Clinical Development and Commercialization of CD22-Targeting Chimeric Antigen Receptor (CAR) T-Cell Therapies for Children and Young Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (ALL), 45913-45914 [2020-16487]
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Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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 Heart, Lung,
and Blood Advisory Council.
Date: August 25, 2020.
Closed: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Room
206–Q, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Laura K. Moen, Ph.D.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6705
Rockledge Drive, Room 206–Q, Bethesda, MD
20892, (301) 827–5517, moenl@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/nhlbac/
index.htm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: July 27, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–16509 Filed 7–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Development and
Commercialization of CD22–Targeting
Chimeric Antigen Receptor (CAR) TCell Therapies for Children and Young
Adults With Relapsed/Refractory BCell Acute Lymphoblastic Leukemia
(ALL)
AGENCY:
National Institutes of Health,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is seeking statements
of capability and interest from
prospective licensees and potential
Collaborators interested in participating
in collaborative research under a
SUMMARY:
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
Cooperative Research and Development
Agreement (CRADA) to develop
autologous CD22 CAR T-cells
(m971BBZ lentivirus transduced) for the
treatment of B-cell ALL.
DATES: Statements of capability and
interest should be submitted via email
by September 1, 2020, with a formal
proposal due by October 15, 2020.
ADDRESSES: Statements of capability and
interest should be directed to: Jim
Knabb, Ph.D., Senior Technology
Transfer Manager, NCI, at 240–276–
7856 or Email: knabbjr@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Collaboration Opportunity
NCI is seeking a pharmaceutical or
biotechnology company that can
effectively and efficiently collaborate on
the scientific and commercial
development of CD22–CAR. The goal of
the collaboration will be the successful
transfer of clinical development of
CD22–CAR from NCI to the
Collaborator, which will be responsible
for the rapid scale-up and clinical
manufacture of the agent to support the
pivotal clinical trial and subsequent
BLA. The selected Collaborator will be
responsible for the manufacture and
provision of CD22–CAR lentivirus
(m971BBZ lentivirus) and autologous
CD22–CAR T-cell therapy product in
sufficient quantities to complete the
pivotal clinical trial. The selected
Collaborator will prepare and submit a
BLA to the FDA for CD22–CAR
following the completion of the pivotal
trial.
Subject to federal statutes and NIH
guidelines including those governing
the establishment of CRADAs (15 U.S.C.
3710a) and the licensing of federally
owned inventions (35 U.S.C. 207), it is
anticipated that the Collaborator will
pursue an exclusive or nonexclusive
commercialization license to the CD22–
CAR. Additionally, NCI is able to offer
a CRADA Collaborator the right to use
any and all data developed during the
course of the collaboration for
commercial development of the agent,
as well as access to existing CD22–CAR
clinical study data and regulatory
documents for commercial development
of the agent.
Interested parties may sign a
confidential disclosure agreement to
obtain additional clinical data for its
evaluation of the collaboration.
Roles of Collaboration Partners:
The roles of the National Cancer
Institute in the CRADA may include but
are not limited to the following:
1. NCI will provide intellectual,
scientific, and technical expertise and
experience related to the ongoing
development of CD22–CAR.
PO 00000
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Fmt 4703
Sfmt 4703
45913
2. NCI will continue to support
clinical manufacture and development
of CD22–CAR pending transition of
manufacturing to an appropriate site by
the commercial partner and will make
data available to the Collaborator as
appropriate.
3. NCI will collaborate in the design
of protocols and the evaluation of
results.
4. NCI will provide all clinical data in
its possession to Collaborator to support
FDA regulatory filings.
The roles of the CRADA Collaborator
will include, but are not limited to the
following:
1. The Collaborator will provide
clinical development strategy and
financial and other support for the
collaborative development leading to
BLA filing and FDA approval of CD22–
CAR.
2. The Collaborator will provide
intellectual, scientific, and technical
expertise or experience to the
development of CD22–CAR.
3. The Collaborator will provide
sufficient clinical supply of
autologously-derived CD22 CAR T-cell
therapy product for all clinical trials
under the CRADA; this includes
additional trials that may be needed for
licensing as well as trials required to
meet clinical need for pediatric patients
prior to licensing.
