BioLineRx, a clinical development stage biopharmaceutical company, and Hemispherian, a clinical-stage oncology company developing novel small molecule therapeutics, have announced highly encouraging new preclinical data that further support the recently initiated phase 1/2a clinical trial evaluating GLIX1 for the treatment of recurrent and progressive GBM and other high-grade gliomas.
GBM remains one of the most aggressive and treatment-resistant cancers, urgently in need of breakthrough innovations and more effective treatment.
In a comprehensive pre-clinical programme, orally administered GLIX1 demonstrated robust anti-tumour activity in orthotopic cell-derived xenograft (CDX) GBM models, as well as in a newly completed subcutaneous TMZ-resistant patient-derived xenograft (PDX) GBM model.
In the three orthotopic CDX studies, significant tumour growth inhibition and survival benefit were observed following treatment with GLIX1 across all doses tested, with greater benefit at higher dose levels. In these models, mice treated with TMZ also showed significantly decreased tumour volume and survival benefit. Most notably, in the subcutaneous PDX model, GLIX1 demonstrated a robust anti-tumour effect while TMZ showed no effect.
BioLineRx and Hemispherian plan to present the data from these studies at one or more future medical conferences.
The phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors).
These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimisation data, serving as the basis for a rapid and effective advanced clinical development plan.
