Notice2024-17129
Collaboration Opportunity for Combination of Vaccine With Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers
Primary source
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Published
August 2, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 149 (Friday, August 2, 2024)</title>
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[Federal Register Volume 89, Number 149 (Friday, August 2, 2024)]
[Notices]
[Pages 63209-63210]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17129]
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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.
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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: <a href="/cdn-cgi/l/email-protection#accdc5c8cd82cfdec9c1c9dfd8c5ecc1cdc5c082c2c5c482cbc3da"><span class="__cf_email__" data-cfemail="8aebe3eeeba4e9f8efe7eff9fee3cae7ebe3e6a4e4e3e2a4ede5fc">[email protected]</span></a>. 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:
<a href="/cdn-cgi/l/email-protection#1f7e717b66317d6a6d747a5f71767731787069"><span class="__cf_email__" data-cfemail="dfbeb1bba6f1bdaaadb4ba9fb1b6b7f1b8b0a9">[email protected]</span></a>.
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
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