Business Wire

Genexine’s First-in-Class Therapeutic DNA Vaccine Shows Significant Potential to Extend Survival in Late-Stage Cervical Cancer

Share

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.

Contact information

For further information, please contact Genexine Investor Relations:
Mr. Edward Shin
edward.shin@genexine.com

Mr. Jongsoo Lee
jongsoo.lee@genexine.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Acathia Capital Completes Acquisition of Swedish Life Insurer Futur Pension7.10.2022 11:51:00 CEST | Press release

With the receipt of approvals from the Swedish Financial Supervisory Authority, Acathia Capital has completed the increase of its stake in Futur Pension Försäkrings AB, the most successful life insurer in Sweden. Since 2019, Acathia Capital has been the joint lead investor, together with the Nordic private equity manager Polaris, in this investment, within a group of 5 institutional investors. As a result of the transaction, investment vehicles advised by Acathia have increased their joint stake in Futur Pension from 30% to almost 50%. Futur Pension is a powerful demonstration of how digitalization is fundamentally transforming the insurance business. The fintech, founded in 2000, has already fundamentally transformed the Swedish life insurance market in terms of cost and market share structure. Dr. Thomas Schmitt, managing partner of Acathia Capital, comments: “Futur Pension has increased its market share from 7% to over 11% of premium volume since we have become owners in 2019, makin

EIG’s MidOcean Energy to Acquire Tokyo Gas’ Interests in Portfolio of Four Australian Integrated LNG Projects for US$2.15 Billion7.10.2022 10:44:00 CEST | Press release

MidOcean Energy (“MidOcean”), an LNG company formed and managed by EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced that it has entered into a definitive agreement with Tokyo Gas Co., Ltd (“Tokyo Gas”) to acquire Tokyo Gas’ interests in a portfolio of four Australian integrated LNG projects. Under the terms of the agreement, MidOcean will acquire Tokyo Gas’ interests in Gorgon LNG, Ichthys LNG, Pluto LNG and Queensland Curtis LNG for total cash consideration of US$2.15 billion. These integrated projects span Australia’s western and eastern seaboard and are major suppliers of LNG to Asia, with a diverse set of long-dated take or pay contracts with investment grade counterparties, and to Australia’s domestic gas markets. The portfolio is expected to generate approximately 1 million tonnes per annum of LNG net to MidOcean, production that is underpinned by long-life reserves and a globally competitive cost structure. The portfolio bene

LabGenius Secures Government Innovation Grant to Expand ML-driven Drug Discovery Platform, EVA™7.10.2022 09:00:00 CEST | Press release

LabGenius, a pioneer in the use of machine learning (ML) for antibody engineering, today announced that it has been awarded a highly competitive SMART grant from Innovate UK. Grants from the £25 million fund allow businesses like LabGenius to realize the potential of new ideas by investing in game-changing, commercially viable research and development projects. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221007005023/en/ To date, LabGenius’ EVA platform has been used to co-optimize mono- and multi-specific single domain antibodies for biochemical and bio functional properties, including stability, potency and selective tumor cell killing. This grant will be used to further expand EVA's capabilitiesby accelerating the platform’s ability to optimize antibody-based immune cell engager molecules. Many existing antibody therapeutics have poor selective cell killing profiles, which can result in on-target, off-tumor effects, an

Slate Asset Management Provides Fleet Financing to Move About Group AB to Support Rollout of Electric Vehicles and Charging Infrastructure Across Europe7.10.2022 09:00:00 CEST | Press release

Slate Asset Management (“Slate”), a global alternative investment platform targeting real assets, today announced that it has agreed to provide financing to Move About Group AB (“Move About”), a Swedish electric mobility service, to support the roll out of more than 150 electric vehicles and electric vehicle charging infrastructure throughout Europe. The car funding provided by Slate will be used to bolster Move About’s electric car fleet, which currently owns and operates over 800 electric cars and has more than 71,000 users on its platform. Move About is a Sweden-based electric mobility service that delivers environmentally friendly and cost-effective mobility solutions to over 300 locations across Sweden, Norway, and Germany. Move About has partnered with some of the largest companies across Europe to save tons of carbon dioxide emissions every year. Since it was founded in 2007, Move About has become the largest provider of emission-free carsharing in the Nordic region. Christian S

Valbiotis Accelerates Its Marketing Strategy7.10.2022 07:35:00 CEST | Press release

Regulatory News: Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, is accelerating its marketing strategy. Sébastien PELTIER, Chairman of the Valbiotis Board of Directors, states: "Today, we are embarking on a complementary development cycle to commercialize our innovative active substances, with the aim of providing breakthrough solutions for reducing the risk factors of cardio-metabolic diseases. Our new strategy aims to accelerate the growth of Valbiotis and to boost its capacity for innovation using two main levers: firstly, the signing of international partnerships (global or regional) with major players in the nutrition and healthcare sectors, supported by the specialist firm AEC Partners1, and secondly, the company's own marketing of its products on the French market. This dual strategy, creating value, will enable Valbiotis to rapidly tar