US-based biotechnology firm Ziopharm Oncology has started dosing paediatric patients in a Phase I clinical trial of Ad-RTS-hIL-12 in combination with veledimex to treat brain tumours.
Ad-RTS-hIL-12 is an adenoviral vector being formulated as an intratumoural injection for expressing hIL-12 cytokine, which could potentially trigger a targeted, anti-tumour immune response.
Veledimex, a small molecule activator ligand, controls and modulates the expression of hIL-12 through the RheoSwitch Therapeutic System (RTS).
The open label Phase I trial will evaluate the safety and tolerability of a single injection of Ad-RTS-hIL-12 in two separate groups.
One group includes subjects with recurrent or progressive brain tumours in the cortex, while the other consists of diffuse intrinsic pontine glioma (DIPG) patients.
Ziopharm Oncology Research and Development executive vice-president and chief medical officer Francois Lebel said: “Studies in adults with recurrent glioblastoma have shown that Ad-RTS-hIL-12 with veledimex is not only well-tolerated, but also have shown growing evidence that this treatment elicits a targeted immune response against brain tumour cells that gives rise to improvement in overall survival.
"We look forward to advancing our studies in paediatric patients with brain tumours as these patients have limited-to-no therapeutic options."
The trial is being conducted at US paediatric cancer centres such as Dana-Farber Cancer Institute in Boston, the University of California, San Francisco, and Ann & Robert H Lurie Children's Hospital in Chicago.
Ziopharm is also planning to commence enrolment of adults with recurrent GBM (rGBM) to evaluate a single dose of Ad-RTS-hIL-12 and veledimex combined with an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.