Interius BioTherapeutics has announced that the Paul Ehrlich Institute (PEI), the German regulatory agency, has approved the expansion of the INVISE Phase 1 clinical trial to Europe. The trial is evaluating INT2104, a novel in vivo CAR gene therapy, for the treatment of B-cell malignancies.
The INVISE trial (NCT06539338) is a first-in-human, global, multi-center, open-label, single-dose, dose-escalation study. It is designed to assess the safety of INT2104, administered via intravenous infusion, in adult patients with relapsed or refractory B-cell malignancies. The first patient in the INVISE study was recently dosed in Australia.
INT2104: A Novel In Vivo CAR-T Approach
INT2104 is a first-in-class gene therapy designed to deliver a CAR transgene to CD7-positive T and NK cells, generating effector CAR-T and CAR-NK cells in vivo. These CAR cells then target CD20-positive B cells, offering a potential treatment for B-cell malignancies. Unlike traditional ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single-dose treatment administered systemically via intravenous infusion, eliminating the need for lymphodepletion, specialized equipment, or extensive training.
Overcoming Limitations of Ex Vivo CAR-T Therapy
Existing ex vivo CAR-T cell therapies require extracting cells from a patient, modifying them in a lab, and re-infusing them weeks later. This personalized approach leads to high treatment costs and logistical challenges. Patients also need to undergo chemotherapy to prepare their bodies for CAR-T cell infusion, which can cause severe side effects.
INT2104 aims to overcome these limitations by creating therapeutic CAR cells directly in the patient's body. This in vivo approach eliminates the need for cell extraction, prolonged wait times, and pre-conditioning chemotherapy. According to Interius BioTherapeutics, this simplified process could lower costs and expand access to CAR-T therapy.
Expert Commentary
"We are thrilled to have received approval from PEI regulators to expand our INVISE clinical study into the EU," said Phil Johnson, M.D., President and CEO of Interius. "The PEI has a rich history in supporting the advancement of novel medicines, including foundational research for in vivo CAR T therapy, and this approval highlights the strength of our preclinical data and the breakthrough potential of INT2104 to broaden access to CAR therapies."
Dr. Marion Subklewe, M.D., Ph.D., Principal Investigator for the INVISE trial and professor at the LMU University Hospital in Munich, added, "Interius' groundbreaking approach has the potential to simplify treatment, provide faster and more accessible care, and significantly improve patient outcomes while transforming the treatment journey by reducing delays and eliminating complicated procedures."
Interius plans to present interim safety and proof-of-concept data from the INVISE trial in the second half of 2025.
