Invenra’s Novel Antibody INV724 Receives Rare Pediatric Disease and Orphan Drug Designations from the US FDA for Neuroblastoma Treatment

Invenra Inc. is pleased to announce that its innovative bispecific antibody, INV724, developed for the treatment of neuroblastoma, has been awarded both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations by the U.S. Food and Drug Administration (FDA). These designations provide strategic advantages, including accelerated development, cost reductions, and financial incentives, further driving the advancement of groundbreaking therapies for rare pediatric diseases.

INV724, a product of Invenra’s proprietary B-Body^® Bispecific Platform, was developed in collaboration with the University of Wisconsin Carbone Cancer Center. The antibody simultaneously targets GD2 and B7-H3 tumor antigens, demonstrating exceptional specificity for neuroblastoma. Designed to mitigate the severe pain associated with GD2-targeted therapies, INV724 has shown promising preclinical results, including strong therapeutic potential and robust developability.

“Anti-GD2 antibodies are a key component in treating neuroblastoma, but their use is often limited by severe pain due to nerve binding. Our studies indicate that INV724 binds effectively to neuroblastoma cells while sparing nerves, offering a significant advantage over existing therapies. Our next goal is to transition from laboratory research to clinical trials, aiming to provide effective treatment with fewer side effects,” stated Dr. Paul Sondel, Professor of Pediatrics and Human Oncology at the University of Wisconsin.

The pressing need for improved neuroblastoma therapies has garnered interest from leading researchers and clinicians, including the New Approaches to Neuroblastoma Care (NANT) consortium, a coalition 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, added, “Invenra’s work with INV724 opens the door to developing a new agent that may offer enhanced anti-tumor activity with reduced side effects.”

The RPDD and ODD designations afford numerous benefits, such as a transferrable priority review voucher, extended market exclusivity, and eligibility for grants and research support. These advantages are crucial in facilitating the development and accessibility of life-saving therapies.

“Invenra is deeply committed to advancing INV724 as a potentially transformative treatment for children with neuroblastoma. The FDA's RPDD and ODD designations not only validate our innovative approach but also give us the critical support to fast-track its development in collaboration with potential partners. We are eager to bring this therapy to patients who need it most,” said Roland Green, Invenra’s CEO.

About Invenra Inc.

Invenra Inc. is at the forefront of bispecific antibody technology, driven by a mission to deliver transformative therapies. Our B-Body^® Platform enables rapid engineering and development of therapeutic antibodies with unparalleled performance. With a strong portfolio of innovative bispecifics, Invenra continues to lead in therapeutic innovation.

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