Infinitopes has dosed the first patient with ITOP1, its lead investigational therapeutic cancer vaccine, marking the first clinical evaluation of the company’s Precision Immunomics platform.
The approach combines immunopeptidomic antigen discovery with engineered viral vector technologies to identify naturally presented tumour antigens capable of generating durable anti‑tumour T‑cell responses.
The VISTA study is a multicentre, randomised, double‑blind, placebo‑controlled phase 1/2a trial conducted with the University of Oxford. It will evaluate ITOP1 in patients with newly diagnosed, surgically resectable oesophageal and gastro‑oesophageal junction adenocarcinoma.
Unlike post‑surgical vaccination strategies, VISTA investigates treatment while the primary tumour remains in situ, aiming to determine whether earlier immune priming can generate stronger anti‑tumour responses.
Current standard‑of‑care for resectable disease consists of neoadjuvant FLOT / durvalumab chemoimmunotherapy, surgery and adjuvant chemoimmunotherapy. In VISTA, ITOP1 is administered between chemoimmunotherapy and surgery, both before and after oesophagectomy, allowing investigators to assess vaccine‑induced immune responses throughout first‑line treatment.
Professor Mark Middleton, Chief Investigator of the VISTA trial, said: “The first patient dosed in VISTA is an important landmark for our programme and for the wider field of therapeutic cancer vaccines. The neoadjuvant setting provides a fantastic opportunity to study immune responses while the patient’s primary tumour is still there.”
He added: “VISTA is designed to determine if this approach safely generates meaningful anti‑tumour immunity and can delay recurrence after standard treatment and surgery.”
Dr Jonathan Kwok, Co‑Founder, President and Chief Medical Officer at Infinitopes, explained: “Entering the clinic is a defining milestone for successful future medicines. For Infinitopes, VISTA represents the first clinical evaluation of our integrated approach that combines Precision Immunomics target discovery with proven viral vectors, to engineer precise, off‑the‑shelf therapies for cancer patients.”
He continued: “By identifying the antigens that are naturally presented by patients’ tumours, and delivering these using vectors designed to generate durable T‑cell immunity, we believe this approach has the potential to build an exciting pipeline of future programmes across multiple solid tumours. We look forward to evaluating the safety and immunological signals from early 2027.”
The phase 1 safety lead‑in will recruit eight participants before progressing to the randomised, placebo‑controlled phase 2a stage enrolling a further 52 patients. Initial safety and immunological data are expected in early 2027.
