SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), a publicly traded, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, announced today that late-breaking results from the Phase 2 clinical trial study of its therapeutic DNA vaccine GX-188E in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), were selected for an oral presentation at the 2022 European Society for Medical Oncology Congress which is being held from September 9-13 in Paris, France.
Efficacy and safety of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab in HPV 16- and/or 18- positive advanced cervical cancer (Phase II): Safe & effective both in PD-L1 positive and negative
Date and Time
Sat, 10th September 2022 at 08:35~08:40 AM CEST
Mini Oral Session 1: Gynaecological cancers (#LBA32)
7.2.E – Évry Auditorium
“We are delighted to have been invited to present these very important clinical results of Genexine’s innovative immuno-oncology DNA vaccine, GX-188E in combination with pembrolizumab, an approved immune checkpoint inhibitor,” said Neil Warma Genexine’s CEO. “With the completion of this Phase 2 clinical trial, we plan to submit for conditional approval to the Korean MFDS (Ministry of Food and Drug Safety). We believe this could offer hope for a new immunotherapy treatment option to patients with recurrent/metastatic end-stage cervical cancer.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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 hyFcTM 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.
GX-188E is a DNA-based therapeutic vaccine that was discovered and is being developed by Genexine for the treatment of cervical cancer and squamous cell carcinoma of the head and neck. It is being jointly developed with the National Cancer Drug Development Project of Korea. Its mechanism of action is to induce an antigen-specific T-cell immune response to E6/E7, a cancer-causing protein produced by Human Papillomavirus (HPV) types 16 and 18, which are the main causes of cervical cancer. The activated T cells elicit an immune-anticancer mechanism that effectively eliminates cervical cancer cells by inducing a cytotoxic T lymphocyte response.
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 Supervisory Service. 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.
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