药明生物祝贺战略合作伙伴Immutep创新肿瘤免疫疗法IMP-321获积极临床中期数据

中国，上海

2020年2月24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）的战略合作伙伴Immutep近日公布了主要候选产品可溶性LAG-3蛋白eftilagimod alpha（“efti”或“IMP321”）正在进行的II期临床试验TACTI-002中期数据，药明生物对其取得的积极临床研究结果表示祝贺。

Immutep是一家致力于研发针对癌症和自身免疫疾病创新免疫疗法的全球生物技术公司。公司在2010年创立之初仅有4名员工，2013年成为药明生物第一个欧洲客户，并已在药明生物卓越生物制药能力和技术平台赋能下顺利推进IMP321在欧洲和美国的临床试验。2016年11月，双方签署谅解备忘录针对IMP321研发和生产建立战略合作伙伴关系。

此次公布的TACTI-002临床试验数据是基于eftilagimod alpha联合帕博利珠单抗（KEYTRUDA®，pembrolizumab）一线治疗非小细胞肺癌（NSCLC）。该研究结果显示，联合治疗总缓解率（ORR）达到47%，而帕博利珠单抗单药治疗一般仅为20%左右。对比单独使用帕博利珠单抗，LAG-3蛋白能够激活抗原呈递细胞（APC）使T细胞聚集，从而可能产生更强的抗肿瘤效应。

Immutep是一家活跃的全球生物技术公司，在研发LAG-3相关免疫疗法治疗癌症和自身免疫疾病领域处于领先地位。Immutep致力于利用先进科技和专业知识为患者提供创新治疗方案，使股东价值最大化。Immutep已在澳大利亚证券交易所（股票代码：IMM）和美国纳斯达克交易所（股票代码：IMMP）上市。作为Immutep目前主要候选产品，eftilagimod alpha（“efti”或“IMP321”）是一种基于LAG-3免疫调控机制的可溶性LAG-3蛋白（LAG-3Ig），LAG-3免疫调控机制在调节T细胞免疫应答中发挥着重要作用。Efti目前正在进行的临床试验包括：一项IIb期临床试验AIPAC，作为化学免疫疗法用于治疗转移性乳腺癌；一项与默沙东合作的II期临床试验TACTI 002，评估efti与KEYTRUDA®（pembrolizumab，抗PD-1疗法）联合治疗在不同实体瘤中的疗效（clinicaltrials.gov 登记号：NCT03625323）；一项与德国默克/辉瑞合作的I期临床试验INSIGHT-004，评估efti与avelumab联合治疗的疗效（clinicaltrials.gov 登记号：NCT03252938）以及一项治疗转移性黑色素瘤组合疗法I期临床试验TACTI-mel（clinicaltrials.gov 登记号：NCT02676869）。Immutep的大型制药合作伙伴正在开发用于调节自身免疫和癌症免疫应答的其他LAG-3产品，包括抗体。Immutep也在开发针对自身免疫疾病的LAG-3激动剂（IMP761）。如需更多信息，请访问：www.immutep.com。

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2019年6月30日，在药明生物平台上研发的综合项目达224个，包括106个处于临床前研究阶段，102个在临床早期（I期，II期）阶段，15个在后期临床（III期）以及1个在商业化生产阶段。预计到2022年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能将超过28万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。

如需更多信息，请访问：www.wuxibiologics.com.cn。

SHANGHAI, China, 

Feb 24, 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 strategic partner Immutep, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, on the positive interim data from the company’s ongoing Phase II TACTI-002 study.

The data relates to use of Immutep’s lead product candidate eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, as part of a combination treatment with pembrolizumab. The study shows encouraging results that the Overall Response Rate (ORR) of the combination treatment reaches 47% among first line non-small cell lung cancer patients, while that of pembrolizumab monotherapy is only about 20%. The activation of antigen presenting cells (APC) and subsequent T cell recruitment with efti may lead to stronger anti-tumor responses than observed with pembrolizumab alone.

Empowered by WuXi Biologics’ proprietary technology platforms, Immutep, which had only four employees initially, has been expediting clinical trials of the innovative IMP321 in Europe and the United States since 2010. In November 2016, the two companies signed an MOU to form a strategic biologics development and manufacturing partnership for IMP321.

Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein (LAG-3Ig) based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC; a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) referred to as TACTI 002 (Two ACTive Immunotherapies) to evaluate a combination of efti with KEYTRUDA® (or pembrolizumab, an anti-PD-1 therapy) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869). Additional LAG-3 products, including antibodies, for immune response modulation in autoimmunity and cancer are being developed by Immutep’s large pharmaceutical partners. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Further information can be found on the Company’s website www.immutep.com.

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.