Inovio and QIAGEN Establish Collaboration to Develop Diagnostic Test for VGX-3100, Inovio's Novel Immunotherapy Targeting Advanced Cervical Pre-Cancer

制药公司Inovio与样本和分析技术供应商QIAGEN将合作开展VGX-3100诊断测试

2019-05-17 04:02:00 PR Newswire

本文共1313个字,阅读需4分钟

Liquid biopsy-based Precision Medicine test to guide patient selection for Inovio's VGX-3100 Inovio Pharmaceuticals Inc. (INO) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration to co-develop a diagnostic test to identify patients most likely to respond to VGX-3100, Inovio's immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus virus (HPV). This precision medicine partnership focuses on Inovio's VGX-3100, a late-stage product candidate currently in two pivotal Phase 3 clinical trials (REVEAL 1 and 2) with potential to become the first treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions associated with the virus. Financial arrangements were not disclosed. Dr. J. Joseph Kim, Inovio's President & CEO, said, "As we advance our Synthetic Nucleics platform we are always looking for ways to drive innovation within our own technology or via a creative partner like QIAGEN. QIAGEN is bringing their extensive track record of commercially developing and marketing novel diagnostic tests to this important collaboration. Inovio is developing VGX-3100 as a non-surgical treatment for women with cervical pre-cancer and pre-treatment biomarkers we have discovered could provide a targeted way to identify patients most likely to respond to treatment with VGX-3100, increasing absolute efficacy of the product." "We are pleased to support Inovio by developing a liquid biopsy-based companion diagnostic to identify patients who would benefit from VGX-3100, which has potential to make a dramatic difference in the treatment of HPV infections and precancerous disease. Our Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine in immuno-oncology are well-suited to help Inovio address this large unmet medical need," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "Our team has deep experience in HPV-related molecular testing and cervical cancer and is looking forward to applying this expertise in partnership with Inovio, This project is also a case study of a collaboration that started in the discovery phase, when Inovio selected QIAGEN Genomic Services to work on the discovery of novel microRNA biomarkers that now contribute to the power of this unique molecular assay. The project progressed into development and Inovio now aims to make regulatory submissions for VGX-3100 in 2021." HPV is the most common viral infection of the reproductive tract and the major cause of cervical cancer, the fourth most common cancer among women. The World Health Organization (WHO) reported an estimated 570,000 new cases of cervical cancer and 311,000 deaths in 2018. Almost 300 million women globally are estimated to be infected with HPV, and about 30 million additional cases have progressed to the precancerous stage. The high-risk HPV 16 and HPV 18 genotypes are estimated to cause at least 70% of cervical cancers. Inovio's VGX-3100 is a novel immunotherapy under clinical investigation for the treatment of infection with HPV 16 and HPV 18 and advanced cervical dysplasia (Phase 3), and the vulva and anus (Phase 2). VGX-3100 propels the patient's own immune system to clear the HPV 16 and HPV 18 infections and precancerous lesions without the increased risks associated with surgery.
基于液体活检的精准医学检验,指导患者选择 Inovio 的 VGX-3100 Inovio Pharmaceuticals Inc .( INO )和 QIAGEN.V .( NYSE : QGEN ; Frankfurt Prime Standard : QIA )今天宣布合作开发一项诊断测试,以确定最有可能对 VGX-3100作出反应的患者, Inovo 的免疫治疗与人类乳头瘤病毒(人乳头状瘤病毒(HPV))相关的晚期宫颈发育不良。该精准医疗合作伙伴关系专注于 Inovio 公司的 VGX-3100,是目前处于两个关键的3期临床试验( REVEAL 1和2)阶段的后期产品候选者,有可能成为子宫颈人乳头状瘤病毒(HPV)感染的第一个治疗方案,也是首个与病毒相关的宫颈癌前病变的非手术治疗方案。财务安排未披露。 Inovio 总裁兼首席执行官 J . Joseph Kim 博士说:“随着我们推进合成核技术平台,我们一直在寻找方法,在我们自己的技术范围内或通过 QIAGEN 等创造性合作伙伴推动创新。QIAGEN 正在为这一重要的合作带来他们在商业开发和营销新诊断测试方面的广泛记录。Inovio 正在开发 VGX-3100作为一种非手术治疗女性宫颈癌前和治疗前生物标志物,我们发现可以提供一种有针对性的方法,以确定最有可能对 VGX-3100治疗作出反应的患者,提高该产品的绝对疗效。” “我们很高兴通过开发一种基于液体活检的伴随诊断来支持英诺珐公司,以确定哪些患者将受益于 VGX-3100,这有可能在治疗人乳头状瘤病毒(HPV)感染和癌前病变方面产生巨大的差异。QIAGEN 首席执行官 Peer M . Schatz 说:“我们的工作流程样本和开发免疫肿瘤精准医疗诊断解决方案的经验非常适合帮助 Inovo 解决这一未得到满足的巨大医疗需求。”“我们的团队在 HPV 相关的分子检测和宫颈癌方面拥有丰富的经验,并期待着与 Inovo 合作应用这一专业知识,该项目也是在发现阶段开始的合作的一个案例研究。当 Inovio 选择 QIAGEN 基因服务公司致力于发现新的 microRNA 生物标记物,现在有助于这种独特的分子分析的力量。该项目已进入开发阶段, Inovo 现在的目标是在2021年提交 VGX-3100的法规。” 人乳头状瘤病毒(HPV)是生殖道最常见的病毒感染和宫颈癌的主要病因,是女性第四大常见癌症。据世界卫生组织(世卫组织)报告,2018年估计有570000例新的宫颈癌病例和311,000人死亡。据估计,全球约有3亿妇女感染了人乳头状瘤病毒(HPV),另有约3000万病例已进入癌前阶段。据估计,高风险的人乳头状瘤病毒(HPV)16和 HPV 18基因型至少会导致70%的宫颈癌。 Inovio 公司的 VGX-3100是一种新型免疫疗法,临床研究中用于治疗 HPV 16和人乳头状瘤病毒(HPV)18感染和晚期宫颈发育不良(第3期),以及外阴和肛门(第2期)。VGX-3100推动患者自身免疫系统清除人乳头状瘤病毒(HPV)16和 HPV 18感染和癌前病变,而不增加手术相关的风险。

以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。

阅读原文