TGA grants green light for next-gen CAR-T therapy clinical trial

Biotech News: Biotech companies are pioneering advancements in CAR T therapy to make them more accessible and affordable, shifting from customised to off-the-shelf solutions. For patients in Australia, a next-generation CAR-T therapy for B Cell malignancies is set to enter early phase clinical trials.

Interius Biotherapeutics has unveiled plans for the trial, marking the debut of an in vivo CAR-T therapy. Unlike existing ex vivo treatments, Interius’ INT2104 offers a single-dose, off-the-shelf therapy delivered intravenously. This approach eliminates the need for complex preparatory steps like lymphodepletion chemotherapy, special equipment or training.

The current landscape of CAR-T therapies, including Novartis’ Kymriah, Gilead Sciences’ Tecartus and Yescarta, and Johnson & Johnson Innovative Medicine’s Carvykti involves extracting T cells from patients, genetically modifying them to express chimeric antigen receptors (CARs), and then reintroducing them to the patient to target cancer cells.

Interius President and CEO, Dr Phil Johnson, stated “The approval allows us to enrol patients in our first clinical study and recognises 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 phase 1 trial is slated to commence in late 2024, with pivotal milestones expected in early 2025.

In vivo CAR T therapy represents a paradigm shift, offering a potentially faster and more cost-effective path compared to traditional methods. Leveraging viral vectors to deliver therapeutic genes directly to T cells in vivo underscores its potential.

However, challenges such as viral tropism – the tendency of viruses to target specific cell types – may impact treatment efficacy. Moreover, similar to conventional CAR T therapies, in vivo methods may face limitations in treating solid tumours and carry a risk of secondary cancers in rare instances.

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