[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58262-58263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25197]


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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 Chimeric Antigen Receptor (CAR) Therapies for the 
Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) Expressing Cancers

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 ElevateBio. 
(``Elevate''), located in Cambridge, 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 December 4, 2018 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: Jim Knabb, 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)-276-7856; Facsimile: (240)-276-5504; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 58263]]

Intellectual Property

E-133-2016: FLT3-Specific Chimeric Antigen Receptors and Methods Using 
Same

    1. US Provisional Patent Application 62/342,394, filed May 27, 2016 
(E-133-2016-0-US-01);
    2. International Patent Application PCT/US2017/034,691, filed May 
26, 2017 (E-133-2016-0-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:
    ``The development of a mono- or multi-specific FMS-like tyrosine 
kinase 3 (FLT3; also known as CD135) chimeric antigen receptor (CAR)-
based immunotherapy using autologous or allogenic human lymphocytes (T 
cells or NK cells) transduced with lentiviral vectors, wherein the 
viral transduction leads to the expression of a CAR that targets FLT3 
(comprised of the FLT3-binding domain referenced as NC7 in the 
invention as well as an intracellular signaling domain), for the 
prophylaxis or treatment of FLT3-expressing cancers.''
    This technology discloses a CAR vector that targets FLT3 comprised 
of an anti-FLT3 antibody known as NC7, and an intracellular signaling 
domain. FLT3 (CD135) is a cytokine receptor expressed on hematopoietic 
progenitor cells, and is one of the most frequently mutated genes in 
acute myeloid leukemia (AML) and infant acute lymphoblastic leukemia 
(ALL). FLT3 mutation leads to increased cell surface expression and 
therefore on leukemic cells, which makes it an attractive candidate for 
cellular therapies such as CAR-T.
    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: November 8, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-25197 Filed 11-16-18; 8:45 am]
 BILLING CODE 4140-01-P