4. The Collaborator will prepare and
submit regulatory documents to FDA,
culminating in the submission of a BLA
for CD22–CAR.
5. The Collaborator will demonstrate
its capability of providing a commercial
supply of CD22–CAR in a timely
manner.
Selection Criteria
Interested parties should notify the
NCI of their interest in filing a formal
proposal no later than September 1,
2020. Potential licensees/CRADA
Collaborators will have until October
15, 2020 to submit a formal proposal.
Additional proposals will be considered
after the posted deadline in the event
that a Collaborator, meeting the
necessary criteria, is not found during
the initial posted time period. Selection
criteria for choosing the CRADA
Collaborator shall include, but not be
limited to:
1. Possession of or access to the
resources needed to support and
perform the activities required to
expeditiously commercially develop
CD22–CAR (e.g., facilities, personnel
and expertise), including preparation
and submission of regulatory
documents;
2. Demonstrated ability to access the
expertise required for successful
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45914
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
commercial development of biologically
active anti-cancer agents, with an
emphasis on adoptive cell therapies;
3. Demonstration of the necessary
resources to produce and supply
autologously-derived CD22–CAR in a
timely manner for clinical trials at the
NCI and additional clinical sites;
4. Demonstration of access to
financial resources required to support
the CRADA collaboration and to
successfully support the development of
CD22–CAR for commercial sale;
5. Willingness to cooperate with the
NCI in the timely publication of
research results;
6. Willingness to accept the legal
provisions and language of the CRADA
and commercial license with only minor
modifications, if any;
7. Willingness to pursue a commercial
license to the CD22–CAR in accordance
with federal statutes; and
8. The agreement to be bound by the
appropriate HHS regulations relating to
human subjects.
khammond on DSKJM1Z7X2PROD with NOTICES
Proposal Content
Please submit a proposal outlining
your qualifications as a licensee/CRADA
Collaborator for the advertised
opportunity. Include any relevant
information, however, please address
the following in your proposal
submission:
1. Describe the type and level of
resources you have available to commit
to a CRADA collaboration with the NCI,
including, but not limited to the
following:
a. What is your current capacity for
production of CD22–CAR lentiviral
vector and autologous T-cell product?
b. Are you able to fund several
potential clinical trials?
c. Would you be willing to provide
funding to the NCI to support the
collaboration?
Please describe the company’s related
experience in the development of
therapeutics, specifically:
a. Describe any experience or
expertise with the development of
adoptive cell therapy-based
therapeutics, preferably autologous Tcell therapeutics.
b. Describe related experience with
FDA approval and commercialization of
adoptive cell therapy-based
therapeutics, preferably autologous Tcell therapeutics.
c. Describe any experience
determining administration of
autologously-derived T-cell
therapeutics.
d. Describe any other collaborations
with Federal or academic laboratories.
Please provide relevant company
information, including:
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
a. Related Product Portfolio.
b. Current Related Product Pipeline.
c. Annual Revenues/financial
resources.
d. Size of company/affiliated
companies.
Dated: July 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–16487 Filed 7–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2020–0026]
Privacy Act of 1974; System of
Records
Department of Homeland
Security.
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security (DHS) proposes to
establish a new DHS system of records
titled, ‘‘Department of Homeland
Security/ALL–047 Records Related to
DHS Personnel, Long-Term Trainees,
Contractors, and Visitors During a
Declared Public Health Emergency
System of Records.’’ This system of
records describes DHS’s collection, use,
and maintenance of records on
individuals associated with DHS and its
facilities during a declared public health
emergency. This newly established
system will be included in DHS’s
inventory of record systems.
DATES: Submit comments on or before
August 31, 2020. This new system will
be effective upon publication. New or
modified routine uses will be effective
August 31, 2020.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2020–0026 by one of the following
methods:
• Federal e-Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–343–4010.
• Mail: Constantina Kozanas, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528–0655.
