Theolytics Doses First Patient in Phase 1/2a Trial of THEO-260 in Ovarian Cancer

Theolytics has dosed the first patient in its Phase 1/2a multi-centre, open-label first-in-human trial (OCTOPOD – NCT06618235) of THEO-260 in patients with advanced-stage platinum-resistant ovarian cancer (PROC).

Ovarian Cancer is one of the leading causes of cancer related deaths among women. It exhibits a stromal rich, immune-suppressed TME, abundant with cancer-associated fibroblasts (CAFs). CAFs drive chemo-resistance, relapse, exclusion of T cells and disease progression.

Theolytics’ discovery platform, with >100 million oncolytic candidates and clinically relevant phenotypic selection systems, was applied to identify a mechanistically differentiated adenovirus – THEO-260 – for high grade serous ovarian cancer. It is capable of lysing both ovarian patient cancer cells and CAFs, whilst triggering immunogenic cell death and promoting T-cell activation in preclinical studies. The potential therapeutic impact of this multi-front approach is significant, particularly in the PROC patient population, a complex solid cancer with few treatment options.

The Phase 1/2a clinical trial is designed to investigate the safety and tolerability of THEO-260 administered via intravenous delivery and determine the recommended Phase 2 dose. Demonstration of THEO-260’s differentiated oncolytic mechanism in the clinic will be supported by comprehensive biomarker analysis.

“Treatment for ovarian cancer at diagnosis depends on the stage of the disease, but invariably includes a combination of surgery followed by platinum-based chemotherapy and possibly other targeted therapies,” said Dr. John Krell, MBChB BSc PhD MRCP Clinical Reader & Consultant Medical Oncologist, Imperial College London, and Chief Investigator. “Whilst many patients respond very well to initial treatment, relapse from remission is common and further treatment is needed to try to control the disease. Platinum-based treatments can be effective at relapse but eventually resistance to this form of therapy occurs. There remains a lack of good treatment options with few advances in the last decades and is a significant unmet need in this population. The extensive preclinical data with THEO-260 in ex vivo patient samples is very encouraging and gives promise of a differentiated approach for ovarian patient treatment.”

Theolytics CSO and Co-Founder Margaret Duffy, PhD, added “Enrolling the first patient into our Phase I/IIa trial for THEO-260 marks a major milestone for Theolytics. As a team, we seek to deliver effective new treatment options for the many women who suffer from platinum resistant ovarian cancer. Using our discovery platform, THEO-260 has been developed to combat the stromal rich nature of this advanced solid cancer, and we look forward to reporting on the progress of this trial.”

Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an adenoviral 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 1/2a clinical trial by intravenous delivery in ovarian cancer patients. Details of the trial can be found at https://clinicaltrials.gov/ under study identifier NCT06618235.  A clinical study of THEO-260 administered by intraperitoneal delivery to advanced ovarian cancer patients is also being planned.

Theolytics is working to develop best-in-class adenoviral oncolytic immunotherapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for direct and systemic intravenous delivery.

The company is focused on the advancement of its lead program THEO-260 in the clinic 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 and Oxford University Innovation. For more information, visit www.theolytics.com.