PHILADELPHIA, PA — Interius BioTherapeutics has secured approval from Germany’s Paul Ehrlich Institute (PEI) to expand its pioneering INVISE Phase 1 clinical trial into Europe. This marks the first-ever clearance for an in vivo CAR gene therapy trial in the region, a significant leap forward in the fight against B-cell malignancies.
The trial focuses on INT2104, a revolutionary gene therapy designed to deliver a CAR transgene directly into the body, enabling the generation of CAR-T and CAR-NK cells to target CD20-positive B cells. By eliminating the need for complex manufacturing processes, INT2104 could radically simplify and accelerate access to life-saving treatments.
Interius President and CEO, Dr. Phil Johnson, hailed the approval as a testament to the strength of their preclinical data and the therapy’s vast potential. “This milestone underscores our commitment to transforming cancer treatment and making CAR therapies more accessible for patients worldwide,” Johnson said.
The expansion into Europe builds on progress at Australian clinical sites, where the first participant was dosed in October. INVISE Principal Investigator, Dr. Marion Subklewe of LMU University Hospital in Munich, emphasized the game-changing potential of this approach, calling it a bold step toward delivering faster, more effective, and accessible treatments for cancer patients.
With the approval, Interius BioTherapeutics is poised to redefine cancer care, offering hope for streamlined, impactful therapies in the battle against B-cell malignancies.
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