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BioLineRx Ltd. announced the initiation of a first-in-human Phase 1/2a study of GLIX1, a first-in-class oral TET2 activator targeting DNA damage response, for recurrent and progressive glioblastoma and other high-grade gliomas (NCT07464925). The trial, conducted at NYU Langone Health, Northwestern University, and Moffitt Cancer Center, aims to establish dosing and provide initial data in H1 2027, addressing high unmet need in this aggressive cancer.
Key Takeaways
1Initiation of Phase 1/2a trial of GLIX1 (NCT07464925) for recurrent/progressive GBM and high-grade glioma
2Phase 1 to recruit up to 30 patients to determine MTD/recommended dose, with data expected H1 2027
3Phase 2a expansion to include newly diagnosed GBM and other cancers with/without standard care
4Led by Dr. Roger Stupp (Northwestern), Dr. Alexandra Miller (NYU Langone), Dr. Patrick Grogan (Moffitt)
5GLIX1 showed potent anti-tumor activity, blood-brain barrier penetration, favorable safety in preclinical GBM models
6Developed under collaboration with Hemispherian AS