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Interius BioTherapeutics Receives Approval to Commence Phase 1 Trial of In Vivo CAR Therapeutic for B Cell Malignancies

• Interius BioTherapeutics has received approval to begin a Phase 1 clinical trial for INT2104, a novel in vivo CAR therapy targeting B cell malignancies. • The INVISE trial will assess the safety of a single INT2104 infusion in adults with relapsed or refractory B cell malignancies, with initial results expected in early 2025. • INT2104 is a systemically administered gene therapy that creates CAR-T and CAR-NK cells in vivo, targeting CD20-positive B cells without requiring lymphodepletion. • This first-in-human trial marks a significant step for Interius, potentially offering a new off-the-shelf treatment option for patients with B cell lymphomas.

Interius BioTherapeutics 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 Phase 1 clinical trial of INT2104, its lead in vivo CAR candidate for the treatment of B-cell malignancies. The trial, named INVISE (Injectable Vectors for In Situ Engineering), is set to begin in the fourth quarter of 2024.

INT2104: A Novel In Vivo CAR-T Approach

INT2104 is an investigational gene therapy designed to target CD7-positive T and NK cells, delivering a CAR transgene to create effector CAR-T and CAR-NK cells directly within the patient's body. These CAR cells are engineered to target CD20-positive B cells, offering a potential treatment for B cell malignancies. Unlike traditional ex vivo CAR-T therapies, INT2104 is administered systemically via intravenous infusion, eliminating the need for lymphodepletion or specialized equipment and training.

Trial Design and Objectives

The Phase 1 INVISE trial is a global, two-part, multicenter, open-label, single-dose study. It will evaluate the safety of a single INT2104 infusion in adult patients with refractory or relapsing B cell malignancies. The trial includes a dose escalation phase to determine the optimal dose for the dose confirmation part of the trial and future studies. Interius anticipates delivering key program milestones as early as the first quarter of 2025.

Addressing Unmet Needs in B Cell Malignancies

"Receiving HREC approval and CTN clearance for our first clinical trial is a significant milestone for Interius," said Phil Johnson, M.D., President and Chief Executive Officer of Interius. "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."
The company believes that INT2104 represents a differentiated therapeutic modality for precision delivery of gene medicines, potentially offering a readily available treatment option without the delays and preconditioning chemotherapy associated with ex vivo CAR-T cell therapies.
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Reference News

[1]
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
prnewswire.com · Jul 9, 2024

Interius BioTherapeutics received HREC approval and CTN clearance to start a Phase 1 trial for INT2104, a novel in vivo ...

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