Theolytics Begins Phase I/IIa Trial of THEO-260 for Ovarian Cancer

Oxford, UK November 19, 2024. Theolytics, a clinical-stage biotechnology company focusing on next-generation oncolytic immunotherapies, has initiated its Phase I/IIa multi-centre, open-label first-in-human trial for THEO-260. This trial, known as OCTOPOD (NCT06618235), involves patients with advanced-stage platinum-resistant ovarian cancer (PROC).

Ovarian cancer remains one of the leading causes of cancer-related deaths in women, featuring a stromal rich tumour microenvironment (TME) that is heavily immune-suppressed and abundant with cancer-associated fibroblasts (CAFs). CAFs are known to drive chemo-resistance, cause relapse, exclude T cells, and accelerate disease progression.

Theolytics utilized its discovery platform, encompassing over 100 million oncolytic candidates, to identify THEO-260. This novel adenovirus is specifically designed for high-grade serous ovarian cancer. In preclinical studies, THEO-260 has shown the ability to lyse cancer cells and CAFs, trigger immunogenic cell death, and promote T-cell activation. This multi-faceted approach is particularly promising for the PROC patient population, a complex solid cancer with limited treatment options.

The ongoing Phase I/IIa trial aims to evaluate the safety and tolerability of THEO-260 when administered intravenously, and to determine the recommended Phase II dose. The trial includes comprehensive biomarker analysis to support demonstration of THEO-260's differentiated oncolytic mechanism in the clinic.

Dr. John Krell, a Clinical Reader and Consultant Medical Oncologist at Imperial College London and the trial’s Chief Investigator, remarked on the standard treatment for ovarian cancer, which typically involves surgery followed by platinum-based chemotherapy and possibly other targeted therapies. Although initial treatment responses can be favorable, relapse is common, necessitating further treatment. Over time, resistance to platinum-based therapies often develops, leaving patients with few effective treatment options. Dr. Krell noted the encouraging preclinical data for THEO-260 in ex vivo patient samples, highlighting its potential as a differentiated approach for treating ovarian cancer.

Margaret Duffy, Theolytics’ Chief Scientific Officer and Co-Founder, expressed enthusiasm about enrolling the first patient in the trial. She emphasized the company's commitment to delivering new treatment options for women suffering from platinum-resistant ovarian cancer. Using their discovery platform, Theolytics developed THEO-260 to combat the stromal-rich nature of this advanced solid cancer. The company looks forward to reporting on the trial's progress.

THEO-260 is an oncolytic immunotherapy designed to address the complex, immune-suppressed nature of advanced solid tumours. It effectively kills cancer cells and CAFs, while inducing immune activation in advanced preclinical models, including extensive panels of ovarian cancer patient samples. Currently, THEO-260 is being evaluated in a Phase I/IIa clinical trial through intravenous delivery in ovarian cancer patients.

Theolytics, founded in 2017 and headquartered in Oxford, UK, strives to develop best-in-class adenoviral oncolytic immunotherapies. The company has pioneered new approaches to create targeted candidates suitable for direct and systemic intravenous delivery. Theolytics is dedicated to advancing its lead program THEO-260 in clinical settings, aiming to improve outcomes for patients with ovarian cancer, who have limited treatment options. Their pipeline also includes preclinical programs for colorectal cancer and haematological malignancies, areas with significant unmet needs.

The company is supported by international life sciences investors including Taiho Ventures, M Ventures, Oxford Science Enterprises, Epidarex Capital, Sound Bioventures, and Oxford University Innovation.

For further information, please visit Theolytics' website.