Invenra Inc. is excited to announce that its innovative bispecific antibody, INV724, designed for the treatment of neuroblastoma, has received both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations from the U.S. Food and Drug Administration (FDA). These designations offer strategic benefits, including accelerated development, cost reductions, and financial incentives, supporting the advancement of pioneering therapies for rare pediatric diseases.
INV724, developed using Invenra’s proprietary B-Body® Bispecific Platform in collaboration with the University of Wisconsin Carbone Cancer Center, is a bispecific antibody targeting both GD2 and B7-H3 tumor antigens. This dual targeting approach demonstrates exceptional specificity for neuroblastoma while aiming to reduce the severe pain commonly associated with GD2-targeted therapies. INV724 has shown promising preclinical results, including strong therapeutic potential and robust developability.
Dr. Paul Sondel, Professor of Pediatrics and Human Oncology at the University of Wisconsin, explained, “Anti-GD2 antibodies are crucial for treating neuroblastoma but are often limited by severe pain due to nerve binding. INV724 binds effectively to neuroblastoma cells while sparing nerves, providing a significant advantage over current therapies. Our next step is to move from laboratory research to clinical trials to deliver 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, which comprises 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 development of INV724 represents a significant advancement, potentially offering enhanced anti-tumor activity with reduced side effects.”
The FDA’s Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) designations provide several benefits, including a transferable priority review voucher, extended market exclusivity, and eligibility for grants and research support. These advantages are critical for advancing the development and accessibility of this potentially life-saving therapy.
Roland Green, CEO of Invenra, stated, “The RPDD and ODD designations validate our innovative approach and provide crucial support to expedite the development of INV724. We are committed to advancing this therapy and collaborating with potential partners to bring it to the children who need it most.”
About Invenra Inc.
Invenra Inc. is a leader in bispecific antibody technology, focused on delivering transformative therapies. Our B-Body® Platform allows for the rapid engineering and development of high-performance therapeutic antibodies. With a strong portfolio of innovative bispecifics, Invenra continues to lead in therapeutic innovation.
