Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20, 33270 [2019-14822]
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Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mehrdad Mohseni, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7854, Bethesda, MD 20892, 301–435–
0484, mohsenim@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–AI–
18–057: Long-acting Drug Delivery Systems
for ART Optimization in HIV–1 Infected
Children.
Date: August 9, 2019.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Rockledge II 6701 Rockledge Drive Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 8, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–14805 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Allogeneic Therapy
Using Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 Kite Pharma,
Inc. (‘‘Kite’’) located in Santa Monica,
CA.
DATES: Only written comments and/or
complete applications for a license
which are received by the National
Cancer Institute’s Technology Transfer
Center on or before July 29, 2019 will
be considered.
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:55 Jul 11, 2019
Jkt 247001
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: David A Lambertson, 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)-276–5530;
Facsimile: (240)-276–5504 Email:
david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
United States Provisional Patent
Application No. 62/732,263, filed 17
September 2018 and entitled
‘‘Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20 and
Their Uses’’ [HHS Reference No. E–205–
2018–0–US–01]; and U.S. and foreign
patent applications claiming priority to
the aforementioned application.
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
field of use may be limited to the
following:
‘‘The development, production and
commercialization of an anti-CD19 antiCD20 dual targeting chimeric antigen
receptor (CAR)-based immunotherapy
using allogeneic (where the donor and
the recipient are different) immune
cells, wherein the genome editing is
meditated only by zinc-finger nucleases,
and where the CAR has at least:
(1) A dual antigen specificity;
(2) the complementary determining
region (CDR) sequences of the anti-CD19
antibody known as Hu19;
(3) the complementary determining
region (CDR) sequences of the anti-CD20
antibody known as 2.1.2; and
(4) a T cell signaling domain;
for the treatment of B-cell derived
human cancers.’’
This technology discloses the
development of chimeric antigen
receptors that recognize both the CD19
and CD20 cell surface proteins. CD19
and CD20 are expressed on the cell
surface of several hematological
malignancies, including Non-Hodgkins
Lymphoma (NHL), acute lymphoblastic
leukemia (ALL) and chronic
lymphocytic leukemia (CLL). Although
the FDA has recently approved CARbased therapies which target only CD19
(Yescarta, Kymriah), tumors are capable
of undergoing tumor antigen escape (the
downregulation of target antigen
expression on tumor cells), which
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
results in gradual resistance to ‘‘single
target therapies.’’ As a result, patients
receiving single target CAR therapies are
susceptible to relapse. This has
prompted investigators to pursue dual
targeting CAR therapies to provide as a
means of overcoming tumor antigen
escape, thereby providing a more
comprehensive therapeutic alternative.
The development of a new therapeutic
targeting both CD19 and CD20 will
benefit public health by offering up an
improved treatment for patients that
would otherwise be subject to relapse
due to tumor antigen escape.
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 completed 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 in 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: July 2, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–14822 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Application and Impact of
Clinical Research Training on
Healthcare Professionals in Academia
and Clinical Research (Office of the
Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
SUMMARY:
E:\FR\FM\12JYN1.SGM
12JYN1
]]>Agencies
[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Page 33270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14822]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Allogeneic
Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and
CD20
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 Patent License to practice the
inventions embodied in the Patents and Patent Applications listed in
the Supplementary Information section of this notice to Kite Pharma,
Inc. (``Kite'') located in Santa Monica, CA.
DATES: Only written comments and/or complete applications for a license
which are received by the National Cancer Institute's Technology
Transfer Center on or before July 29, 2019 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an Exclusive Patent License
should be directed to: David A Lambertson, 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)-276-5530; Facsimile: (240)-
276-5504 Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
United States Provisional Patent Application No. 62/732,263, filed
17 September 2018 and entitled ``Bicistronic Chimeric Antigen Receptors
Targeting CD19 and CD20 and Their Uses'' [HHS Reference No. E-205-2018-
0-US-01]; and U.S. and foreign patent applications claiming priority to
the aforementioned application.
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 field of use may be limited to the following:
``The development, production and commercialization of an anti-CD19
anti-CD20 dual targeting chimeric antigen receptor (CAR)-based
immunotherapy using allogeneic (where the donor and the recipient are
different) immune cells, wherein the genome editing is meditated only
by zinc-finger nucleases, and where the CAR has at least:
(1) A dual antigen specificity;
(2) the complementary determining region (CDR) sequences of the
anti-CD19 antibody known as Hu19;
(3) the complementary determining region (CDR) sequences of the
anti-CD20 antibody known as 2.1.2; and
(4) a T cell signaling domain;
for the treatment of B-cell derived human cancers.''
This technology discloses the development of chimeric antigen
receptors that recognize both the CD19 and CD20 cell surface proteins.
CD19 and CD20 are expressed on the cell surface of several
hematological malignancies, including Non-Hodgkins Lymphoma (NHL),
acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia
(CLL). Although the FDA has recently approved CAR-based therapies which
target only CD19 (Yescarta, Kymriah), tumors are capable of undergoing
tumor antigen escape (the downregulation of target antigen expression
on tumor cells), which results in gradual resistance to ``single target
therapies.'' As a result, patients receiving single target CAR
therapies are susceptible to relapse. This has prompted investigators
to pursue dual targeting CAR therapies to provide as a means of
overcoming tumor antigen escape, thereby providing a more comprehensive
therapeutic alternative. The development of a new therapeutic targeting
both CD19 and CD20 will benefit public health by offering up an
improved treatment for patients that would otherwise be subject to
relapse due to tumor antigen escape.
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
completed 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 in 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: July 2, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2019-14822 Filed 7-11-19; 8:45 am]
BILLING CODE 4140-01-P
