The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer
Shots:
- The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT
- Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all pts & its 2EPs of improved RFS & OS in pts with BRCAwt molecular profile; Data published in the Lancet Oncology & the Gynecologic Oncology
- Vigil is an immunotherapy platform that utilizes bi-shRNA for modifying pts' tumors & maximizes GM-CSF expression to stimulate the immune system with the activation of key immune response cells incl. T-cells
Ref: Globenewswire | Image: Gradalis
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
