Prospective Grant of an Exclusive Patent License: Development and Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination With CARs Targeting CD19 for the Treatment of B-Cell Malignancies, 50895-50897 [2021-19618]
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<![CDATA[
50895
Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0475]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before November 12,
2021.
SUMMARY:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0475–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
ADDRESSES:
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: ASPA COVID–
19 Public Education Campaign
Evaluation Surveys.
Type of Collection: Extension.
OMB No. 0990–0475.
Abstract: The Office of the Assistant
Secretary for Public Affairs (ASPA), U.S.
Department of Health and Human
Services (HHS) is requesting an
extension on a currently approved
collection including two components: 1.
COVID–19 Attitudes and Beliefs Survey
(CABS), and 2. Monthly Outcome
Survey (MOS). Throughout execution of
the campaign, this information will
primarily be used by ASPA to determine
whether the campaign is having the
intended impact on target audiences’
(e.g., parents, young adults, 65+)
knowledge, attitudes, and beliefs as they
relate to COVID–19, COVID–19
vaccination, and adherence to
preventative behaviors. It will also keep
key stakeholders informed of the
Campaign’s progress. Ultimately, the
data will inform a thorough evaluation
of the efficacy of the campaign and its
impact on vaccine uptake.
COVID–19 Attitudes and Beliefs Survey
(CABS)
The CABS is a longitudinal survey
that will be fielded tri-annually to 4,000
U.S. adults for the duration of the
Campaign via NORC at the University of
Chicago’s AmeriSpeak Panel. The
survey will be fielded online, and each
fielding period will last between 3 and
6 weeks. Those that respond to wave 1
of the survey will be recontacted in each
wave, facilitating a comparison of
COVID–19 behavior change over time
for a representative sample and
evaluation of U.S. adults. Panel
members selected to participate in the
study will receive one pre-invitation
postcard in the mail, one email
invitation, and three email reminders to
complete the survey in each wave.
Monthly Outcome Survey (MOS)
The MOS is a shorter, cross-sectional
survey that will be fielded monthly to
5,000 U.S. adults for the duration of the
Campaign via the Ipsos KnowledgePanel
5K Omnibus Survey. The survey will be
fielded online, and each fielding period
will last between 7 and 10 days.
ANNUALIZED BURDEN HOUR TABLE
CABS
Hours to complete survey ........................................................................................................................................
Participants (per wave) ............................................................................................................................................
Number of waves (per year) ....................................................................................................................................
0.58
4,000
3
0.17
5,000
12
Total respondents per year ..............................................................................................................................
12,000
60,000
Total burden hours per year .............................................................................................................................
6,960
10,200
Sum of Both Studies
Total respondents per year: 72,000.
Total burden hours per year: 17,160.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–19681 Filed 9–10–21; 8:45 am]
BILLING CODE 4150–25–P
lotter on DSK11XQN23PROD with NOTICES1
MOS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Allogeneic T Cell
and Gene Therapy Vector Chimeric
Antigen Receptor (CAR) Therapies
Targeting CD22 Alone or in
Combination With CARs Targeting
CD19 for the Treatment of B-Cell
Malignancies
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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Notice.
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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 Sana
Biotechnology Inc. Life Sciences Inc.,
(‘‘Sana’’), located in Seattle,
Washington.
SUMMARY:
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 September 28, 2021
will be considered.
DATES:
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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
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, at
Telephone: (240)–276–7856; or at Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
E–080–2012–0: Human Monoclonal
Antibodies Specific for CD22
1. US Provisional Patent Application
61/042,329, filed April 4, 2008 (E–080–
2008–0–US–01);
2. International Patent Application
PCT/US2009/039,080, Filed April 1,
2009 (E–080–2008/0–PCT–02);
3. US Patent Application: 12/934,214,
filed September 23, 2010 (E–080–2008–
0–US–03);
4. US Patent Application 13/959,061,
filed August 5, 2015 (E–080–2008–0–
US–04);
5. US Patent Application 15/012,023,
filed February 1, 2016 (E–080–2008–0–
US–05);
6. US Patent Application 15/424,238,
filed February 3, 2017 (E–080–2008–0–
US–06).
