BLRX · BioLineRx Ltd.

BioLineRx Ltd. announced a significant clinical milestone with the dosing of the first patient in the Phase 1/2a study of GLIX1, a first-in-class, oral small molecule targeting DNA damage response. The program targets recurrent and progressive glioblastoma (GBM), an aggressive cancer with high unmet medical need and limited treatment innovation over the past two decades. GLIX1 operates via a novel mechanism involving TET2 activation to induce selective DNA damage in cancer cells, demonstrating potent anti-tumor activity and blood-brain-barrier penetration in pre-clinical models. The clinical trial (NCT07464925) is being conducted under a collaboration with Hemispherian AS established in September 2025. The Phase 1 dose escalation portion will enroll up to 30 patients at sites including NYU Langone Health, Northwestern University, and Moffitt Cancer Center, aiming to establish a maximum tolerated dose. Management highlighted the potential for GLIX1 to address multiple cancer indications where DNA damage repair is critical. Initial data from the Phase 1 portion is anticipated in the first half of 2027.