Invenra Inc.’s bispecific antibody, INV724, has received Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations from the FDA. These designations provide advantages that accelerate development, reduce costs, and offer financial incentives for advancing therapies for rare pediatric diseases like neuroblastoma.
INV724 targets GD2 and B7-H3 antigens in neuroblastoma. It has demonstrated reduced side effects compared to existing GD2-targeted therapies, mitigating the severe pain often associated with them. Dr. Paul Sondel of the University of Wisconsin Carbone Cancer Center believes INV724 may offer effective treatment with fewer adverse effects, paving the way for clinical trials.
The RPDD and ODD designations provide benefits such as transferrable priority review vouchers, extended market exclusivity, and grants for research and development. These advantages are essential for developing and providing access to life-saving therapies.
Invenra’s CEO, Roland Green, expressed their commitment to advancing INV724 as a potential breakthrough treatment for children with neuroblastoma. The FDA designations support their innovative approach and fast-track the development process with potential partners. Invenra aims to bring INV724 to patients in need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
