Gate2Brain, a pioneering technology platform focused on enhancing drug delivery to the brain, has achieved a significant milestone in the fight against pediatric brain tumors. The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to Gate2Brain’s innovative product, G2B-002.
Gate2Brain is a biotech company spin-off from IRB Barcelona, the University of Barcelona and Sant Joan de Déu Hospital, founded in 2020 that uses a proprietary peptide-based technology to cross biological barriers, such as the blood-brain barrier, to improve drug delivery to the brain and reduce side effects. Gate2Brain’s most advanced product, G2B-002, is based on a peptide transport system that delivers an anti-cancer agent that targets diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM), two aggressive brain tumors that are among the leading causes of childhood cancer mortality.
The EMA’s Orphan Drug Designation for G2B-002 is a crucial step forward, accelerating the progress of G2B-002 toward clinical trials for pediatric brain tumor treatment. The EMA grants this designation to drugs aimed at conditions affecting fewer than 5 in 10,000 people in the European Union, recognizing their potential to offer significant advantages over existing treatments.
With a research programme centered on pediatric brain tumors as its first indication, Gate2Brain aims to leverage EMA’s recognition to advance G2B-002 to clinical trials and pave the way for a new era of treatment options in a high unmet need area. “We are moving toward clinical trials that could transform the treatment of pediatric brain tumors,” said Meritxell Teixidó, CEO of Gate2Brain, underscoring the company’s strong commitment to pediatric patients and their families.
