4D Pharma and Merck Team to Develop Microbiome-based Vaccines

4D制药公司和默克合作研发基于微生物的治疗疫苗

2019-10-10 10:58:40 BioSpace

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4D Pharma, based in Leeds, UK, is partnering with U.S.-based Merck to develop Live Biotherapeutics vaccines. Outside the U.S., Merck & Co. is known as MSD. 4D Pharma focuses on the microbiome, the trillions of microorganisms that live in the human body. Live Biotherapeutics are a new class of medicines made up of strains of gut long-term bacteria originally isolated from healthy human donors. They are then encapsulated and administered orally, where they are selectively delivered to the gut where they can interact with the patient to exert therapeutic effects. Under the terms of the deal, 4D will use its proprietary MicroRx platform with Merck’s expertise in novel vaccine development and commercialization to discover and develop Live Biotherapeutics (LBPs) as vaccines in up to three currently undisclosed indications. Merck, under specific conditions, will acquire $5 million in 4D shares in the first year of the collaboration. There is an undisclosed upfront cash payment. In addition, 4D is eligible for up to $347.5 million for each indication for various milestones, as well as tiered royalties on annual net sales of any product that comes out of the collaboration. Merck will cover development, manufacturing and commercialization. “This research collaboration agreement brings together 4D’s innovation in the microbiome space and [Merck’s] track record of developing cutting-edge vaccines,” said Duncan Peyton, 4D’s chief executive officer. “[Merck] and 4D have worked closely combining world leading science to develop a workplan to advance the understanding of this field, with the aim of generating a new class of vaccines in areas of high unmet need.” 4D currently has four clinical trials in progress: a Phase II study of Blautix in Irritable Bowel Syndrome; a Phase I/II trial of MRx0518 in combination with Merck’s Keytruda (pembrolizumab) in solid tumors; a Phase I trial of MRx0518 in a neoadjuvant setting for solid tumors; and a Phase I/II study of MRx-4DP0004 in asthma. The company also has programs in other areas, including central nervous system (CNS) disorders. On the vaccine front, Merck announced on September 17 that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for the company’s Ebola vaccine (V920). It has a target action date of March 14, 2020. It has been granted Priority Review status and in July 2016, received the FDA’s Breakthrough Therapy Designation. In addition, Merck launched an updated replenishment strategy to increase the V920 Ebola vaccine supply in consultation with the U.S. Department of Health and Human Services, WHO and Gavi (the Vaccine Alliance). The strategy has a production target of another 650,000 1.0mL investigational doses to be released and become available over the next six to eighteen months, bringing total producing to more than 900,000 1.0mL doses. Of the deal with 4D, Daria Hazuda, chief scientific officer of Merck’s Exploratory Science Center and vice president of Infectious Diseases and Vaccines Discovery Research, said, “A key element of our focus in the Exploratory Science Center is the evaluation of emerging new areas of biology that have the potential to offer major beneficial impact to human health. By applying 4D’s MicroRx technology we hope to gain meaningful insights into the role for the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.”
英国利兹的4D 制药公司正与美国默克(Merck)公司合作开发生物治疗疫苗。在美国以外,默克(Merck)公司被称为默沙东(MSD)。 4D 制药公司的重点是微生物,生活在人体内的几万亿微生物。生物活疗法是一种新的药物,由最初从健康的人类捐赠者分离出来的肠道长期细菌组成。然后,他们被封装和口服,在那里他们被选择性地传递到肠道,他们可以与病人互动,发挥治疗效果。 根据协议条款,4D 将利用其专有的 MicroRx 平台,借助默克(Merck)公司在新型疫苗研发和商业化方面的专业知识,在目前尚未公开的三个适应症中,发现并开发 Live Biotherapeutics ( LBP )作为疫苗。默克(Merck)公司在特定条件下,将在合作的第一年获得500万美元的4D 股份。 有未披露的前期现金支付。此外,对于各种里程碑的每个指示,4D 最多可获得3.475亿美元,以及合作产生的任何产品的年度净销售额的分级特许权使用费。默克(Merck)公司将涵盖开发、制造和商业化。 4D 首席执行官邓肯•佩顿( Duncan Peyton )表示:“这项研究合作协议将4D 在微生物领域的创新与(默克(Merck))开发尖端疫苗的记录结合起来。”“(默克(Merck)公司)和4D 公司密切合作,将世界领先的科学结合起来,制定一项工作计划,以推进对该领域的了解,目的是在未得到满足的高需求领域生产一类新疫苗。” 4D 目前有四个临床试验正在进行中:一项关于勃鲁替尼治疗肠易激综合征的 II 期研究;一项 MRx0518与默克(Merck)公司的可瑞达(Keytruda)( pembrolizumab )联合治疗实体瘤的 I / II 期试验;一项针对实体瘤的新辅助制剂 MRx0518的 I 期试验;一项关于哮喘 MRx-4DP0004的 I / II 期研究。 该公司在其他领域也有项目,包括中枢神经系统( CNS )紊乱。 在疫苗方面,默克(Merck)公司于9月17日宣布,美国食品药品监督管理局(Food and Drug Administration)( FDA )已接受其针对公司埃博拉(Ebola)疫苗( V920)的生物逻辑许可证申请( BLA )。目标行动日期为2020年3月14日。已获得优先审评地位,并于2016年7月获得 FDA 的突破性治疗指定。 此外,默克(Merck)公司还与美国卫生和人类服务部、世卫组织和疫苗联盟 Gavi 协商,推出了一项更新的补充战略,以增加 V920埃博拉(Ebola)疫苗的供应。该战略的生产目标是在今后6至18个月内再释放65万1.0毫升的研究剂量,并使总生产量超过90万1.0毫升。 在与4D 公司的交易中,默克(Merck)开发科学中心首席科学官、传染病和疫苗发现研究副总裁 Daria Hauda 说,“我们在探索科学中心关注的一个关键因素是评估有可能对人类健康产生重大有益影响的新兴生物领域。通过应用4D 的 MicroRx 技术,我们希望获得对宿主微生物在调节免疫反应和最终保护疫苗方面的作用的有意义的见解。”

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