药明生物WuXiBody技术平台赋能英国OBT公司研发第二个双特异性抗体

中国, 上海

英国，牛津

2021年1月19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）和在肿瘤免疫与抗体偶联药物（ADC）领域拥有多个产品的英国临床阶段生物技术公司Oxford BioTherapeutics（以下简称OBT）宣布，借助药明生物具有自主知识产权的双特异性抗体技术平台WuXiBody®，OBT公司已筛选出靶向PD-L1/OX003的双特异性抗体，这也是OBT公司基于WuXiBody®开发的第二个双抗，并将负责进一步的研究和开发工作。

OX003R是OBT公司发现的一种独特的免疫调节受体，在十种不同实体肿瘤的肿瘤浸润淋巴细胞（TILs）和活化的T细胞中高表达。OBT公司已开发了针对OX003R抗原细胞外结构域的首个人源抗体，该抗体对活化的CD8+ T细胞具有较强的拮抗作用，能够促进其增殖和分泌细胞因子，提升细胞溶解能力，抑制调节性T细胞（Treg）的功能。OX003的抗肿瘤活性通过增强肿瘤细胞（包括HCT116、MDA-MB-231和BT474）的细胞毒性得到验证。OBT公司计划开展I期临床试验研究OX003单药疗法的安全性、药代动力学和初步疗效，用于治疗一系列实体肿瘤，尤其是小细胞肺癌、非小细胞肺癌、皮肤癌、乳腺癌等表达TILs的肿瘤类型。

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。

Oxford BioTherapeutics是一家临床阶段肿瘤领域公司，总部位于英国牛津和美国圣何塞。公司通过其领先的OGAP®靶点发现平台建立了丰富的first-in-class免疫肿瘤（IO）研发管线和基于抗体偶联药物（ADC）的疗法，以解决癌症领域未满足的患者需求。如需更多信息，请访问：www.oxfordbiotherapeutics.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2020年10月15日，在药明生物平台上研发的综合项目达312个，包括161个处于临床前研究阶段，127个在临床早期（I期，II期）阶段，23个在后期临床（III期）以及1个在商业化生产阶段。预计到2023年后，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将超过30万升，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。

SHANGHAI and OXFORD, UK

January 19, 2021 

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and Oxford BioTherapeutics Ltd. ("OBT"), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate based therapies, today announced that OBT has selected a second bispecific program that will combine an anti-PD-L1 antibody with OBT's immuno-oncology (IO) candidate, OX003. OBT will research and develop OX003/PD-L1, which employs WuXi Biologics' proprietary bispecific antibody platform WuXiBody®.

OX003R is a unique immuno-modulatory receptor discovered by OBT to be highly expressed in tumor infiltrating lymphocytes (TILs) of ten different solid tumor types and in activated T cells. OBT has developed anti-OX003 as a humanized first-in-class antibody directed against the human extracellular domain of OX003R antigen. It shows a strong agonistic effect on activated CD8+ T cells promoting their proliferation, cytokine secretion, and cytolytic ability, and suppresses Treg function. The antitumor activity of OX003 is demonstrated by enhancement of cytotoxicity of tumor cells (including HCT116, MDA-MB-231, and BT474). OBT plans to investigate the safety, pharmacokinetics and efficacy of OX003 antibody therapy as a single agent in a Phase I clinical study in patients across a range of solid tumors, especially in human cancers that show the presence of TILs, including small cell lung cancer, non-small cell lung cancer, skin cancer, breast cancer.

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.

Oxford BioTherapeutics is a clinical stage oncology company; based in Oxford, UK; Morristown, New Jersey and San Jose, California, USA; with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC)-based therapies identified using OBT's proprietary OGAP® target discovery platform. OBT's approach aims to fulfil major unmet patient needs by targeting difficult-to-treat cancers. For more information on Oxford BioTherapeutics, please visit www.oxfordbiotherapeutics.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. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of October 15, 2020, there were a total of 312 integrated projects, including 161 projects in pre-clinical development stage, 127 projects in early-phase (phase I and II) clinical development, 23 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 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.