Genexine announced the dosing of the first patient in phase 2 clinical trial using triple combination therapy in patients with recurrent/metastatic HNSCC. The combination therapy consists 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), and OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor. The phase 2 clinical trial is being conducted in South Korea under the leadership of Professor Hye-Ryun Kim of the Department of Oncology at Yonsei Severance Hospital Cancer Center.

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. Recurrent/metastatic head and neck squamous cell carcinoma is considered an incurable disease with a very poor prognosis and limited treatment options.

It requires active treatments from the early stages. Since tumor cells develop in the oropharyngeal region, it significantly impacts patients' lives, causing functional disability and a high mortality rate. Genexine's 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 tumor microenvironment. Another innovative drug being used in the triple combination is GX-188E. It is an anticancer DNA vaccine and has a mechanism of preferentially targeting HPV antigens to dendritic cells.

Therefore, it is expected that the triple combination of the two novel pipelines with PD-1 immune checkpoint inhibitor OpdivoR will be an effective treatment strategy for HPV-positive head and neck cancer patients.