BioLineRx Ltd. (NASDAQ: BLRX) and Hemispherian AS announced preclinical study results showing GLIX1 demonstrated anti-tumor activity in glioblastoma models, including a temozolomide-resistant patient-derived xenograft model.

The orally administered drug showed tumor growth inhibition and survival benefits across multiple dose levels in three orthotopic cell-derived xenograft studies. In a subcutaneous patient-derived xenograft model resistant to temozolomide, GLIX1 showed anti-tumor effects while temozolomide showed no effect.

The companies are currently conducting a Phase 1/2a clinical trial evaluating GLIX1 for recurrent and progressive glioblastoma and other high-grade gliomas. Part 1 of the trial expects to recruit up to 30 patients and aims to establish a maximum tolerated dose. Updates on the trial are anticipated in the second half of 2026, with full dose escalation results expected in 2027.

GLIX1 is described as a first-in-class, orally administered, brain-penetrating small molecule that activates the TET2 pathway. The drug is designed to overwhelm cancer cells' DNA repair capacity, resulting in cell death.

The Phase 2a expansion portion will include additional indications such as newly diagnosed glioblastoma and select cancers, testing GLIX1 as monotherapy or in combination with standard treatments including PARP inhibitors.

BioLineRx and Hemispherian plan to present the study data at future medical conferences. The information was disclosed in a press release statement.