[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]


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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: [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