Instructions: All submissions received
must include the agency name and
docket number DHS–2020–0026. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
SUMMARY:
PO 00000
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Fmt 4703
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Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
general and privacy questions, please
contact: Constantina Kozanas, (202)
343–1717, Privacy@hq.dhs.gov, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528–0655.
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary of the Department of
Health and Human Services (HHS) may,
under section 319 of the Public Health
Service (PHS) Act (codified at 42 U.S.C.
247d), declare that: (a) A disease or
disorder presents a public health
emergency; or (b) that a public health
emergency, including significant
outbreaks of infectious disease or
bioterrorist attacks, otherwise exists.
The declaration lasts for the duration of
the emergency or 90 days, but may be
extended by the Secretary. Congress
must be notified of the declaration
within 48 hours. The Department of
Homeland Security must ensure the
safety of its workforce, including when
the Secretary of HHS or the responsible,
designated State official declares and
determines that a public health
emergency exists. Responses to public
health emergencies depend on the
nature of the emergency, but in the
context of infectious disease or other
events that can cause and spread
deleterious health impacts to DHS
personnel and others in DHS facilities,
in order to ensure a safe and secure
workspace, DHS may collect
information on DHS personnel (meaning
employees, detailees, interns, and
volunteers), contractors, long-term
trainees, and visitors at or on buildings,
grounds, and properties that are owned,
leased, or used by DHS.
This system of records will cover
information collected on DHS
personnel, contractors, long-term
trainees, and visitors at or on buildings,
grounds, and properties that are owned,
leased, or used by DHS who have
contracted or may have been exposed to
a suspected or confirmed disease or
illness that is the subject of a declared
public health emergency. The
information collected may include
identifying and contact information of
individuals who have been suspected or
confirmed to have contracted a disease
or illness, or who have been exposed to
an individual who had been suspected
or confirmed to have contracted a
disease or illness, related to a declared
public health emergency; individual
E:\FR\FM\30JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45913-45914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16487]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Clinical Development and Commercialization of CD22-Targeting
Chimeric Antigen Receptor (CAR) T-Cell Therapies for Children and Young
Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
(ALL)
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
seeking statements of capability and interest from prospective
licensees and potential Collaborators interested in participating in
collaborative research under a Cooperative Research and Development
Agreement (CRADA) to develop autologous CD22 CAR T-cells (m971BBZ
lentivirus transduced) for the treatment of B-cell ALL.
DATES: Statements of capability and interest should be submitted via
email by September 1, 2020, with a formal proposal due by October 15,
2020.
ADDRESSES: Statements of capability and interest should be directed to:
Jim Knabb, Ph.D., Senior Technology Transfer Manager, NCI, at 240-276-
7856 or Email: [email protected].
SUPPLEMENTARY INFORMATION:
Collaboration Opportunity
NCI is seeking a pharmaceutical or biotechnology company that can
effectively and efficiently collaborate on the scientific and
commercial development of CD22-CAR. The goal of the collaboration will
be the successful transfer of clinical development of CD22-CAR from NCI
to the Collaborator, which will be responsible for the rapid scale-up
and clinical manufacture of the agent to support the pivotal clinical
trial and subsequent BLA. The selected Collaborator will be responsible
for the manufacture and provision of CD22-CAR lentivirus (m971BBZ
lentivirus) and autologous CD22-CAR T-cell therapy product in
sufficient quantities to complete the pivotal clinical trial. The
selected Collaborator will prepare and submit a BLA to the FDA for
CD22-CAR following the completion of the pivotal trial.
Subject to federal statutes and NIH guidelines including those
governing the establishment of CRADAs (15 U.S.C. 3710a) and the
licensing of federally owned inventions (35 U.S.C. 207), it is
anticipated that the Collaborator will pursue an exclusive or
nonexclusive commercialization license to the CD22-CAR. Additionally,
NCI is able to offer a CRADA Collaborator the right to use any and all
data developed during the course of the collaboration for commercial
development of the agent, as well as access to existing CD22-CAR
clinical study data and regulatory documents for commercial development
of the agent.
Interested parties may sign a confidential disclosure agreement to
obtain additional clinical data for its evaluation of the
collaboration.
