百濟神州(06160.HK)與BioAtla修訂針對新型條件性啟動生物製劑CTLA-4候選藥物BA3071達成的全球開發和商業化協定
格隆匯 10 月 7日丨百濟神州(06160.HK)發佈公告，百濟神州及BioAtla雙方於2020年10月6日宣佈修訂協定，於2019年4月就BioAtla在研CAB CTLA-4抗體BA3071簽署的全球聯合開發和商業化協定經修訂，現為一項BA3071的全球許可協定。BA3071設計目的是在腫瘤微環境中能被條件性啟動以降低全身毒性，在與檢查點抑制劑(譬如百濟神州的百澤安®)聯用時成為安全性更佳的聯合療法。
根據協定修訂條款，百濟神州將擁有BA3071的全球獨家授權，並將全權負責其在全球範圍內的臨牀開發和商業化，以及有權獲得產品未來銷售的全部利潤。除原協定規定的預付款外，BioAtla還將有資格獲得近期開發和藥政里程碑付款以及經修訂增加的全球銷售分級特許使用費。經修訂協定的其他條款尚未披露。
BioAtla公司總裁Scott Smith稱：“百濟神州是全球臨牀開發上公認的領頭羊，擁有廣泛的腫瘤臨牀項目，其中包括在中國已獲批的抗PD-1抗體百澤安®。該項協定修訂體現了百濟神州開發BA3071的承諾，也反映了BioAtla迅速而廣泛地建立創新性CAB腫瘤候選藥物產品管線的戰略。經修訂的協定將説明提升BioAtla的戰略執行能力，支援公司研發管線發展、推動有意義的聯合療法，同時關注仍有增長潛力和未被滿足醫療需求的市場。BA3071也預計將加入CAB-AXL-ADC和 CAB-ROR2-ADC之列，成為BioAtla第三款進入臨牀試驗的CAB候選藥物。”
百濟神州高級副總裁，全球研究、臨牀運營&生物統計暨亞太臨牀開發負責人汪來博士表示：“BioAtla使用其專利所有的蛋白質研究和表達技術平台來開發條件性啟動生物製劑，並運用於開發新型的在研CTLA-4抑制劑BA3071，該抗體在腫瘤微環境中會被條件性啟動。BA3071的獨特性為這款在研CTLA-4抗體與我們的抗PD-1抗體百澤安®聯用提供了科學依據。我們期待進一步推進針對這款潛在具有獨特性的癌症療法作為單藥或聯合用藥的全球開發與商業化。”
BioAtla董事長、首席執行官兼聯合創始人Jay M. Short博士評論道：“我們相信與百濟神州的該項協定修訂符合並將有可能加速BA3071的全球開發和潛在的商業化進程。百濟神州就BA3071聯合百澤安®開展全球臨牀試驗將有可能為多個腫瘤適應症帶來潛在的新型聯合治療方案。CAB技術能為新型聯合療法提供非常寶貴的機會，特許使用費擴大也是對這一點的認可。”
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