[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13305-13306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06575]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive/Co-Exclusive Patent License: 
Development and Commercialization of Next Generation 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.

-----------------------------------------------------------------------

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/Co-Exclusive Patent License to 
practice the inventions embodied in the Patents and Patent Applications 
listed in the Supplementary Information section of this Notice to Senti 
Bio (``Senti''), located in South San Francisco, CA.

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 April 19, 2019 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive/Co-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: 

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)
    3. EP Patent Application No.:17729627.4, filed December 11, 2018 
(E-133-2016/0-EP-03)
    4. US Patent Application No.: 16/304,552, filed November 26, 2018 
(E-133-2016/0-US-05
    5. Australia Patent Application No.: 2017271606, filed November 13, 
2018 (E-133-2016/0-AU-06)
    6. Canadian Patent Application No.: 3025516, filed November 23, 
2018 (E-133-2016/0-CA-07)
    7. Japan Patent Application No.: 2018-561669, filed November 22, 
2018 (E-133-2016/0-JP-08)
    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/co-exclusive license territory may be 
worldwide, and the fields of use may be limited to the following:
    An exclusive license to: ``the development of a universal/split 
chimeric antigen receptor (CAR)-based immunotherapy using autologous or 
allogeneic human lymphocytes (T cells or NK cells) transduced with 
lentiviral vectors, for the prophylaxis or treatment of cancers 
expressing FMS-like tyrosine kinase 3 (FLT3; also known as CD135), 
wherein the CAR construct binds to the FLT3-binding domain referenced 
as NC7 in the invention, but NC7 is not included in the CAR construct. 
Specifically excluded from the field of use for this exclusive license 
are FLT3-specific CAR -based immunotherapies wherein the CAR construct 
comprises the FLT3-binding domain referenced as NC7 in the invention as 
well as an intracellular signaling domain.'' The proposed territory is 
worldwide.
    A co-exclusive license to: ``the development of a multi-specific 
FLT3 CAR-based immunotherapy using autologous or allogeneic 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.'' The proposed 
territory is worldwide.
    A co-exclusive license to: ``the development of a FLT3-specific 
Regulated/Switch/Logic-Gated CAR-based immunotherapy using autologous 
or allogeneic 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.'' The proposed territory is worldwide.
    This technology discloses a CAR therapy that targets FLT3 by 
utilizing the anti-FLT3 binder known as NC7. 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/co-exclusive license will be 
royalty bearing, and the prospective exclusive/co-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

[[Page 13306]]

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: March 28, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-06575 Filed 4-3-19; 8:45 am]
 BILLING CODE 4140-01-P