GENEXINE
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, today announced that GX-188E, its first-in-class proprietary DNA vaccine, demonstrated potent efficacy and favorable safety in patients with advanced cervical cancer in a phase 2 study when given in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy.
A total of 60 patients with HPV 16- and/or 18- positive advanced cervical cancer were analyzed in the phase 2 treatment group. Top line results showed a Best Overall Response Rate (BORR) of 31.7% (19 of 60 patients). 6 patients (10.0%) had a complete response and 13 patients (21.7%) had a partial response. Median duration of response (DOR) was 12.3 months and overall survival (OS) was 17.2 months.
The BORR increased to 38.5% in PD-L1 positive patients with HPV 16+ and Squamous Cell Carcinoma. Importantly, PD-L1 negative patients showed an ORR of 25.0%, which is extremely encouraging for this patient population, as it demonstrates potential improvement in efficacy compared to monotherapy of immune checkpoint inhibitors, suggesting a beneficial effect of the combination therapy.
In the safety analysis (n=65) 22 of 65 patients (33.8%) had treatment-related adverse events (TRAEs) of any grade and three (4.6%) had grade 3 or 4 TRAEs. The combination therapy was found to be safe and tolerable with a similar safety profile to that of pembrolizumab monotherapy.
“There is an urgent need for better therapies for patients with advanced cervical cancer and the combination of a therapeutic DNA vaccine together with checkpoint inhibition could be a strong alternative,” said professor Sung-Jong Lee of the Catholic University of Korea, College of Medicine and Investigator in the trial. “The data are very encouraging and appear to show a clear efficacy signal and the product appears safe and well tolerated. I am particularly pleased to see a clear efficacy signal in all patients, regardless of PD-L1 expression. Genexine’s combination therapy has strong appeal from a mechanistic perspective. This approach of using checkpoint inhibition to restore immune system function combined with the vaccine’s effect of upregulating and increasing the influx of CD8+ and other immune cells into the tumor microenvironment, appears to result in a strong, beneficial effect as demonstrated by major outcome measures such as BORR (31.7%) and OS (17.2 months) through the elimination of tumor cells and tumors.”
“We are very pleased to have been invited to present our phase 2 top-line data at ESMO and encouraged by the efficacy and safety shown in this study,” said Neil Warma, President and CEO of Genexine. “The combination of GX-188E, our unique DNA vaccine, with pembrolizumab could represent a new standard of care for patients with HPV 16/18 related recurrent or metastatic cervical cancer, regardless of PD-L1 expression. We are encouraged by the ORR of over 31% but particularly excited by the efficacy signal observed in PD-L1 negative patients. This could open the door to a new therapy for this patient population that previously had limited treatment options available.”
The clinical trial was an open-label, single-arm, phase 2 trial conducted in South Korea in patients with HPV-16 or HPV-18 positive advanced cervical cancer, and who had progressed after standard-of-care therapy. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, 19, and optional dose at week 46, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was ORR assessed by the blinded independent central reviewers (BICR) using RECIST version 1.1.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ.
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® 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.
About GX-188E
GX-188E is a novel DNA-based therapeutic vaccine discovered by Genexine and being jointly developed with the National Cancer Center Korea Onco-Innovation Unit (NOIU). It has a mechanism of inducing an antigen-specific T-cell immune response to E6/E7, a cancer-causing protein produced by HPV types 16 and 18, which are the main causes of cervical cancer. The T cells with activated immune response have an immune-anticancer mechanism that effectively eliminates cervical cancer cells by inducing a cytotoxic T lymphocyte response. Genexine is currently developing GX-188E in cervical cancer and is also conducting two on-going combination trials with GX-188E in Squamous Cell Carcinoma of the Head and Neck (SCCHN).