lotter on DSK11XQN23PROD with NOTICES1
E–291–2012–0: M971 Chimeric Antigen
Receptors
1. US Provisional Patent Application
61/717,960, filed October 24, 2012 (E–
291–2012–0–US–01);
2. International Patent Application
PCT/US2013/060332, filed September
18, 2013 (E–291–2012–0–PCT–02);
3. Australia Patent Application No:
2019235926, filed September 2, 2020
(E–291–2012–0–AU–03);
4. Brazil Patent Application
BR112015009003–6, filed April 22, 2015
(E–291–2012–0–BR–04);
5. Canada Application No: 2889055,
filed September 18, 2013 (E–291–2012–
0–CA–05);
6. China Application No:
201380061387.5, filed May 25, 2015 (E–
291–2012–0–CN–06);
7. European Patent Application No:
13773468.7, filed September 18, 2013
(E–291–2012–0–EP–07);
8. India Patent Application No: 2344/
CHENP/2015, filed September 18, 2013
(E–291–2012–0–IN–08);
9. Japan Application No: 539602/
2015, filed April 24, 2015 (E–291–2012–
0–JP–09);
10. Russia Patent Application:
2015117237, filed May 7, 2015 (E–291–
2012–0–RU–10);
11. US Patent Application: 14/
437,889, filed April 23, 2015 (E–291–
2012–0–US–11);
VerDate Sep<11>2014
17:39 Sep 10, 2021
Jkt 253001
12. Hong Kong Patent Application:
16101891.0, filed February 19, 2016 (E–
291–2012–0–HK–12);
13. Russia Patent Application:
2018116582, filed May 4, 2018 (E–291–
2012–0–RU–13);
14. Japan Patent Application: 2018–
088908, filed May 2, 2018, (E–291–
2012–0–JP–14);
15. Australia Patent Application:
2018204257, filed June 14, 2018 (E–
291–2012–0–AU–16);
16. US Patent Application: 16/
107,271, filed August 21, 2018 (E–291–
2012–0–US–17);
17. Germany Patent Application:
13773468.7, filed April 22, 2015 (E–
291–2012–0–DE–18);
18. Spain Patent Application:
13773468.7, filed April 22, 2015 (E–
291–2012–0–ES–19);
19. France Patent Application:
13773468.7, filed April 22, 2015 (E–
291–2012–0–FR–20);
20. Great Britain Patent Application:
13773468.7, filed April 22, 2015 (E–
291–2012–0–GB–21);
21. Italy Patent Application:
13773468.7, filed April 22, 2015 (E–
291–2012–0–IT–22);
22. China Patent Application:
201910500128.7, filed June 11, 2019 (E–
291–2012–0–CN–23);
23. US Patent Application: 16/
869,792, filed May 8, 2020 (E–291–
2012–0–US–24).
E–106–2015–0: Chimeric Antigen
Receptors Targeting Both CD19 and
CD22
1. US Provisional Patent Application
No.: 62/135,442, filed March 19, 2015
(E–106–2015–0–US–01);
2. International Patent Application
PCTUS2016/023055, Filed March 18,
2016 (E–106–2015–0–PCT–02);
3. US Patent Application: 15/559,485.
Filed September 19, 2017 (E–106–2015–
0–US–03).
