美通社（PR Newswire ）/圣地亚哥和上海，2019年10月22日- Ambrx和浙江医药股份有限公司的控股子公司浙江千亿生物医药有限公司（简称“千亿生物”）今天通告，他们已达成第二项合作，开发和商业化Ambrx自主开发的定点修饰的抗体偶联药物（ADCs）。 根据协议，Ambrx和千亿生物将联合继续开发ARX305，即一种由Ambrx开发的用于治疗CD70阳性肿瘤的ADC。
SAN DIEGO and SHANGHAI, October 22, 2019 /PR Newswire/ -- Ambrx and NovoCodex Biopharmaceuticals Ltd., (NovoCodex), a majority owned company of Zhejiang Medicine Co Ltd., today announced that they have formed a second collaboration to develop and commercialize Ambrx's internally developed site-specific antibody drug conjugates (ADCs). Under the agreement, Ambrx and NovoCodex will join forces to continue the development of ARX305, an Ambrx enabled ADC for the treatment of CD70 positive cancers.
Under the terms of the agreement, NovoCodex is responsible for developing and commercializing ARX305 in China while Ambrx is responsible for developing and commercializing ARX305 outside of China. NovoCodex will fund global development activities to the end of Phase 1 clinical trials and pay Ambrx an undisclosed upfront payment, development milestones, and a double-digit royalty on product sales in China. NovoCodex is also eligible to share in undisclosed portion of ARX305 product sales outside of China.
"We are excited to initiate our second collaboration with NovoCodex following our successful collaboration with ARX788, which is currently in Phase 1 clinical trials for HER2 positive breast and gastric cancers. ARX305 is a natural extension to the first collaboration with the inclusion of another Ambrx enabled ADC that is intended to treat CD70 positive cancers such as Renal Cell Carcinoma and Multiple Myeloma. Further, we continue to align ourselves with China's leading pharmaceutical companies" said Feng Tian, Ph.D., Chief Executive Officer of Ambrx. "ARX305, which is expected to start Phase 1 clinical trials in early 2021, allows Ambrx to expand its ADC pipeline into multiple cancer types while gaining access to the China market through our partnership with NovoCodex."
Chunbo Li, Chairman of Zhejiang Medicine, commented, "The smooth progress of our first ZMC-Ambrx collaborated ADC project, ARX788, proves that Ambrx’ technology is one of the best methods to make an ADC drug. The new alliance with Ambrx on ARX305 will strengthen our leading position on ADC research, and hopefully will bring new treatment to related cancer patients.”
CD70在多种实体瘤和液体瘤中高度表达，如肾细胞癌、多发性骨髓瘤、非霍奇金淋巴瘤、AML等。ARX305采用Ambrx自主知识产权的抗体和经临床验证的毒素，是一个经过精密设计的较佳抗CD70 ADC， 在多种肿瘤细胞和模型中已证明强大的体外和体内功效，有望直接杀死过表达CD70的肿瘤，并改善肿瘤微环境中的免疫抑制作用。
CD70 is highly expressed in multiple solid and liquid tumors such as Renal Cell Carcinoma, Multiple Myeloma, Non-Hodgkin’s Lymphoma, AML, and etc. ARX305 is a best-in-class anti-CD70 ADC that was precision-engineered using Ambrx proprietary antibody and clinically validated drug payload. Strong in vitro and in vivo efficacy have been demonstrated in multiple tumor cells and models. It is expected to deliver a direct killing to CD70-overexpressing tumor and improvement of the immune suppression in the tumor microenvironment.
NovoCodex is a majority owned company of Zhejiang Medicine Co., Ltd. (stock code: SH.600216), mainly committed to the research and development of biological products. The company's laboratory has experience and capabilities in genetic engineering, cell culture, toxin synthesis, conjugation, formulation & filling, preclinical study and clinical study. ARX788 project has been successfully advanced to the later stage of Phase 1 clinical trial in China. For additional information, visit /