PHILADELPHIA, July 9, 2024 /PRNewswire/ -- Interius BioTherapeutics, a leading developer of in vivo cell-specific gene medicines, today announced that it has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a first-in-human Phase 1 clinical trial of INT2104, its lead in vivo CAR candidate for treatment of B-cell malignancies..

费城，2024年7月9日/PRNewswire/--体内细胞特异性基因药物的领先开发商Interius BioTherapeutics今天宣布，它已获得人类研究伦理委员会（HREC）的批准和澳大利亚治疗用品管理局（TGA）的临床试验通知（CTN）的批准，以开始其用于治疗B细胞恶性肿瘤的体内CAR候选药物INT2104的首次人体1期临床试验。。

'Receiving HREC approval and CTN clearance for our first clinical trial is a significant milestone for Interius. We are very pleased that the regulators have approved the start of our first-in-human clinical trial for INT2104. The approval allows us to enroll patients in our first clinical study and recognizes the potential of our novel in vivo targeted gene therapy candidate, INT2104, to address an unmet medical need for patients with B cell malignancies,' said Interius President and Chief Executive Officer Phil Johnson, M.D.

“获得HREC批准和CTN批准用于我们的首次临床试验是Interius的一个重要里程碑。我们非常高兴监管机构已经批准开始我们针对INT2104的首次人体临床试验。Interius总裁兼首席执行官Phil Johnson医学博士说，该批准使我们能够在我们的第一项临床研究中招募患者，并认识到我们新的体内靶向基因治疗候选者INT2104的潜力，以解决B细胞恶性肿瘤患者未得到满足的医疗需求。

'We look forward to continuing to work closely with the TGA and other regulators in the future to bring this innovative therapy to patients as quickly as possible.'.

“我们期待着在未来继续与TGA和其他监管机构密切合作，尽快将这种创新疗法带给患者。”。

The CTN clearance was granted based on HREC approval in Australia which included extensive review of Interius's preclinical data and study protocol. Interius intends to begin the trial in the fourth quarter of 2024 and is well positioned to deliver key program milestones as early as the first quarter of 2025..

CTN许可是根据澳大利亚HREC的批准授予的，其中包括对Interius的临床前数据和研究方案的广泛审查。Interius计划在2024年第四季度开始试验，并且最早在2025年第一季度交付关键项目里程碑。。

About the INT2104 Clinical ProgramInterius's Phase 1 trial (INVISE, Injectable Vectors for In Situ Engineering) will evaluate the safety of a single INT2104 infusion in adults with refractory/relapsing B cell malignancies. The Phase 1 study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion designed to inform the dose of INT2104 to be used in the dose confirmation part of the trial and future studies..

关于INT2104临床计划Interius的1期临床试验（INVISE，用于原位工程的可注射载体）将评估单次INT2104输注在患有难治性/复发性B细胞恶性肿瘤的成年人中的安全性。第一阶段研究是一项全球性、两部分、多中心、开放标签、单剂量设计，其剂量递增部分旨在告知INT2104的剂量，以用于试验和未来研究的剂量确认部分。。

About INT2104INT2104 is a wholly-owned investigational gene therapy candidate, which specifically targets CD7-positive T and NK cells and delivers a CAR transgene to create effector CAR-T and CAR-NK cells in vivo. The CAR cells target CD20-positive B cells for the treatment of B cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single dose treatment, administered systemically through intravenous infusion without the need for lymphodepletion or for any special equipment or training..

关于INT2104INT2104是一家全资拥有的研究性基因治疗候选药物，它专门针对CD7阳性T细胞和NK细胞，并传递CAR转基因以在体内产生效应CAR-T和CAR-NK细胞。CAR细胞靶向CD20阳性B细胞用于治疗B细胞恶性肿瘤。与离体CAR-T疗法不同，INT2104是一种现成的单剂量治疗，通过静脉输注全身给药，无需淋巴清除或任何特殊设备或训练。。

About Interius BioTherapeuticsInterius BioTherapeutics, a leading biotechnology company, is developing novel off-the-shelf gene therapies enabling the generation of autologous chimeric antigen receptor (CAR) cells in vivo using targeted lentiviral vector technology. The company's lead program is an intravenous in vivo CAR therapy to treat B cell lymphomas, in which proprietary engineering delivers exquisite specificity for target tissues.

关于Interius BioTherapeutics Interius BioTherapeutics，一家领先的生物技术公司，正在开发新的现成基因疗法，能够使用靶向慢病毒载体技术在体内产生自体嵌合抗原受体（CAR）细胞。该公司的主要项目是治疗B细胞淋巴瘤的静脉内体内CAR疗法，其中专有工程为靶组织提供了极好的特异性。

The company is developing a second program to treat autoimmune diseases. Interius has created a differentiated new therapeutic modality for precision delivery of gene medicines, which could be available to patients without delays, without preconditioning chemotherapy, and in expanded care settings. For more information, visit www.interiusbio.com..

该公司正在开发第二个治疗自身免疫性疾病的项目。Interius为精确递送基因药物创造了一种差异化的新治疗方式，可以毫不延迟地向患者提供，无需预处理化疗，也可以在扩大的护理环境中使用。有关更多信息，请访问www.interiusbio.com。。