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 address tumor recurrence through a personalized immunotherapy platform that can also be extended across multiple tumor types.
The CTA approval follows completion of key preclinical and manufacturing milestones, including in vivo proof-of-concept, GLP toxicology studies, GMP manufacturing of the CARGONAUT platform, and engagement of leading EU clinical sites. With CTA approval in place, YGION’s focus now shifts to clinical execution, with Phase 1 initiation planned in the coming months.
Wolfgang Fischl, CEO of YGION Biomedical, said:
“This major milestone marks YGION’s transition into a clinical-stage company and reflects the work of our dedicated team over the past four years. With the first-in-human clinical trial now underway, we are focused on generating the first clinical data needed to advance YG-01 and our immunotherapy platform.”
About YGION Biomedical
YGION is a private clinical-stage biotechnology company based in Vienna, Austria, developing targeted neoantigen immunotherapies to prevent tumor recurrence. The company’s pipeline includes YG-01, a personalized lead program initially in glioblastoma, as well as additional personalized and off-the-shelf programs under development.
For more information, please contact sophie.zettl@ygion.bio