer'' (HHS Ref. No. E-243-2014-0-US-01);
2. International Patent Application No. PCT/US2015/067406 filed on 
12/22/2015 which is entitled ``Mutant IDH1 Inhibitors Useful for 
Treating Cancer'' (HHS Ref. No. E-243-2014-0-PCT-02);
3. Australian Patent Application No. 2015369712 filed on 12/22/2015 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. 2015369712 on 8/20/2020 (HHS 
Ref. No. E-243-2014-0-AU-03);
4. Canadian Patent Application No. 2971872 filed on 12/22/2015 which 
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' 
(HHS Ref. No. E-243-2014-0-CA-04);
5. Chinese Patent Application No. 2015800763284 filed on 12/22/2015 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. ZL2015800763284 on 4/13/
2021'' (HHS Ref. No. E-243-2014-0-CN-05);
6. European Patent Application No. 15823901.2 filed on 12/22/2015 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which issued as Patent No. 3237385 on 11/24/2021 and 
validated in Germany, Spain, France, Great Britain, and Italy (HHS 
Ref. No. E-243-2014-0-EP-06);
7. Japanese Patent Application No. 2017534314 filed on 6/22/2017 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. 6901394 on 6/21/2021 (HHS 
Ref. No. E-243-2014-0-JP-07);
8. U.S. Patent Application No. 15/538,570 filed on 12/12/2015 which 
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' 
which issued as Patent No. 10,703,746 on 7/7/2020 (HHS Ref. No. E-
243-2014-0-US-08);
9. U.S. Provisional Patent Application No. 62/353,298 filed on 6/22/
2016 which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' (HHS Ref. No. E-189-2016-0-US-01);
10. International Patent Application No. PCT/US2017/038549 filed on 
6/21/2017 which is entitled ``Mutant IDH1 Inhibitors Useful for 
Treating Cancer'' (HHS Ref. No. E-189-2016-0-PCT-02);
11. Australian Patent Application No. 2017281088 filed on 6/21/2017 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. 2017281088 on 9/9/2021 (HHS 
Ref. No. E-189-2016-0-AU-04);
12. Canadian Patent Application No. 3028999 filed on 6/21/2017 which 
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' 
(HHS Ref. No. E-189-2016-0-CA-05);
13. Chinese Patent Application No. 2017800514100 filed on 6/21/2017 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. 201780051410.0 on 9/20/2022 
(HHS Ref. No. E-189-2016-0-CN-06);
14. European Patent Application No. 17735296.0 filed on 6/21/2017 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which issued as Patent No. 3475276 on 3/31/2021 and 
validated in Germany, Spain, France, Great Britain, and Italy (HHS 
Ref. No. E-189-2016-0-EP-07);
15. Japanese Patent Application No. 2018-567108 filed on 6/21/2017 
which is entitled ``Mutant IDH1 Inhibitors Useful for Treating 
Cancer'' which was issued as Patent No. 6987798 on 12/3/2021(HHS 
Ref. No. E-189-2016-0-JP-08); and
16. U.S. Patent Application No. 16/312,206 filed on 12/20/2018 which 
is entitled ``Mutant IDH1 Inhibitors Useful for Treating Cancer'' 
which was issued as Patent No. 10,836,759 on 11/17/2020 (HHS Ref. 
No. E-189-2016-0-US-03).

    The patent rights in these inventions have been either assigned 
and/or exclusively licensed to the government of the United States of 
America and the University of North Carolina at Chapel Hill.
    The prospective exclusive license territory may be worldwide, and 
the field of use may be limited to the following:
    ``Use of mutant isocitrate dehydrogenase 1 (mIDH1) inhibitors, as 
claimed in the licensed patent rights, for the treatment of cancers 
(such as acute myeloid leukemia, glioma, cholangiocarcinoma, 
glioblastoma multiforme (GBM) and other solid tumors) and rare 
diseases.''
    The inventions relate to a series of novel compounds that potently 
and selectively inhibit mIDH1. These compounds reduce 2-HG levels in 
cell lines in vitro as well as in human cancer cells grown in mouse 
xenografts in vivo.
    These compounds show greater than 250-fold selectivity for the 
mutant enzyme over the wild-type, show favorable in vitro stability (in 
mouse, rat, dog and human hepatocyte exposure studies), are AMES 
negative, and exhibit no significant metabolic CYP liabilities. These 
compounds possess very favorable in vivo rodent pharmacokinetics and 
bioavailability and are well tolerated in rodents, even when dosed at 
high levels.
    Thus, the compounds of the subject inventions can be used 
individually or in combination to develop new therapies to treat 
diseases which result from mutant IDH1 activity. The diseases caused by 
mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, 
glioma, cholangiocarcinoma and potentially other solid tumors) and 
selected rare diseases, such as Ollier Disease.
    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

[[Page 75297]]

Center for Advancing Translational Sciences 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 from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

Joni L. Rutter,
Director, Office of the Director, National Center for Advancing 
Translational Sciences.
[FR Doc. 2023-24229 Filed 11-1-23; 8:45 am]
BILLING CODE 4140-01-P

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