80 FR 59790 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

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:

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59790-59791]
From the Federal Register Online  [www.thefederalregister.org]
[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