#United Kingdom #Oxford #Infinitopes #Oesophageal Cancer #ITOP1

Infinitopes Receives Approval for Phase I/IIa Clinical Trial of ITOP1 Vaccine

Infinitopes Ltd, a pioneering biotechnology company based in Oxford, has announced a significant milestone with the recent approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a Phase I/IIa clinical trial for its lead candidate, ITOP1. This novel cancer vaccine aims to target early-stage oesophageal adenocarcinoma (OAC), a challenging and aggressive form of cancer.

Background of the Study

The VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma) study will be a double-blind, randomised, placebo-controlled trial, which is expected to commence in the second quarter of 2025. It will involve 60 patients and will assess the safety, tolerability, and anti-tumour activity of the ITOP1 vaccine. Importantly, this trial represents one of the first instances where a cancer vaccine will be administered while the primary tumour is still present, with a focus on preventing residual cancer cells from leading to recurrence.

Developed using Infinitopes' innovative Precision Immunomics™ platform, ITOP1 is designed to activate the body's immune system to target and eliminate cancer cells with specific tumour antigens. These antigens are identified through advanced AI/ML-driven approaches that ensure high specificity, potentially applicable across various cancer types.

The Significance of ITOP1

According to Prof. Mark Middleton, Chief Investigator and Head of Oncology at the University of Oxford, this vaccine could revolutionize treatment options for cancer patients. Every year, approximately 10,000 people in the UK are diagnosed with oesophageal cancer, leading to about 8,500 deaths. With only 20% of patients surviving beyond five years, effective treatments that can prevent recurrence are desperately needed. ITOP1 could offer hope for many patients facing this diagnosis.

ITOP1 not only aims to stimulate a robust immune response by activating CD8+ cytotoxic T cells but also strives to tackle the issue of epitope spreading, where an immune response can target different cancer antigens that appear as the tumour evolves. This could provide a more comprehensive approach to treating potential recurrences after initial cancer treatment.

Insights from Leadership

Dr. Jonathan Kwok, the CEO of Infinitopes, expressed enthusiasm about moving ITOP1 from initial research phases to clinical trials in a relatively short time, indicating the dedication of the team and the collaborative efforts of partners, including Cancer Research UK and various global cancer research centers.

As part of its mission to advance cancer vaccines, Infinitopes has recently fortified its expertise by appointing notable industry leaders such as Dan Menichella and Jo Brewer to its Board, aiming to enhance its operational capabilities in clinical development.

Future Prospects

With the support of substantial investments and strategic partnerships, Infinitopes is focused on leveraging its proprietary technologies to transform cancer treatment paradigms. The VISTA study will be crucial not just for evaluating ITOP1, but also for potentially changing how the medical community approaches oesophageal cancer therapy in the future.

As the trial date approaches, there is palpable excitement within the scientific community about the potential impact of ITOP1 on patient outcomes in one of the most aggressive cancer types currently treated.