北海康成获肿瘤单抗新药AV203的全球授权

3月21日，北海康成获得AVEO Oncology治疗恶性肿瘤的靶向单抗药物AV203（CAN017）的全球（北美除外）生产、研发及上市的独占权利。此次转让为北海康成带来第二个临床阶段的靶向生物药，也有望为AVEO带来高达1.33亿美元的现金收入。

2016年3月21日，北海康成（北京）医药科技有限公司（以下简称“北海康成”）与美国AVEO Oncology（以下简称“AVEO”）共同宣布，双方已签署治疗恶性肿瘤的靶向单抗药物AV203（CAN017）的全球（北美除外）生产、研发及上市的独家技术转让协议。AV203（CAN017）是AVEO研发产品线里处于临床阶段的一个抗ERBB-3(Her-3)单抗药物。这是北海康成的第一个拥有全球开发上市权利的单抗药物，公司首先探索和验证的适应症是食管癌，数据统计全球80%的食管癌患者在亚洲，其中53%的患者在中国。

根据协议条款，如果产品开发和上市取得成功，AVEO可获得包括100万美元首付款、里程碑付款及报销的高达1.33 亿美元的现金收入。同时，AVEO也有望获得可能高达两位数百分比的销售分成。

北海康成将全权负责AV203（CAN017）在全球范围内的生产，以及在权力区域内的研发和上市。北海康成将承担一系列临床前和临床的研发费用，其中包括验证AV203（CAN017）治疗食管鳞癌疗效的IIa期试验。之后，北海康成和AVEO有可能达成共同开发AV203（CAN017）的协议，双方在各自的权利地域内分别投入相应比例的研发费用。若双方未就下一步共同开发计划达成协议，北海康成有权继续在北美以外开发AV203（CAN017）。

“此次收获AV203的开发上市许可，为北海康成拓展亚洲以外市场开创了先例，” 北海康成创建人及首席执行官薛群博士说，“临床前研究数据显示，AV203（CAN017）是针对食管鳞癌的一个优质潜在治疗药物，食管鳞癌是亚洲食管癌的最常见的病理类型，也是包括发展中国家在内的许多其他国家食管癌的主要病理类型。作为北海康成全球开发战略的起点，我们计划首先在亚洲启动AV203（CAN017）的研发，再逐步推进至 51 28939 51 14940 0 0 1389 0 0:00:20 0:00:10 0:00:10 3516它没有有效治疗食管鳞癌药物的市场。”

“越来越多的临床数据表明，在一系列HER3高表达的肿瘤中，由神经调节蛋白-1驱动的ErbB3信号通路激活，使肿瘤对标准治疗产生了耐药性，”AVEO首席执行官和总裁Michael Bailey说道，“与北海康成这个有使命感的伙伴签署这份协议并发挥他们的优势，能进一步推进AV203的研发进程。北海康成核心团队荟萃了原健赞、Synageva和其它领先的创新公司的具有行业资深经验的企业高管。更为重要的是，我们保留了AV203在北美开发、上市的权利，使我们在主导产品Tivozanib即将在北美上市的同时，拥有了获得第三个临床研发阶段优质候选药物的机会，使AVEO肿瘤治疗产品线更加雄厚。”（北海康成官网）

AVEO and CANbridge Life Sciences Announce Exclusive Licensing Agreement for AV-203 Outside of North America

CAMBRIDGE, Mass. & BEIJING--()--AVEO Oncology (NASDAQ:AVEO) and CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, today announced an exclusive collaboration and license agreement in which AVEO has granted CANbridge Life Sciences worldwide rights, excluding the United States, Canada, and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.

CANbridge plans to develop AV-203 first in esophageal squamous cell cancer (ESCC), the most prevalent form of esophageal cancer. According to the World Health Organization, esophageal cancer is the eighth most common cancer globally, with over 450,000 cases diagnosed each year. To date, AVEO has completed a Phase 1, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors. In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

Under the terms of the agreement, CANbridge Life Sciences is obligated to pay AVEO an upfront payment of $1 million plus up to $133 million in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. AVEO is also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.

CANbridge Life Sciences will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as pre-clinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for squamous cell esophagus cancer, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria. Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which they may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights. If the parties fail to reach such an agreement, CANbridge may continue the development of AV-203 on its own in markets outside of the United States, Canada and Mexico.

“With an exclusive license to AV-203 outside of North America, CANbridge will be expanding outside of Asia for the first time,” said James Xue, CANbridge Chairman and CEO. “Pre-clinical work shows that AV-203 has the potential to treat ESCC, the most common type of esophageal cancer in Asia, with fifty percent of worldwide diagnoses occurring in China. Esophageal cancer is also prevalent in other parts of the world, particularly developing countries. As part of our globalization strategy, we plan to develop AV-203 in Asia first, then bring it to other territories where patients with this form of disease have few treatment options.”

“There is a growing body of clinical data which suggests that heregulin-driven ErbB3 signaling drives resistance to standard therapy in a variety of tumors overexpressing HER3,” said Michael Bailey, president and chief executive officer of AVEO. “This agreement allows us to further advance AV-203 development by leveraging the resources of a motivated partner in CANbridge, which is led by a deeply experienced team hailing from Genzyme, Synageva and other life sciences innovators. Importantly, it also allows us to retain North American rights for future development for a third clinical stage drug candidate, providing AVEO with a robust portfolio of oncology therapeutics.”