82 FR 56622 - Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 228 (November 29, 2017)

Page Range		56622-56623
FR Document		2017-25743

The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to T-Cure Bioscience, Inc. located in Thousand Oaks, California and incorporated under the laws of Delaware.

Federal Register, Volume 82 Issue 228 (Wednesday, November 29, 2017)

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56622-56623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: T-Cells Transduced 
with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the 
Treatment of Renal Cell Carcinoma

AGENCY: National Institutes of Health.

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute (``NHLBI''), an 
institute of the National Institutes of Health; an agency within the 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to commercialize the invention(s) embodied 
in the intellectual property estate stated in the Summary Information 
section of this notice to T-Cure Bioscience, Inc. located in Thousand 
Oaks, California and incorporated under the laws of Delaware.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development

[[Page 56623]]

on or before December 14, 2017 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Cristina Thalhammer-Reyero, Ph.D., MBA, Senior Licensing 
and Patenting Manager, NHLBI Office of Technology Transfer and 
Development, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479; Telephone: +1-301-435-4507; Fax: +1-301-594-3080; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:
    US Provisional Patent Application No. 62/357,265, filed June 30, 
2016; and PCT Patent Application PCT/US2017/040449, filed June 30, 
2017, ``HERV-E Reactive T Cell Receptors and Methods of Use'', NIH 
Reference No. E-120-2016/0,1.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the use of Licensed Patent Rights 
for the following: ``Development and commercialization of T cell 
receptor based cancer immunotherapy for Renal Cell Carcinoma''.
    The subject technology is based on an allogeneic T cell clone 
isolated from a clear cell renal cell carcinoma (ccRCC) HLA-A11 patient 
who showed prolonged tumor regression after an allogeneic transplant. 
This clone was found to have tumor specific cytotoxicity, killing 
patient's tumor cells in vitro. The antigen recognized by this clone is 
an HLA-A11 restricted peptide (named CT-RCC-1) and it is encoded by a 
novel human endogenous retrovirus-E (named CT-RCC HERV-E) whose 
expression was discovered to be restricted to ccRCC, but not observed 
in normal tissues or other tumor types. More than 80% of ccRCC tumors 
express CT-RCC HERV-E provirus, which makes it an ideal target for T 
cell based immunotherapy. The genes for a T cell receptor (TCR) that 
specifically recognizes an HLA-A11 restricted CT-RCC-1 antigen were 
sequenced and cloned. A retroviral vector encoding this TCR as well as 
a truncated CD34 protein lacking the intracellular domain, which can be 
used to facilitate the isolation of T-cells transduced with this TCR, 
was created. The vector can be used to transduce and expand normal T 
cells from HLA-A11 patients with metastatic ccRCC with the TCR. The 
transduced cytotoxic T cells can then be administered to subjects to 
treat or inhibit metastatic kidney cancer. Kidney cancer is responsible 
for approximately 12,000 deaths every year in the United States alone. 
As with most cancer, when detected at early stages, surgical 
intervention is highly effective. Phase I/II clinical trials are 
currently being planned in patients with metastatic ccRCC using normal 
patient's T-cells transduced with this vector.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI Office of Technology Transfer 
and Development 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.
    The public may file comments or objections in response to this 
Notice. 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 in 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: November 16, 2017.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-25743 Filed 11-28-17; 8:45 am]
 BILLING CODE 4140-01-P

