Collaboration Opportunity for Combination of Vaccine With Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers, 63209-63210 [2024-17129]
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Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
technical evaluations. Additional
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167.
Dated: July 30, 2024.
Richard P. Woychik,
Director, National Institute of Environmental
Health Sciences and National Toxicology
Program, National Institutes of Health.
[FR Doc. 2024–17099 Filed 8–1–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 29, 2024.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
16:22 Aug 01, 2024
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Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Samita S. Andreansky,
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 3E71,
Rockville, MD 20852, 240–669–2915,
samita.andreansky@nih.gov.
(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: July 29, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17048 Filed 8–1–24; 8:45 am]
BILLING CODE 4140–01–P
63209
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 29, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17049 Filed 8–1–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Collaboration Opportunity for
Combination of Vaccine With Adoptive
Cell Therapies Made at NCI for the
Treatment of Solid Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Surgery Branch (SB) at
the National Cancer Institute (NCI), is
seeking a partner in the private sector to
provide Good Manufacturing Practicegrade vaccine directed against cancer
neo-antigens with the goal of
conducting a Phase-I human clinical
trial for solid cancers.
FOR FURTHER INFORMATION CONTACT:
Inquiries relating to this collaboration
opportunity should be directed to: Aida
Cremesti, Ph.D., Senior Technology
Transfer Manager, NCI Technology
Transfer Center, Telephone: (240) 276–
5530; Email: aida.cremesti@
mail.nih.gov. Inquiries related to
licensing the related technology E–046–
2022 should be directed to: Andrew
Burke, Ph.D., Senior Technology
Transfer Manager, NCI Technology
Transfer Center, Telephone: (240)–276–
5484; Email: andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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: Center for Scientific
Review Special Emphasis Panel; Biomedical
Technology Optimization and Dissemination
Center (BTOD).
Date: September 26, 2024.
Time: 10:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Joseph Thomas Peterson,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9694, petersonjt@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
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Collaboration Opportunity Summary
The Surgery Branch (SB) at the
National Cancer Institute (NCI), under
the direction of Dr. Steven Rosenberg, is
seeking a partner in the private sector to
provide a GMP-grade vaccine directed
against cancer neo-antigens, either
private (patient-specific neo-antigens) or
shared common tumor antigens (such as
KRAS or P–53), with the goal of
conducting a Phase-I human clinical
trial for solid cancers. The trial would
involve the combination of NCIengineered cell therapies with a vaccine
to be provided by the partner. The NCI
SB has extensive expertise in the latest
technology of tumor infiltrating
lymphocyte (TIL) development, as well
as T-Cell Receptor (TCR)-transduced
Peripheral Blood Lymphocytes (PBL)
development using NCI proprietary
E:\FR\FM\02AUN1.SGM
02AUN1
63210
Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
methodologies, and NCI has the ability
to provide GMP-Grade TIL’s or PBL’s to
be combined with the vaccine. The
vaccine would target the same neoantigens found in the engineered PBL or
TIL, which will be isolated and
characterized using NCI proprietary
methods. The NCI is seeking a partner
with expertise in this area of vaccine
manufacture to provide the GMP-grade
vaccine to be used in combination with
the NCI-engineered T cells. Recruitment
of patients and conduct of the trial
would be done at NCI.
Related NIH Technology Summary
This collaboration opportunity is
related to NIH technology E–046–2022
entitled, ‘‘Neoantigen T Cell Therapy
with Neoantigen Vaccination as a
Combination Immunotherapy Against
Cancer,’’ which is available for
licensing.
The E–046–2022 patent family is
primarily directed to a combination
immunotherapy comprising a
population of antigen-specific immune
cells (e.g., T cells) and a vaccine
targeting the same antigen(s). In
oncology, many investigational adoptive
cell therapies rely on antigen-specific T
cells isolated from the patient in need
of treatment. However, these cells often
exist in a terminally differentiated and
exhausted state and are unable to mount
a robust immune response following
reinfusion. Recent evidence suggests
that administration of a vaccine in
parallel with the T cell product can
ameliorate this performance defect
when the vaccine targets antigen(s)
recognized by the T cells. It is hoped
that this two-part approach will
enhance treatment efficacy.
Dated: July 30, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 29, 2024.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G56,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Maryam Rohani, 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 3G56, Rockville, MD
20892, (301) 761–6656, maryam.rohani@
nih.gov.
(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: July 29, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17047 Filed 8–1–24; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2024–0384]
[FR Doc. 2024–17129 Filed 8–1–24; 8:45 am]
National Merchant Marine Personnel
Advisory Committee; Vacancies
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Coast Guard, Department of
Homeland Security.
ACTION: Notice; request for applications.
National Institutes of Health
SUMMARY:
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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.,
VerDate Sep<11>2014
16:22 Aug 01, 2024
Jkt 262001
The U.S. Coast Guard is
accepting applications to fill eleven
vacancies on the National Merchant
Marine Personnel Advisory Committee
(Committee). This Committee advises
the Secretary of Homeland Security via
the Commandant of the U.S. Coast
Guard on matters relating to personnel
in the United States Merchant Marine,
including the training, qualifications,
certification, documentation, and fitness
of mariners. Individuals currently
holding these appointments will need to
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re-apply if they wish to continue as
Committee members.
