BioLineRx Ltd. and Norwegian biotech Hemispherian AS have established a joint venture to develop GLIX1, a first-in-class oral small molecule designed to target DNA damage response in glioblastoma (GBM) and other cancers. GLIX1 works by activating TET2 in cancer cells, inducing double-stranded DNA breaks and triggering apoptosis specifically in tumor cells.
GLIX1, Hemispherian’s lead candidate, is aimed at treating both newly diagnosed and recurrent GBM. It has shown strong anti-tumor activity in multiple glioblastoma models, effective blood-brain barrier penetration, and a favorable safety profile in preclinical toxicology studies. The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for GLIX1 in August 2025, with a Phase 1/2a clinical trial expected to begin in the first quarter of 2026. The drug has also received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA), reflecting the urgent need for new treatments in this area.
Beyond glioblastoma, GLIX1 has demonstrated anti-tumor effects in other cancer models, with early data indicating potential synergy with PARP inhibitors, particularly in homologous recombination proficient cancers. Plans are underway to explore development in additional solid tumors.
Zeno Albisser, CEO of Hemispherian, highlighted the JV as a powerful combination of expertise in DNA damage response and clinical development, noting the challenges of treating glioblastoma and the promise of GLIX1’s novel mechanism. Philip Serlin, CEO of BioLineRx, expressed enthusiasm for the collaboration, emphasizing the complementary strengths of the two companies and the potential for GLIX1 to bring innovation to cancers with significant unmet needs. The joint venture will initially focus on GLIX1 but will also have priority access to other molecules in Hemispherian’s pipeline.