Hemispherian has initiated a first-in-human Phase I/IIa trial of its oral small molecule, GLIX1, in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas.
The study is being carried out in partnership with BioLineRx across three academic centres in the US.
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These centres are New York University (NYU) Langone Health, led by Dr Alexandra Miller; Northwestern University, led by Dr Roger Stupp and Dr Ditte Primdahl; and Moffitt Cancer Center, spearheaded by Dr Patrick Grogan.
During the Phase I segment, up to 30 patients with recurrent and progressive GBM and other high-grade gliomas will be enrolled.
The trial’s primary objective is to determine the maximum tolerated dose (MTD) or recommend a dose based on safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy data. Hemispherian expects data for this segment in the first half of 2027.
The planned Phase IIa expansion will recruit various patient cohorts, including those with newly diagnosed and recurrent GBM and those with other tumour types.
It will also evaluate combination regimens, such as use with poly adenosine diphosphate-ribose polymerase (PARP) inhibitors. These cohorts aim to identify early efficacy signals, guide dose optimisation, and inform subsequent clinical development.
GLIX1 is a first-in-class small molecule developed to activate ten-eleven translocation methylcytosine dioxygenase 2 (TET2) and selectively induce deoxyribonucleic acid (DNA) damage in tumour cells.
Hemispherian CEO Zeno Albisser said: “The initiation of this Phase I/IIa study marks a defining milestone for Hemispherian and represents the culmination of years of dedicated research and development work by our team and our collaboration partner, BioLineRx.
“GLIX1 has a compelling preclinical profile and a truly differentiated mechanism of action, and we look forward to bringing this innovative therapy to patients who urgently need new treatment options.”
