CoreStem

Company CoreStem

Drug Name NeuroNATA-R

Technology MSC-NTF (Mesenchymal Stem Cells with Neuro-trophic Factors)

Orphan Drug Status YES - EMA & FDA

Website http://corestem.com/en/

NEURONATA-R® inj. (Autologous BM-MSC) is an autologous bone marrow mesenchymal stem cell (autologous BM-MSC) therapy that acts a neuroprotective effect and relieves progression of a disease through prevention of motor nerve cell, survival extension of motor neurons, releasing nerves inflammatory and immune regulation function.

The mechanism of lenzumestrocel (generica name of the drug) on ALS is considered as an expression of anti-inflammatory factors, neuroprotective factors and immunoregulation: lenzumestrocel is considered to show recovery effects on the disease by inhibiting the immune response-initiated apoptosis of neurons through secretion of anti-inflammatory factors that in turn induce an increase in the differentiation of Tregs.

As of 7th Jan 2022, 98 patients out of 115 were registered for a Phase 3 Clinical Trial in South Korea.

Neuronata-R® is already approved to use in South Korea since 2014. Since then, over 350 patients were treated with Neuronata-R® including overseas patients.

The mechanism of NeuroNata-R therapy in ALS is 1) Treg cell induction, 2) Th2 cell activation, 3) Increased conversion of M2 population, 4) Increased anti-inflammatory cytokines, 5) Released neurotropic factor including VEGF, NGF, BNDF.