Policy & Regulation
Genexine doses first patient in phase 2 clinical trial using triple combination therapy in patients with head and neck squamous cell carcinoma
17 August 2022 -

Korean biopharmaceutical company Genexine (KOSDAQ: 095700) reported on Wednesday that it has dosed the first patient in a phase 2 clinical trial using triple combination therapy in patients with recurrent/metastatic HNSCC.

This therapy is a combination of two of Genexine's proprietary drugs, GX-188E (a first-in-class therapeutic DNA vaccine), GX-I7 (a first-in-class long-acting interleukin 7), along with OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor.

Professor Hye-Ryun Kim of the Department of Oncology at Yonsei Severance Hospital Cancer Center is leading the phase 2 clinical trial, which is being conducted in South Korea. The trial will evaluate the safety and efficacy in 21 patients with HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Endpoints assessed during the study include those related to safety and efficacy, including the overall rate of response, Genexine stated.

The company added that its proprietary immuno-oncology drug GX-I7 is being developed globally as a first-in-class drug. It amplifies absolute lymphocyte counts, therefore, increasing the number of T cells and has a mechanism to penetrate them into the tumour microenvironment. Another innovative drug being used in the triple combination is GX-188E, an anticancer DNA vaccine that has a mechanism of preferentially targeting HPV antigens to dendritic cells.

Genexine is focused on the development and commercialisation of immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFcR fusion technology.