Interius BioTherapeutics, a pioneering developer of in vivo cell-specific gene medicines, has secured Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance from the Australian Therapeutic Goods Administration (TGA) to initiate a first-in-human Phase 1 clinical trial for INT2104, its leading in vivo CAR candidate targeting B-cell malignancies.'Receiving HREC approval and CTN clearance for our inaugural clinical trial marks a significant achievement for Interius.

Interius BioTherapeutics是体内细胞特异性基因药物的先驱开发人员，已获得澳大利亚治疗用品管理局（TGA）的人类研究伦理委员会（HREC）批准和临床试验通知（CTN）批准，以启动针对B细胞恶性肿瘤的领先体内CAR候选药物INT2104的首次人体1期临床试验获得HREC批准和CTN批准用于我们的首次临床试验，标志着Interius取得了重大成就。

We are thrilled that regulators have authorized the commencement of our first-in-human clinical trial for INT2104,' stated Phil Johnson, M.D., President and CEO of Interius. 'This approval enables us to begin enrolling patients in our initial clinical study and highlights the potential of our novel in vivo gene therapy candidate, INT2104, to meet the critical needs of patients with B cell malignancies.

Interius总裁兼首席执行官菲尔·约翰逊（PhilJohnson）医学博士表示，我们很高兴监管机构授权开始我们针对INT2104的首次人体临床试验这一批准使我们能够开始在最初的临床研究中招募患者，并突出了我们新型体内基因治疗候选物INT2104的潜力，以满足B细胞恶性肿瘤患者的关键需求。

We anticipate continued collaboration with the TGA and other regulatory bodies to expedite this innovative therapy to patients.'The CTN clearance, based on the HREC approval in Australia, followed a comprehensive review of Interius's preclinical data and study protocol. Interius aims to launch the trial in the fourth quarter of 2024 and expects to achieve significant milestones by the first quarter of 2025.The Phase 1 trial, termed INVISE (Injectable Vectors for In Situ Engineering), will assess the safety of a single infusion of INT2104 in adults with refractory or relapsing B cell malignancies.

我们预计将继续与TGA和其他监管机构合作，以加快对患者的这种创新疗法。”根据澳大利亚HREC的批准，CTN的批准是在对Interius的临床前数据和研究方案进行全面审查之后进行的。Interius计划在2024年第四季度启动该试验，并预计在2025年第一季度实现重大里程碑。第一阶段试验称为INVISE（原位工程注射载体），将评估单次输注INT2104在难治性或复发性B细胞恶性肿瘤成人中的安全性。

This global, two-part, multicenter, open-label study involves a dose escalation phase to determine the appropriate dose for the dose confirmation phase and subsequent studies.INT2104 is an investigational gene therapy candidate designed to target CD7-positive T and NK cells, delive.

这项由两部分组成的全球多中心开放标签研究涉及剂量递增阶段，以确定剂量确认阶段和后续研究的适当剂量。INT2104是一种研究性基因治疗候选药物，旨在靶向CD7阳性T细胞和NK细胞。