ArticleJournal of immunotherapy (Hagerstown, Md. : 1997)2018
Whole Recombinant Saccharomyces cerevisiae Yeast Expressing Ras Mutations as Treatment for Patients With Solid Tumors Bearing Ras Mutations: Results From a Phase 1 Trial.
Article in Journal of immunotherapy (Hagerstown, Md. : 1997), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 37 citations in OpenAlex.
- Crosstalk between KRAS and miRNAs in pancreatic cancer: Opportunities for its diagnosis, prognosis and therapeutic intervention (Review).International journal of oncology · 2026Review
- Yeast-Based Vaccine Platforms: Applications and Key Insights from the COVID-19 Era.Biomolecules · 2026Review
- The evolution of vaccine strategies for colorectal cancer: from conventional approaches to the mRNA era.Frontiers in immunology · 2026Review
- Immunoinformatic insights for design and clinical prospects of pan-RAS cancer vaccine.Frontiers in medicine · 2026Article
- Recombinant Yeast-Based Vaccines: Importance and Applications.Infectious disease reports · 2025Article
- Review
- RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches.Medicina (Kaunas, Lithuania) · 2025Review
- Therapeutic Colorectal Cancer Vaccines: Emerging Modalities and Translational Opportunities.Vaccines · 2025Review
- Emerging Frontiers in Colorectal Cancer Therapy: From Targeted Molecules to Immunomodulatory Breakthroughs and Cell-Based Approaches.Digestive diseases and sciences · 2025Review
- Review
- Engineering Saccharomyces cerevisiae for medical applications.Microbial cell factories · 2025Review
- Developing Vaccines in Pancreatic Adenocarcinoma: Trials and Tribulations.Current oncology (Toronto, Ont.) · 2024Review
- Current and future immunotherapeutic approaches in pancreatic cancer treatment.Journal of hematology & oncology · 2024Review
- RAS signaling and immune cells: a sinister crosstalk in the tumor microenvironment.Journal of translational medicine · 2023Review
- RNA Vaccines: Yeast as a Novel Antigen Vehicle.Vaccines · 2023Review
- Colorectal Cancer Immunotherapy: State of the Art and Future Directions.Gastro hep advances · 2023Article
- Standardization and Key Aspects of the Development of Whole Yeast Cell Vaccines.Pharmaceutics · 2022Review
- Tumor microenvironment in pancreatic ductal adenocarcinoma: Implications in immunotherapy.World journal of gastroenterology · 2022Review
- Colorectal cancer vaccines: The current scenario and future prospects.Frontiers in immunology · 2022Review
- Yeasts in nanotechnology-enabled oral vaccine and gene delivery.Bioengineered · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We are developing whole, heat-killed, recombinant Saccharomyces cerevisiae yeast, engineered to encode target proteins, which stimulate immune responses against malignant cells expressing those targets. This phase 1 trial, enrolling patients with advanced colorectal or pancreas cancer, was designed to evaluate safety, immunogenicity, response, and overall survival of ascending doses of the GI-4000 series of products, which express 3 different forms of mutated Ras proteins. The study enrolled 33 heavily pretreated subjects (14 with pancreas and 19 with colorectal cancer), whose tumors were genotyped before enrollment to identify the specific ras mutation and thereby to identify which GI-4000 product to administer. No dose limiting toxicities were observed and no subject discontinued treatment due to a GI-4000 related adverse event (AE). The majority of AEs and all fatal events were due to underlying disease progression and AE frequencies were not significantly different among dose groups. GI-4000 was immunogenic, as Ras mutation-specific immune responses were detected on treatment in ∼60% of subjects. No objective tumor responses were observed but based on imaging, clinical status and/or biochemical markers, stable disease was observed in 6 subjects (18%) on day 29, while 1 subject had stable disease at days 57 and 85 follow-up visits. The median overall survival was 3.3 months (95% confidence interval, 2.3-5.3 mo), and 5 subjects survived past the 48-week follow-up period. No significant dose-dependent trends for survival were observed. This first clinical trial in humans with GI-4000 demonstrated a favorable safety profile and immunogenicity in the majority of subjects.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.