If you are a large pharma company dealing with a stagnant oncology pipeline where the last GBM approval was in 2004 — this project developed GLIX1 that showed 94% tumor growth inhibition in mice. This provides a high-potential asset for licensing to fill a critical gap in brain cancer therapy.
Clinical Validation of a New Epigenetic Drug for Aggressive Brain Cancer Treatment
Imagine a cancer cell has a master switch that keeps it growing and resisting medicine. This project created a small molecule that flips that switch back, forcing the cancer to stop growing. It's like rewriting the cell's instruction manual to make it vulnerable to treatment again. Early tests showed it could almost completely stop tumors from growing in mice.
What needed solving
Glioblastoma Multiforme has a dismal 6.8% five-year survival rate, and no new approved therapies have entered the market since 2004. There is a massive global unmet need for effective oncology treatments for this specific brain cancer.
What was built
A clinical-ready small molecule drug (GLIX1) and a full non-clinical safety package, including GLP-compliant toxicology and GMP-manufactured drug products.
Who needs this
Who can put this to work
If you are a biotech firm dealing with the high risk of early-stage clinical failure — this project developed a full non-clinical safety package and GMP manufacturing. This reduces the risk of moving a small molecule into first-in-human Phase 1/2 studies.
If you are a clinical center dealing with GBM patients who typically die 12-18 months after diagnosis — this project developed a clinically ready drug candidate. This allows the center to lead first-in-human trials for a therapy targeting a newly discovered mechanism.
Quick answers
What is the licensing strategy for this technology?
The objective is to prove clinical safety and efficacy to make GLIX1 globally available through licensing to a large pharma company.
What is the estimated cost of the development so far?
The project received an EU contribution of EUR 2,500,000.
Has the drug been scaled for production?
Yes, GMP manufacturing of the clinical drug substance and drug product has been achieved, including quality release and long-term stability.
What regulatory milestones have been reached?
The project has successfully prepared and cleared a U.S. Investigational New Drug (IND) application.
What is the timeline for clinical testing?
The project period runs from 2023-01-01 to 2025-12-31, with the current goal of executing a first-in-human Phase 1/2 study.
Who built it
The project is led by a single Norwegian SME, Hemispherean AS, which holds 100% of the industry ratio. This lean structure indicates a high level of agility and direct control over the IP, though it relies heavily on the coordinator's internal capacity and external academic clinical centers for trial execution.
Contact Hemispherean AS in Norway regarding GLIX1 licensing
Talk to the team behind this work.
Contact us to explore licensing opportunities for GLIX1