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TOL-3021
- Development stage
- Phase 1
- Lead developer
- Tolerion
- Modality
- DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, Gene Therapies
- Administration
- Intramuscular
01
Overview
TOL-3021 is an antigen-specific immunotherapeutic DNA vaccine designed to treat type 1 diabetes mellitus. It consists of a plasmid encoding the full-length human proinsulin gene, which is delivered via intramuscular injection. The mechanism involves presenting proinsulin antigens to the immune system in a way that induces immune tolerance, thereby selectively suppressing autoimmune responses against pancreatic beta cells while sparing normal immune function. This approach aims to preserve endogenous insulin production and slow or halt disease progression in patients with recent-onset or established type 1 diabetes. Developed by Tolerion (originator: Stanford University), TOL-3021 has shown in phase II trials that it can increase C-peptide levels (a marker of beta cell function) and reduce proinsulin-reactive CD8+ T cells without significant adverse events[1][5][7].
- Other names
- DNA plasmid vaccine for type 1 diabetes - Bayhill Therapeutics
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