SEONGNAM, South Korea--(BUSINESS WIRE)--Genexine (KOSDAQ:095700), a clinical stage biotechnology company developing innovative biologics, today announced that it has entered into a clinical research collaboration with Merck & Co., Inc. (NYSE:MRK), Kenilworth, NJ, USA (known as MSD outside the US and Canada), for the assessment of Genexine’s GX-188E, HPV therapeutic DNA vaccine, in combination with MSD’s anti-PD-1 therapy, Keytruda® (pembrolizumab), for the treatment of patients with HPV-induced cancers.
Under the terms of the agreement between Genexine and MSD, through a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Genexine will conduct a Phase 1b/2a clinical trial to access safety and efficacy of the combination therapy, and MSD will provide clinical supplies of Keytruda and offer support to the study. The agreement also includes provision for potential expansion to include Phase III registration studies in the same indication. Additional details were not disclosed.
Immuno-oncology is a rapidly evolving field of medicine designed to improve the ability of a patient’s immune system to detect and destroy tumors. The purpose of the study is to investigate which combination modalities of treatment will work best in patients with advanced HPV-induced cervical cancer. An objective response rate (ORR) of 12.5% was observed in a Keytruda clinical trial in patients with advanced cervical squamous cell cancer. Genexine expects that Keytruda is well suited to complement its HPV therapeutic DNA vaccine and that the combination with GX-188E can increase those response rates.
Gleaning from the trial in CIN, the Phase 1b/2a cancer study is scheduled to begin in the first half of 2017 with plans to enroll up to 40 patients. GX-188E induces T cells specific to E6/E7 protein originated from HPV type 16 and 18 and preclinical results for the combination therapy show the potential that the induced disease-specific T cells will work synergistically with anti-PD1 Ab. The combination trial with Keytruda and GX-188E will test to replicate animal POC in human to increase T cell specific immunotherapy.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
GX-188E, currently being developed in Phase 2 clinical trials, is a 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.
Genexine, Inc. is a leading biotherapeutics company focused on immuno-oncology and metabolic/autoimmune diseases. 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 after the completion of an EU Phase I study. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea. GX-I7 is a long-acting Interleukin-7 (IL-7-hyFc) currently developed as a treatment of cancer and infectious diseases. Founded in 1999, Genexine consists of about 140 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. Genexine has been listed on KOSDAQ (095700) since 2009.