药明生物祝贺昂科免疫(OncoImmune)新一代CTLA-4抗体ONC-392获FDA批准IND
WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392
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中国上海
2020年1月2日
全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）合作伙伴昂科免疫（OncoImmune）近日宣布其新一代CTLA-4抗体ONC-392获得美国食品药品监督管理局（FDA）批准开展新药临床试验（IND），药明生物对此表示祝贺。
药明生物拥有世界一流的生物药研发生产服务能力，通过全方位、一体化生物制药技术平台为ONC-392项目提供了CMC开发、生物药原液和制剂GMP生产等服务。
“此次ONC-392项目获FDA批准开展临床试验对于OncoImmune而言无疑是一个重要里程碑，我们很高兴与药明生物合作推进该项目的发展进程，” OncoImmune创始人、董事长兼首席执行官刘阳博士表示，“药明生物卓越的一体化生物制药平台助力公司成功完成IND申报的所有临床前CMC研究工作，为我们提交IND申请并顺利获FDA批准开展临床试验提供了强有力的支持。我们非常期待这一具有全新作用机理的新一代CTLA-4抗体能够改善治疗效果，同时显著降低毒性。”
“祝贺合作伙伴OncoImmune的ONC-392项目取得重大进展。我们很高兴赋能OncoImmune加速生物药从DNA到IND的开发进程，预祝该项目临床研究进展顺利，早日造福癌症患者。”药明生物首席执行官陈智胜博士表示，“公司将继续赋能全球合作伙伴开发出更多拯救生命的创新治疗方案以应对健康挑战。”
关于OncoImmune
OncoImmune（www.oncoimmune.com）是一家总部位于美国马里兰州罗克韦尔的临床阶段生物制药国际私人控股公司，致力于研究和开发针对癌症，炎症， 代谢综合征和自身免疫性疾病的新型免疫疗法。
ONC-392项目是OncoImmune第二个即将进入临床试验的生物产品，一项即将于2020年初启动的1A/1B期临床试验旨在评估ONC-392作为单药治疗晚期实体瘤以及与抗PD-(L)1标准疗法联用在非小细胞肺癌患者的安全性、药代动力学及疗效。
OncoImmune主导产品CD24Fc是一种可调节宿主对组织损伤的炎症反应的新型疗法，对癌症、自身免疫性疾病、代谢综合征和移植物抗宿主病（GvHD）的发病机理研究具有广泛的意义。CD24Fc已完成IIa期临床试验，针对白血病患者接受造血干细胞移植（HSCT）后的急性移植物抗宿主病（GvHD）预防性治疗，结果显示准备用于Ⅲ期临床试验的主要研究终点——III-IV级移植物抗宿主病180天无病生存率显著改善，CD24Fc预防疗法相比对照组还可降低白血病复发率，总生存率、非复发死亡率和无复发生存率均有提高，并观察到严重粘膜炎（3级以上）剂量依赖性降低。一项包含20名患者、按照临床推荐剂量的开放标签剂量扩展队列研究已完成患者入组，药物持续表现良好。Ⅲ期临床试验预计于2020年初启动。
关于药明生物
WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392
SHANGHAI，CHINA
January 2, 2020
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner OncoImmune on the U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for ONC-392, a novel, next generation anti-CTLA-4 antibody.
As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.
“It has been our great pleasure working with WuXi Biologics on our ONC-392 program. The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune,” said Yang Liu, PhD, Founder and CEO of OncoImmune. “WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity.”
“Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND,” said Dr. Chris Chen, CEO of WuXi Biologics. “We wish the program a great success to benefit more patients suffering from cancers. WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges.”
OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immuno therapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.
ONC-392 is OncoImmune’s second biological product to reach clinical testing and a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non-Small Cell Lung Cancer is expected to begin in early 2020.
OncoImmune’s lead product, CD24Fc, is a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). CD24Fc has completed a Phase IIa trial for the prophylactic treatment of acute Graft versus Host Disease (GvHD) in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT) and resulted in a significant improvement in 180 Day Grade III-IV GVHD Free Survival, the Phase III primary endpoint. CD24 Fcprophylaxis also resulted in a reduced relapse and, compared to match controls, CD24Fc demonstrated improvement in Overall Survival, Non-Relapse Mortality and Relapse-Free Survival. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patient open label dose expansion cohort at the recommended clinical dose is fully enrolled and the drug continues to perform very well. A Phase III study is anticipated to start in early 2020.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of June 30, 2019, there were a total of 224 integrated projects,including 106 projects in pre-clinical development stage, 102 projects in early-phase (phase I and II) clinical development, 15 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, Singapore, and the U.S. exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.
注：本信息不构成药明生物的信息披露或投资建议
