Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75295 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W248, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Anita T. Tandle, Ph.D., 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W248, 

Rockville, Maryland 20850, 240–276–5085, 

tandlea@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Program Project (P01) Review SEP–B. 

Date: February 6–7, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W618, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: E. Tian, Ph.D., Scientific 

Review Officer, Research Program Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W618, Rockville, 

Maryland 20850, 240–276–6611, tiane@

mail.nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group; Institutional 

Training and Education Study Section (F). 

Date: February 21–22, 2024. 

Time: 9:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W234, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Adriana Stoica, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W234, Rockville, Maryland 20850, 

240–276–6368, Stoicaa2@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Program Project (P01) Review SEP–A. 

Date: February 21–22, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W120, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Majed M. Hamawy, Ph.D., 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W120, 

Rockville, Maryland 20850, 240–276–6457, 

mh101v@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Program Project (P01) Review SEP–C. 

Date: February 22–23, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W126, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Mukesh Kumar, Ph.D., 

Scientific Review Officer, Research Program 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W126, 

Rockville, Maryland 20850, 240–276–6611, 

mukesh.kumar3@nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI SPORE 

(P50) Review SEP–IV. 

Date: February 28, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W522, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Klaus B. Piontek, Ph.D., 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NCI, 

9609 Medical Center Drive, Room 7W522, 

Rockville, Maryland 20850, 240–276–5413, 

klaus.piontek@nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group; Career 

Development Study Section (J). 

Date: February 28–29, 2024. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute Shady 

Grove, 9609 Medical Center Drive, Room 

7W624, Rockville, Maryland 20850 (Virtual 

Meeting). 

Contact Person: Tushar Deb, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W624, Rockville, Maryland 20850, 

240–276–6132, tushar.deb@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: October 30, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–24225 Filed 11–1–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 Center for 

Advancing Translational Sciences 

Advisory Council. 

This meeting is being held virtually 

only. The open session will be videocast 

and may be accessed by the public from 

the NIH Videocasting and Podcasting 

website (http://videocast.nih.gov). 

Individuals who 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 Center for 

Advancing Translational Sciences Advisory 

Council. 

Date: January 18, 2024. 

Closed: 11:00 a.m. to 12:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, One Democracy Plaza, 9th Floor, 

Conference Room 987/989, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Open: 12:30 p.m. to 6:00 p.m. 

Agenda: Report from the Center Director, 

Program Update(s), Clearance of Concept(s), 

Special Topic presentation. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, One Democracy Plaza, 9th Floor, 

Conference Room 987/989, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Anna L. Ramsey-Ewing, 

Ph.D., Executive Secretary, National Center 

for Advancing Translational Sciences, One 

Democracy Plaza, Room 1072, Bethesda, MD 

20892, (301) 435–0809, anna.ramseyewing@

nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice no later than 15 days after the 

meeting at NCATSCouncilInput@

mail.nih.gov. 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 


khammond on DSKJM1Z7X2PROD with NOTICES
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