Invenra’s antibody gets US FDA designations for neuroblastoma treatment

Invenra has achieved significant regulatory milestones with its bispecific antibody, INV724, which is under development to treat neuroblastoma. The US Food and Drug Administration (FDA) has granted the company both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for this promising therapy.

These designations bring a range of strategic benefits that are expected to accelerate the development of INV724. Apart from potentially reducing costs, these designations also come with financial incentives that can be crucial in bringing critical therapies to market. For example, they include a transferrable priority review voucher, extended market exclusivity, and eligibility for additional grants and research support.

INV724 originates from Invenra’s B-Body Bispecific Platform and is the result of a collaboration with the University of Wisconsin Carbone Cancer Center. The therapy is designed to target GD2 and B7-H3 tumor antigens. Notably, INV724 has been engineered to mitigate severe pain commonly associated with GD2-targeted treatments. Preclinical studies have shown that INV724 possesses strong therapeutic potential and is highly developable, showcasing its promise as a treatment option for neuroblastoma.

The advantages of RPDD and ODD are especially vital for expediting the development and availability of therapies for rare pediatric diseases. Invenra’s B-Body Platform supports the rapid engineering and development of high-performing therapeutic antibodies, making it a valuable tool in the fight against cancer.

Roland Green, Invenra’s CEO, commented on the significance of these designations: “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.”

In addition to its work on INV724, Invenra has an ongoing partnership with Exelixis. In August 2021, the companies extended their discovery and licensing agreement to include 20 additional oncology targets. This partnership aims to develop multi-specific antibodies, antibody-drug conjugates, and other biologic candidates. This collaboration initially began in May 2018, focusing on the discovery and development of mono-specific and multi-specific antibodies for new cancer therapies.

In conclusion, the FDA's RPDD and ODD designations for INV724 mark a pivotal moment for Invenra. These regulatory benefits will likely accelerate the development of this promising bispecific antibody, bringing new hope to children suffering from neuroblastoma. Invenra’s innovative approaches and strategic partnerships further underscore its commitment to developing effective cancer treatments.