On September 29, 2025, BioLineRx Ltd. announced the establishment of a joint venture (JV) with Hemispherian AS to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma (GBM) and other cancers. GLIX1 has received FDA Investigational New Drug (IND) clearance in August 2025, with a Phase 1/2a study expected to initiate in Q1 2026.
GLIX1 agonizes TET2 activity, leading to double-stranded DNA breaks and apoptosis specifically in cancer cells, and has demonstrated potent anti-tumor activity in preclinical glioblastoma models. The asset has also been granted Orphan Drug Designation by both the FDA and the European Medicines Agency (EMA), underscoring the urgent unmet need in this indication.
Under the JV terms, Hemispherian contributes global rights to GLIX1, while BioLineRx will manage, perform, and fund all development activities. BioLineRx will initially hold a 40% stake, increasing incrementally to a potential maximum of 70% with continued investment. The glioblastoma market opportunity is estimated to exceed $3.8 billion annually across the US and EU5 by 2030, and BioLineRx affirmed its cash runway into the first half of 2027.
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