Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD33-Specific Chimeric Antigen Receptor (CAR) Therapies for CD33-Expressing Malignancies Using Natural Killer Cells (NK Cells) Transduced With Retroviral or Lentiviral Vectors, 3163-3164 [2021-00637]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Notices
Contact Person: Ming Yan, MD, Ph.D.,
Scientific Review Officer, Immunology
(IMM), DPPS, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, RM 4205, Bethesda, MD 20892, (301)
594–0343, yanming@mail.nih.gov.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
Fellowship and Career Development.
Date: February 19, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Boulevard, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ming Yan, MD, Ph.D.,
Scientific Review Officer, Immunology
(IMM), DPPS, Center for Scientific Review,
National Institute of Nursing Research,
National Institutes of Health, 6701 Rockledge
Drive, RM 4205 Bethesda, MD 20892, (301)
594–0343, yanming@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: January 8, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–00653 Filed 1–13–21; 8:45 am]
BILLING CODE 4140–01–P
Dated: January 8, 2021.
Tyeshia Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–00651 Filed 1–13–21; 8:45 am]
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of CD33-Specific
Chimeric Antigen Receptor (CAR)
Therapies for CD33-Expressing
Malignancies Using Natural Killer Cells
(NK Cells) Transduced With Retroviral
or Lentiviral Vectors
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Porter Neuroscience Research
Center, Building 35A, 35 Convent Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lorna W. Role, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, 35A Convent Drive,
MSC 3716, Bethesda, MD 20892, lorna.role@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
AGENCY:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKE, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
SUMMARY:
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
Date: April 11–13, 2021.
Time: 3:00 p.m. to 12:00 p.m.
VerDate Sep<11>2014
20:43 Jan 13, 2021
Jkt 253001
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 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 29, 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: Jim Knabb, Senior
Technology Transfer Manager, NCI
Technology Transfer Center at Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
3163
Intellectual Property
E–097–2018–0: Anti-CD33 Chimeric
Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. US Provisional Patent Application
62/643,015, filed March 14, 2018
(E–097–2018–0–US–01);
2. International Patent Application PCT/
US2019/022,309, filed March 14,
2019 (E–097–2018–0–PCT–02)
3. United Arab Emirates Application
No: P6001291/2020, filed
September 13, 2020 (E–097–2018–
0–AE–03)
4. Australia Application No:
2019235926, filed September 2,
2020 (E–097–2018–0–AU–04)
5. Canada Application No: 3,093,567,
filed September 9, 2020 (E–097–
2018–0–CA–05)
6. China Application No:
201980018105.0, filed September 9,
2020 (E–097–2018–0–CN–06)
7. Eurasia Application No: 202092044,
filed September 25, 2020 (E–097–
2018–0–EA–07)
8. European Patent Application No:
19714007.2, filed October 14, 2020
(E–097–2018–0–EP–08)
9. Israel Application No: 277078, filed
September 1, 2020 (E–097–2018–0–
IL–09)
10. India Application No:
202047039152, filed September 10,
2020 (E–097–2018–0–IN–10)
11. South Korea Application No: 2020–
7029302, filed October 13, 2020 (E–
097–2018–0–KR–11)
12. Mexico Application No: MX/a/2020/
009472, filed September 10, 2020
(E–097–2018–0–MX–12)
13. New Zealand Application No:
767782, filed September 13, 2020
(E–097–2018–0–NZ–13)
14. Saudi Arabia Application No:
520420134, filed September 13,
2020 (E–097–2018–0–SA–14)
15. Singapore Application No:
11202008796V, filed September 9,
2020, (E–097–2018–0–SG–15)
16. United States of America
Application No: 16/980,205, filed
September 11, 2020 (E–097–2018–
0–US–16)
17. South Africa Application No: 2020/
05571, filed September 8, 2020 (E–
097–2018–0–ZA–17)
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:
1. The development of a CD33specific logic-gated CAR-based
E:\FR\FM\14JAN1.SGM
14JAN1
khammond on DSKJM1Z7X2PROD with NOTICES
3164
Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Notices
immunotherapy using autologous
human T cells transduced with
lentiviral vectors, wherein the viral
transduction leads to the expression of
a CAR that targets CD33 (comprised of
the CD33-binding domain referenced as
Hu195 or hP67.6 in the invention as
well as an intracellular signaling
domain), for the prophylaxis or
treatment of CD33-expressing cancers.
For clarity, ‘‘CD33-specific logic-gated
CAR-based immunotherapy’’ means
therapies where the CAR-expressing T
cells recognize CD33 and are engineered
to respond to one or more additional
antigens (but not necessarily all of the
antigens).
2. The development of a CD33specific logic-gated CAR-based
immunotherapy using allogeneic human
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 CD33 (comprised of
the CD33-binding domain referenced as
Hu195 or hP67.6 in the invention as
well as an intracellular signaling
domain), for the prophylaxis or
treatment of CD33-expressing cancers.
For clarity, ‘‘CD33-specific logic-gated
CAR-based immunotherapy’’ means
therapies where the CAR-expressing NK
cells recognize CD33 and are engineered
to respond to one or more additional
antigens (but not necessarily all of the
antigens).
