This segment focuses on the development and commercialization of antibody-based therapies targeting the GD2 disialoganglioside, a tumor-associated antigen highly expressed in neuroblastoma and other cancers. Key activities include clinical trials for DANYELZA (naxitamab) in various neuroblastoma settings, including first-line, third-line, and relapsed osteosarcoma. Research efforts are directed towards improving antibody affinity, reducing immunogenicity, and enhancing delivery to tumor sites. Technologies employed include monoclonal antibody engineering, cell line development, and advanced purification techniques. The goal is to improve survival rates and quality of life for pediatric cancer patients with high-risk neuroblastoma. Future opportunities include expanding the use of GD2-targeted therapies to other GD2-expressing tumors and developing novel combination therapies. Regulatory and clinical aspects involve ongoing interactions with the FDA and EMA to secure approvals for new indications and formulations. Partnerships and collaborations are essential for expanding market access and accelerating clinical development.

This segment is dedicated to developing immunotherapies targeting B7-H3, an immune checkpoint protein overexpressed in various solid tumors. Research and development efforts focus on Nivatrotamab, a monoclonal antibody in Phase I/II trials for refractory GD2 positive adult and pediatric solid tumors, and Lu-omburtamab-DTPA, a radiolabeled antibody in Phase I clinical development for medulloblastoma and B7-H3 positive leptomeningeal metastases. The segment utilizes antibody engineering, radiochemistry, and preclinical modeling to optimize therapeutic efficacy and safety. The aim is to provide targeted treatment options for patients with cancers that express B7-H3, addressing unmet medical needs in these populations. Future opportunities include exploring combination therapies with other immunomodulatory agents and expanding the B7-H3 targeting platform to other cancer types. Regulatory and clinical aspects involve navigating the complexities of clinical trial design and regulatory submissions for novel immunotherapies. Strategic partnerships and collaborations are crucial for advancing the B7-H3 pipeline and expanding the therapeutic reach.