Interius BioTherapeutics Launches Innovative Gene Therapy Trial for B-Cell Malignancies

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PHILADELPHIA, PA — Interius BioTherapeutics has taken a significant step forward with the dosing of its first participant in the Phase 1 clinical trial of INT2104, a pioneering gene therapy designed to treat B-cell malignancies. This trial, known as INVISE, marks a groundbreaking moment in cancer treatment as it explores the potential of delivering CAR-T and CAR-NK cells directly within the body to target CD20-positive B cells.

Phil Johnson, M.D., President and CEO of Interius BioTherapeutics, emphasized the urgency driving the company’s efforts to offer new therapeutic options. “Interius was founded with a sense of urgency to provide patients with a new therapeutic option that does not require preconditioning or long manufacturing and wait times,” he stated. The INT2104 therapy stands out as it circumvents the typical complexities of ex vivo CAR therapies, offering a single-dose, off-the-shelf solution that could be more accessible to patients.

The innovative approach of INT2104 lies in its intravenous administration, which allows precise targeting of gene therapies to specific cells without the need for chemotherapy preconditioning. This method was shown to successfully deplete B cells in preclinical trials without causing cytokine release syndrome (CRS) or neurotoxicity.

Dr. Michael Dickinson, the Principal Investigator for INVISE and Lead of the Aggressive Lymphoma Disease Group at the Peter MacCallum Cancer Centre, highlighted the potential impact of this therapy. “The need for new, accessible treatment options for patients with cancer is critical. Innovative approaches, like in vivo CAR gene therapies, have the potential to transform how we treat cancer, offering faster, single-dose solutions that are less burdensome on patients and treatment centres,” he explained.

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The INVISE trial is a two-part, multicenter, open-label study aimed at evaluating the safety of INT2104 in adults with refractory or relapsing B-cell malignancies. Following a dose escalation phase, the results will guide future studies and establish the most effective dosage. The trial has received approval from the Human Research Ethics Committee and clearance from the Australian Therapeutic Goods Administration.

As Interius BioTherapeutics moves forward with this trial, the medical community eagerly anticipates the potential findings and their implications for advancing cancer treatment. The company plans to share interim clinical safety and proof-of-concept data at a scientific meeting next year, paving the way for new cancer therapies that prioritize accessibility and efficacy.

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