Genexine’s First-in-Class Therapeutic DNA Vaccine Shows Significant Potential to Extend Survival in Late-Stage Cervical Cancer
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.
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.
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.
For further information, please contact Genexine Investor Relations:
Mr. Edward Shin
Mr. Jongsoo Lee
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
IEEE Announces Decision on Its Standards-related Patent Policy30.9.2022 18:31:00 CEST | Press release
The IEEE Standards Association Board of Governors (IEEE SA BOG) took action to update the Patent Policy for IEEE standards development, which will go into effect 01 January 2023. These updates are intended to improve the clarity of IEEE’s standards processes related to patented technologies, while offering more options for stakeholders. In accordance with IEEE SA’s policies and procedures, the following resolutions were approved by consensus without objections by the full IEEE SA BOG. The IEEE SA BOG approved proposed updates to the IEEE SA Standards Board Bylaws, effective 01 January 2023. The IEEE SA BOG approved proposed updates to the IEEE SA Letter of Assurance (LOA) form, effective 01 January 2023. The IEEE SA BOG approved proposed updates to the patent policy FAQs, effective 01 January 2023. For the same IEEE standard, in instances where there is one Submitter of an Accepted LOA under the 2015 policy and another Submitter of an Accepted LOA under a subsequent policy or using the
Calling All Sake Aficionados! October 1st Is "Sake Day." Let's Kampai Together!! (Kampai Means "Toast" in Japanese)30.9.2022 16:00:00 CEST | Press release
There are countless events around the world celebrating the delights of wine and beer; October 1st is known as "Sake Day," where sake lovers worldwide gather, enjoy, and appreciate this delicious beverage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220929005349/en/ toast (Photo: Business Wire) Sake Day was set as October 1st by the Japan Sake and Shochu Makers Association (JSS), the largest sake industry organization in Japan with members consisting of some 1,700 producers of sake, Honkaku Shochu, Awamori, and Hon-Mirin. This date was selected because October 1st marked the beginning of the new brewing season using freshly harvested rice crops. Events celebrating sake have been planned worldwide for Sake Day on October 1st. In Japan, the "Kampai! with Sake Week" event will run for ten days around Sake Day on October 1st, where JSS, prefectural sake organizations, breweries, restaurants, liquor stores, and sake lovers wil
Alkegen Launching Trio of New High Efficiency Filtration Products for Air, Liquid and Molecular Applications30.9.2022 14:30:00 CEST | Press release
Alkegen, a leading specialty materials platform that provides high performance materials used in advanced applications, announced they will be launching three new High Efficiency Filtration (HEF) products during their exhibition at the upcoming World Filtration Congress in San Diego, CA. These are the first new filtration products launched under the Alkegen brand name since the merger of Lydall and Unifrax last October. “This trio of HEF media – one for air, one for liquid, one for molecular applications – represents the first wave of advanced materials developed and released under our new Alkegen filtration product development team. These launches combine Lydall’s well-known filtration and manufacturing expertise with Unifrax’s proven, rapid innovation capabilities,” said Paul Vallis, President of the Filtration & Catalysis Group. “This is the first of many innovations we expect to deliver as our portfolio evolves to meet the continuous demand for ever-higher efficiency and reduced en
Nexign’s Article Included in TM Forum’s Benchmark Report30.9.2022 13:12:00 CEST | Press release
Nexign, a leading provider of BSS and digitalization solutions, announces that its article has been included in TM Forum’s benchmark report “Telco Revenue Growth: Taking It to the Next Level”. The report investigates the primary sectors and services affecting communications service providers (CSPs) and the areas of growth and decline. It draws on research collected from 33 of the world’s largest operators and serves as a source of valuable information about factors influencing successful telco-to-techco transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220930005236/en/ Nexign’s Article Included in TM Forum’s Benchmark Report (Photo: Business Wire) Nexign’s article “Harnessing Traditional and New Revenue Streams on Track to Maturity: Harmonization of the BSS Core” discusses key challenges faced by modern CSPs while shifting beyond traditional communications and exploring vertical markets. The authors state that o
The Estée Lauder Companies Launches 2022 Breast Cancer Campaign to Honor 30 th Anniversary and Positively Impact the Global Breast Cancer Community30.9.2022 12:45:00 CEST | Press release
In the 30 years since Evelyn H. Lauder launched The Estée Lauder Companies’ Breast Cancer Campaign (The Campaign) and co-created the Pink Ribbon in 1992, The Campaign’s mission to help create a breast cancer-free world for all has remained steadfast. The Estée Lauder Companies (ELC) has a long-standing commitment to helping women and girls achieve their highest potential. As ELC’s largest corporate social impact program, The Campaign is a cornerstone of ELC’s social investments in women’s advancement and health, uniting people everywhere to positively impact the global breast cancer community. As breast cancer is the most commonly diagnosed cancer in the world,1 ELC's continued commitment to improving the lives of all those touched by the disease remains unwavering. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220930005040/en/ The Estée Lauder Companies Launches 2022 Breast Cancer Campaign (Graphic: Business Wire) Together
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