Vigil Demonstrates Significant Survival Benefit in cTMB-H/HRP Ovarian Cancer Patients; Ph 2b VITAL Trial Analysis Published in JCO – Precision Oncology

John Nemunaitis, MD, Gradalis’ Chief Scientific Officer and co-founder stated: “Frontline ovarian cancer treatment protocols involving bevacizumab, PARP inhibitors and PD-1/PD-L1 inhibitors have failed to improve overall survival in patients with HRP tumors. To determine mechanistic mutation signatures associated with OS advantage, we conducted blinded post-hoc analyses of the 91 patients treated in the VITAL trial. Based on these data, we hypothesized that patients with an HRP profile and high clonal tumor mutation burden might achieve greater response when undergoing maintenance therapy with Vigil. Results published today validate our hypothesis demonstrating that Vigil delivered a median OS of nearly six years compared to less than two years with placebo. With FDA RMAT Fast Track designation, we are positioned to accelerate development and bring this innovative therapy to patients sooner.”