Infinitopes Starts VISTA Precision Cancer Vaccine Trial

ITOP1 is the lead candidate from Infinitopes’ Precision Immunomics platform, which combines immunopeptidomic antigen discovery with engineered viral vector technologies to identify naturally presented tumour antigens and generate durable anti-tumour T-cell responses. Unlike traditional post-surgical vaccination strategies, VISTA delivers the vaccine while the primary tumour is still in situ, aiming to establish whether earlier immune priming can generate stronger anti-tumour responses. Current standard-of-care for resectable disease is neoadjuvant FLOT/durvalumab chemoimmunotherapy, followed by surgery and adjuvant chemoimmunotherapy. In VISTA, ITOP1 is administered between chemoimmunotherapy and surgery, both before and after oesophagectomy.

The trial is a multicentre, randomised, double-blind, placebo-controlled Phase 1/2a design. The Phase 1 safety lead-in will enrol eight participants before progressing to the Phase 2a stage, which will randomise a further 52 patients. Initial safety and immunological data are expected in early 2027. Professor Mark Middleton, Chief Investigator of VISTA, framed the neoadjuvant setting as an opportunity to study immune responses while the primary tumour is still present. Dr Jonathan Kwok, Co-Founder, President and Chief Medical Officer at Infinitopes, positioned the platform as targeting off-the-shelf precision cancer therapies across multiple solid tumour types.

The commercial signal is the therapeutic cancer vaccine category maturing beyond the early wave of mRNA-focused programmes into differentiated viral-vector and immunopeptidomics-based approaches. Infinitopes’ neoadjuvant positioning in oesophageal adenocarcinoma is strategically distinctive. Expect competitors including BioNTech, Moderna (with Merck), Ultimovacs, Nykode Therapeutics and IO Biotech to sharpen their own neoadjuvant and pre-surgical trial strategies through 2026 and 2027.

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