BioLineRx (NASDAQ:BLRX), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announced the initiation of a first-in-human Phase 1/2a clinical trial evaluating GLIX1 for the treatment of recurrent and progressive glioblastoma (GBM) and other high-grade gliomas.
The study represents a critical milestone in the company’s transition toward its next generation of DNA damage response therapies.
GLIX1 is a first-in-class, oral small molecule designed to restore the activity of TET2, an enzyme frequently downregulated in aggressive brain cancers.
In preclinical models, the compound demonstrated potent anti-tumor activity, a favorable toxicology profile, and the essential ability to penetrate the blood-brain barrier.
The Phase 1 portion of the study will enroll up to 30 patients across three premier academic institutions—NYU Langone Health, Northwestern University, and Moffitt Cancer Center—to establish the maximum tolerated dose and recommended Phase 2 dose.
Initial data from this cohort is anticipated in the first half of 2027.