BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers

Core Insights - BioLineRx and Hemispherian AS have established a joint venture to develop GLIX1, a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers [1][2][3] - GLIX1 has shown potent anti-tumor activity, excellent blood-brain barrier penetration, and a favorable safety profile in preclinical studies [2][3] - The glioblastoma market opportunity is projected to exceed $3.8 billion annually across the US and EU5 by 2030 [1][7] Joint Venture Details - Hemispherian will contribute the global rights of GLIX1, while BioLineRx will manage and fund all development activities [4] - Hemispherian will hold 60% of the joint venture's share capital, with BioLineRx's stake potentially increasing to 70% based on continued investment [4] Clinical Development Plans - An Investigational New Drug (IND) application for GLIX1 was cleared by the FDA, with a Phase 1/2a study expected to start in Q1 2026 [1][2] - The Phase 1 trial will recruit up to 30 patients with recurrent GBM to establish a maximum tolerated dose and assess safety and preliminary efficacy [9] Market Opportunity - GBM is the most common and aggressive form of primary brain cancer, with a median overall survival of 12-18 months under current standard treatments [5][6] - The annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and 13,400 across the EU5 by 2030, with total addressable markets estimated at $2.5 billion in the U.S. and $1.3 billion in the EU5 [7]