Theolytics has dosed the first patient in a phase 1 clinical trial investigating intraperitoneal administration of THEO‑260 for women with platinum‑resistant ovarian cancer.
The US study, Octopod‑IP, is the company’s second clinical trial of THEO‑260 in this indication, following the ongoing phase 1/2a Octopod‑IV trial running across the UK, Spain and Canada.
THEO‑260 is designed to target and eliminate cancer cells and cancer‑associated fibroblasts while inducing immune activation. Platinum‑resistant ovarian cancer is described as a prototype of a broader group of stroma‑rich solid tumours for which the therapy is being developed.
The Octopod‑IP trial will assess the safety and tolerability of THEO‑260 delivered directly into the peritoneal cavity and will include extensive biomarker studies to demonstrate the therapy’s differentiated mode of action.
The study is sponsored by Theolytics and led by principal investigator Amir Jazaeri, Professor in the Department of Gynecologic Oncology and Reproductive Medicine at the University of Texas MD Anderson Cancer Center.
David Apelian, CEO of Theolytics, said: “We are proud to announce the dosing of the first patient in this important study.” He added: “The initiation of our US trial to evaluate the intraperitoneal delivery of THEO‑260 in patients with PROC under the company’s first IND marks an important new milestone for Theolytics.”
Apelian explained: “THEO‑260 is designed to be effective against ovarian cancer and other stroma‑rich cancers by destroying cancer‑associated fibroblasts within the tumour microenvironment as well as killing cancer cells directly, triggering immunogenic cell death and promoting T‑cell activation.”
He added: “By advancing THEO‑260 for the treatment of ovarian cancer, we hope to address the high unmet need for patients suffering with this disease and potentially for broader use in other difficult‑to‑treat, stroma‑rich solid tumours.”
