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VISTA: A first in human, open-label, randomised, controlled phase 1/2a study to assess the safety, tolerability, immunogenicity and early anti-tumour response with ITOP1 a prime/boost viral vector vaccine targeting tumour specific antigens in subjects with surgically resectable oesophageal cancer

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The VISTA study will explore the safety, tolerability, immunogenicity and early clinical activity of ITOP1 administration in patients with resectable oesophageal adenocarcinoma (OAC) in reducing the risk of disease relapse.

 

ITOP1 is a novel adenoviral-based, anti-cancer vaccine that utilises a homologous prime-boost viral vector regimen. To elicit a broad anti-tumour response and to optimise for potential benefit across the target patient population, ITOP1 will be a multiepitope vaccine where patients receive up to 6 recombinant adenovirus type-5 (Ad5) vectors, each transduced with one of 6 minigene sequences to deliver novel oesophageal cancer-specific antigens.

Viral delivery of these selected epitopes, via a prime-boost vaccination regimen, is expected to result in T cell recognition of the ensuing peptide-human leucocyte antigen (HLA) complexes, which will prime minigene antigen-specific T cells, resulting in their activation and proliferation. Subsequent exposure of the oesophageal cancer-specific antigens to the primed T cells boosts this response, promoting persistence, further activation, and expansion of the antigen-specific T cell pool, enhancing the clinically desirable anti-tumour T cell memory response.