Interius BioTherapeutics, a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, today announced that the first study participant has been dosed in INVISE, its first-in-human Phase 1 clinical trial of INT2104, a first-in-class gene therapy that delivers a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo for the targeting of CD20-positive B cells for the treatment of B-cell malignancies.
“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. Interius’s breakthrough technology allows precise targeting of gene therapies to specific cells via intravenous administration,” said Interius President and CEO, Phil Johnson, M.D. “This milestone marks the first time that a durable in vivo CAR therapy has been used in the clinic. INT2104 has the potential to overcome ex vivo CAR therapy challenges with a single-dose, off-the-shelf, widely accessible therapy for the treatment of B cell malignancies enabled by Interius’s programmable platform. In our preclinical studies, we achieved successful B cell depletion in small and large animal models without chemotherapy and observed no signs of cytokine release syndrome (CRS) or neurotoxicity. We look forward to sharing interim clinical safety and proof-of-concept data at a scientific meeting next year.”