Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84357 

4. US Patent Application No.: 16/ 

304,552, filed November 26, 2018 

(E–133–2016/0–US–05 

5. Australia Patent Application No.: 

2017271606, filed November 13, 

2018 (E–133–2016/0–AU–06) 

6. Canadian Patent Application No.: 

3025516, filed November 23, 2018 

(E–133–2016/0–CA–07) 

7. Japan Patent Application No.: 2018– 

561669, filed November 22, 2018 

(E–133–2016/0–JP–08) 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The prospective exclusive license 

territory may be worldwide, and the 

fields of use may be limited to the 

following: 

An exclusive license to: ‘‘the 

development and commercialization of 

a universal or split chimeric antigen 

receptor (CAR)-based immunotherapy 

using autologous or allogeneic T cells 

transduced with lentiviral vectors, or 

autologous or allogeneic NK cells 

transduced with retroviral vectors, 

including but not limited to lentiviral 

vectors, for the prophylaxis or treatment 

of cancers expressing FMS-like tyrosine 

kinase 3 (FLT3; also known as CD135), 

wherein the CAR construct binds to the 

FLT3-binding domain referenced as 

NC7 in the invention, but NC7 is not 

included in the CAR construct. 

Specifically excluded from the field of 

use for this exclusive license are FLT3- 

specific CAR-based immunotherapies 

wherein the CAR construct comprises 

the FLT3-binding domain referenced as 

NC7 in the invention as well as an 

intracellular signaling domain.’’ For 

clarity, ‘‘universal/split CAR-based 

immunotherapy’’ in the context of this 

license means CAR therapies wherein 

the FLT3-binder is soluble and infused 

into the patient independent from the 

modified lymphocytes. The patient is 

then infused with lymphocytes 

expressing a CAR construct that 

recognizes the FLT3-binder (an 

exogenous protein tag like FITC or the 

heavy chain of an scFv for example). 

A co-exclusive license to: ‘‘the 

development and commercialization of 

a multi-specific FLT3 CAR-based 

immunotherapy using autologous or 

allogeneic T cells transduced with 

lentiviral vectors, or autologous or 

allogeneic NK cells transduced with 

retroviral vectors, including but not 

limited to lentiviral vectors, wherein the 

viral transduction leads to the 

expression of a CAR that targets FLT3 

(comprised of the FLT3-binding domain 

referenced as NC7 in the invention as 

well as an intracellular signaling 

domain), for the prophylaxis or 

treatment of FLT3-expressing cancers.’’ 

For clarity, ‘‘multi-specific FLT3 CARbased immunotherapy’’ in the context of 

this license means therapies wherein 

the CAR-expressing lymphocytes 

recognize FLT3 and additional antigens. 

A co-exclusive license to: ‘‘the 

development of a FLT3-specific 

Regulated or Switch or Logic-Gated 

CAR-based immunotherapy using 

autologous or allogeneic T cells 

transduced with lentiviral vectors, or 

autologous or allogeneic NK cells 

transduced with retroviral vectors, 

including but not limited to lentiviral 

vectors, wherein the viral transduction 

leads to the expression of a CAR that 

targets FLT3 (comprised of the FLT3- 

binding domain referenced as NC7 in 

the invention as well as an intracellular 

signaling domain), for the prophylaxis 

or treatment of FLT3-expressing 

cancers.’’ For clarity, FLT3-specific 

Regulated or Switch or Logic-Gated 

CAR-based immunotherapy in the 

context of this license means therapies 

wherein the CAR-expressing 

lymphocytes recognize FLT3 and are 

engineered to respond to one or more 

signals, such as recognizing one or more 

additional antigens, responding to an 

exogenous small molecule, or 

responding to a biological signal (but 

not necessarily all of the signals). 

These technologies disclose therapies 

to treat AML by utilizing CARs that 

recognize AML cells through a binder 

for FLT3, specifically through the FLT3 

binder known as NC7. FLT3 is a 

validated immunotherapeutic target that 

is expressed on the surface of cancerous 

cells, its expression is amplified on the 

surface of acute myelogenous leukemia 

(AML) blasts and cells in chronic 

myeloid leukemia-blast crisis (CML– 

BC). 

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 

Cancer Institute 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. 

Dated: December 17, 2020. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2020–28569 Filed 12–23–20; 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 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following 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 Special 

Emphasis Panel; NTU Bench/Clinical Testing 

for COVID–19. 

Date: February 3, 2021. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

1080, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jing Chen, Ph.D., Scientific 

Review Officer, Office of Scientific Review, 

National Center for Advancing Translational 

Sciences, National Institutes of Health, 6701 

Democracy Boulevard, Room 1080, Bethesda, 

MD 20892–4874, chenjing@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: December 18, 2020. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–28526 Filed 12–23–20; 8:45 am] 

BILLING CODE 4140–01–P 


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