Infinitopes to Showcase Breakthroughs on Cancer Vaccine Development at SITC 2024: Insight into a double-blind, Phase I/IIa clinical trial

• Infinitopes' lead vaccine candidate ITOP1 is a novel, precision targeted, immunologically durable, "off-the-shelf" cancer vaccine, designed to save lives by preventing disease recurrence in first-line patients with surgically resectable cancers
• Infinitopes' proprietary vector delivery system reliably triggers durable T-cell protection, which halted or delayed tumour progression in industry standard preclinical mouse models, without checkpoint inhibitor co-treatment
• The Company's approach utilises its AI/ML Precision ImmunomicsTM antigen discovery platform, capable of identifying best-in-class pools of hundreds of novel cancer-specific antigens, to empower collaborator's T-cell & TCR therapies, in addition to Infinitopes' own vaccine pipeline
• Infinitopes has begun discussions with potential commercial collaboration partners seeking best in class vectors and targets that enable next generation cancer therapies, and will soon begin reaching out to new investors for its Series A round

OXFORD, England, Nov. 8, 2024 /PRNewswire/ -- Infinitopes, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, today announces that it will be presenting three posters on its pioneering cancer vaccine discovery and development, including one that has been recognised as a 'top 100' poster presentation, at the Society for Immunotherapy of Cancer (SITC) 2024, held in Houston, US, from 6-10th November.

A spinout from Oxford University, supported by Cancer Research UK (CRUK), Infinitopes announced its oversubscribed £12.8 million seed financing in April 2024, to advance its AI/ML Precision ImmunomicsTM antigen discovery platform. The Company exploits this technology to accurately design 'best-in-class' therapeutics for multiple cancer indications. Led by an exceptional Scientific Advisory Board (SAB) and world-class team of clinicians, scientists, and regulatory leaders, Infinitopes is poised to commence its lead vaccine candidate ITOP1 in a highly anticipated, double-blind, randomised, placebo-controlled phase I/IIa clinical trial, starting H1'25 at four UK NHS university cancer centres, to treat patients with oesophageal cancer (OC).

Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, said: "Using our integrated 'right targets, right vectors, right patients, right time' approach, we aim to address the unmet clinical need for durably effective, accessible therapies, to save lives by preventing or significantly delaying disease recurrence for cancer patients. We combine our deep knowledge of the field of immunology with our uniquely sensitive AI/ML Precision ImmunomicsTM platform to identify and select optimal synergistic tumour targets, alongside engineering safe and effective proprietary vector delivery systems, designed to reliably stimulate lasting T-cell protection. With our expert capabilities and highly experienced team, our strategy to win an Innovation & Licensing Access Pathway (ILAP) innovation passport from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) has unlocked rapid entry into an ambitious clinical development programme for our lead vaccine candidate, ITOP1. The VISTA study, commencing H1'25, will open to oesophageal cancer patients most likely to positively respond, at the moment of their cancer journey where long-term protection is anticipated to be most likely."

Abstract One, number 635 is titled 'A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)'. It details the overall design and purpose of the Oxford University-led VISTA study, to test Infinitopes' ITOP1 vaccine in HLA-matched patients undergoing surgery to remove their oesophageal cancers (OC). ITOP1 is an "off-the-shelf" vaccine administered as a prime-boost regimen before and after surgery, to prevent recurrence for patients with OC. OC is the 12th most common type of cancer in the UK, with about 10,000 cases a year. Due to its poor prognosis OC is the UK's sixth most common cause of cancer deaths, claiming around 8,500 lives annually. Surgical resection plus neoadjuvant/adjuvant chemotherapy is the current best standard of care. Nearly half of those patients undergoing this 'curative' surgery suffer recurrence even after best standard of care; with a median disease-free survival of 11 months.

Abstract Two, number 1039 recognised as a 'top 100' SITC poster, is titled 'Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical models'. It details how Infinitopes has developed a foundational, proprietary vector delivery system and confirmed the success of this approach in industry-standard preclinical models. Immunisation with a single priming dose reliably generated durable, antigen-specific immune T-cell protection, capable of halting or significantly delaying tumour progression, without checkpoint inhibitor co-treatment. Up to 80% of mice survived tumour challenge, versus control animals dying within three weeks. Metastases were completely suppressed in multiple models.

