Hemispherian AS, an Oslo-based oncology company, announced the initiation of a first-in-human Phase I/IIa GLIX1 clinical trial in glioblastoma (GBM). The study is enrolling patients with recurrent and progressive GBM and other high-grade gliomas. No clinical data have been reported. The announcement confirms trial initiation only.
The Phase I portion will enroll up to 30 patients across three US academic centers — NYU Langone Health, Northwestern University, and Moffitt Cancer Center — with the primary objective of establishing a maximum tolerated dose and recommended dose based on safety, pharmacokinetics/pharmacodynamics, and preliminary efficacy signals. Dosing schedule and specific dose levels were not disclosed. Hemispherian said it anticipates Phase I data in the first half of 2027. The trial is registered as NCT07464925. The study is being conducted through Tetragon Biosciences, a joint venture between Hemispherian and BioLineRx Ltd. (NASDAQ/TASE: BLRX). No randomization, blinding, or independent data monitoring details were disclosed. The trial is covered on AllSci, where additional context on the TET2 activator mechanism in recurrent glioblastoma therapy is available.
GLIX1 is an oral small molecule designed to activate TET2, a DNA dioxygenase enzyme, with the stated intent of inducing selective DNA damage in tumor cells; the company has cited orthotopic in vivo GBM models showing anti-tumor activity, blood-brain barrier penetration, and favorable preclinical toxicology, though no quantitative preclinical data were disclosed in the announcement. In recurrent GBM, temozolomide re-challenge and bevacizumab remain the most commonly used agents, though neither has demonstrated a consistent overall survival benefit in the recurrent setting in randomized trials. Cross-trial comparisons are limited by differences in study design, duration, and patient populations.
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