Genexine Inc., a clinical stage biotechnology company developing innovative biologics focused on immuno-oncology and orphan diseases, 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 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.

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.

▶ About Genexine:

Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric growth hormone deficiencies, currently in multinational phase II trials. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III, and plans to enter into a Phase 1b/2 trial in cervical cancer with GX-188E in combination with KEYTRUDA, an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, NJ, USA. Founded in 1999, Genexine has over 150 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.