Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor T-Cell Therapies (CAR-T) That are Specific to CD22 and Other B-Cell Antigens for the Treatment of B-Cell Malignancies, 11451-11452 [2022-04245]
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11451
Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
NEPA EID Checklist ............................................................
1,500
1
1,500
1
1,500
Total ..............................................................................
1,500
........................
1,500
........................
1,500
HRSA specifically requests comments
on (1) the necessity and utility of the
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proper performance of the agency’s
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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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–04267 Filed 2–28–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Chimeric Antigen
Receptor T-Cell Therapies (CAR–T)
That are Specific to CD22 and Other BCell Antigens for the Treatment of BCell Malignancies
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 Syncopation
Life Sciences Inc., (‘‘Syncopation’’),
located in Palo Alto, California.
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 March 16, 2022 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
SUMMARY:
jspears on DSK121TN23PROD with NOTICES1
Number of
responses per
respondent
VerDate Sep<11>2014
19:01 Feb 28, 2022
Jkt 256001
Technology Transfer Manager, at
Telephone: (240)–276–7856; or at email:
jim.knabb@nih.gov.
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 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);
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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–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);
E:\FR\FM\01MRN1.SGM
01MRN1
jspears on DSK121TN23PROD with NOTICES1
11452
Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices
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:
‘‘Development, manufacture and
commercialization of chimeric antigen
receptor T cell (CAR–T)
immunotherapies for the treatment of B
cell malignancies, wherein the T cells
are:
1. Manufactured ex vivo;
2. Not engineered to overexpress
CD47;
3. Engineered to express a CAR that
targets CD22 via the m971 scFv in
combination with both:
a. Binders, CARs, or other receptors
targeting: CD19, CD20, CD79b, or any
combination thereof; and
b. At least one of the following:
—A technology to activate CD2
signaling in the CAR T cell, and/or
—Manufacturing of the cell product
using the Storage by Actuated
Shuttling (StASh)
Where ‘‘ex vivo’’ specifically means
where the cells or tissue are removed
from a healthy donor (in the case of
allogeneic therapy) or the patient (in the
case of autologous therapy), modified ex
vivo and then, implanted, transplanted,
infused, or transferred into the patient.
For purposes of clarity, specifically
excluded from these Fields of Use are
the following:
1. Allogeneically-derived CAR–T
immunotherapies that have been
engineered to overexpress CD47;
2. CAR–T immunotherapies wherein
the CAR–T cells are manufactured
within the patient via gene therapy
vectors delivered to the patient (in vivo
CAR–T immunotherapies);
3. Autologously-derived CAR–T
immunotherapies that have been
engineered to be specific for CD19,
CD20, and CD22 (via the m971 scFv)
VerDate Sep<11>2014
19:01 Feb 28, 2022
Jkt 256001
absent the engineering of the CAR–T
therapies to activate CD2 signaling and/
or StASh as described in the Fields of
Use 3(b) above;
4. CAR–T immunotherapies wherein
the CAR–T cells are engineered to
express a bispecific CAR that is
engineered to bind to CD19 and CD22,
as described in HHS Ref. E–106–2015
and encompassing the m971 scFv and
the CD22 CAR.’’
The government-owned technologies
that are contemplated in this proposed
license are CAR therapies that target
CD22 by utilizing the anti-CD22 binder
known as m971 alone. The E–080–2008
technology encompasses the m971
binder, while E–291–2012 describes a
CAR encompassing the m971 binder.
Additionally, E–017–2017 describes a
bicistronic CAR vector that
encompasses the CD22-targeting m971
CAR and a CAR that targets CD19. CD22
is expressed on the surface of B cells in
B cell malignancies and CD22-targeting
CAR–T has shown early promise in
clinical trials for ALL and NHL both as
a monospecific and multispecific
therapy. Targeting CD22 in combination
with other B cell antigens (CD19, CD20,
and/or CD79b in this instance) can lead
to more effective CAR–T cell therapies.
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: February 23, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2022–04245 Filed 2–28–22; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Research
Projects in Cancer Systems Biology (CSBC
Research Projects) (U01).
Date: March 31, 2022.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W234, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Adriana Stoica, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
7W234, Rockville, Maryland 20850, 240–
276–6368, Stoicaa2@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–1 NCI
Clinical and Translational R21 and Omnibus
R03 Review.
Date: March 31, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W602, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Delia Tang, M.D.,
Scientific Review Officer, Resources Training
and Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W602,
Rockville, Maryland 20850, 240–276–6456,
tangd@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Social and
Behavioral Intervention Research to Address
Modifiable Risk Factors for Cancer in Rural
Populations (R01).
Date: May 5, 2022.
Time: 10:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11451-11452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04245]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and
Commercialization of Chimeric Antigen Receptor T-Cell Therapies (CAR-T)
That are Specific to CD22 and Other B-Cell Antigens 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 Syncopation
Life Sciences Inc., (``Syncopation''), located in Palo Alto,
California.
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 March 16, 2022 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,
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 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-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);
[[Page 11452]]
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:
``Development, manufacture and commercialization of chimeric
antigen receptor T cell (CAR-T) immunotherapies for the treatment of B
cell malignancies, wherein the T cells are:
1. Manufactured ex vivo;
2. Not engineered to overexpress CD47;
3. Engineered to express a CAR that targets CD22 via the m971 scFv
in combination with both:
a. Binders, CARs, or other receptors targeting: CD19, CD20, CD79b,
or any combination thereof; and
b. At least one of the following:
--A technology to activate CD2 signaling in the CAR T cell, and/or
--Manufacturing of the cell product using the Storage by Actuated
Shuttling (StASh)
Where ``ex vivo'' specifically means where the cells or tissue are
removed from a healthy donor (in the case of allogeneic therapy) or the
patient (in the case of autologous therapy), modified ex vivo and then,
implanted, transplanted, infused, or transferred into the patient.
For purposes of clarity, specifically excluded from these Fields of
Use are the following:
1. Allogeneically-derived CAR-T immunotherapies that have been
engineered to overexpress CD47;
2. CAR-T immunotherapies wherein the CAR-T cells are manufactured
within the patient via gene therapy vectors delivered to the patient
(in vivo CAR-T immunotherapies);
3. Autologously-derived CAR-T immunotherapies that have been
engineered to be specific for CD19, CD20, and CD22 (via the m971 scFv)
absent the engineering of the CAR-T therapies to activate CD2 signaling
and/or StASh as described in the Fields of Use 3(b) above;
4. CAR-T immunotherapies wherein the CAR-T cells are engineered to
express a bispecific CAR that is engineered to bind to CD19 and CD22,
as described in HHS Ref. E-106-2015 and encompassing the m971 scFv and
the CD22 CAR.''
The government-owned technologies that are contemplated in this
proposed license are CAR therapies that target CD22 by utilizing the
anti-CD22 binder known as m971 alone. The E-080-2008 technology
encompasses the m971 binder, while E-291-2012 describes a CAR
encompassing the m971 binder. Additionally, E-017-2017 describes a
bicistronic CAR vector that encompasses the CD22-targeting m971 CAR and
a CAR that targets CD19. CD22 is expressed on the surface of B cells in
B cell malignancies and CD22-targeting CAR-T has shown early promise in
clinical trials for ALL and NHL both as a monospecific and
multispecific therapy. Targeting CD22 in combination with other B cell
antigens (CD19, CD20, and/or CD79b in this instance) can lead to more
effective CAR-T cell therapies.
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: February 23, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2022-04245 Filed 2-28-22; 8:45 am]
BILLING CODE 4140-01-P
