ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) today announced that the first patient has been dosed in a Phase 1 clinical study of ZIN ATI-001, a novel DNA-based therapeutic candidate, in patients with advanced melanoma. ZIN ATI-001 is the second clinical oncology product candidate from the ZIOPHARM-Intrexon Corporation exclusive synthetic biology channel partnership.
The multi-center, single-arm, open-label, dose-escalation study, treating patients with unresectable Stage III or IV melanoma, will assess the safety and tolerability of intratumoral injections of ZIN ATI-001 (Ad-RTS-IL-12 or INXN-2001). Secondary endpoints include a determination of the recommended Phase 2 dose, an evaluation of T cell immunity markers, and preliminary anti-tumor activity.
"ZIN ATI-001 demonstrates the ability to engineer complex, controllable transgenes whose properties cannot be reproduced through traditional therapeutic approaches," said John Nemunaitis, MD, Executive Medical Director, Mary Crowley Medical Research Center. "ZIN ATI-001 is designed to express a potent anti-cancer cytokine with a known ability to stimulate the immune system against cancer directly within tumor cells and under the control of an 'oral activator drug'. Melanoma is a cancer particularly susceptible to immune-modulating therapy and this early, melanoma-focused study will provide a preliminary understanding of the properties of this DNA-based therapeutic. Such results may then allow for an accelerated clinical program in other cancer types."