On October 13, 2025 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported it will present a Trials in Progress Poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21 (Press release, Theolytics, OCT 13, 2025, View Source [SID1234656586]). Dr Margaret Duffy, CSO and Dr Matilde Saggese, CMO will be attending and will showcase the OCTOPOD-IV Phase I/IIa clinical trial of THEO-260, a novel oncolytic immunotherapy, given by intravenous delivery in patients with ovarian cancer.
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Details of the ESMO (Free ESMO Whitepaper) presentation are:
Phase I/IIa, open-label, dose finding, safety and exploratory trial of THEO-260, a novel oncolytic immunotherapy, by intravenous delivery in patients with high grade serous or endometrioid ovarian cancer
· Presenter: Matilde Saggese, MD, MD (Res), CMO at Theolytics
· Presentation Number: 1238eTiP
· Session: Trials in Progress: – eTrial in Progress
· Session Time/ Place: Poster Session 2, Saturday 18 October 2025 [Messe Berlin]
The abstract is available online on the ESMO (Free ESMO Whitepaper) website.
OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase II dose and demonstrate THEO-260’s differentiated cancer-associated fibroblast ‘CAF-lytic’ mechanism of action in patients through comprehensive biomarker analysis.
Recruitment at UK clinical sites is ongoing and expansion into further international sites is planned (including Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).
Matilde Saggese, MD, MD (Res), Theolytics’ CMO, said, "Recruitment is now well under way for our first ever clinical trial with THEO-260. Ovarian cancer remains a leading cause of cancer-related death amongst women, but with THEO-260’s differentiated mechanism of action in targeting and eliminating ovarian patient cancer cells and cancer-associated fibroblasts, whilst triggering immunogenic cell death and promoting T-cell activation, we hope that we can deliver a therapy that transforms outcomes for women with this devastating disease."
Patients with epithelial ovarian cancer almost invariably develop platinum-resistant disease, for which the prognosis is very poor. Treatment in this setting is challenging due to the complexity of the tumour microenvironment (TME) and most immunotherapies including checkpoint blockade have not proven effective. This may be attributed to an immune suppressed and stromal rich TME, with up to 60% of the tumour volume comprising cancer-associated fibroblasts (CAFs). THEO-260 is a novel oncolytic immunotherapy specifically evolved to target stromal rich tumours. In preclinical studies, THEO-260 has been shown to kill cancer cells and CAFs, trigger immunogenic cell death, and promote T-cell activation.