Active vaccination induced immunity in advanced colorectal cancer.
Research type
Research Study
Full title
Active vaccination mediated induction of therapeutic immunity for advanced colorectal cancer patients.
IRAS ID
208450
Contact name
Guy Chung-Faye
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The aim of this study is to assess whether a vaccination strategy can induce an immune response in vitro and in vivo against cancer cells in patients with advanced colorectal cancer. We have developed a novel strategy (Combined Adjuvants for the Synergistic Activation of Cytotoxicity - CASAC) for the vaccination-induced immunity against a range of novel cell markers, including cancer-associated markers. This vaccination induced cell-killing activity results in the in vivo reduction of marker-positive cancer cells by several orders of magnitude. We wish to combine CASAC vaccination with the recently developed high-throughput whole genome sequencing and algorithms that enable the identification and selection of the most appropriate markers. These markers and CASAC adjuvants will be then used to achieve vaccination-induced immunity against the cancer. Specifically, state-of-the-art whole genome sequencing will be employed to identify cancer specific mutations that are present in samples from advanced bowel cancer patients who have or are taking part in the already established 100,000 Genome Project. The identified markers will be synthetically generated. This library of cancer specific markers will be used in combination with a novel CASAC formulation consisting of multiple immune stimulating compounds, combined with the active recruitment of dedicated immune activating cells (patent pending). The initial studies will employ a recently developed in vitro screening test to confirm the ability of this combination to induce immunity, including the production of activated immune signals and cell-killing activity against the cancer cells expressing the chosen markers. This evidence, combined with vaccinations in mouse models, will be used as the core to apply for a subsequent clinical safety/efficacy Phase-I study. The outlined studies will be completed in 12 months, enabling regulatory submissions by month 18 and the subsequent Phase-I clinical trials.
REC name
West of Scotland REC 3
REC reference
16/WS/0178
Date of REC Opinion
21 Sep 2016
REC opinion
Further Information Favourable Opinion