Genexine Announces Dosing of First Patient in Phase 2 clinical trial with Triple Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)

SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today 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 Opdivo^R (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.

“I am very pleased to be leading this study with such a unique approach of combining a DNA vaccine, a long-acting Il-7 T-cell amplifier and a proven checkpoint inhibitor,” said Professor Hye-Ryun Kim. “Based on the potential synergy of the mechanisms of action of the three therapies, we could expect that the overall response rate in this patient population will be further enhanced versus the standard of care. The unmet medical need in HNSCC patients is substantial, so this landmark study will be an important milestone for these patients.”

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

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.

According to the National Institute of Health (NIH), around 70% of oropharyngeal cancer which takes a major portion of head and neck cancers in the United States are caused by human papillomavirus (HPV) infection. In addition, the unmet medical needs for HPV-positive head and neck cancer are very high due to the increasing incidence rate around the world.

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 Opdivo^R

will be an effective treatment strategy for HPV-positive head and neck cancer patients.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutics and next-generation long-acting biologics. Primary technology platforms are Therapeutic DNA vaccine technology and hyFc^R fusion technology. The company has multiple products in clinical development, including several undergoing Phase 3 registration trials. The company’s proprietary pipeline includes GX-188E for cervical cancer and head and neck cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean stock exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide.

Forward Looking Statements

This press release contains forward-looking statements regarding the business of Genexine, Inc. (“Genexine”). Any statement describing Genexine’s goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Genexine’s drug development pipeline, including without limitation GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), GX- E4 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs.

Genexine’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Genexine’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Genexine. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Genexine’s programs are described in additional detail in Genexine’s annual reports on DART (Data Analysis, Retrieval and Transfer System) internet site (https://dart.fss.or.kr/ ) of the Korean Financial Services Commission. Genexine assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.