BioLineRx and Hemispherian have formed a joint venture to develop GLIX1, a groundbreaking therapy targeting DNA damage response in glioblastoma and other cancers, with clinical trials expected to begin in Q1 2026.

Information on the Target

GLIX1 is a groundbreaking oral small molecule developed for targeting DNA damage response in glioblastoma (GBM) and other cancers. This innovative drug candidate, which belongs to Hemispherian AS, aims to restore TET2 activity in cancer cells, leading to the induction of double-stranded DNA breaks and subsequent apoptosis, specifically within malignant cells. Initially designed for treating both newly diagnosed and recurrent GBM, GLIX1 exhibits impressive anti-tumor activity in a variety of glioblastoma models, showcases excellent blood-brain barrier penetration, and presents a favorable safety profile as indicated by preclinical toxicology studies.

Following the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) in August 2025, a Phase 1/2a clinical study is anticipated to commence in the first quarter of 2026. Furthermore, the drug has been awarded Orphan Drug Designation by both the FDA and the European Medicines Agency (EMA), highlighting the critical unmet medical need in treating this aggressive form of brain cancer. Notably, GLIX1 has also displayed anti-tumor activity in other cancer types, indicating its potential for broader applications beyond GBM.

Industry Overview in the Target’s Specific Country

The glioblastoma market is characterized by a pressing need for novel therapies, as GBM remains the most prevalent and aggressive form of primary brain cancer. The standard of care has remained largely unchanged since its establishment in 2005, primarily consisting of surgical resecti