Drug intelligence / Profile preview

ITI-3000

Development stage
Phase 1
Lead developer
Immunomic Therapeutics
Modality
Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

ITI-3000 is a plasmid DNA vaccine developed by Immunomic Therapeutics for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive skin cancer most often caused by the Merkel cell polyomavirus. The vaccine targets the large T antigen (LT) of MCPyV, using Immunomic's UNITE platform, which leverages lysosome-associated membrane protein (LAMP)-mediated nucleic acid-based immunotherapy to enhance antigen presentation and stimulate robust immune responses. Preclinical and Phase I clinical data indicate that ITI-3000 induces strong antigen-specific CD4+ T cell responses and anti-LT antibodies, with favorable safety and tolerability profiles observed in early human trials[3][4][5][6]. The vaccine is administered intramuscularly using a needle-free injection system.

02

Targets

LTag (Polyomavirus large T antigen)CD4+ T-cell receptor recognizing Merkel cell polyomavirus large T antigen-derived peptide presented on MHC class II

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