Interius BioTherapeutics Secures HREC Approval and TGA Clearance for Phase 1 Trial of First-of-its-Kind In Vivo CAR Therapy for B Cell Cancers
Wednesday, July 10, 2024
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. 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. 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. 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, delivering a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo. These CAR cells are engineered to attack CD20-positive B cells, providing a treatment for B cell malignancies. Unlike traditional ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single-dose treatment administered intravenously without the need for lymphodepletion or specialized equipment or training.
Source: prnewswire.com
