First participant receives GLIX1 in early glioblastoma clinical trial
Companies expect Phase 1 data from the study in 2027
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The first participant has been dosed in a clinical trial testing the experimental therapy GLIX1 in people with recurrent or progressive glioblastoma, an aggressive form of glioma.
The Phase 1/2a study (NCT07464925) is currently recruiting participants at a site in New York, with other sites in Florida and Illinois expected to open for recruitment. The Phase 1 portion will test escalating doses of GLIX1 as monotherapy, or on its own, in up to 30 people with recurrent or progressive glioblastoma and other high-grade gliomas.
Its main goal is to establish a maximum tolerated dose and/or recommended dose based on safety, pharmacokinetic and pharmacodynamic measures, and early signs of efficacy. The Phase 2a part is planned to expand testing into additional groups, including newly diagnosed glioblastoma and selected other cancers.
First-in-human study tests GLIX1 dosing and safety
The trial is sponsored by Tetragon Biosciences, a joint venture established by Biolinerx and Hemispherian to develop GLIX1. Results from the Phase 1 part are expected in the first half of 2027, according to a press release from the two companies.
“The dosing of the first patient in our Phase 1/2a study of GLIX1 is an important milestone for BioLineRx and, more importantly, for patients battling glioblastoma, a very challenging tumor where there has been very little innovation over the past 20 years,” said Philip Serlin, CEO of Biolinerx.
Zeno Albisser, CEO of Hemispherian, added that the start of dosing in the trial “is the culmination of years of focused scientific and operational work, and an important step toward bringing a new therapeutic approach to patients with glioblastoma.”
Glioblastoma is the most common malignant brain tumor in adults and an aggressive form of glioma, a tumor that arises from glial cells that help support and protect nerve cells. In glioblastoma tumors, cancer cells grow and divide rapidly, and as part of this process, they must replicate their DNA. Too much DNA damage can cause cancer cells to die.
GLIX1 is designed to activate TET2, a protein involved in DNA regulation. The experimental oral therapy aims to selectively increase DNA damage in glioblastoma cells, triggering cancer cell death. The therapy has shown promising antitumor activity, excellent blood-brain-barrier penetration, and a favorable safety profile in preclinical models, according to Biolinerx and Hemispherian.
“We believe GLIX1 has the potential to offer a novel therapeutic approach in this cancer indication, as well as in multiple other cancer indications, where DNA damage repair is critical for cancer survival,” Serlin said. “We are excited to advance GLIX1 development into this first-in-human clinical trial and look forward to initial data in the first half of 2027.”
