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. 

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: 

sury.vepa@nih.gov. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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 

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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES