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news.BioLineRx and Hemispherian have formed a joint venture to advance the development of GLIX1, an oral small molecule aimed at targeting DNA damage response in glioblastoma (GBM) and other types of cancer.
GLIX1 has exhibited anti-tumour activity in glioblastoma models. Credit: National Cancer Institute on Unsplash.
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The companies will collaborate on the development of GLIX1 as a potential treatment for both newly diagnosed and recurrent GBM.
This molecule functions by enhancing TET2 activity within cancer cells, resulting in double-stranded DNA breaks formation and ultimately leading to the death of cancer cells.
GLIX1 has exhibited anti-tumour activity across various glioblastoma models, showcasing penetration of the blood-brain barrier and a favourable safety profile in preclinical toxicology studies.
In August this year, the US Food and Drug Administration (FDA) approved an Investigational New Drug application, with a Phase I/IIa study anticipated to commence in the first quarter of 2026.
The compound received orphan drug designation from both the FDA and the European Medicines Agency, highlighting a significant unmet medical need in this area.
Hemispherian CEO Zeno Albisser said: “This joint venture combines our expertise in DNA damage response research and discovery, with BioLineRx’s proven track record of clinical and regulatory success. Glioblastoma is a notoriously challenging tumour type in urgent need of new treatment options.
“GLIX1 is a small molecule that crosses the blood-brain-barrier, has a novel mechanism of action targeting a DNA repair mechanism in cancer cells, and has demonstrated impressive efficacy and a favourable safety profile in pre-clinical models.”
BioLineRx CEO Philip Serlin said: “Following a comprehensive review of pipeline expansion opportunities in oncology and rare diseases, we are thrilled to have identified a highly innovative asset such as GLIX1, with the potential to become an effective and safe treatment option for cancer patients with high unmet needs.”