E–017–2017–0: CD19/CD22 Bicistronic
CAR Targeting Human B-Cell
Malignancies
1. US Provisional Patent Application
No.: 62/135,442, filed May 15, 2017 (E–
017–2017–0–US–01);
2. International Patent Application
PCT/US2018/032,809, filed May 15,
2018 (E–017–2017–0–PCT–02);
3. Australia Patent Application No.:
2018269194, filed October 28, 2019 (E–
017–2017–0–AU–03;
4. Canada Patent Application No:
3062433, filed May 15, 2018 (E–017–
2017–0–CA–04);
5. China Patent Application No.:
201880032676.5, filed Date: May 15,
2018 (E–017–2017–0–CN–05);
PO 00000
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6. European Patent Application No.:
18733012.1, filed May 15, 2018 (E–017–
2017–0–EP–06);
7. Japan Patent Application No.:
2019–563082, filed November 13, 2019
(E–017–2017–0–JP–07);
8. Korea Patent Application No.:
2019–7017289, filed December 13, 2019,
(E–017–2017–0–KR–08);
9. Singapore Patent Application No.:
11201910499V, filed November 11, 2019
(E–017–2017–0–SG–09);
10. United States Patent Application
No.: 16/613,187, filed November 13,
2019 (E–017–2017–0–US–10).
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:
‘‘Field 1: ‘‘Ex vivo allogeneic CAR–T’’
The development, manufacture and
commercialization of chimeric antigen
receptor T cells (CAR–T cells) for the
treatment of B cell malignancies, wherein the
CAR–T cells are engineered to express a CAR
that comprises the m971 binder and is monospecific for CD22, or is specific to both CD22
and CD19 (but are not engineered to bind to
any other B cell antigen), and the engineered
CAR–T cells are generated ex vivo using
allogeneic T cells that are engineered to overexpress CD47.
Field 2: ‘‘In vivo gene therapy vector’’
The development, manufacture and
commercialization of gene therapy vectors
encoding a chimeric antigen receptor
construct (CAR construct), wherein the CAR
construct comprises either (i) a CD22 binder
m971 or (ii) the CD22 binder m971 and a
CD19 binder, but, in each case (i) and (ii),
comprises no other binder against a B cell
antigen. For the avoidance of doubt, the field
of use excludes development, manufacture
and commercialization of genetically
modified autologous T cells made by
obtaining a patient’s T cells via a standard
leukapheresis procedure, genetically
modifying the T cells ex vivo, expanding the
T cells in cell culture, and formulating the T
cells for later administration to the patient.’’
This technology discloses CAR
therapies that target CD22 alone or in
combination with CD19 by utilizing the
anti-CD22 binder known as m971. CD22
and CD19 are expressed on the surface
of B cells in B cell malignancies and
CAR–T utilizing binders targeting CD 19
and CD22 have shown early promise in
clinical trials for B cell malignancies.
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
E:\FR\FM\13SEN1.SGM
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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
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: September 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Kristianna Pettibone,
Evaluator, Program Analysis Branch,
NIEHS, NIH, 530 Davis Dr., Room 3055,
Morrisville, NC 20560, or call non-tollfree number (984) 287–3303 or Email
your request, including your address to:
pettibonekg@niehs.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Division of
Extramural Research and Training
SUPPLEMENTARY INFORMATION:
[FR Doc. 2021–19618 Filed 9–10–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Division of Extramural
Research and Training (DERT)
Extramural Grantee Data Collection
National Institute of Environmental
Health Science (NIEHS)
National Institutes of Health,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, to provide
opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), will publish
periodic summaries of proposed
SUMMARY:
(DERT) Extramural Grantee Data
Collection, 0925–0757, Expiration Date
11/30/2021—REVISION, National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: In order to make informed
management decisions about its
research programs and to demonstrate
the outputs, outcomes and impacts of its
research programs NIEHS will collect,
analyze and report on data from
extramural grantees who are currently
receiving funding or who have received
funding in the past on topics such as: (1)
Key scientific outcomes achieved
through the research and the impact on
the field of environmental health
science; (2) Contribution of research
findings to program goals and
objectives; (3) Satisfaction with the
program support received; (4)
Challenges and benefits of the funding
mechanism used to support the science;
and (5) Emerging research areas and
gaps in the research.
Information gained from this primary
data collection will be used in
conjunction with data from grantee
progress reports and presentations at
grantee meetings to inform internal
programs and new funding initiatives.
