Interius Approved for Phase I Trial of In Vivo CAR-T Therapy in Australia

Interius BioTherapeutics has announced a significant milestone in its development of a pioneering in vivo CAR-T therapy for B cell malignancies. The Philadelphia-based biotech company received approval to conduct its first-in-human Phase I trial in Australia. This regulatory clearance came from the Human Research Ethics Committee under the Therapeutic Goods Administration. The company anticipates beginning the trial in the fourth quarter of 2024, with key milestones expected as early as the first quarter of 2025.

The initial trial aims to enroll up to 30 patients from various global sites and is primarily designed to assess the safety of a single infusion of the investigational therapy, named INT2104. The trial will not use blinding and will feature a dose-escalation component to identify the optimal dose for future studies.

Interius CEO Phil Johnson explained that the decision to conduct the trial outside the U.S. was influenced by the FDA's cautious stance on in vivo therapies. The FDA had requested a study design that could be halted if a grade 3 safety event occurred, a condition Johnson and his team found overly restrictive. An FDA spokesperson indicated that it would be unusual for grade 3 events to automatically pause a study. Despite these hurdles, Johnson emphasized that the regulatory clearance marks a significant achievement, highlighting the potential of Interius' novel in vivo gene therapy candidate.

Current CAR-T treatments, like Johnson & Johnson and Legend’s Carvykti and Bristol Myers Squibb’s Breyanzi, involve ex vivo processes. This means that patients' T cells are collected and modified outside the body in specialized labs to produce CAR proteins on their surfaces. These modified cells are then reintroduced into the patients to target and destroy cancer cells through the CAR proteins.

In contrast, Interius aims to perform this entire process within the patient's body. INT2104 targets CD7-positive T and natural killer cells, delivering a CAR transgene to enable these cells to bind to the CD20 antigen commonly present on malignant B cells. This approach distinguishes INT2104 from existing CAR-T therapies by offering an off-the-shelf, single-dose intravenous treatment that eliminates the need for lymphodepletion.

This innovative approach could revolutionize CAR-T therapy by simplifying the treatment process and potentially improving patient outcomes. The Phase I trial’s results will be eagerly awaited by the medical and scientific communities, as they could pave the way for more efficient and accessible CAR-T treatments.

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