DATES: Complete applications must
reach the U.S. Coast Guard on or before
October 1, 2024.
ADDRESSES: Applications must include
(a) a cover letter expressing interest in
an appointment to the National
Merchant Marine Personnel Advisory
Committee, (b) a resume detailing the
applicant’s relevant experience for the
position applied for (including the U.S.
Coast Guard issued mariner reference
number if applicable), and (c) a brief 2–
3 paragraph biography written in thirdperson perspective. Applications should
be submitted via email with subject line
‘‘Application for NMERPAC’’ to
megan.c.johns@uscg.mil.
FOR FURTHER INFORMATION CONTACT: Ms.
Megan Johns Henry, Alternate
Designated Federal Officer of the
National Merchant Marine Personnel
Advisory Committee; telephone 202–
372–1255 or email at megan.c.johns@
uscg.mil.
The
National Merchant Marine Personnel
Advisory Committee is a Federal
advisory committee. The Committee
was established on December 4, 2018,
by section 601 of the Frank LoBiondo
Coast Guard Authorization Act of 2018
(Pub. L. No 115–282, 132 Stat 4192),
and is codified in 46 U.S.C. 15103. The
Committee operates under the
provisions of the Federal Advisory
Committee Act, and 46 U.S.C. 15109.
The Committee is required to meet at
least once a year in accordance with 46
U.S.C. 15109(a). We expect the
Committee will hold meetings twice per
year, typically in the last week of March
and the week of September immediately
following the Labor Day holiday. The
meetings are held at locations across the
country selected by the U.S. Coast
Guard.
Under provisions in 46 U.S.C.
15109(f)(6), if you are appointed as a
member of the Committee, your
membership term will expire on
December 31st of the third full year after
the effective date of your appointment.
Under provisions 46 U.S.C. 15109(f)(4)
the Secretary of Homeland Security may
require an individual to have passed an
appropriate security background
examination before appointment to the
Committee. Committee members are
required to attend and participate in
meetings regularly; members may be
recommended for removal if they miss
two consecutive meetings without a
valid reason that is acceptable to the
Chair of the Committee and the
Designated Federal Officer.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 89, Number 149 (Friday, August 2, 2024)]
[Notices]
[Pages 63209-63210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17129]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Collaboration Opportunity for Combination of Vaccine With
Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Surgery Branch (SB) at the National Cancer Institute
(NCI), is seeking a partner in the private sector to provide Good
Manufacturing Practice-grade vaccine directed against cancer neo-
antigens with the goal of conducting a Phase-I human clinical trial for
solid cancers.
FOR FURTHER INFORMATION CONTACT: Inquiries relating to this
collaboration opportunity should be directed to: Aida Cremesti, Ph.D.,
Senior Technology Transfer Manager, NCI Technology Transfer Center,
Telephone: (240) 276-5530; Email: [email protected]. Inquiries
related to licensing the related technology E-046-2022 should be
directed to: Andrew Burke, Ph.D., Senior Technology Transfer Manager,
NCI Technology Transfer Center, Telephone: (240)-276-5484; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Collaboration Opportunity Summary
The Surgery Branch (SB) at the National Cancer Institute (NCI),
under the direction of Dr. Steven Rosenberg, is seeking a partner in
the private sector to provide a GMP-grade vaccine directed against
cancer neo-antigens, either private (patient-specific neo-antigens) or
shared common tumor antigens (such as KRAS or P-53), with the goal of
conducting a Phase-I human clinical trial for solid cancers. The trial
would involve the combination of NCI-engineered cell therapies with a
vaccine to be provided by the partner. The NCI SB has extensive
expertise in the latest technology of tumor infiltrating lymphocyte
(TIL) development, as well as T-Cell Receptor (TCR)-transduced
Peripheral Blood Lymphocytes (PBL) development using NCI proprietary
[[Page 63210]]
methodologies, and NCI has the ability to provide GMP-Grade TIL's or
PBL's to be combined with the vaccine. The vaccine would target the
same neo-antigens found in the engineered PBL or TIL, which will be
isolated and characterized using NCI proprietary methods. The NCI is
seeking a partner with expertise in this area of vaccine manufacture to
provide the GMP-grade vaccine to be used in combination with the NCI-
engineered T cells. Recruitment of patients and conduct of the trial
would be done at NCI.
Related NIH Technology Summary
This collaboration opportunity is related to NIH technology E-046-
2022 entitled, ``Neoantigen T Cell Therapy with Neoantigen Vaccination
as a Combination Immunotherapy Against Cancer,'' which is available for
licensing.
The E-046-2022 patent family is primarily directed to a combination
immunotherapy comprising a population of antigen-specific immune cells
(e.g., T cells) and a vaccine targeting the same antigen(s). In
oncology, many investigational adoptive cell therapies rely on antigen-
specific T cells isolated from the patient in need of treatment.
However, these cells often exist in a terminally differentiated and
exhausted state and are unable to mount a robust immune response
following reinfusion. Recent evidence suggests that administration of a
vaccine in parallel with the T cell product can ameliorate this
performance defect when the vaccine targets antigen(s) recognized by
the T cells. It is hoped that this two-part approach will enhance
treatment efficacy.
Dated: July 30, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-17129 Filed 8-1-24; 8:45 am]
BILLING CODE 4140-01-P
