百济神州(06160.HK)与BioAtla修订针对新型条件性启动生物制剂CTLA-4候选药物BA3071达成的全球开发和商业化协定
格隆汇 10 月 7日丨百济神州(06160.HK)发布公告，百济神州及BioAtla双方于2020年10月6日宣布修订协定，于2019年4月就BioAtla在研CAB CTLA-4抗体BA3071签署的全球联合开发和商业化协定经修订，现为一项BA3071的全球许可协定。BA3071设计目的是在肿瘤微环境中能被条件性启动以降低全身毒性，在与检查点抑制剂(譬如百济神州的百泽安®)联用时成为安全性更佳的联合疗法。
根据协定修订条款，百济神州将拥有BA3071的全球独家授权，并将全权负责其在全球范围内的临床开发和商业化，以及有权获得产品未来销售的全部利润。除原协定规定的预付款外，BioAtla还将有资格获得近期开发和药政里程碑付款以及经修订增加的全球销售分级特许使用费。经修订协定的其他条款尚未披露。
BioAtla公司总裁Scott Smith称：“百济神州是全球临床开发上公认的领头羊，拥有广泛的肿瘤临床项目，其中包括在中国已获批的抗PD-1抗体百泽安®。该项协定修订体现了百济神州开发BA3071的承诺，也反映了BioAtla迅速而广泛地建立创新性CAB肿瘤候选药物产品管线的战略。经修订的协定将说明提升BioAtla的战略执行能力，支援公司研发管线发展、推动有意义的联合疗法，同时关注仍有增长潜力和未被满足医疗需求的市场。BA3071也预计将加入CAB-AXL-ADC和 CAB-ROR2-ADC之列，成为BioAtla第三款进入临床试验的CAB候选药物。”
百济神州高级副总裁，全球研究、临床运营&生物统计暨亚太临床开发负责人汪来博士表示：“BioAtla使用其专利所有的蛋白质研究和表达技术平台来开发条件性启动生物制剂，并运用于开发新型的在研CTLA-4抑制剂BA3071，该抗体在肿瘤微环境中会被条件性启动。BA3071的独特性为这款在研CTLA-4抗体与我们的抗PD-1抗体百泽安®联用提供了科学依据。我们期待进一步推进针对这款潜在具有独特性的癌症疗法作为单药或联合用药的全球开发与商业化。”
BioAtla董事长、首席执行官兼联合创始人Jay M. Short博士评论道：“我们相信与百济神州的该项协定修订符合并将有可能加速BA3071的全球开发和潜在的商业化进程。百济神州就BA3071联合百泽安®开展全球临床试验将有可能为多个肿瘤适应症带来潜在的新型联合治疗方案。CAB技术能为新型联合疗法提供非常宝贵的机会，特许使用费扩大也是对这一点的认可。”
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