BioLineRx and Hemispherian Form Joint Venture to Advance GLIX1 for Glioblastoma Treatment

Overview

BioLineRx Ltd. and Hemispherian AS have come together to create a joint venture aimed at advancing GLIX1, a promising new oral medication designed for fighting glioblastoma and several other cancers. This novel compound is pioneering in its method, primarily targeting the DNA damage response within cancer cells.

Background on GLIX1

GLIX1 operates by enhancing the activity of the TET2 enzyme, which leads to the selective induction of double-stranded breaks within the DNA of cancer cells. This mechanism specifically targets cancerous tissues while leaving healthy cells largely unaffected. As a result, GLIX1 showcases significant potential for therapeutic use in both newly diagnosed and recurrent cases of glioblastoma (GBM).

The FDA has already granted Investigational New Drug (IND) clearance for a Phase 1/2a clinical trial, anticipated to kick off in the first quarter of 2026. The glioblastoma market is poised for considerable growth, with projections indicating an annual market opportunity exceeding $3.8 billion across the United States and EU5 by 2030.

Joint Venture Dynamics

In this joint venture, Hemispherian will contribute exclusive global rights to GLIX1, while BioLineRx will oversee the operational management and funding of all necessary development activities. Stake distribution will see Hemispherian owning 60% of the venture, with BioLineRx starting at 40% and having the opportunity to grow their stake up to 70% registration by further investment.

Both companies aim to leverage their combined expertise to expedite the clinical development of GLIX1, with a focus initially on GBM. Hemispherian's CEO, Zeno Albisser, emphasized the necessity for innovative treatments in addressing the challenges posed by glioblastoma, citing GLIX1's favorable safety profile demonstrated in preclinical studies.

Urgent Need in Glioblastoma Treatment

Glioblastoma is currently the most aggressive form of primary brain cancer, with treatment options severely limited since 2005. Patients often face challenging prognoses, with survival rates significantly lacking, leading to an urgent need for innovative therapies like GLIX1. The annual incidence in both the U.S. and the EU5 is projected to increase, highlighting the growing market need for effective treatments.

Clinical Development Plans

The Phase 1 segment of the clinical trial aims to recruit approximately 30 patients diagnosed with recurrent GBM. The primary goal is to determine a maximum tolerated dose through analyzing safety, pharmacokinetics, and preliminary efficacy data. Expected results from this initial phase are projected for the first half of 2027.

For the subsequent phase, three distinct population cohorts are planned, including GLIX1 as a standalone treatment for recurrent GBM,
it in conjunction with standard care for newly diagnosed patients, and a combination with PARP inhibitors for various solid tumors.

Conference Call Insights

On September 29, 2025, both companies will conduct a conference call to offer further insights into these developments. Interested parties may join by dialing designated numbers provided by the companies, ensuring robust information access to shareholders and stakeholders.

Conclusion

This collaboration marks a significant development in the effort to combat glioblastoma and other aggressive cancers. With intense emphasis on innovation and growth, the combined capabilities of BioLineRx and Hemispherian stand to facilitate important progress in cancer treatment, addressing critical unmet needs and significantly enhancing patient outcomes.