YGION Biomedical receives CTA approval for YG-01
Vienna June 30th, 2026 - YGION today announces it has received regulatory approval for its Clinical Trial Application (CTA) for YG-01. YG-01 is YGION’s personalized neoantigen immunotherapy and is initially being developed for newly diagnosed glioblastoma in the adjuvant setting, with the goal of eliminating residual disease following standard-of-care treatment. YGION’s CTA approval enables the company to initiate its first-in-human Phase 1 study in the EU. The planned dose-escalation study will evaluate YG-01 in glioblastoma patients, representing an important step forward in the development of the program. YG-01 combines YGNITE™, YGION’s AI-driven neoantigen discovery engine, with its proprietary CARGONAUT™ delivery platform to deliver neoantigens to antigen-presenting cells and activate a tumor-specific immune response. The company’s approach is designed to ...