Gemogenovatucel-T (Vigil): bi-shRNA plasmid-based targeted immunotherapy

Area of Science:

• Oncology
• Immunotherapy
• Cancer Research

Background:

• Vigil (gemogenovatucel-T) is a targeted immunotherapy.
• It is designed for systemic anticancer activity.
• Historical evidence supports its concept and design.

Purpose of the Study:

• To review the development and clinical applications of Vigil.
• To assess the safety and efficacy of Vigil in a Phase IIB trial.
• To support advancement to confirmatory clinical trials.

Main Methods:

• Harvest of autologous malignant tissue for neoantigen targeting.
• Transfection with a plasmid containing human GMCSF DNA and bi-shRNAfurin.
• A two-day process to create a permissive immune system training environment.

Main Results:

• Vigil demonstrated preclinical and clinical systemic anticancer activity.
• The Phase IIB trial assessed safety and efficacy.
• Results support further clinical development.

Conclusions:

• Vigil is a unique triple-function targeted immunotherapy.
• Its design enhances anticancer immune response and reduces cancer-mediated inhibition.
• Further trials are justified for regulatory approval.