Abstract Three, number 1427 is titled 'Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform'. It details how Infinitopes has used its unique AI/ML Precision ImmunomicsTM antigen discovery platform to identify hundreds of novel cancer-specific antigens from primary tumour samples. The abstract explains how this best-in-class pool of therapeutic combination targets could be used to accurately treat tumours, forming the basis for a suite of "off-the-shelf" therapies for many different cancer types. Infinitopes has begun discussions with potential Big Pharma collaboration partners to licence these for use in T-cell, TCR and other modalities, and is excited to progress its own vaccine programme.

Prof. David Curiel, Professor of Radiation Oncology and Director of the Biologic Therapeutic Centre at Washington University St Louis., commented: "Infinitopes' systematic approach to cancer vaccine development is making rapid and substantive progress. This week's findings support acceleration towards clinical development. Infinitopes' lead candidate ITOP1 represents a significant milestone for the Company, and is a potential treatment paradigm change for the early and effective treatment of future patients with cancerous tumours, beginning with oesophageal cancer."

Details of the poster presentations are as follows:

Poster Title: A randomised, placebo-controlled, multi-centre Phase I/IIa study evaluating the safety and clinical activity of a novel viral vector cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study)Abstract Number: 635Primary Category: Clinical Trials in ProgressPresenting Author: Michael Grant, Executive Medical Director at InfinitopesDate & Time: Friday 8 November 2024, 9am – 7pm CDTAbstract Authors: Michael Grant¹, Jonathan Kwok¹, Paul Smith¹, Lian Ni Lee¹, Senthil Chinnakannan¹, Orion Tong¹, David Thompson², Paul Klenerman², Nicola Ternette² and Mark Middleton²

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Vaccination with a single dose of a novel delivery platform confers durable >8 month immune responses, with lasting protection against tumour and metastases in preclinical modelsAbstract Number: 1039Primary Category: Immune-Stimulants and Immune ModulatorsPresenting Author: Lian Lee, VP Preclinical & Co-Founder at InfinitopesDate & Time: Friday 8 November 2024, 9am – 7pm CDTAbstract Authors: Lian Ni Lee1, Jonathan Kwok1, Anna Maria Theresa Kroon2, Senthil Chinnakannan1, Spyridoula Marinou1, Annemieke Kok1, Callum Beach1, Steve John1, Tim Davies1, Andrew Highton2, Catherine de Lara2, Claire Hutchings2, Robert Parker1, Silvia Salatino2, Orion Tong1, Nicola Ternette2, Uzi Gileadi2, Paul Klenerman2

¹ Infinitopes, Oxford, UK, ² University of Oxford, Oxford, UK

Poster Title: Precision ImmunomicsTM: Identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platformAbstract Number: 1427Primary Category: Antigen PresentationPresenting Author: Georges Bedran, Senior Scientist & Computational Immunomics Lead at InfinitopesDate & Time: Friday 8 November 2024, 9am – 7pm CDTAbstract Authors: Yuxin Sun¹, Nil Adell Mill¹, Tiffany Ma¹, Yves du Toit¹, Ava Van Ess¹, Chloe Hyun-Jung Lee¹, Spyridoula Marinou¹, Annemieke ten Bokum¹, May Ke¹, Oliver Turnbull¹, Luke Heirene¹, Lian Ni Lee¹, Alexey I. Nesvizhskii², Pouya Faridi³, Paul Klenerman⁴, Jonathan Kwok¹, Orion Tong¹, Robert Parker¹ and Georges Bedran¹

¹ Infinitopes, Oxford, UK, ² University of Michigan Medical School, Ann Arbor, USA, ³ Monash University, Melbourne, Australia, ⁴ University of Oxford, Oxford, UK

About Infinitopes

Infinitopes Ltd is a soon to be 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 antigen discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines for use against multiple solid tumour indications. The lead vaccine candidate is expected to begin Phase I/IIa trials in H1' 25. Infinitopes has gathered together and cultivated 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, funding 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 SITC

SITC 2024 provides a multidisciplinary educational and interactive environment focused on improving outcomes for cancer patients by incorporating strategies based on basic and applied cancer immunotherapy. The Annual Meeting consists of cutting-edge research presentations by experts in the field, oral and poster abstract presentations and ample opportunity for structured and informal discussions, including important networking opportunities. SITC 2024 also includes updates on major national and international initiatives from academia, government and industry, as well as important society projects.

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