ITOP1 / Infinitopes - LARVOL DELTA

Infinitopes Doses First Patient With Precision Off-the-Shelf Therapeutic Cancer Vaccine ITOP1 (Businesswire) - "The VISTA study (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma to evaluate Safety, Tolerability and Anti-tumour activity) is a multicentre, randomised, double-blind, placebo-controlled Phase 1/2a clinical trial conducted in partnership with the University of Oxford. The study will evaluate ITOP1 in patients with newly diagnosed, surgically resectable oesophageal and gastro-oesophageal junction adenocarcinoma (OAC)....Initial safety and immunological data from the Phase 1 cohort are anticipated from early 2027."

First-in-human • P1 data • Trial status • Gastroesophageal Junction Adenocarcinoma

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

New P1/2 trial • Esophageal Adenocarcinoma

Infinitopes to Showcase Breakthroughs on Cancer Vaccine Development at SITC 2024… (PRNewswire) - "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)....Infinitopes...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....It details how Infinitopes has developed a foundational, proprietary vector delivery system and confirmed the success of this approach in industry-standard preclinical models....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."

New trial • Preclinical • Esophageal Adenocarcinoma • Oncology

A randomised, placebo-controlled, phase I/IIa study evaluating the safety and clinical activity of a novel cancer vaccine (ITOP1) in patients with resectable oesophageal adenocarcinoma (VISTA study) (SITC 2024) - P1/2 | "Secondary endpoints are recurrence free survival (RECIST v1.1) and immunogenicity. Enrolment is due to begin in September 2024."

Clinical • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Precision ImmunomicsTM: identification of hundreds of novel cancer antigens using a sensitive immunopeptidomics-led platform (SITC 2024) - "Conclusions By combining sensitive immunopeptidomics with a bespoke computational engine, DenoVax, we can identify a best-in-class pool of therapeutic antigens with unprecedented precision and present large tumor target maps on a per-indication basis. We have combined our Precision ImmunomicsTM antigens with our proprietary vector platform in our lead asset, ITOP1, and are initiating a Phase 1/2a clinical trial in 2024 in the UK."

IO biomarker • Gastrointestinal Cancer • Oncology • Solid Tumor

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 (SITC 2024) - "A first-in-human Ph1/2a trial using our lead asset, ITOP-1, will be initiated in 2024 across 4 sites in the UK. Ethics Approval All work was performed under UK Home Office license PPL P874AC0F0, PP3430109, PBA43A2E4 or 40/3636 in accordance with the UK Animal (Scientific Procedures) Act 1986. All work was performed by trained and licensed individuals."

IO biomarker • Preclinical • Lung Cancer • Oncology • Solid Tumor • CD69 • CD8 • GZMB • HAVCR2 • ITGAE • LAG3 • PD-1

Integrated cancer biotech Infinitopes secures £12.8m seed financing to enhance its Precision Immunomics antigen discovery technologies to target five more cancers (PRNewswire) - "Infinitopes Precision Immunomics...announced the completion of a £12.8m seed funding round led by Octopus Ventures. The round was heavily oversubscribed, also drawing in funds from Cancer Research Horizons, Cancer Research Institute, CRIS Cancer Foundation, Kindred Capital, Manta Ray, Martlet Capital, Meltwind Advisory, Saras Capital, Wilbe Capital, and expert angel investors. The total funds raised combine new equity investment and a prestigious non-dilutive award from Innovate UK's Future Economy Investor Partnership scheme....Infinitopes' lead asset, a novel cancer vaccine called ITOP1, is scheduled to commence a phase I/IIa study in first line cancer patients in the third quarter of 2024."

Financing • New P1/2 trial • Oncology