Genexine Announces Dosing for First Patient in Phase 2 Clinical Trial with Triple Therapy in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

Seoul, South Korea–(BUSINESS WIRE)–Genexin (KOSDAQ:095700), a publicly listed, clinical-stage Korean biopharmaceutical company engaged in the discovery and development of novel biologics for the treatment of unmet medical needs, today announced the dosage of the first patient in the Phase 2 clinical trial using triple therapy in patients with recurrent/metastatic HNSCC. Combination therapy consists of two of Genexin’s proprietary drugs, GX-188E (a first therapeutic DNA vaccine), GX-I7 (a first long-acting interleukin 7) and OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor.

The Phase 2 clinical trial is being conducted in South Korea under the direction of Professor Hye-Ryun Kim from the Department of Oncology at Yonsei Severance Hospital Cancer Center. The trial will evaluate safety and efficacy in 21 patients with recurrent/metastatic HPV-16 or 18 positive head and neck squamous cell carcinoma (R/M HNSCC). Endpoints assessed during the study include those related to safety and efficacy, including overall response rate.

“I am very pleased to lead this study with such a unique approach combining a DNA vaccine, a long-acting Il-7 T cell enhancer 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 might expect the overall response rate in this patient population to be further improved compared to the standard of care. Unmet Medical Need in HNSCC patients is important, so this landmark study will be a milestone for these patients.

“This study is very important for Genexine because 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 of ​​combining the two with a checkpoint inhibitor in the HNSCC could challenge the standard of care and truly provide an important alternative for these patients and possibly many 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 earliest stages. As tumor cells grow in the oropharyngeal region, it greatly impacts the lives of patients, leading to functional disability and a high mortality rate.

According to the National Institute of Health (NIH), approximately 70% of oropharyngeal cancers, which account for the bulk of head and neck cancers in the United States, are caused by human papillomavirus (HPV) infection. . Additionally, the unmet medical need for HPV-positive head and neck cancer is very high due to the increasing incidence rate worldwide.

Genexine’s proprietary immuno-oncology drug, GX-I7, is being developed globally as a first-in-class drug. It amplifies the absolute number of lymphocytes, thereby increasing the number of T cells and has a mechanism to enter them into the tumor microenvironment. Another innovative drug used in the triple combination is GX-188E. It is a DNA cancer vaccine and has a mechanism of preferential targeting of HPV antigens to dendritic cells. Therefore, it is expected that the triple combination of the two novel pipelines with the PD-1 immune checkpoint inhibitor OpdivoR will be an effective treatment strategy for HPV-positive head and neck cancer patients.

About Genexin

Genexine, Inc. is a publicly traded clinical-stage biotechnology company focused on the development and commercialization of next-generation immunotherapies and long-acting biologics. The main technology platforms are therapeutic DNA vaccine technology and hyFcR fusion technology. The Company has several products in clinical development, several of which are in Phase 3 registration trials. The Company’s proprietary pipeline includes GX-188E for cervical cancer and head cancer and neck, GX-I7 (efineptakine alfa) for several 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 to accelerate 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 goals, expectations, financial or other projections, intentions or beliefs, development plans and commercial potential for Genexin’s drug development pipeline, including without limitation GX-I7 (efineptakine 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, in particular the challenges inherent in the process of discovering, developing and commercializing safe and effective new pharmaceutical products for human therapeutic use and in the effort to create a company around these drugs.

Genexine’s forward-looking statements also involve assumptions which, if they never materialize or prove to be incorrect, 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, such statements are based solely on facts and factors currently known to Genexine. Accordingly, you are cautioned not to rely on these forward-looking statements. These and other risks relating to Genexine’s programs are further described in Genexine’s annual reports on the Data Analysis, Retrieval and Transfer System (DART) website (https://dart.fss.or.kr/) of the Korea Financial Services Commission. Genexine undertakes no obligation to update any 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.

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