–Genexine Inc.-South Korean Company has been granted the approval to develop an HPV therapeutic DNA vaccine for the treatment of the cervical cancer. Genexine is a clinical stage biotechnology company developing innovative biologics focused on immuno-oncology and orphan diseases.
The company announced that the Ministry of Food and Drug Safety (MFDS) in Korea has granted approval to initiate a Phase Ib/II trial of GX-188E, an HPV therapeutic DNA vaccine, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), for the treatment of patients with HPV-induced advanced non-resectable cervical cancer.
The goal of this clinical trial is to evaluate the safety and efficacy of this combination, which aims to promote an anti-tumor immune response in multiple ways. In previous clinical trials, GX-188E has demonstrated the ability to induce a tumor-specific immune response and curative activity against high-grade cervical intraepithelial neoplasia. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Genexine and Merck & Co., Inc., Kenilworth, NJ, USA believe the combination of GX-188E with KEYTRUDA may have synergistic qualities that could improve the clinical response rates already observed with KEYTRUDA monotherapy in cervical cancer patients; a hypothesis further supported by data presented at the 2016 American Society of Clinical Oncology (ASCO).
The Phase Ib/II study will be initiated in Korea with plans to enroll up to 46 patients. Under the terms of the agreement, Genexine will undertake and fund the study and Merck & Co., Inc., Kenilworth, NJ, USA will provide KEYTRUDA. The agreement includes the potential for further expansion to a Phase III study.