C09基因編輯

At NVI Therapeutics, we’re revolutionizing the future of gene editing. Our proprietary non-viral Direct-Integrate platform represents a transformative leap beyond the limitations of viral-based gene insertion. Inspired by the natural precision of retroviral integrase systems, our technology enables stable, efficient integration of genes directly into the host genome—without the need for viral particles. By eliminating the safety risks, manufacturing hurdles, and regulatory complexity tied to viral vectors, NVI’s platform delivers a safer, simpler, and more economical solution for next-generation cell and gene therapies.

NVI Therapeutics is focused on revolutionizing cancer treatment through next-generation cell therapies. Our main therapeutic focus is on hematologic malignancies, particularly acute leukemia, where we are developing allogeneic, non-activated CAR-T cell therapies as a first-line treatment. Our lead product is an off-the-shelf, microdose CAR-T therapy designed to maximize the efficacy and improve safety but reduce the manufacturing cost. This candidate is currently in the discovery phase, with preclinical and IND-enabling studies planned over the next 12-18 months. Supporting this therapeutic pipeline is our proprietary Direct Integrate platform—a non-viral gene insertion system that enables stable and efficient genome modification, even in quiescent or non-dividing cells. This platform overcomes the key limitations of viral vectors, CRISPR, and transposon-based systems by offering a safer, faster, and more scalable solution for therapeutic development. It utilizes a novel integrase-DNA payload complex that can be delivered through standard ex vivo transfection methods, significantly reducing manufacturing time and costs. The platform also serves as a foundation for future partnerships, licensing opportunities, and CDMO services in gene modification and cell engineering. Together, our platform and therapeutic pipeline position NVI Therapeutics to address major clinical and commercial challenges in oncology with transformative technology and first-in-class product innovation.