[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28063-28064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of Cell Therapies for Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this Notice to Tailored 
Therapeutics, LLC. (``Tailored''), located in Potomac, MD.

[[Page 28064]]


DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before July 2, 2019 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer 
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)-276-5484; Facsimile: (240)-
276-5504; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

Group A

HLA-A3-Restricted T Cell Receptors Against Mutated RAS
    1. U.S. Provisional Patent Application 62/749,750, filed October 
24, 2018 (E-166-2018-0-US-01).
HLA Class II-Restricted T Cell Receptors Against RAS With G12R Mutation
    1. U.S. Provisional Patent Application 62/795,203, filed January 
22, 2019 (E-029-2019-0-US-01).

Group B

Methods of Producing T Cell Populations Using Hydroxycitric Acid and/or 
a Salt Thereof
    1. U.S. Provisional Patent Application 62/661,941, filed April 24, 
2018 (E-094-2018-0-US-01); and
    2. International Patent Application PCT/US2019/028513, filed April 
22, 2019 (E-094-2018-0-PCT-02).
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the fields of use may be limited to the following:
Fields of Use Applying to Intellectual Property Groups A and B
    ``Development, manufacture and commercialization of autologous, 
peripheral blood T cell therapy products engineered by CRISPR to 
express T cell receptors reactive to mutated KRAS, as claimed in the 
Licensed Patent Rights, for the treatment of human cancers. 
Specifically excluded from this field of use are retrovirally-
engineered peripheral blood T cell therapy products for the treatment 
of human cancers.
    Development, manufacture and commercialization of companion 
diagnostics approved or cleared by the FDA or equivalent foreign 
regulatory agency for Licensee-proprietary T cell therapy products.''
Fields of Use Applying to Intellectual Property Group B
    ``Development, manufacture and commercialization of autologous, 
peripheral blood T cell therapy products engineered by CRISPR to 
express T cell receptors reactive to mutated p53, as claimed in the 
Licensed Patent Rights, for the treatment of cancer in humans.
    ``Development, manufacture and commercialization of autologous, 
tumor infiltrating lymphocyte (TIL)-based adoptive T cell therapy 
products reactive to mutated p53, isolated as claimed in the Licensed 
Patent Rights, for the treatment of human cancers. Specifically 
excluded from this field of use are genetically engineered TIL cell 
therapy products for the treatment of human cancers.
    Development, manufacture and commercialization of companion 
diagnostics approved or cleared by the FDA or equivalent foreign 
regulatory agency for Licensee-proprietary T cell therapy products.''
    Intellectual Property Group A is primarily directed to isolated T 
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral 
oncogene homolog (KRAS), within the context of several human leukocyte 
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role 
in oncogenesis, is expressed by a variety of human cancers, including: 
pancreatic, lung, endometrial, ovarian and prostate. Due to its 
restricted expression in precancerous and cancerous cells, this antigen 
may be targeted on mutant KRAS-expressing tumors with minimal normal 
tissue toxicity.
    Intellectual Property Group B is primarily directed to methods of 
preparing isolated populations of T cells by culturing them in the 
presence of hydroxycitric acid and/or a salt thereof, and methods of 
treating cancer using populations of T cells cultured in such a manner.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published Notice, the National 
Cancer Institute receives written evidence and argument which 
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.
    In response to this Notice, the public may file comments or 
objections. 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 from 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: June 3, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-12707 Filed 6-14-19; 8:45 am]
 BILLING CODE 4140-01-P