[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84356-84357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28569]


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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 Malignancies 
Using Natural Killer Cells (NK Cells) Transduced With Retroviral or 
Lentiviral Vectors

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 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 January 12, 2021 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: at Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

E-133-2016-0: 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)

[[Page 84357]]

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 license territory may be worldwide, and 
the fields of use may be limited to the following:
    An exclusive license to: ``the development and commercialization of 
a universal or split chimeric antigen receptor (CAR)-based 
immunotherapy using autologous or allogeneic T cells transduced with 
lentiviral vectors, or autologous or allogeneic NK cells transduced 
with retroviral vectors, including but not limited to 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.'' For clarity, ``universal/split 
CAR-based immunotherapy'' in the context of this license means CAR 
therapies wherein the FLT3-binder is soluble and infused into the 
patient independent from the modified lymphocytes. The patient is then 
infused with lymphocytes expressing a CAR construct that recognizes the 
FLT3-binder (an exogenous protein tag like FITC or the heavy chain of 
an scFv for example).
    A co-exclusive license to: ``the development and commercialization 
of a multi-specific FLT3 CAR-based immunotherapy using autologous or 
allogeneic T cells transduced with lentiviral vectors, or autologous or 
allogeneic NK cells transduced with retroviral vectors, including but 
not limited to 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.'' For clarity, ``multi-specific FLT3 CAR-based 
immunotherapy'' in the context of this license means therapies wherein 
the CAR-expressing lymphocytes recognize FLT3 and additional antigens.
    A co-exclusive license to: ``the development of a FLT3-specific 
Regulated or Switch or Logic-Gated CAR-based immunotherapy using 
autologous or allogeneic T cells transduced with lentiviral vectors, or 
autologous or allogeneic NK cells transduced with retroviral vectors, 
including but not limited to 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.'' For clarity, 
FLT3-specific Regulated or Switch or Logic-Gated CAR-based 
immunotherapy in the context of this license means therapies wherein 
the CAR-expressing lymphocytes recognize FLT3 and are engineered to 
respond to one or more signals, such as recognizing one or more 
additional antigens, responding to an exogenous small molecule, or 
responding to a biological signal (but not necessarily all of the 
signals).
    These technologies disclose therapies to treat AML by utilizing 
CARs that recognize AML cells through a binder for FLT3, specifically 
through the FLT3 binder known as NC7. FLT3 is a validated 
immunotherapeutic target that is expressed on the surface of cancerous 
cells, its expression is amplified on the surface of acute myelogenous 
leukemia (AML) blasts and cells in chronic myeloid leukemia-blast 
crisis (CML-BC).
    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: December 17, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-28569 Filed 12-23-20; 8:45 am]
BILLING CODE 4140-01-P