Outcome information to be collected
includes measures of agency-funded
research resulting in dissemination of
findings, investigator career
development, grant-funded knowledge
and products, commercial products and
drugs, laws, regulations and standards,
guidelines and recommendations,
information on patents and new drug
applications and community outreach
and public awareness relevant to
extramural research funding and
emerging areas of research.
OMB approval is requested for 3
years. There are no costs to respondents,
other than their time. The total
estimated annualized burden hours are
700.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Type of respondent
Number of
responses
per
respondent
Average time
per response
(in hours)
Total annual
burden hour
NICHD Grantee ...............................................................................................
NIDCD Grantee ...............................................................................................
NIMH Grantee ..................................................................................................
NINDS Grantee ................................................................................................
NCI Grantee .....................................................................................................
NIEHS Grantee ................................................................................................
200
200
200
200
400
200
1
1
1
1
1
1
30/60
30/60
30/60
30/60
30/60
30/60
100
100
100
100
200
100
Total ..........................................................................................................
1,400
1,400
........................
700
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E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50895-50897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric
Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination
With CARs Targeting CD19 for the Treatment of B-Cell Malignancies
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 Sana
Biotechnology Inc. Life Sciences Inc., (``Sana''), located in Seattle,
Washington.
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 September 28, 2021 will be considered.
[[Page 50896]]
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,
at Telephone: (240)-276-7856; or at Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-080-2012-0: Human Monoclonal Antibodies Specific for CD22
1. US Provisional Patent Application 61/042,329, filed April 4,
2008 (E-080-2008-0-US-01);
2. International Patent Application PCT/US2009/039,080, Filed April
1, 2009 (E-080-2008/0-PCT-02);
3. US Patent Application: 12/934,214, filed September 23, 2010 (E-
080-2008-0-US-03);
4. US Patent Application 13/959,061, filed August 5, 2015 (E-080-
2008-0-US-04);
5. US Patent Application 15/012,023, filed February 1, 2016 (E-080-
2008-0-US-05);
6. US Patent Application 15/424,238, filed February 3, 2017 (E-080-
2008-0-US-06).
E-291-2012-0: M971 Chimeric Antigen Receptors
1. US Provisional Patent Application 61/717,960, filed October 24,
2012 (E-291-2012-0-US-01);
2. International Patent Application PCT/US2013/060332, filed
September 18, 2013 (E-291-2012-0-PCT-02);
3. Australia Patent Application No: 2019235926, filed September 2,
2020 (E-291-2012-0-AU-03);
4. Brazil Patent Application BR112015009003-6, filed April 22, 2015
(E-291-2012-0-BR-04);
5. Canada Application No: 2889055, filed September 18, 2013 (E-291-
2012-0-CA-05);
6. China Application No: 201380061387.5, filed May 25, 2015 (E-291-
2012-0-CN-06);
7. European Patent Application No: 13773468.7, filed September 18,
2013 (E-291-2012-0-EP-07);
8. India Patent Application No: 2344/CHENP/2015, filed September
18, 2013 (E-291-2012-0-IN-08);
9. Japan Application No: 539602/2015, filed April 24, 2015 (E-291-
2012-0-JP-09);
10. Russia Patent Application: 2015117237, filed May 7, 2015 (E-
291-2012-0-RU-10);
11. US Patent Application: 14/437,889, filed April 23, 2015 (E-291-
2012-0-US-11);
12. Hong Kong Patent Application: 16101891.0, filed February 19,
2016 (E-291-2012-0-HK-12);
13. Russia Patent Application: 2018116582, filed May 4, 2018 (E-
291-2012-0-RU-13);
14. Japan Patent Application: 2018-088908, filed May 2, 2018, (E-
291-2012-0-JP-14);
15. Australia Patent Application: 2018204257, filed June 14, 2018
(E-291-2012-0-AU-16);
16. US Patent Application: 16/107,271, filed August 21, 2018 (E-
291-2012-0-US-17);
17. Germany Patent Application: 13773468.7, filed April 22, 2015
(E-291-2012-0-DE-18);
18. Spain Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-ES-19);
19. France Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-FR-20);
20. Great Britain Patent Application: 13773468.7, filed April 22,
2015 (E-291-2012-0-GB-21);
21. Italy Patent Application: 13773468.7, filed April 22, 2015 (E-
291-2012-0-IT-22);
22. China Patent Application: 201910500128.7, filed June 11, 2019
(E-291-2012-0-CN-23);
23. US Patent Application: 16/869,792, filed May 8, 2020 (E-291-
2012-0-US-24).
