BioLineRx Ltd. and Hemispherian AS have established a joint venture (JV) to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma (GBM) and other cancers.
GLIX1 agonizes TET2 activity in cancer cells, resulting in the formation of double-stranded DNA breaks and apoptosis specifically in cancer cells.
GLIX1, Hemispherian’s lead drug candidate, is being developed as a potential treatment for newly diagnosed and recurrent GBM. GLIX1 has demonstrated potent anti-tumour activity in multiple glioblastoma models, excellent blood-brain barrier penetration and a favourable safety profile in preclinical toxicology studies.
An Investigational New Drug (IND) application was cleared by the U.S. Food and Drug Administration (FDA) in August 2025, and a phase 1/2a study is expected to initiate in Q1 2026. GLIX1 has also been granted Orphan Drug Designation by both the FDA and the European Medicines Agency (EMA), underscoring the substantial unmet need in this indication. In addition, GLIX1 has shown anti-tumour activity in other cancer models, and early data also suggest the potential for strong synergy of GLIX1 with PARP inhibitors, particularly in homologous recombination (HR) proficient cancers. Further development in other solid tumours is being planned.
“This joint venture combines our expertise in DNA damage response research and discovery, with BioLineRx’s proven track record of clinical and regulatory success,” said Zeno Albisser, CEO of Hemispherian.
“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. We are eager to initiate the phase 1/2a study as expeditiously as possible, and are working with leading neuro-oncology centres and the BioLineRx team to bring this promising asset to patients.”
“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. I could not be more excited to work alongside the Hemispherian team,” said Philip Serlin, CEO of BioLineRx.
“This JV brings together highly complementary capabilities in DNA repair research, alongside clinical development and regulatory expertise, to create an entity that I believe is well positioned to bring much-needed innovation to the most challenging cancer types while creating shareholder value. The JV also has a first look at other molecules in Hemispherian’s pipeline, but will initially focus on GLIX1.”
Pursuant to the terms of the JV agreement, Hemispherian will contribute the global rights of GLIX1 to the JV, and BioLineRx will be responsible for managing, performing and funding all JV development activities. In consideration for their respective contributions, as of the JV’s inception, Hemispherian will hold 60% of the JV’s share capital, and BioLineRx will hold a 40% stake, with BioLineRx’s stake increasing incrementally to a potential maximum of 70% in parallel with its continued investment in the programme. The parties agreed that all funding from BioLineRx would go strictly to asset development. The JV also has a first look at other molecules in Hemispherian’s pipeline.
GBM is the most common and aggressive form of primary brain cancer. The current standard of care (SoC) treatment was established in 2005, with only limited further advancements since. Treatment includes surgical resection, followed by radiotherapy, and concomitant and adjuvant chemotherapy (Temozolomide), yet most patients will succumb to their disease within less than 18 months (median OS of 12-18 months).
GBM occurs at all ages, but peaks in the fifth and sixth decades of life, with an increasing incidence in light of the aging global population. New and better treatments are desperately needed aiming at improving survival, maintaining quality of life and delaying tumour progression and symptoms.
The annual incidence of GBM is expected to be approximately 18,500 patients in the US and approximately 13,400 across France, Germany, Italy, Spain and the UK by 2030. Total addressable markets across both the newly diagnosed and recurrent settings are estimated to be approximately $2.5bn in the US, and approximately $1.3bn across Europe at that time.
Roger Stupp and Ditte Primdahl of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University will serve as principal investigators for the study.
The phase 1 part of the trial is expected to recruit up to 30 patients with recurrent GBM. The objective of this part is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the phase 1 part of the trial is anticipated in H1 2027.
The phase 2a expansion part of the trial is planned to include three population cohorts: (1) GLIX1 as monotherapy in recurrent GBM, (2) GLIX1 in combination with standard of care in newly diagnosed GBM patients (likely a “window of opportunity” study), and (3) GLIX1 in combination with PARP inhibitors in other solid tumours.
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