[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59790-59791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of Non-viral
Adoptive Cell Transfer-based Immunotherapies (ACT) for the Treatment
and Prophylaxis of Patients With Metastatic Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404.7, that the National Institutes of Health, Department of Health and
Human Services, is contemplating the grant of an exclusive patent
license to Intima Biosciences, Inc., which is located in New York City,
New York to practice the inventions embodied in the following patent
applications and applications claiming priority to these applications:
1. U.S. Provisional Patent Application No. 61/771,251 filed
March 1, 2013 entitled ``Methods of Producing Enriched Populations
of Tumor Reactive T Cells from Peripheral Blood'' (HHS Ref No. E-
085-2013/0-US-01);
2. PCT Application No. PCT/US2013/038813 filed April 30, 2013
entitled ``Methods of Producing Enriched Populations of Tumor
Reactive T Cells from Peripheral Blood'' (HHS Ref No. E-085-2013/0-
PCT-02) and all resulting national stage filings; and
3. PCT Application No. PCT/US2014/058796 filed October 2, 2014
entitled ``Methods of Isolating T Cell Receptors Having Antigenic
Specificity for a Cancer-Specific Mutation'' (HHS Ref No. E-233-
2014/0-PCT-01);
The patent rights in these inventions have been assigned to 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 the
Licensed Patent Rights with the Licensee's non-viral clustered
regularly interspaced short palindromic repeats (CRISPR)/cellular
apoptosis susceptibility (Cas) systems and proprietary non-viral
constructs for the insertion of genes encoding T-Cell Receptors (TCR)
against mutated antigens into peripheral blood lymphocytes for the
treatment and prophylaxis of patients with metastatic cancer.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 2, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A.,
Senior Licensing and Patenting Manager, NCI Technology Transfer Center,
9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702
(for business mail), Rockville, MD 20850-9702; Telephone: (240) 276-
5530; Facsimile: (240) 276-5504; Email: [email protected].
SUPPLEMENTARY INFORMATION: The first technology describes a process to
select highly tumor-reactive T cells from a patient's peripheral blood
sample based on the expression of two specific T cell surface markers:
Programmed cell death protein 1 (PD-1; CD279) and/or T cell Ig- and
mucin-domain-containing molecule-3 (TIM-3). After this enriched
population of tumor-reactive T cells is selected and expanded to large
quantities, it gets re-infused into the patient via an ACT regimen. The
enrichment of tumor-reactive cells from a patient's peripheral blood
based on these markers provides a simple alternative to the current
strategies based on isolation tumor-reactive cells from the tumor, as
it reduces the cost and complications of tumor of resection, as well as
provides a T cell product for patients without resectable lesions. The
second technology describes a method to identify and generate TCR
engineered T cells for personalized cancer therapy. Using tandem mini-
gene constructs encoding all of the patient's tumor mutations, T cells
that were reactive with the unique mutated antigens expressed only in
the patient's tumors
[[Page 59791]]
are identified, and then the mutation-reactive TCRs and engineered
peripheral blood T cells from the same patient are isolated to express
these mutation-reactive TCRs. These personalized TCR engineered T cells
are expanded and infused back into the same patient with the potential
to induce tumor regression.
The prospective exclusive license may be granted unless within
thirty (30) days from the date of this published notice, the NIH
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 404.7.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated exclusive license. Comments and objections submitted
to this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24990 Filed 10-1-15; 8:45 am]
BILLING CODE 4140-01-P