Drug intelligence / Profile preview

amolimogene bepiplasmid

Development stage
Phase 3
Lead developer
Eisai
Modality
DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, Gene Therapies
Administration
Intramuscular
01

Overview

Amolimogene bepiplasmid is a plasmid DNA-based therapeutic vaccine developed for the treatment of human papillomavirus (HPV)-associated diseases such as cervical dysplasia. The drug consists of small biodegradable poly(lactide-co-glycolide) polymer microparticles encapsulating a plasmid-DNA vector encoding a chimeric protein with epitopes derived from the E6 and E7 oncoproteins of HPV types 16 and 18[1][5][8]. Upon administration, these microparticles are phagocytosed by antigen-presenting cells (APCs), leading to direct transfection and expression of HPV epitopes in the context of MHC class I and II molecules. This process primes T cells against HPV-infected cells[5][8]. Amolimogene was tested in clinical trials for high-grade cervical intraepithelial lesions but did not demonstrate significant efficacy over placebo except in women under 25 years old[4][5][8]. Development for anal dysplasia was discontinued[3].

Other names
amolimogene
02

Targets

E6/E7 (HPV E6/E7 oncoproteins)E7 (Papillomavirus E6/E7 oncoproteins)

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