Drug intelligence / Profile preview

mis416

Development stage
Phase 2
Lead developer
Amplia Therapeutics
Modality
Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

MIS416 is an experimental immune modulator derived from the cytoskeleton of the bacterium Propionibacterium acnes. It is a microparticle containing two naturally occurring ligands, TLR-9 and NOD-2, which target myeloid cells by activating pattern recognition receptors involved in innate immunity. Originally developed as a vaccine adjuvant, MIS416 has been investigated primarily for secondary progressive multiple sclerosis (SPMS) and as an immunotherapy for cancer. The drug acts by stimulating low-level production of inflammatory cytokines through TLR-9 and NOD-2 signaling pathways, leading to modulation of immune responses—specifically reducing inflammatory T-cell activity and promoting regulatory cell populations. Clinical trials have shown that MIS416 is generally well tolerated but failed to demonstrate efficacy in phase II studies for SPMS[1][2][5].

Other names
Microparticle Immune Stimulator 416
02

Targets

TLR9 (Toll-like receptor 9)NOD2 (Nucleotide-binding oligomerization domain-containing protein 2)

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