The trial will enrol 21 HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma patients. Credit: KGH / commons.wikimedia.org.

Genexine has dosed the first subject in the Phase II clinical trial of triple combination therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). 

The combination treatment comprises the company’s two drugs GX-188E and GX-I7, along with Opdivo (nivolumab).

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Being carried out in South Korea, the trial will assess the safety and efficacy of the triple combination treatment in 21 subjects with HPV-16 or 18-positive recurrent/metastatic (R/M) HNSCC. 

In the trial, endpoints evaluated will include those linked to safety and efficacy such as the overall rate of response.

A long-acting interleukin 7, immuno-oncology drug, GX-I7 enhances absolute lymphocyte counts to boost the number of T cells. It also has a mechanism for penetrating into the tumour microenvironment. 

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GX-188E is an anticancer, therapeutic deoxyribonucleic acid (DNA) vaccine and could specifically target HPV antigens to dendritic cells. 

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Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor of Bristol Myers Squibb.

Genexine president and CEO Neil Warma said: “This study is very important for Genexine as it represents a unique approach to treating a very complicated and difficult cancer. 

“We are running separate trials with GX-188E in cervical cancer and GX-I7 in triple-negative breast cancer and glioblastoma, but the idea to combine both with a checkpoint inhibitor in HNSCC could challenge the standard of care and truly provide an important alternative for these patients and possibly to numerous other HPV related cancers.”

R/M HNSCC is regarded as an incurable disease, with a reduced prognosis and a few options for treatment. 

As the tumour cells grow in the oropharyngeal region, it substantially affects the lives of patients, leading to functional disability and an increased death rate.