FDA has granted Invenra Inc. Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations for INV724, a novel bispecific antibody, for treating neuroblastoma.
Developed in collaboration with the University of Wisconsin Carbone Cancer Center, INV724 utilizes Invenra’s proprietary B-Body® Bispecific Platform and simultaneously targets GD2 and B7-H3 tumor antigens.
Preclinical studies of INV724 have shown promising results, demonstrating its potential as a therapy for neuroblastoma.
Dr. Paul Sondel, Professor of Pediatrics and Human Oncology at the University of Wisconsin, acknowledged the FDA’s decision to grant RPDD and ODD to Invenra Inc. for INV724.
He emphasized the potential of INV724 to address the limitations of current anti-GD2 antibodies, which are a key component in treating neuroblastoma but often cause severe pain due to nerve binding.
He stated that studies indicate INV724 effectively targets neuroblastoma cells while sparing nerves, offering a significant advantage over existing therapies.
The RPDD and ODD designations are offered by the FDA to encourage the development of treatments for severe or life-threatening rare diseases and provide certain benefits to the sponsors.
The FDA’s RPDD and ODD designations were awarded to drugs and biologics targeting severe or life-threatening rare diseases, incentivizing sponsors to develop therapies for unmet medical needs.
Source: Invenra’s Novel Antibody INV724 Receives Rare Pediatric Disease and Orphan Drug Designations from the US FDA for Neuroblastoma Treatment
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