[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52890-52891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21519]


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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 Ziopharm 
Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.

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 October 18, 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

E-029-2019: 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

E-135-2019: T Cell Receptors Recognizing R175H or Y220C Mutation in P53
    1. U.S. Provisional Patent Application 62/867,619, filed June 27, 
2019 (E-135-2019-0-US-01).
    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 Group A
    ``Development, manufacture and commercialization of autologous, 
peripheral blood T cell therapy products engineered by transposon-
mediated gene transfer 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, (a) 
retrovirally-engineered peripheral blood T cell therapy products for 
the treatment of human cancers, and (b) CRISPR-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 transposon-
mediated gene transfer to express T cell receptors reactive to mutated 
P53, as claimed in

[[Page 52891]]

the Licensed Patent Rights, for the treatment of human cancers. 
Specifically excluded from this field of use are CRISPR-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.''
    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 isolated 
TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the 
context of several HLAs. P53 is the archetypal tumor suppressor gene 
and the most frequently mutated gene in cancer. Contemporary estimates 
suggest that >50% of all tumors carry mutations in P53. Because of its 
prevalence in cancer and its restricted expression to precancerous and 
cancerous cells, this antigen may be targeted on mutant P53-expressing 
tumors with minimal normal tissue toxicity.
    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 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.
    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: September 26, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-21519 Filed 10-2-19; 8:45 am]
BILLING CODE 4140-01-P