RiboX wins FDA clearance for first circular RNA CAR therapy
RiboX Therapeutics received FDA IND clearance for RXIM002 the first circular RNA based in vivo CAR therapy for autoimmune cytopenias supporting the initiation of its Phase 1 clinical trial
Shanghai and Cambridge, Massachusetts witnessed a significant milestone in the field of biotechnology on August 8, 2026. RiboX Therapeutics Ltd., a global clinical-stage company specializing in engineered circular RNA (circRNA) therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for RXIM002.
RXIM002 is the world's first circular RNA-based in vivo Chimeric Antigen Receptor T (CAR-T) therapy delivered by targeted lipid nanoparticles (tLNP). This breakthrough signifies the advancement of circRNA-based in vivo CAR-T into clinical development, marking the first of its kind to gain FDA approval. RXIM002 is an investigational product that utilizes tLNP encapsulated circRNA encoding a CD19-targeting CAR for the treatment of autoimmune cytopenias.
This innovative approach allows for durable CAR expression and generation of functional CAR-T cells directly within the patient's body, bypassing the complex and costly ex vivo manufacturing processes of conventional CAR-T therapies. The IND submission included data from investigator-initiated trials in China, which have shown promising safety and early efficacy results.
The FDA's approval has paved the way for potentially outpatient administration of RXIM002, potentially transforming the CAR-T treatment paradigm. The approval of RXIM002 is a pivotal milestone for RiboX and the circRNA medicines field, highlighting the company's leadership in precision RNA therapeutics.
Written by urgent.news from Vietnam Investment Review's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
