Notices. Notice
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/register/2024/08/02/2024-17129·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. 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: *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: 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.* [FR Doc. 2024-17129 Filed 8-1-24; 8:45 am]