Theolytics, a biotechnology company focused on oncolytic immunotherapies, has dosed the first patient in its Phase I/IIa clinical trial (OCTOPOD - NCT06618235) evaluating THEO-260 in patients with advanced-stage platinum-resistant ovarian cancer (PROC). THEO-260, administered intravenously, is a novel oncolytic immunotherapy designed to target the stromal-rich tumor microenvironment (TME) characteristic of advanced ovarian cancer and other solid tumors.
Addressing Unmet Needs in Ovarian Cancer
Ovarian cancer remains a leading cause of cancer-related deaths among women, characterized by an immune-suppressed TME abundant with cancer-associated fibroblasts (CAFs). These CAFs contribute to chemo-resistance, relapse, T-cell exclusion, and disease progression. Current treatment for ovarian cancer typically involves surgery followed by platinum-based chemotherapy, but resistance to platinum therapies often develops, creating a significant unmet need for new treatment options.
THEO-260: A Multi-Front Oncolytic Approach
Theolytics' discovery platform identified THEO-260 as a mechanistically differentiated adenovirus capable of lysing both ovarian cancer cells and CAFs. Preclinical studies have demonstrated that THEO-260 triggers immunogenic cell death and promotes T-cell activation. This multi-faceted approach holds promise, particularly for patients with PROC, a complex solid cancer with limited treatment options.
Clinical Trial Details and Expert Commentary
The Phase I/IIa trial is designed to investigate the safety and tolerability of THEO-260 when administered intravenously and to determine the recommended Phase 2 dose. Comprehensive biomarker analysis will support the demonstration of THEO-260’s oncolytic mechanism in the clinic.
Dr. John Krell, Clinical Reader & Consultant Medical Oncologist at Imperial College London and Chief Investigator, stated, "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' Perspective
Margaret Duffy PhD, Theolytics CSO and Co-Founder, added, "Enrolling the first patient into our Phase I/IIa trial for THEO-260 marks a major milestone for Theolytics... 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."
About THEO-260
THEO-260 is positioned as an adenoviral oncolytic immunotherapy designed to address the immune-suppressed nature of advanced solid tumors. It has demonstrated effective killing of cancer cells and CAFs, along with the induction of immune activation in preclinical models, including ovarian cancer patient samples. A clinical study of THEO-260 administered by intraperitoneal delivery to advanced ovarian cancer patients is also being planned.
