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

---
identifier: "/us/fr/2024-17129"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Collaboration Opportunity for Combination of Vaccine With Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers"
title_number: 0
title_name: "Federal Register"
section_number: "2024-17129"
section_name: "Collaboration Opportunity for Combination of Vaccine With Adoptive Cell Therapies Made at NCI for the Treatment of Solid Cancers"
positive_law: false
currency: "2024-08-02"
last_updated: "2024-08-02"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2024-17129"
document_type: "notice"
publication_date: "2024-08-02"
agencies:
  - "Health and Human Services Department"
  - "National Institutes of Health"
fr_citation: "89 FR 63209"
fr_volume: 89
fr_action: "Notice."
---

#  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  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,