About Cervical Cancer
Cervical cancer is a cancer arising from the cervix and is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Human Papilloma Virus (HPV) causes more than 90% of cases and HPV 16 and 18 strains are responsible for the majority of high grade cervical cancers. According to WHO, cervical cancer is the fourth most common cancer among women globally, with an estimated 604,000 new cases and 342,000 deaths in 2020. A recent Arizton research report estimated that the cervical cancer therapeutics market was $5.5 billion in 2021 and expected to grow at a CAGR of 4.14% during 2021-2027 to reach $7.1 billion with targeted therapies expected to be the fastest-growing segment during the forecast period.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220907006295/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
NIQ Launches New Brand Traction Score Designed to Reveal How Effectively FMCG Brands Convert Shelf Presence Into Real Consumer Purchases18.11.2025 12:45:00 CET | Press release
Coca-Cola, Philadelphia and Nutella rank highest among the top 15 FMCG brands that have the highest traction score in Western EuropeThe higher the score, the more effectively a brand not only reaches consumers but also converts visibility into salesNIQ also highlights a growing trend across Europe, where rising brand traction scores are closely aligned with the strongest sales growth Coca-Cola has been recognised as the top FMCG brand in Western Europe for its success in driving conversions, according to NielsenIQ (NIQ)’s Brand Traction Score, a new metric that measures how effectively brands convert their shelf presence into actual consumer purchases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118769598/en/ NIQ Brand Traction Score The NIQ Brand Traction Score combines two of NIQ’s most powerful data sources: insights from its Consumer Panel, which tracks how frequently shoppers buy a brand, and its Retail Measuremen
Barilla Opens Its New Innovation Center to Drive Food Innovation Worldwide18.11.2025 12:37:00 CET | Press release
A reimagined space where research, technology, and collaboration merge with global expertise to advance the future of Barilla’s pasta, sauces, and bakery products How can we bring the excellence of Italian culinary tradition into the future? How can we transform everyday products into experiences that surprise the senses, create emotions, and accompany people in moments of pleasure, sharing, and discovery? The answer for Barilla Group is the Barilla Innovation & Technology Experience (BITE) in Parma, marking the company’s most significant investment in food innovation in recent years. With almost 14,000m², more than €20 million invested and an additional €2 million per year dedicated to equipment upgrades, BITE stands as a global hub designed to foster development across the Group’s portfolio. Pasta, sauces, and bakery become a territory of exploration here, where research and technology serve Barilla's passion for good food. This press release features multimedia. View the full releas
HP Becomes Sisvel Wi-Fi 6 Pool Licensee, Ending Disputes with Wilus, Huawei and Philips18.11.2025 10:58:00 CET | Press release
HP Inc and Sisvel have concluded an agreement for the Palo Alto-based global technology leader to become a licensee of the Sisvel Wi-Fi 6 patent pool. The deal follows a mediation process ordered by Judge Rodney Gilstrap, of the US District Court for the Eastern District of Texas, as part of patent infringement litigation brought against HP by Wilus Institute of Standards and Technology, a licensor in the pool. The agreement not only ends the Wilus suit, but also actions launched against HP by other Sisvel Wi-Fi 6 pool licensors, Huawei and Philips. HP now has one-stop access to approximately 2,000 patents (245 patent families) recognised to date, through the pool’s process of independent patent evaluations, as essential to the 802.11ax Wi-Fi 6 standard. Close to 40 entities license the patents in the Sisvel Wi-Fi 6 patent pool. In addition to HP Inc, these include other recent additions such as Cisco, Netgear and Acer. “We are grateful to HP for the constructive way in which they enga
Europe's GetVocal raises $26m to scale trustworthy conversational agents for enterprises18.11.2025 10:00:00 CET | Press release
Series A led by Creandum, with Elaia and Speedinvest, will accelerate the product development of GetVocal’s AI customer experience platform GetVocal, Europe’s leading provider of conversational AI agents for enterprise customer support, today announced the closing of a $26 million Series A investment round led by Creandum with participation from Elaia and Speedinvest, bringing GetVocal’s total fundraising to $30 million. GetVocal will use the funding to fuel product innovation, market expansion, and hiring across Europe as the company accelerates its mission to help enterprises build hybrid human-AI workforces. Founded in 2023 by AI entrepreneurs Roy Moussa and Antonin Bertin, GetVocal is headquartered in Paris, with a 60-strong team spread across Europe. It serves 23 markets, with a stronghold in France and Portugal, and a rapidly growing presence in the UK and DACH. The company tackles one of the biggest barriers to conversational AI adoption – the lack of trust and confidence in bla
Ant Group Unveils China’s First Multimodal AI Assistant with Code-Driven Outputs18.11.2025 09:05:00 CET | Press release
Ant Group today launched LingGuang, a next-generation multimodal AI assistant and the first of its kind in China that interacts with users through code-driven outputs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117438567/en/ Equipped with the capability to understand and produce language, image, voice and data, LingGuang delivers precise, structured responses to complex queries through 3D models, audio clips, charts, animations, interactive maps, and even immediately generated applications, in addition to traditional text-based conversation. Designed around three key features, LingGuang aims to make complex knowledge simpler and more intuitive, transforming how users access information and interact with AI tools. Fast Research: LingGuang responds to user questions or keywords with dynamic, multimodal content, making research on any topic clearer and more engaging. Its 3D digital modeling capability transcends traditio
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom