[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