On June 19, 2017 Genexine Inc., a clinical stage biotechnology company developing innovative biologics focused on immuno-oncology and orphan diseases, reported 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. Schedule your 30 min Free 1stOncology Demo! 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 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) (Free ASCO Whitepaper).
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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.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
▶ About GX-188E:
GX-188E, currently being developed in Phase 2 clinical trials, is an HPV therapeutic DNA vaccine for cervical intraepithelial neoplasia (CIN) and HPV-induced cancers caused by persistent infection by high-risk HPV types, 16/18. A Phase I study demonstrated that GX-188E, a rationally designed HPV DNA vaccine to target HPV antigens preferentially on dendritic cells, elicited significant E6/E7 specific IFN-γ-producing T-cell responses in all CIN3 patients when administered intramuscularly by electroporation. Seven out of nine patients had complete regression of their CIN3 lesions, viral clearance, and exhibited enhanced antigen-specific polyfunctional CD8 T-cell responses within 36 weeks of follow-up. These results were published in October 2014 in Nature Communications.