The Phase I trial will assess INT2104’s ability to treat B-cell malignancies. Credit: Nemes Laszlo / Shutterstock.

US-based biotechnology company Interius BioTherapeutics has received approval to begin a Phase I trial of INT2104, a drug candidate designed to treat B-cell malignancies.

The Australian Therapeutic Goods Administration approved the trial through its Human Research Ethics Committee (HREC) and granted Clinical Trial Notification (CTN) clearance to Interius.

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For granting the HREC approval, a broad review of Interius’ preclinical findings and trial protocol was carried out.

Interius plans to begin the first-in-human trial in the fourth quarter of this year.

Named Injectable Vectors for In Situ Engineering (INVISE), the trial will assess the safety of a single infusion of INT2104 in adult patients with refractory/relapsing B cell malignancies.

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The multicentre, open-label study will have a dose escalation segment to help identify the ideal dose of INT2104.

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This dose will be evaluated in the INVISE trial’s dose confirmation part and studies, which will be carried out in the future.

Interius president and CEO Phil Johnson said: “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 enrol 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.”

INT2104 is an investigational in vivo chimeric antigen receptor (CAR) gene therapy candidate.

The drug targets the CD7-positive T and NK cells and provides a CAR transgene to create effector CAR-T and CAR-NK cells in vivo, while the CAR cells act on CD20-positive B cells to treat B cell malignancies.

Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf therapy for single-dose intravenous administration infusion that does not require lymphodepletion or any special equipment or training.