Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
Interius BioTherapeutics announced Tuesday that it has secured a regulatory go-ahead to conduct a first-in-human Phase I trial for its potentially first-in-class in vivo CAR-T therapy for B cell malignancies.
The Philadelphia-based biotech will conduct its trial in Australia after the Human Research Ethics Committee for the country’s Therapeutic Goods Administration granted the company its Clinical Trial Notification clearance. Interius expects to initiate the Phase I study in the fourth quarter of 2024, with the expected delivery of key milestones “as early as the first quarter of 2025,” according to Tuesday’s announcement.
STAT News reported that Interius is looking to enroll up to 30 patients from various sites globally. The early-stage trial is primarily designed to evaluate the safety of a single infusion of the investigational in vivo cell therapy, dubbed INT2104. The study will not be blinded and will include a dose-escalation part to determine the optimal dose of INT2104 for future trials.
The decision to start trials outside the U.S. was informed by the FDA’s overly cautious approach to the in vivo therapy, Interius CEO Phil Johnson told STAT. The regulator wanted a study that could be stopped when a grade 3 safety event occurred. An FDA spokesperson in a statement to STAT said that it would be “unusual” for grade 3 events to cause an automatic pause in a study.
Regardless of where the study is conducted, Johnson in a statement said that the regulatory clearance for a Phase I trial for INT2014 is a “significant milestone” for Interius and “recognizes the potential of our novel in vivo targeted gene therapy candidate.”
Currently available CAR-T treatments—such as Johnson & Johnson and Legend’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel)—are ex vivo therapies. Doctors collect patients’ T cells and engineer them outside of the body, typically in specialized laboratories, to produce the CAR proteins on their surface.
The modified cells are reintroduced into the patients, where the CAR proteins seek out and target antigens on cancer cells causing their destruction.
Interius’ approach hopes to replicate this process—but entirely inside the patient’s body. INT2104 targets CD7-positive T and natural killer cells to deliver a CAR transgene, allowing these effector cells to bind to the CD20 antigen which is commonly found on malignant B cells. INT2104 distinguishes itself from current CAR-T therapies by providing an off-the-shelf, single-dose intravenous treatment and by eliminating the need for lymphodepletion, according to the biotech.
