BioLineRx Doses First GLIX1 Patient in 30-Patient GBM Phase 1/2a Trial

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BioLineRx dosed the first patient at NYU Langone Health in the Phase 1/2a GLIX1 trial for recurrent and progressive glioblastoma, with Phase 1 data expected in H1 2027. The oral small molecule, designed to restore TET2 activity and induce selective tumor DNA damage, will escalate doses in up to 30 patients across multiple US centers to establish a recommended dose.

1. First Patient Dosed in GLIX1 Phase 1/2a Study

BioLineRx and Hemispherian dosed the first patient at NYU Langone Health under Dr. Alexandra Miller, marking the trial's clinical start in recurrent and progressive glioblastoma and other high-grade gliomas.

2. Novel Mechanism Validated Preclinically

GLIX1 is an oral small molecule that activates TET2 to induce selective DNA damage in cancer cells, demonstrating potent anti-tumor activity, blood-brain barrier penetration and favorable safety in multiple preclinical GBM models.

3. Dose Escalation Design and Timeline

The Phase 1 dose-escalation phase will recruit up to 30 patients across major US centers to establish a maximum tolerated and recommended dose, with initial safety, PK/PD and preliminary efficacy data expected in H1 2027.

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