Merck & Co. in Cancer PactBy
Merck & Co. has formed a clinical research collaboration with Genexine, a Pangyo Techno Valley, Korea-based clinical-stage biotechnology company, to assess Genexine’s GX-188E, a human papillomavirus (HPV)-therapeutic DNA vaccine, in combination with Merck’s anti-cancer biologic, Keytruda (pembrolizumab), for treating HPV-induced cancers.
Under the agreement Genexine will conduct a Phase Ib/IIa clinical trial to access safety and efficacy of the combination therapy, and Merck 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.
Keytruda was approved in September 2014 by the US Food and Drug Administration. It is indicated for unresectable or metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.
GX-188E is an HPV therapeutic DNA vaccine for cervical intraepithelial neoplasia and HPV-induced cancers caused by persistent infection by high-risk HPV types, 16/18.