Theolytics, a clinical-stage biotechnology company focused on next-generation oncolytic immunotherapies, has been awarded €8 million in non-dilutive grant funding from Horizon Europe 2025, pending final negotiation. This funding is part of the European Union’s flagship research and innovation programme, aimed at fostering high-impact clinical-stage projects that enhance patient outcomes and bolster Europe’s scientific leadership.
The grant will significantly support the company’s Phase 2 OCTOPOD-IV clinical trial, which evaluates THEO-260, a novel therapeutic candidate designed to meet the critical needs of patients suffering from advanced ovarian cancer. This study will include up to 20 patients with platinum-resistant ovarian cancer.
THEO-260 is an innovative oncolytic immunotherapy that aims to effectively eliminate both cancer cells and cancer-associated fibroblasts (CAFs), while simultaneously activating the immune response. Platinum-resistant ovarian cancer serves as a representative example of a broader category of stroma-rich solid tumours, for which THEO-260 is being developed.
Margaret Duffy, CSO and Co-founder of Theolytics, stated, “Our collective success with this grant award reflects the extraordinary work being done by the team at Theolytics, and the calibre of our clinical and translational partner centres. The Horizon Europe award validates both the scientific rationale behind our THEO-260 programme and the huge potential of its novel oncolytic and ‘CAF-lytic’ mechanism to address a significant unmet need in stroma-rich solid cancers. By integrating advanced translational analyses into our clinical trial design, we will clinically demonstrate the differentiated mechanism of action of THEO-260 and provide key data to advance this programme and deliver true impact for cancer patients.”
This competitive Horizon Europe 2025 award follows a meticulous grant review process, highlighting Theolytics’ innovative science, strong technical area expertise, and a clear clinical development plan. It presents an opportunity for THEO-260 to address a pressing unmet patient need.
The grant application was coordinated with several prominent partners and expert clinical and translational centres involved in the OCTOPOD-IV study. Notable collaborators include the University of Navarra and the Catalan Institute of Oncology in Spain, the Princess Margaret Hospital in Toronto, Canada, and The Institute of Cancer Research (ICR) in London, UK. Theolytics will directly receive two-thirds of the funds to support the OCTOPOD-IV Phase 2a expansion trial, while the remaining third will be allocated to partner institutions in support of their contributions to the trial.
The OCTOPOD-IV trial (NCT06618235) is a first-in-human, multi-centre study designed to evaluate the safety, tolerability, and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. Additionally, the trial aims to establish the recommended Phase 2 dose and to demonstrate THEO-260’s unique cancer/cancer-associated fibroblast-lytic mechanism of action through comprehensive biomarker analysis.
Prof Alan Melcher, Professor of Translational Immunotherapy at The Institute of Cancer Research, London, remarked, “The differentiated mechanism of action—targeting the stroma and inducing immune activity in the suppressed tumour microenvironment (TME)—of this oncolytic immunotherapy THEO-260 offers the potential to provide an important new treatment option for patients with advanced solid tumours. We are pleased to support the OCTOPOD-IV study, for which the ICR will provide important translational data to assess this novel and promising approach.”
Dr Antonio González, Director of the Department of Medical Oncology and Cancer Center at the Clínica Universidad de Navarra, also expressed hope regarding the study’s potential impact: “We see many women with advanced platinum-resistant ovarian cancer, whose life expectancy is typically only a year or less. There remains a serious lack of effective treatment options for these women, and so we are hopeful that THEO-260 may bring an advance in therapy that will improve and extend the lives of our patients.”
Recruitment at UK and Spanish clinical sites for the OCTOPOD-IV trial is currently ongoing, with plans to expand into additional international centres, including further sites in Spain and Canada. Furthermore, a second clinical trial (OCTOPOD-IP) has been initiated in the US, investigating intraperitoneal delivery of THEO-260 to advanced ovarian cancer patients, in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).
About Theolytics
Theolytics is dedicated to developing best-in-class oncolytic immunotherapies. The company has pioneered a novel approach to create efficacious, targeted adenoviral candidates suitable for direct and systemic intravenous delivery. Theolytics is focused on advancing its lead programme, THEO-260, in clinical trials, with the ambition of providing improved outcomes for patients with stroma-rich solid cancers, for whom current treatment options remain limited. Additionally, the company is developing further pipeline programmes in preclinical stages targeting colorectal cancer and haematological malignancies, recognising the significant unmet needs in these areas.