56622 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices

concatenated L2 peptides for the DEPARTMENT OF HEALTH AND Activities, National Cancer Institute, NIH,
prevention of Human Papillomavirus HUMAN SERVICES 9609 Medical Center Drive, Room 7W248,
Bethesda, MD 20892–9750, 240–276–5007,
(HPV) infection and associated diseases.
National Institutes of Health tandlea@mail.nih.gov.
Specifically excluded from the field of
Name of Committee: National Cancer
use are L2 based virus-like particles Institute Special Emphasis Panel;
National Cancer Institute; Notice of
(VLPs), L1/L2 chimeric peptides, and Quantitative Imaging.
Closed Meetings
L1/L2 chimeric peptide/protein based Date: February 14, 2018.
VLPs.’’ Pursuant to section 10(d) of the Time: 10:00 a.m. to 5:00 p.m.
Federal Advisory Committee Act, as Agenda: To review and evaluate grant
The subject technologies are applications.
papillomavirus L2 capsid protein based amended, notice is hereby given of the
Place: National Cancer Institute, Shady
vaccines against HPV. The L2 protein is following meetings. Grove, 9609 Medical Center Drive, Room
The meetings will be closed to the 4W030, Rockville, MD 20850 (Telephone
the minor papillomavirus capsid protein
public in accordance with the Conference Call).
for papillomaviruses. It is known that provisions set forth in sections Contact Person: Eduardo E. Chufan, Ph.D.,
antibodies to this protein can neutralize 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review Officer, Research
homologous infection. Furthermore, L2 as amended. The grant applications and Technology and Contract Review Branch,
proteins can induce cross-neutralizing the discussions could disclose Division of Extramural Activities, National
antibodies. Specifically, epitopes at the confidential trade secrets or commercial Cancer Institute, NIH, 9609 Medical Center
N-terminus of L2 shared by cutaneous Drive, Room 7W254, Bethesda, MD 20892–
property such as patentable material, 9750, 240–276–7975, chufanee@mail.nih.gov.
and mucosal types of papillomavirus and personal information concerning
types and by types that infect divergent (Catalogue of Federal Domestic Assistance
individuals associated with the grant Program Nos. 93.392, Cancer Construction;
species are broadly cross-neutralizing. applications, the disclosure of which 93.393, Cancer Cause and Prevention
These epitopes at the N-terminus of L2 would constitute a clearly unwarranted Research; 93.394, Cancer Detection and
can be used to elicit cross-neutralizing invasion of personal privacy. Diagnosis Research; 93.395, Cancer
antibodies against different types of Treatment Research; 93.396, Cancer Biology
Name of Committee: National Cancer
HPV. Research; 93.397, Cancer Centers Support;
Institute Special Emphasis Panel; NCI SPORE
93.398, Cancer Research Manpower; 93.399,
This notice is made in accordance V Review.
Cancer Control, National Institutes of Health,
Date: February 5–6, 2018.
with 35 U.S.C. 209 and 37 CFR part 404. HHS)
Time: 4:00 p.m. to 5:00 p.m.
The prospective exclusive license will Agenda: To review and evaluate grant Dated: November 22, 2017.
be royalty bearing, and the prospective applications. Melanie J. Pantoja,
exclusive license may be granted unless Place: Gaithersburg Washingtonian Program Analyst, Office of Federal Advisory
within fifteen (15) days from the date of Marriott, 9751 Washingtonian Boulevard, Committee Policy.
this published notice, the National Gaithersburg, MD 20878.
[FR Doc. 2017–25732 Filed 11–28–17; 8:45 am]
Cancer Institute receives written Contact Person: Mukesh Kumar, Ph.D.,
Scientific Review Officer, Research Program BILLING CODE 4140–01–P
evidence and argument that establishes Review Branch, Division of Extramural
that the grant of the license would not Activities, National Cancer Institute, NIH,
be consistent with the requirements of 9609 Medical Center Drive, Room 7W618, DEPARTMENT OF HEALTH AND
35 U.S.C. 209 and 37 CFR part 404. Bethesda, MD 20892–9750, 240–276–6611, HUMAN SERVICES
mukesh.kumar3@nih.gov.
In response to this Notice, the public
Name of Committee: National Cancer National Institutes of Health
may file comments or objections.
Institute Special Emphasis Panel; Molecular
Comments and objections, other than and Cellular Analysis Technologies. Prospective Grant of Exclusive Patent
those in the form of a license Date: February 8, 2018. License: T-Cells Transduced with HLA
application, will not be treated Time: 10:00 a.m. to 4:00 p.m. A11 Restricted CT–RCC HERV–E
confidentially, and may be made Agenda: To review and evaluate grant Reactive T-Cell Receptors for the
publicly available. applications. Treatment of Renal Cell Carcinoma
Place: National Cancer Institute, Shady
License applications submitted in Grove, 9609 Medical Center Drive, Room AGENCY: National Institutes of Health.
response to this Notice will be 7W030, Rockville, MD 20850 (Telephone ACTION: Notice.
presumed to contain business Conference Call).
confidential information and any release Contact Person: Nadeem Khan, Ph.D., SUMMARY: The National Heart, Lung, and
of information in these license Scientific Review Officer, Research Blood Institute (‘‘NHLBI’’), an institute
applications will be made only as Technology and Contract Review Branch, of the National Institutes of Health; an
Division of Extramural Activities, National agency within the Department of Health
required and upon a request under the Cancer Institute, NIH, 9609 Medical Center
Freedom of Information Act, 5 U.S.C. and Human Services, is contemplating
Drive, Room 7W260, Bethesda, MD 20892–
552. 9750, 240–276–5856, nadeem.khan@nih.gov.
the grant of an Exclusive Patent License
to commercialize the invention(s)
Dated: November 14, 2017. Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
embodied in the intellectual property
Richard U. Rodriguez, estate stated in the Summary
VI Review.
Associate Director, Technology Transfer Date: February 8–9, 2018. Information section of this notice to
pmangrum on DSK3GDR082PROD with NOTICES1

Center, National Cancer Institute. Time: 4:00 p.m. to 5:00 p.m. T-Cure Bioscience, Inc. located in
[FR Doc. 2017–25744 Filed 11–28–17; 8:45 am] Agenda: To review and evaluate grant Thousand Oaks, California and
BILLING CODE 4140–01–P
applications. incorporated under the laws of
Place: Gaithersburg Washingtonian Delaware.
Marriott, 9751 Washingtonian Boulevard,
Gaithersburg, MD 20878. DATES: Only written comments and/or
Contact Person: Anita T. Tandle, Ph.D., applications for a license which are
Scientific Review Officer, Research Program received by the NHLBI Office of
Review Branch, Division of Extramural Technology Transfer and Development

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Document Created: 2017-11-29 01:26:43
Document Modified: 2017-11-29 01:26:43

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development on or before December 14, 2017 will be considered.
FR Citation		82 FR 56622

82 FR 56622 - Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 228 (November 29, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health