Posted by Michael Wonder on 06 Feb 2025
Gradalis secures FDA regenerative medicine advanced therapy designation for Vigil (gemogenovatucel-T): an investigational personalised immunotherapy for advanced ovarian cancer
5 February 2025 - Recognising clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient patients with high clonal tumour mutation burden.
Gradalis today announced that the US FDA has granted Gradalis’ personalized investigational cellular immunotherapy, Vigil (gemogenovatucel-T) regenerative medicine advanced therapy designation based on favoirable clinical results from the on-going Phase 2b VITAL trial.
