2024-17129. Collaboration Opportunity for Combination of Vaccine With Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers

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Department of Health and Human Services

National Institutes of Health

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: [phone]; Email: [e-mail]. 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: [phone]; Email: [e-mail].

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 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.