These technologies disclose therapies
to treat AML by utilizing CARs that
recognize AML cells through a binder
for CD33. The CD33 binders are known
as Hu195 or hP67.6. CD33 is a well
validated immunotherapeutic target that
is expressed on the surface of malignant
cells, most notably on the surface of
acute myelogenous leukemia (AML)
blasts.
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
VerDate Sep<11>2014
20:43 Jan 13, 2021
Jkt 253001
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: January 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–00637 Filed 1–13–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2021–1 Phase I: Production of Adjuvants
Mimics (Topic 093) (For SBIRs Phase I)
Date: February 1, 2021.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Maggie A. Morris Fears,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20852, 301–761–5444,
maggie.morrisfears@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2021–1 Phase I: Adjuvant Discovery for
Vaccines and for Autoimmune and Allergic
Disease (Topic 092) (For SBIRs Phase I).
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Date: February 1, 2021.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Maggie A. Morris Fears,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20852, 301–761–5444,
maggie.morrisfears@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2021–1 Phase II: Adjuvant Discovery for
Vaccines and for Autoimmune and Allergic
Disease (Topic 092) (For SBIRs Phase II).
Date: February 1, 2021.
Time: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Maggie A. Morris Fears,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52,
Rockville, MD 20852, 301–761–5444,
maggie.morrisfears@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 8, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–00573 Filed 1–13–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
E:\FR\FM\14JAN1.SGM
14JAN1
]]>Agencies
[Federal Register Volume 86, Number 9 (Thursday, January 14, 2021)]
[Notices]
[Pages 3163-3164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of CD33-Specific Chimeric Antigen Receptor (CAR)
Therapies for CD33-Expressing Malignancies Using Natural Killer Cells
(NK Cells) Transduced With Retroviral or Lentiviral Vectors
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 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 29, 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: Jim Knabb, Senior Technology Transfer Manager,
NCI Technology Transfer Center at Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-097-2018-0: Anti-CD33 Chimeric Antigen Receptors for Treatment of
Human Acute Myeloid Leukemia
1. US Provisional Patent Application 62/643,015, filed March 14, 2018
(E-097-2018-0-US-01);
2. International Patent Application PCT/US2019/022,309, filed March 14,
2019 (E-097-2018-0-PCT-02)
3. United Arab Emirates Application No: P6001291/2020, filed September
13, 2020 (E-097-2018-0-AE-03)
4. Australia Application No: 2019235926, filed September 2, 2020 (E-
097-2018-0-AU-04)
5. Canada Application No: 3,093,567, filed September 9, 2020 (E-097-
2018-0-CA-05)
6. China Application No: 201980018105.0, filed September 9, 2020 (E-
097-2018-0-CN-06)
7. Eurasia Application No: 202092044, filed September 25, 2020 (E-097-
2018-0-EA-07)
8. European Patent Application No: 19714007.2, filed October 14, 2020
(E-097-2018-0-EP-08)
9. Israel Application No: 277078, filed September 1, 2020 (E-097-2018-
0-IL-09)
10. India Application No: 202047039152, filed September 10, 2020 (E-
097-2018-0-IN-10)
11. South Korea Application No: 2020-7029302, filed October 13, 2020
(E-097-2018-0-KR-11)
12. Mexico Application No: MX/a/2020/009472, filed September 10, 2020
(E-097-2018-0-MX-12)
13. New Zealand Application No: 767782, filed September 13, 2020 (E-
097-2018-0-NZ-13)
14. Saudi Arabia Application No: 520420134, filed September 13, 2020
(E-097-2018-0-SA-14)
15. Singapore Application No: 11202008796V, filed September 9, 2020,
(E-097-2018-0-SG-15)
16. United States of America Application No: 16/980,205, filed
September 11, 2020 (E-097-2018-0-US-16)
17. South Africa Application No: 2020/05571, filed September 8, 2020
(E-097-2018-0-ZA-17)
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:
1. The development of a CD33-specific logic-gated CAR-based
[[Page 3164]]
immunotherapy using autologous human T cells transduced with lentiviral
vectors, wherein the viral transduction leads to the expression of a
CAR that targets CD33 (comprised of the CD33-binding domain referenced
as Hu195 or hP67.6 in the invention as well as an intracellular
signaling domain), for the prophylaxis or treatment of CD33-expressing
cancers. For clarity, ``CD33-specific logic-gated CAR-based
immunotherapy'' means therapies where the CAR-expressing T cells
recognize CD33 and are engineered to respond to one or more additional
antigens (but not necessarily all of the antigens).
2. The development of a CD33-specific logic-gated CAR-based
immunotherapy using allogeneic human 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 CD33 (comprised of the CD33-binding domain referenced as Hu195
or hP67.6 in the invention as well as an intracellular signaling
domain), for the prophylaxis or treatment of CD33-expressing cancers.
For clarity, ``CD33-specific logic-gated CAR-based immunotherapy''
means therapies where the CAR-expressing NK cells recognize CD33 and
are engineered to respond to one or more additional antigens (but not
necessarily all of the antigens).
These technologies disclose therapies to treat AML by utilizing
CARs that recognize AML cells through a binder for CD33. The CD33
binders are known as Hu195 or hP67.6. CD33 is a well validated
immunotherapeutic target that is expressed on the surface of malignant
cells, most notably on the surface of acute myelogenous leukemia (AML)
blasts.
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: January 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-00637 Filed 1-13-21; 8:45 am]
BILLING CODE 4140-01-P
