drug_type
RELEVANT_DRUG
intervention_type
Vaccine (DNA vaccine)
drug_description
Multi-antigen DNA vaccine (nucleic acid immunotherapy) encoding CMV antigens IE-1+pp65 (fusion) and gB, each fused to LAMP1 to enhance MHC II presentation and cross-presentation to MHC I, intended to elicit CMV-specific CD4+ and CD8+ T-cell responses against CMV-expressing GBM cells.
nci_thesaurus_concept_id
C201131
nci_thesaurus_preferred_term
DNA Plasmid Vaccine ITI-1001
nci_thesaurus_definition
An off-the-shelf (OTS) plasmid DNA cancer vaccine containing two DNA plasmids, one encoding for the two human cytomegalovirus (CMV) antigens immediate-early 1 (IE-1) and the matrix protein pp65 (65 kDa lower matrix phosphoprotein; UL83) fused to the lysosome-associated membrane protein 1 (LAMP-1), and one plasmid encoding for the CMV glycoprotein B (gB) antigen which is also fused to LAMP-1, with potential immunomodulating and antineoplastic activities, Upon intramuscular (IM) administration and following electroporation, the DNA plasmid vaccine ITI-1001 is taken up by antigen presenting cells (APCs) and transported via LAMP-1 and the lysosome-mediated pathway. This results in enhanced major histocompatibility (MHC) class II antigen presentation of the three antigens to the immune system, thereby promoting CD4-positive T-cell responses as well as CD8-positive T-cell responses against tumor cells expressing the three viral antigens. IE1, pp65 and gB are expressed in certain tumor types. The incorporation of LAMP-1 routes the CMV antigens into the lysosomal compartment.
drug_mesh_term
Cytomegalovirus Vaccines
drug_category
GENE THERAPY
drug_class
Vaccine
drug_delivery_route
Intramuscular
drug_mechanism_of_action
Off‑the‑shelf plasmid DNA vaccine encoding CMV IE‑1/pp65 (fusion) and gB, each fused to LAMP1. Following intramuscular delivery with electroporation, plasmids are taken up by antigen‑presenting cells; LAMP1 targets antigens to lysosomes to enhance MHC II presentation with cross‑presentation on MHC I, inducing CMV‑specific CD4+ and CD8+ T‑cell responses to recognize and kill CMV‑expressing GBM cells.
drug_name
ITI-1001
nct_id_drug_ref
NCT05698199