[20230525, Seoul, South Korea] Genexine (KQ 095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, announced the publication of an abstract of its phase 2 clinical trial on triple combination neoadjuvant therapy for HNSCC (head and neck squamous cell carcinoma) in the ASCO (American Society of Clinical Oncology). The study evaluated the DNA vaccine GX-188E (tirvalimogene teraplasmid) and the lymphopenia-correcting immune-oncology drug GX-I7 (efineptakin alfa) in combination with immune checkpoint inhibitor Keytruda® (pembrolizumab). 

The phase 2 investigator-initiated clinical trial (IIT) being conducted in South Korea led by Professor Hye-Ryun Kim, Division of Medical Oncology of Yonsei University Severance Hospital, and jointly conducted with a research team of Professor Yoon Woo Koh, Department of Otolaryngology, enrolled a total of 11 patients with HPV-positive cervical cancer who were scheduled for surgery. The patients received Keytruda 200㎎ on day 1 and 22, Genexine’s GX-188E DNA vaccine 2㎎ on day 1, 8, 22 and GX-I7 on day 8 to amplify the number of T cells before surgery. The primary endpoint evaluated the major pathological response (MPR) and other evaluation criteria included safety, recurrence rate and survival rate.

All 11 patients who participated in the trial underwent surgery as planned after neoadjuvant therapy with no increase in surgical delay or surgical complications. Seven patients (63.6%) showed a major pathological response (MPR), and four patients (36.3%) achieved a pathological complete response (pCR), indicating satisfactory primary evaluation variables. Furthermore, comparative analysis of the tissue before and after combination therapy revealed an increase in follicular helper T cells (CD4+) and reactivation of killer T cells (CD8+) in the tumor microenvironment.

Using AI-based analysis technology, the triple combination therapy was found to increase the density of tumor-infiltrating lymphocytes (TIL) and completely transform tumors classified as immune-desert or immune-excluded types into inflamed tumors.

Professor Hye-Ryun Kim, who led the clinical trial, said, “Through this clinical study conducted for human papillomavirus (HPV)-positive HNSCC patients, the efficacy and safety of the triple combination therapy appear to be confirmed, and the therapy could become an effective new treatment strategy for HPV positive HNSCC patients in the future."

"We are pleased by these early data in this important trial as this is the first time this combination therapy has been used,” said Neil Warma, President and CEO of Genexine. “Head and neck cancer remains such a serious unmet need and we believe there is potential to expand the label for GX-188E beyond cervical cancer to include HNSCC."  

HNSCC cancer is one of the malignant tumors that occur on the patient's facial area and is commonly caused by factors such as smoking and high-risk HPV infection. While various treatment methods such as surgery, radiation therapy and chemotherapy have been used in the past, the size of the surgical area can significantly impact the patient's quality of life. Therefore, immunotherapy has been gaining attention as a treatment option along with the development of immune checkpoint inhibitors. The results of this study will be presented in a poster session at the ASCO 2023 Annual Meeting, which will be held in Chicago from June 2 to 6, 2023.

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Details of the poster presentation are as follows: