Genexine said on Tuesday that it has completed the first patient dosing of the triple combination DNA cancer vaccine therapeutic for phase 2 trials.
Genexine will combine its GX-188E and GX-I7 with BMS’ global immuno-anticancer drug Opdivo in the clinical trial. Professor Kim Hye-ryun of Yonsei Cancer Center will administer the triple combination drug to 21 patients with recurrent/metastatic head and neck squamous cell carcinoma who are positive for HPV-16 or HPV-18 to evaluate its efficacy and safety.
Recurrent/metastatic head and neck squamous cell carcinoma is an incurable disease with a poor prognosis that develops in the area of the oral pharynx. It significantly impacts patients' quality of life and can cause functional loss at onset, and requires active treatment as it has a high mortality rate.
According to the National Institutes of Health (NIH), about 70 percent of oral pharyngeal cancers in the U.S. are caused by human papillomavirus (HPV) infection. Similar figures have also been reported domestically.
Genexine’s anticancer immuno-booster drug GX-I7 can induce the proliferation and enhancement of T cells. In addition, its DNA therapeutic vaccine, GX-188E, can induce an antigen-specific T-cell immune response by selectively delivering HPV 16/18 type E6 and E7 antigens to dendritic cells. Together with PD-1 immune gateway inhibitor Opdivo, these drugs are expected to deliver an effective therapeutic strategy for HPV-positive head and neck cancer patients, according to Genexine.
"Through this triple combination therapy, we expect to improve the response rate compared to Opdivo monotherapy for these patients.” Professor Kim said.
Genexine CEO Neil Warma said, “Due to the growing global trend of HPV-caused cancers, we expect the market for GX-188E to grow as it expands indications for head and neck cancers.”
“Based on the proven anti-cancer effects and high safety of GX-188E and GX-I7 demonstrated in prior combination clinical trials, we also expect this triple combination therapy clinical trial to confirm the potential for combination with a variety of immune gateway inhibitors," Warma added.