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Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma
Open accessAbstract
Yeast-CEA (GI-6207) is a therapeutic cancer vaccine genetically modified to express recombinant carcinoembryonic antigen (CEA) protein, using heat-killed yeast (Saccharomyces cerevisiae) as a vector. In preclinical studies, yeast-CEA induced a strong immune response to CEA and antitumor responses. Patients received subcutaneous vaccines every 2 weeks for 3 months and then monthly. Patients were enrolled at 3 sequential dose levels: 4, 16, and 40 yeast units (10(7) yeast particles/unit). Eligible patients were required to have serum CEA > 5 ng/mL or > 20 % CEA(+) tumor block, ECOG PS 0-2, and no history of autoimmunity. Restaging scans were performed at 3 months and then bimonthly. Peripheral blood was collected for the analysis of immune response (e.g., by ELISPOT assay). Twenty-five patients with metastatic CEA-expressing carcinomas were enrolled. Median patient age was 52 (range 39-81). A total of 135 vaccines were administered. The vaccine was well tolerated, and the most common adverse event was grade 1/2 injection-site reaction. Five patients had stable disease beyond 3 months (range 3.5-18 months), and each had CEA stabilization while on-study. Some patients showed evidence post-vaccination of increases in antigen-specific CD8(+) T cells and CD4(+) T lymphocytes and decreases in regulatory T cells. Of note, a patient with medullary thyroid cancer had substantial T cell responses and a vigorous inflammatory reaction at sites of metastatic disease. Yeast-CEA vaccination had minimal toxicity and induced some antigen-specific T cell responses and CEA stabilization in a heterogeneous, heavily pre-treated patient population. Further studies are required to determine the clinical benefit of yeast-CEA vaccination.
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“In the case of CRC, numerous tumor-associated antigens have been identified and utilized in order to target MHC class I. Among these antigens are carcinoembryonic antigen (CEA), mucin-1, squamous cell carcinoma antigen recognized by T cells 3 (SART3), β-human chorionic gonadotropin (β-hCG), Survivin-2B, and p53 [153,154].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [154]
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Metadata
- Authors
- Bilusic, M., Heery, C. R., Arlen, P. M., Rauckhorst, M., Apelian, D., Tsang, K. Y., Tucker, J. A., Jochems, C., Schlom, J., Gulley, J. L., & Madan, R. A.
- Affiliations
- National Institutes of Health (US)
- GlobeImmune (United States) (US)
- Corresponding author
- Gulley, James L.
- Venue
- Cancer Immunology, Immunotherapy
- Published
- 2013-12-07
- Volume
- 63
- Issue
- 3
- Pages
- 225-234
- ISSN
- 0340-7004 (ISSN-L)
- 1432-0851
- PMC
- PMC3944709
- OpenAlex
- W2022660421
- Cited by
- 102
- References
- 44
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 5 · 2023: 6 · 2022: 6 · 2021: 10 · 2020: 12 · 2019: 5 · 2018: 7 · 2017: 10 · 2016: 10 · 2015: 15 · 2014: 7
- FWCI
- 5.89
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Cancer Immunology Immunotherapy (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- National Cancer Institute (Z01BC010666)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Bacterial Cancer Therapy
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- carcinoembryonic antigen, recombinant yeast vaccine, therapeutic cancer vaccines, metastatic carcinoma, medullary thyroid carcinoma, antigen-specific T cell responses, regulatory T cells, vaccine safety, dose escalation
- MeSH terms
- Adenocarcinoma, Adult, Aged, Aged, 80 and over, Carcinoembryonic Antigen, Cells, Cultured, Colonic Neoplasms, Female, Follow-Up Studies, Genetic Engineering, Genetic Vectors, Humans, Injections, Subcutaneous, Male, Middle Aged, Neoplasm Metastasis, Saccharomyces cerevisiae, CD4-Positive T-Lymphocytes, Cytokines, Treatment Outcome, CD8-Positive T-Lymphocytes, Vaccines, DNA, Cancer Vaccines, T-Lymphocytes, Regulatory, Enzyme-Linked Immunospot Assay
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