Patient with HNSCC dosed with triple combination therapy in Phase II of Genexine clinical trial

Genexine, a South Korean clinical-staged biopharmaceutical company, have announced the dosing with triple combination therapy of the first patient with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in a phase II clinical trial.

The trial hopes to prove the safety and efficacy of the treatment for patients with R/M HNSCC, as the “current unmet medical need in HNSCC patients is substantial,” says Professor Hye-Ryun Kim of the Department of Oncology at Yonsei Severance Hospital Cancer Center. Additionally, these needs are high due to the increasing incident rate of R/M HNSCC globally.

It will evaluate the safety and efficacy in 21 patients with HPV-16 or -18 positive R/M HNSCC. 70% of oropharyngeal cancers are caused by human papillomavirus (HPV) infection.  

R/M HNSCC is considered incurable with a very poor prognosis and limited treatment options, requiring active treatment from the earliest stages. Tumour cells develop in the oropharyngeal region of the body, causing functional disability and a high mortality rate.

The triple combination therapy involves two of Genexine’s own drugs — GX-188E, a therapeutic DNA vaccine, and GX-I7 (a long-acting interleukin 7) — and OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor.

GX-188E is an anti-cancer DNA vaccine which targets HPV antigens; GX-I7 amplifies absolute lymphocyte counts, increasing the number of T cells, and penetrates them into the tumour microenvironment. This combination, with help from OpdivoR, is hoped to be an effective treatment strategy for HPV-positive HNSCC patients.

Genexine’s drugs are also being trialled for treatment of other cancers; GC-188E for cervical cancer, and GX-I7 for triple-negative breast cancer and glioblastoma.

Neil Warma, President and CEO of Genexine said: “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.”

James Spargo