Infinitopes Granted Phase I/IIa Clinical Trial Application Approval to Evaluate Precision Vaccine Targeting Early-Stage Oesophageal Cancer

• Revolutionary 'off-the-shelf' cancer vaccine designed to prevent the recurrence of oesophageal cancer
• ITOP1 to enter first-in-human Phase I/IIa clinical development in the VISTA study in H1 2025
• Multicentre study to be conducted at four university cancer centres, aiming to raise the standard of care by reducing the recurrence of metastases and cancer-related deaths

OXFORD, England, April 9, 2025 /PRNewswire/ -- Infinitopes Ltd today announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company's lead 'off-the-shelf' cancer vaccine. ITOP1 is a precision cancer vaccine, designed to safely and accurately target tumour antigens, leveraging the company's vector delivery system, aiming to drive strong and durable T-cell protection for patients with surgically resectable oesophageal adenocarcinoma (OAC).

The vaccine is designed to stimulate a robust immune response, including activation of CD8+ cytotoxic T cells, to eliminate residual cancer cells expressing the target antigens, reducing the risk of disease recurrence. Tumour antigen targets for ITOP1, Infinitopes' lead asset from its Precision Immunomics™ platform, are derived using the company's bespoke AI/ML-driven immunopeptidomics approach and demonstrate high tumour-specificity and inter-patient conservation with potential clinical applicability across multiple cancer types.   

The VISTA* study is a phase I/IIa double-blind, randomised, placebo-controlled trial to assess the safety, tolerability and anti-tumour activity of ITOP1 in reducing OAC recurrence rates. 60 patients will receive ITOP1 in a prime/boost regimen, in combination with the best standard of care, i.e., a priming dose following neoadjuvant and a boost dose before adjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy. Infinitopes' VISTA trial will be one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ, unlocking the potential for enhanced protection from epitope spreading.

The multicentre VISTA study will be conducted at specialist cancer centres in the UK under the leadership of Prof Mark Middleton, a world-renowned Chief Investigator. The VISTA* study is set to commence in Q2 2025. For further details, visit the UK Clinical Trials Registry for Integrated Research Application System (IRAS) project 1008088.

Prof Mark Middleton, Chief Investigator, Head of Oncology & Co-director, CRUK Oxford Centre, University of Oxford, and Scientific Advisory Board Member for Infinitopes, said: "Half of us will suffer cancer in our lifetimes, so we need better, affordable treatments for the disease. ITOP1 is an exciting new immunotherapy with the potential to make a difference across a wide range of cancers, bringing hope to many patients. This first trial in oesophageal cancer will evaluate ITOP1's precision targeting, which enables anti-tumour immunity through epitope spreading to tackle residual cancer cells and prevent recurrence. We are particularly excited that, by working with the MHRA, we can test ITOP1 where we believe it will achieve the best protection, in potentially curable disease."

Dr Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, commented: "We are delighted that we have advanced our lead vaccine candidate, ITOP1, from university research to a groundbreaking clinical programme in just over three years. This marks a major performance milestone for the company, bringing Infinitopes an important step closer to offering lifesaving solutions for patients with oesophageal and other aggressive cancers. This achievement is a testament to the power of our team, across immunopeptidomics, computational biology/AI/ML, immunology, oncology, advanced trial design, and our collaborations with Cancer Research UK and leading centres around the world."

Infinitopes recently strengthened its scientific and clinical team with the appointments of exceptional industry leaders, Dan Menichella and Jo Brewer, PhD, supporting the company's ambition to advance ITOP1 through clinical development to prolong survival and improve the quality of life for patients.

Dan Menichella, Non-Executive Director at Infinitopes, noted: "Infinitopes' Precision Immunomics approach has the potential to revolutionise cancer treatment as we know it today. I am very excited for the start of our VISTA study, to validate our ITOP1 vaccine and the fundamental enabling technologies."

*VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma, to evaluate Safety, Tolerability & Anti-tumour activity)

About Infinitopes

Infinitopes Ltd is now a clinical stage, integrated cancer biotechnology company supported by Cancer Research UK (CRUK) and the University of Oxford. The Company combines two world leading platforms, in precision target discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines against multiple solid tumour indications. The lead vaccine candidate is scheduled to begin Phase I/IIa trials in Q2 2025. Infinitopes has gathered together in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, clinical trials and regulation, winning an 'Innovative Licensing and Access Pathway' (ILAP) innovation passport from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in 2022. Infinitopes has also won two prestigious, maximum size, nondilutive awards from Innovate UK, a Cancer Therapeutics Award (in 2022) and a Future Economy Investor Partnership (in 2023). Since incorporation, the Infinitopes team has raised nearly $20m from sector expert investors including Cancer Research Horizons, Cancer Research Institute, Kindred Capital, Manta Ray Ventures, Martlet, Meltwind, Octopus Ventures, Saras Capital, Wilbe and the Fundación CRIS Contra el Cáncer, fuelling its rapid growth from three academic co-founders to 28 full time equivalents. It is now the largest tenant of Oxford University's BioEscalator innovation accelerator. For more information, visit www.infinitopes.com

About Oesophageal Adenocarcinoma (OAC)

Oesophageal cancer is an aggressive tumour. In the UK, approximately 10,000 people are diagnosed annually, resulting in around 8,500 deaths, making it the 12th most common cancer and the sixth leading cause of cancer deaths. Survival rates depend on the stage at diagnosis, with only 20% of patients surviving beyond five years. The disease is often diagnosed late due to a lack of early symptoms and the absence of effective population screening. Infinitopes selected oesophageal cancer as our proof-of-concept indication because of the obviously high unmet clinical need and limited effective treatment options.