Interius BioTherapeutics Receives HREC Approval and CTN Clearance from the TGA to Commence a Phase 1 Clinical Trial for Its First-in-Class In Vivo CAR Therapeutic for B Cell Malignancies

Will initiate a first-in-human Phase 1 clinical trial for INT2104, its first-in-class in vivo targeted gene therapy, creating CAR cells for the treatment of B cell malignancies in 4Q24

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.

“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. “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.”

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.

About the INT2104 Clinical Program

Interius’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.

About INT2104

INT2104 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.

About Interius BioTherapeutics

Interius 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. 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.

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