Drug intelligence / Profile preview

gemogenovatucel-T

Development stage
Phase 2
Lead developer
Gradalis
Modality
Vaccines & Immunotherapeutics, Cell Therapies, Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intradermal
01

Overview

Gemogenovatucel-T is a first-in-class, personalized autologous tumor cell vaccine immunotherapy designed for the treatment of advanced ovarian cancer and other solid tumors. It is engineered using a dual bi-shRNA platform to knock down furin (a convertase involved in activating immunosuppressive TGFβ-1 and TGFβ-2) while simultaneously augmenting expression of granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent immune system stimulator. This approach aims to reduce tumor-mediated immune suppression and enhance recruitment of immune effector cells at the vaccination site. The therapy uses each patient’s own harvested tumor tissue to create an individualized vaccine targeting unique clonal neoantigens present in their cancer. Gemogenovatucel-T has demonstrated significant improvements in recurrence-free survival and overall survival—especially among patients with BRCA wild-type or homologous recombination proficient (HRP) ovarian cancer with high clonal tumor mutation burden—in randomized controlled trials[1][2][6][7][9].

Brand names
Vigil
Other names
FANGgemogenovatucel-TVigil
02

Targets

Furin

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