Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions.

Vigil is a fully personalized cancer immunotherapy utilizing genetically modified tumor cells. To date, we have conducted Phase 1 studies identifying the clinical dose and established the early safety profile for the platform.

The tumor types studied in Phase 1 included, but not limited to: Ovarian cancer, breast cancer, melanoma, Ewing’s sarcoma, non-small cell lung cancer, colon cancer, and hepatocellular cancer. We have also initiated Phase 2 studies in advanced ovarian cancer and Ewing’s sarcoma.

We are currently conducting clinical studies with primary focus on Vigil immunotherapy in patients with recurrent / refractory Ewing’s sarcoma, as well as in combination with other immunotherapies, such as checkpoint inhibitors in patients with advanced women’s cancers.

Ongoing clinical trials involving Vigil®

Stage III/IV Ovarian cancer

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL).
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Status: Active, Not Recruiting

Advanced Gynecological Cancer

A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecological Cancers (A Companion Study to CL-PTL-119 VITAL).
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Status: Active, NOT RECRUITING

Advanced Women’s cancer

Pilot Study of Durvalumab (MEDI4736) in Combination with Vigil in Advanced Women’s Cancers.
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Status: COMPLETED

Ewing's sarcoma

Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma

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Status: Active, NOT RECRUITING

Ewing’s sarcoma

A two-part Phase IIb Trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing’s Sarcoma.
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Status: COMPLETED

Advanced Ewing's sarcoma

Phase I Trial of pbi-shRNA™ EWS/FLI1 Type 1 lipoplex (LPX) in Subjects with Advanced Ewing’s sarcoma.
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Status: Active, NOT RECRUITING

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