Invenra Inc. is excited to announce that its cutting-edge bispecific antibody, INV724, designed for neuroblastoma treatment, has received both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations from the U.S. Food and Drug Administration (FDA). These designations offer significant benefits, including accelerated development timelines, reduced costs, and financial incentives, which will further propel the progress of this innovative therapy for rare pediatric conditions. INV724, developed using Invenra’s proprietary B-Body® Bispecific Platform in collaboration with the University of Wisconsin Carbone Cancer Center, targets both GD2 and B7-H3 tumor antigens with exceptional precision, making it highly effective against neuroblastoma. The antibody is engineered to reduce the severe pain often associated with GD2-targeted treatments, and preclinical results have demonstrated its strong therapeutic potential and robust development prospects.
Dr. Paul Sondel, Professor of Pediatrics and Human Oncology at the University of Wisconsin, remarked, “Anti-GD2 antibodies are crucial for neuroblastoma treatment, but their efficacy is often compromised by significant nerve pain. INV724’s ability to bind to neuroblastoma cells while sparing nerves represents a major advancement over current therapies. Our next step is to transition from lab research to clinical trials, aiming to offer an effective treatment with fewer side effects.”
The need for improved neuroblastoma treatments has attracted attention from top researchers and clinicians, including the New Approaches to Neuroblastoma Care (NANT) consortium, a network of 18 universities and children’s research hospitals. Dr. Julie R. Park, Chair of the Department of Oncology at St. Jude Children’s Research Hospital and Scientific Chair of NANT, noted, “Invenra’s work with INV724 represents a promising new agent that could deliver enhanced anti-tumor activity with fewer side effects.”
The RPDD and ODD designations provide several advantages, such as a transferrable priority review voucher, extended market exclusivity, and eligibility for grants and research support. These benefits are essential for accelerating the development and availability of life-saving therapies.
Roland Green, CEO of Invenra, said, “We are dedicated to advancing INV724 as a potentially transformative solution for children with neuroblastoma. The FDA’s RPDD and ODD designations validate our innovative approach and provide crucial support for expediting its development in partnership with potential collaborators. We are committed to bringing this therapy to the patients who need it most.
