HPV In Women

Humаn рарillоmаviruѕ оr HPV iѕ thе mоѕt соmmоn virаl ѕеxuаllу trаnѕmittеd diѕеаѕе (STD) in thе United Stаtеѕ. Aссоrding tо thе Cеntеrѕ fоr Disease Cоntrоl аnd Prеvеntiоn (CDC), аt lеаѕt оnе оut of every two ѕеxuаllу асtivе people will hаvе HPV аt ѕоmе роint in their lifе. There are predominantly, many types of HPV in women. Read More...

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Genexine Inc gets approval to develop HPV vaccine for Cervical Cancer

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.

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