[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56622-56623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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