YGION Biomedical: CTA approval for personalized glioblastoma immunotherapy YG-01
YGION Biomedical has received Clinical Trial Application (CTA) approval for YG-01, its personalized neoantigen immunotherapy for glioblastoma. The approval enables the company to begin its first-in-human Phase 1 clinical trial in Europe.
YGION Biomedical has announced that it has received regulatory approval for its Clinical Trial Application (CTA) for YG-01. The personalized neoantigen immunotherapy is initially being developed for patients with newly diagnosed glioblastoma in the adjuvant setting, with the aim of eliminating residual disease following standard-of-care treatment.
The CTA approval allows the company to initiate its first-in-human Phase 1 study in the European Union. The planned dose-escalation trial will evaluate the safety and feasibility of YG-01 in patients with glioblastoma and represents an important milestone in the clinical development of the programme.
YG-01 combines YGNITE™, the company's AI-driven neoantigen discovery engine, with its proprietary CARGONAUT™ delivery platform. The technology is designed to deliver personalized neoantigens directly to antigen-presenting cells, thereby activating a tumour-specific immune response. According to YGION, the platform is intended to reduce tumour recurrence and can potentially be adapted for multiple cancer types.
The CTA approval follows completion of key preclinical and manufacturing milestones, including in vivo proof-of-concept studies, GLP toxicology testing, GMP manufacturing of the CARGONAUT platform and the engagement of leading European clinical trial sites. With regulatory approval now in place, the company plans to initiate the Phase 1 study in the coming months.
“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,” said Wolfgang Fischl, CEO of YGION Biomedical. “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.”