Laminar Pharma

Laminar Pharma’s lead compound, idroxioleic acid (LAM561), is a synthetic lipid derivative administered orally. It has shown an outstanding safety profile and promising efficacy signals in patients with solid tumors and brain tumors such as glioblastoma multiforme. The pivotal phase 2b/3 trial ("CLINGLIO") for newly diagnosed GBM is ongoing; the company has reported positive open-label progression-free survival data and received recommendations to advance from its Independent Data Monitoring Committee. Three phase 2 studies have been completed with no serious adverse effects associated with LAM561—an unusually favorable toxicity profile for an anti-tumor agent. Conditional approval submission to EMA was targeted for Q2/Q3 2024.