Roles of Collaboration Partners:
The roles of the National Cancer Institute in the CRADA may include
but are not limited to the following:
1. NCI will provide intellectual, scientific, and technical
expertise and experience related to the ongoing development of CD22-
CAR.
2. NCI will continue to support clinical manufacture and
development of CD22-CAR pending transition of manufacturing to an
appropriate site by the commercial partner and will make data available
to the Collaborator as appropriate.
3. NCI will collaborate in the design of protocols and the
evaluation of results.
4. NCI will provide all clinical data in its possession to
Collaborator to support FDA regulatory filings.
The roles of the CRADA Collaborator will include, but are not
limited to the following:
1. The Collaborator will provide clinical development strategy and
financial and other support for the collaborative development leading
to BLA filing and FDA approval of CD22-CAR.
2. The Collaborator will provide intellectual, scientific, and
technical expertise or experience to the development of CD22-CAR.
3. The Collaborator will provide sufficient clinical supply of
autologously-derived CD22 CAR T-cell therapy product for all clinical
trials under the CRADA; this includes additional trials that may be
needed for licensing as well as trials required to meet clinical need
for pediatric patients prior to licensing.
4. The Collaborator will prepare and submit regulatory documents to
FDA, culminating in the submission of a BLA for CD22-CAR.
5. The Collaborator will demonstrate its capability of providing a
commercial supply of CD22-CAR in a timely manner.
Selection Criteria
Interested parties should notify the NCI of their interest in
filing a formal proposal no later than September 1, 2020. Potential
licensees/CRADA Collaborators will have until October 15, 2020 to
submit a formal proposal. Additional proposals will be considered after
the posted deadline in the event that a Collaborator, meeting the
necessary criteria, is not found during the initial posted time period.
Selection criteria for choosing the CRADA Collaborator shall include,
but not be limited to:
1. Possession of or access to the resources needed to support and
perform the activities required to expeditiously commercially develop
CD22-CAR (e.g., facilities, personnel and expertise), including
preparation and submission of regulatory documents;
2. Demonstrated ability to access the expertise required for
successful
[[Page 45914]]
commercial development of biologically active anti-cancer agents, with
an emphasis on adoptive cell therapies;
3. Demonstration of the necessary resources to produce and supply
autologously-derived CD22-CAR in a timely manner for clinical trials at
the NCI and additional clinical sites;
4. Demonstration of access to financial resources required to
support the CRADA collaboration and to successfully support the
development of CD22-CAR for commercial sale;
5. Willingness to cooperate with the NCI in the timely publication
of research results;
6. Willingness to accept the legal provisions and language of the
CRADA and commercial license with only minor modifications, if any;
7. Willingness to pursue a commercial license to the CD22-CAR in
accordance with federal statutes; and
8. The agreement to be bound by the appropriate HHS regulations
relating to human subjects.
Proposal Content
Please submit a proposal outlining your qualifications as a
licensee/CRADA Collaborator for the advertised opportunity. Include any
relevant information, however, please address the following in your
proposal submission:
1. Describe the type and level of resources you have available to
commit to a CRADA collaboration with the NCI, including, but not
limited to the following:
a. What is your current capacity for production of CD22-CAR
lentiviral vector and autologous T-cell product?
b. Are you able to fund several potential clinical trials?
c. Would you be willing to provide funding to the NCI to support
the collaboration?
Please describe the company's related experience in the development
of therapeutics, specifically:
a. Describe any experience or expertise with the development of
adoptive cell therapy-based therapeutics, preferably autologous T-cell
therapeutics.
b. Describe related experience with FDA approval and
commercialization of adoptive cell therapy-based therapeutics,
preferably autologous T-cell therapeutics.
c. Describe any experience determining administration of
autologously-derived T-cell therapeutics.
d. Describe any other collaborations with Federal or academic
laboratories.
Please provide relevant company information, including:
a. Related Product Portfolio.
b. Current Related Product Pipeline.
c. Annual Revenues/financial resources.
d. Size of company/affiliated companies.
Dated: July 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2020-16487 Filed 7-29-20; 8:45 am]
BILLING CODE 4140-01-P
