Interius BioTherapeutics Granted Approval to Start Phase 1 Trial for CAR Therapy in B Cell Malignancies

Interius BioTherapeutics, a prominent developer of in vivo cell-specific gene medicines, has received approval from the Human Research Ethics Committee (HREC) and Clinical Trial Notification (CTN) clearance from the Australian Therapeutic Goods Administration (TGA) to commence a first-in-human Phase 1 clinical trial of INT2104. This investigational gene therapy, designed to treat B-cell malignancies, represents a significant milestone for the company.

Dr. Phil Johnson, President and CEO of Interius, expressed his satisfaction with the regulatory approvals, highlighting their importance in addressing the unmet medical needs of patients with B-cell malignancies. He emphasized the company's commitment to working closely with regulators to expedite the delivery of this innovative therapy to patients.

The approval from HREC and CTN follows a thorough evaluation of Interius's preclinical data and study protocol. The company plans to initiate the clinical trial in the fourth quarter of 2024, with key program milestones anticipated as early as the first quarter of 2025.

The Phase 1 clinical trial, named INVISE (Injectable Vectors for In Situ Engineering), aims to 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 will employ a single dose design with a dose escalation phase. The results from the dose escalation phase will inform the dose confirmation part of the trial and future studies.

INT2104 is a unique investigational gene therapy that targets CD7-positive T and NK cells, delivering a CAR transgene to create effector CAR-T and CAR-NK cells in vivo. These CAR cells then target CD20-positive B cells to treat B-cell malignancies. Unlike traditional ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single-dose treatment administered intravenously, eliminating the need for lymphodepletion or specialized equipment and training.

Interius BioTherapeutics is a leading biotechnology company focused on developing novel off-the-shelf gene therapies. Their technology enables the in vivo generation of autologous chimeric antigen receptor (CAR) cells using targeted lentiviral vectors. The company’s flagship program involves an intravenous in vivo CAR therapy for B cell lymphomas, which utilizes proprietary engineering for precise targeting of tissues. Additionally, Interius is working on a second program aimed at treating autoimmune diseases.

Interius’s approach represents a differentiated therapeutic modality, allowing for precision delivery of gene medicines. This could provide patients with timely access to treatments without the need for preconditioning chemotherapy and in a variety of care settings.

Interius BioTherapeutics continues to innovate in the field of gene therapy, offering potential new treatment options for patients with significant unmet medical needs. The initiation of the INT2104 clinical trial marks a pivotal step in bringing these therapies to the clinic and ultimately to the patients who need them.