药明生物授权Aravive使用WuXiBody™平台开发高亲和力双抗药物治疗癌症及纤维化疾病

中国， 上海

美国， 休斯顿

2020年4月30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）与美国生物技术公司Aravive (纳斯达克股票代码: ARAV)，共同宣布签署一项战略合作协议，药明生物将授权Aravive使用创新技术平台WuXiBody™开发高亲和力双特异性抗体用于治疗癌症及纤维化疾病。

借助药明生物领先的生物制药能力和技术赋能平台，Aravive将筛选出多款CCN2抗体。CCN2是一种多结构域蛋白，也称结缔组织生长因子（CTGF），在一次类似证实AXL/GAS6信号通路对于肿瘤显著影响的靶点筛选中被发现。临床前实验数据显示，CCN2在肿瘤生长和进展中有重要作用。

此次合作中，药明生物将提供抗体发现、工艺开发与生产等服务，Aravive将负责临床前及临床开发等工作，相关财务细节未披露。Aravive和药明生物已建立长期紧密合作关系，在2018年，双方基于Aravive候选药物AVB-500工艺开发、中试放大及cGMP生产等方面合作取得的快速进展及新药临床试验申请（IND）的成功获批，进一步扩大在生物药研发管线的全方位合作。

WuXiBody™是药明生物具有自主知识产权的双特异性抗体技术平台。该平台突破了绝大多数双特异性抗体平台技术瓶颈，有效克服了双特异性抗体开发过程中表达量低、多聚体高、纯化收率低等挑战，具有为每个项目节约6到18个月研发时间以及显著降低双特异性抗体生产成本等优势。

WuXiBody™平台几乎可将所有抗体序列用以构建双特异性抗体，并且有望降低免疫原性风险及延长其体内半衰期。WuXiBody™平台还兼具独特的灵活性，可以构建各种不同的价数（如二价、三价或四价双特异性抗体），以满足不同项目的生物学特性需求。

Aravive  (纳斯达克股票代码: ARAV)  是一家临床阶段的美国生物制药公司，旨在研发减缓或阻止危及生命疾病（包括癌症和纤维化疾病）的治疗药物。Aravive主要候选产品AVB-500是一种作用于GAS6-AXL信号通路的超高亲和力蛋白，作为一种诱饵分子结合GAS6阻断AXL信号通路激活，进而终止其促进疾病进展的生物学机制。AXL受体信号在多种恶性肿瘤中发挥着重要的作用，包括促进肿瘤转移、肿瘤细胞存活、治疗耐性及免疫抑制等。GAS6-AXL信号通路在纤维形成中也起到重要作用。Aravive正在评估AVB-500治疗对铂类耐药的卵巢癌、肾透明细胞癌和肾纤维化的疗效，并打算将其应用扩展到其他肿瘤类型和纤维化疾病。Aravive总部位于美国德克萨斯州休斯顿市，于2016年获得德克萨斯州癌症预防与研究所（CPRIT）的产品开发奖。

如需更多信息，请访问：www.aravive.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12月31日，在药明生物平台上研发的综合项目达250个，包括121个处于临床前研究阶段，112个在临床早期（I期，II期），16个在后期临床（III期）以及1个在商业化生产阶段。预计到2022 年之后，公司在中国、爱尔兰、美国、德国和新加坡规划的生物制药生产基地合计产能约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

HOUSTON,  U.S.

April 30, 2020 

WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, and Aravive Inc. (NASDAQ: ARAV), a clinical-stage biopharmaceutical company, today announced a strategic collaboration agreement granting Aravive the right to use the proprietary WuXiBody™ platform to develop high-affinity bispecific antibodies for a target implicated in cancer and fibrosis.

WuXi Biologics and Aravive will collaborate to discover antibodies against CCN2, a multidomain protein also known as connective tissue growth factor (CTGF).  CCN2 was identified from a similar target discovery screen that identified the significance of AXL/GAS6 pathway in cancer.  Preclinical data identified CCN2 as important for tumor growth and progression.   

WuXi Biologics will be responsible for biologics discovery, process development, and manufacturing.  Aravive will be responsible for preclinical and clinical development. The companies did not disclose the financial terms of the collaboration.  

In 2018, and following the successful filing of a U.S. Investigational New Drug application (IND) for AVB-500, WuXi Biologics and Aravive announced expansion of their biologics manufacturing collaboration based on the rapid success achieved in the process development, scale-up and cGMP manufacture of Aravive’s lead drug candidate, AVB-500. 

WuXiBody™ is a leading proprietary bispecific antibody platform developed by WuXi Biologics. It can effectively break through the CMC barriers for many bispecific antibodies development with high expression yield, high stability, good solubility, and easy purification to homogeneity, expedite the process by 6-18 months and significantly reduce manufacturing costs, a limitation still faced by many other current bispecific platforms. WuXiBody™ Platform enables almost any mAb sequence pairs to be assembled into bispecific constructs, which are expected to have low immunogenicity risk and longer in vivo half-life. WuXiBody™ Platform also has a unique structural flexibility, which makes it convenient to build various formats with different combination of valencies (1+1, 1+2, 2+2) to meet the requirements of different target biologies.

Aravive, Inc. (Nasdaq: ARAV) is a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis. Aravive’s lead product candidate, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500 starves the AXL pathway of its signal, potentially halting the biological programming that promotes disease progression. AXL receptor signaling plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. The GAS6-AXL signaling pathway also plays a significant role in fibrogenesis. Aravive is evaluating AVB-500 in platinum-resistant ovarian cancer and clear cell renal cell carcinoma, and intends to expand development into additional oncology and fibrotic indications. Aravive is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. For more information, please visit www.aravive.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 December 31, 2019, there were a total of 250 integrated projects, including 121 projects in pre-clinical development stage, 112 projects in early-phase (phase I and II) clinical development, 16 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany and Singapore 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