E-106-2015-0: Chimeric Antigen Receptors Targeting Both CD19 and CD22
1. US Provisional Patent Application No.: 62/135,442, filed March
19, 2015 (E-106-2015-0-US-01);
2. International Patent Application PCTUS2016/023055, Filed March
18, 2016 (E-106-2015-0-PCT-02);
3. US Patent Application: 15/559,485. Filed September 19, 2017 (E-
106-2015-0-US-03).
E-017-2017-0: CD19/CD22 Bicistronic CAR Targeting Human B-Cell
Malignancies
1. US Provisional Patent Application No.: 62/135,442, filed May 15,
2017 (E-017-2017-0-US-01);
2. International Patent Application PCT/US2018/032,809, filed May
15, 2018 (E-017-2017-0-PCT-02);
3. Australia Patent Application No.: 2018269194, filed October 28,
2019 (E-017-2017-0-AU-03;
4. Canada Patent Application No: 3062433, filed May 15, 2018 (E-
017-2017-0-CA-04);
5. China Patent Application No.: 201880032676.5, filed Date: May
15, 2018 (E-017-2017-0-CN-05);
6. European Patent Application No.: 18733012.1, filed May 15, 2018
(E-017-2017-0-EP-06);
7. Japan Patent Application No.: 2019-563082, filed November 13,
2019 (E-017-2017-0-JP-07);
8. Korea Patent Application No.: 2019-7017289, filed December 13,
2019, (E-017-2017-0-KR-08);
9. Singapore Patent Application No.: 11201910499V, filed November
11, 2019 (E-017-2017-0-SG-09);
10. United States Patent Application No.: 16/613,187, filed
November 13, 2019 (E-017-2017-0-US-10).
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:
``Field 1: ``Ex vivo allogeneic CAR-T''
The development, manufacture and commercialization of chimeric
antigen receptor T cells (CAR-T cells) for the treatment of B cell
malignancies, wherein the CAR-T cells are engineered to express a
CAR that comprises the m971 binder and is mono-specific for CD22, or
is specific to both CD22 and CD19 (but are not engineered to bind to
any other B cell antigen), and the engineered CAR-T cells are
generated ex vivo using allogeneic T cells that are engineered to
over-express CD47.
Field 2: ``In vivo gene therapy vector''
The development, manufacture and commercialization of gene
therapy vectors encoding a chimeric antigen receptor construct (CAR
construct), wherein the CAR construct comprises either (i) a CD22
binder m971 or (ii) the CD22 binder m971 and a CD19 binder, but, in
each case (i) and (ii), comprises no other binder against a B cell
antigen. For the avoidance of doubt, the field of use excludes
development, manufacture and commercialization of genetically
modified autologous T cells made by obtaining a patient's T cells
via a standard leukapheresis procedure, genetically modifying the T
cells ex vivo, expanding the T cells in cell culture, and
formulating the T cells for later administration to the patient.''
This technology discloses CAR therapies that target CD22 alone or
in combination with CD19 by utilizing the anti-CD22 binder known as
m971. CD22 and CD19 are expressed on the surface of B cells in B cell
malignancies and CAR-T utilizing binders targeting CD 19 and CD22 have
shown early promise in clinical trials for B cell malignancies.
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
[[Page 50897]]
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: September 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-19618 Filed 9-10-21; 8:45 am]
BILLING CODE 4140-01-P
