-- BriaCell Therapeutics（BCT.TO）周三宣布，其下一代细胞免疫疗法Bria-BRES+已获得美国食品药品监督管理局（FDA）批准，可启动针对转移性乳腺癌的临床评估。 该公司致力于开发新型免疫疗法，并表示FDA批准其研究性新药（IND）申请，标志着Bria-BRES+的1/2a期临床研究正式启动。Bria-BRES+添加了额外的免疫激活成分，旨在提升临床疗效。 Bria-BRES+基于Bria-OTS乳腺癌临床项目，该项目首例接受Bria-BRES+治疗的患者实现了肺转移灶的持续完全消退。声明指出，该患者接受了17个疗程的Bria-OTS治疗，完成了12个月的研究，目前仍在接受生存随访。 “我们很荣幸地宣布，FDA批准了我们下一代个性化免疫疗法Bria-BRES+的首个IND申请，”首席执行官William Williams表示。 “Bria-BRES+ 的独特设计使其在转移性乳腺癌治疗中展现出良好的安全性和显著的疗效。我们期待推进 Bria-BRES+ 的临床试验，为这些几乎没有有效治疗选择的患者带来新的希望。” BriaCell 股票在纽约交易中最新报收于 4.05 美元，下跌 0.02 美元。
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