Laminar Pharmaceuticals’ first-in-class autophagy inducer Minerval (LAM561, 2-hydroxyoleic acid (2-OHOA)) has reportedly demonstrated  encouraging activity in the difficult-to-treat malignant braintumor patient population, placing it as a potential candidate for the treatment of glioma and other solid tumor malignancies. With a unique membrane-level targeting approach and encouraging early-stage clinical trial data, Minerval holds potential to address urgent medical needs in the glioblastoma multiforme (GBM) landscape, according to the likelihood of approval (LoA) data of GlobalData, a leading data and analytics company.

GlobalData forecasts the number of incident cases of GBM across the 16 major markets (Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, the UK, and the US) to increase from over 79,000 in 2023 to 87,000 cases in 2028.

The Phase I/IIa trial of Minerval demonstrated a manageable safety profile up to very high doses (500–16,000 mg total oral daily dose), although it is important to note that ≥Grade-3 treatment-emergent adverse events (TEAEs) occurred in 46.3% of patients and Grade-4 TEAEs in 5.6%. These findings underscore the need for careful monitoring and management of TEAEs, even as the drug shows significant promise in halting tumor progression.

Minerval works by changing the chemical composition of the plasma membrane in brain cancer cells. This reduces the activity of proteins that promote tumor growth.

GlobalData’s LoA data shows that Minerval’s indication benchmark LoA is 27%, which is higher than Phase III LoA (14%) for small molecules in glioblastoma treatment.

Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData, comments: “While it is still early days for Minerval, its innovative approach of targeting cancer cells at the membrane level and encouraging early-stage data are noteworthy.”

Minerval is currently undergoing a Phase IIb/III clinical study for the treatment of adult patients with newly diagnosed glioblastoma in combination with standard care in Europe and a Phase I/IIa study in pediatric patients with advanced solid tumors in the US.

Podder concludes: “Minerval’s clinical development is marked by its designation as a rare pediatric disease (RPD) and orphan drug for the treatment of malignant glioma in both adult and pediatric patients by the FDA and the EMA. Minerval has also received Fast Track designation from the FDA for the treatment of glioblastoma, highlighting its potential to meet an urgent and unmet medical need.”