Genexine's HPV Therapeutic Vaccine Achieved High Efficacy in Phase I Cervical Dysplasia Trial

- GX-188E treatment induces complete regression of precancerous cervical disease and HPV infection clearance with an unprecedented high efficacy

SEONGNAM, South Korea I October 30, 2014 I Genexine, Inc (KOSDAQ:095700), a Korean biopharmaceutical company, announced successful results from its phase I cervical dysplasia trial of GX-188E in women with biopsy-proven cervical intraepithelial neoplasia 3 (CIN3) associated with human papillomavirus (HPV). Treatment with GX-188E, Genexine's latest HPV DNA immunotherapeutic vaccine, resulted in viral clearance in conjunction with complete lesion regression in seven of the nine treated patients with severe dysplasia or carcinoma in situ. In collaboration with Genexine, Dr. Tae-Jin Kim, at Cheil General Hospital in Seoul, Korea, led the clinical trial study, in which patients were administered with a series of three vaccine injections at weeks 0, 4, and 12. By week 36, cervical lesions were completely eradicated in seven responders, as determined by cytological, histological, and virological evaluations. Follow-up studies are currently in progress to monitor the vaccine's long-term effects, and no case of lesion recurrence has been reported thus far, 1 year post-administration. The clinical trial was successfully concluded, having met its primary and secondary endpoints of safety, tolerability, and systemic induction of specific T-cell immune response. Robust HPV-specific poly-functional killer T-cell responses were observed in the seven patients who responded to the vaccine compared to the two non-responders. Such pattern in T-cell activity is significant in its ability to serve as predictive bio-markers for determining clinical outcomes of the therapeutic vaccine.
Although a variety of vaccine candidates have been studied in foreign clinical trials until now, none of them were able to yield an efficacy rate above 50%, and demonstrate the drug's specific mechanism of action, thus failing to lead to commercialization. However, Genexine's new DNA vaccine technology has shown to elicit specific T-cell immunological response by targeting the HPV antigens to dendritic cells for further processing, and presentation. Such mode of action contributed to an unprecedented high efficacy rate, while eliminating serious vaccine-associated adverse events. The breakthrough in DNA vaccine technology was made possible at Genexine, Inc., where the technology was adopted from original developments made at Pohang University of Science and Technology (POSTECH). 
About HPV and Cervical Dysplasia
As the second most common female-specific cancer worldwide, cervical cancer is known to develop from a series of pre-cancerous stages, one of which is cervical intraepithelial neoplasia (CIN). Persistent human papilloma virus (HPV) infection is known to be the greatest risk factor associated with cervical cancer. Preventative vaccines for cervical cancer is estimated to create a yearly market of US $2,000 million, with products from the pharma giants Merck and Glaxo-Smith Kline being distributed on a global scale. These vaccines, however, are ineffective in women who are already infected with the virus. Thus, the only treatment options available for HPV-infected women are surgical procedures to remove the lesions, which could lead to various reproductive risks associated with infertility, miscarriage, pre-mature births, bleeding, and other complications. However, if the surgical procedure did not completely remove the lesions, there are risks of recurrence. As such, there is a serious medical need for effective non-surgical treatment options.
According to the World Health Organization (WHO), approximately 300 million women are estimated to be infected with HPV, with another 30 million additional cases that have already progressed to the pre-cancerous CIN stage. Because most of the patients are between the ages 20-35, there is a serious unmet need to develop commercially available therapeutic vaccines and other non-surgical treatments that allow healthy pregnancies and births. Genexine's DNA vaccine hopes to provide an effective non-surgical therapeutic relief to HPV-infected women worldwide. Additionally, the present DNA vaccine is expected to be also effective in other HPV-induced cancer indications, such as, but not limited to oral cancer, anal cancer, and vulvar cancer.
Future Developments
Dr. Jong Sup Park of the Catholic University of Korea is currently leading a phase II clinical trial of GX-188E in 72 CIN patients across four Korean hospitals (Seoul St. Mary's Hospital, Cheil General Hospital, Korea University Guro Hospital, and Keimyung University Dongsan Medical Center). Phase II studies are also scheduled to take place in Europe early 2015. Besides the clinical developments, Genexine, Inc. has also successfully secured a contract with a leading Chinese pharmaceutical company for 50% of the HPV vaccine rights in China. Furthermore, the Korean company is striving to establish a joint venture with the Chinese partner by the end of the year in order to more dynamically expand its vaccine-related clinical studies and commercialization efforts. For a more global commercialization of the vaccine, Genexine is looking forward to starting a series of discussions with other multinational pharmaceutical companies.
The latest developments in the GX-188E DNA vaccine are achievements of an inter-disciplinary collaboration between academia, industry, and government. The research teams at POSTECH were funded in part by the Korea Biotechnology R&D Group (KBRDG) of the Korean Ministry of Science, ICT and Future Planning. The POSTECH research groups, through a series of fundamental natural science research projects, were able to finalize and identify a promising therapeutic lead candidate. Research teams at Genexine, Inc. were able to further develop the vaccine and successfully complete pre-clinical studies. With support from the Korean Ministry of Public Health, Genexine's research teams were also able to begin clinical trials and make progress in identifying the mechanism of action. Detailed results of the latest clinical trial study was published in the high impact scientific journal Nature Communications. (Title : Clearance of persistent HPV infection and cervical lesion by therapeutic DNA vaccine in CIN3 patients).
About Genexine, Inc.
Headquartered in Seongnam, South Korea, Genexine, Inc. is a biopharmaceutical company that specializes in developing therapeutic vaccines for intractable diseases and next-generation Fc fusion protein drugs. By employing its proprietary hy-Fc long-acting protein platform and DNA vaccine technology, the company strives to globally improve patients' quality of lives. Currently, the company's leading project pipelines, including, but not limited to: GX-188E, GX-H9 (hyFc-hGH), GX-G3 (hyFc-GCSF), and GX-E2 (hyFC-EPO), are either preparing to enter, or in the middle of phase II of clinical trials. The company has been listed on the KOSDAQ, a Korean stock exchange similar to the American counterpart NASDAQ, since 2009. As of Oct. 23 2014, the company's market capital is valued at over USD 0.4 billion.


SOURCE: Genexine