Theolytics to Present Ongoing Phase I/IIa OCTOPOD-IV Trial of THEO-260 in Ovarian Cancer at ESMO 2025
- THEO-260 is an oncolytic immunotherapy developed for effective targeting of cancer cells and cancer-associated fibroblasts, whilst inducing immune activation in stromal rich tumours
- UK clinical trial recruitment is on track, and additional international clinical sites are set to open for OCTOPOD-IV
- US trial (OCTOPOD-IP) utilising intraperitoneal delivery has been initiated
Oxford UK, October 13, 2025. Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, will present a Trials in Progress Poster at the European Society for Medical Oncology (ESMO) Congress, taking place in Berlin, Germany from October 17-21. 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.
Details of the ESMO 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 on Saturday 18 October 2025 [Messe Berlin]
The abstract is available online on the ESMO website (link).
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.
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About Theolytics
Theolytics is working to develop best-in-class oncolytic immunotherapies. The company has pioneered a new approach to develop efficacious, targeted adenoviral candidates suitable for direct and systemic intravenous delivery.
The company is focused on the advancement of its lead program THEO-260 in clinical trials with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and haematological malignancies where there remains significant unmet need.
Theolytics was founded in 2017, is headquartered in Oxford UK, and is backed by international life sciences investors Taiho Ventures, M Ventures, Oxford Science Enterprises, Epidarex Capital, Sound Bioventures, BGF and Oxford University Innovation.
For more information, please see our website www.theolytics.com
About THEO-260
Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an oncolytic immunotherapy demonstrating effective killing of cancer cells and cancer-associated fibroblasts, whilst inducing immune activation, in advanced preclinical models, including extensive panels of ovarian cancer patient samples. THEO-260 is being evaluated in a Phase I/IIa clinical trial by intravenous delivery in ovarian cancer patients (OCTOPOD-IV) (NCT06618235). A clinical study of THEO-260 administered by intraperitoneal delivery to advanced ovarian cancer patients (OCTOPOD-IP) is also underway in the US in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).
Contact
Theolytics
David Apelian, CEO
MEDiSTRAVA
Frazer Hall, Mark Swallow
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