Gradalis® Clinical Trials

Generations Group

A dedicated patient-friendly website is available for Vigil clinical trials.  Please click here to go to the Vigil® Clinical Trials website.

Vigil® is a fully personalized cancer immunotherapy that can be applied to virtually any cancer from which a surgical sample can be gathered. To date we have conducted a Phase 1 study identifying the dose and establishing the early safety profile for the platform. The tumor types studied in Phase 1 included ovarian, breast, melanoma, Ewing’s sarcoma, non-small cell lung, colon, hepatocellular, carcinoid, and sarcomas. We have also initiated Phase 2 studies in advanced ovarian cancer, and Ewing’s sarcoma.

In February 2015, the company announced that it initiated a multicenter, randomized, double-blind, placebo-controlled, Phase 2/3 study of Vigil® immunotherapy in women with Stages III/IV high-grade ovarian cancer who have completed primary cytoreduction and standard consolidation chemotherapy. This trial will form the basis of a registration package for this indication. 

Vigil® utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy.  The goal of our platform is to activate the patient’s immune system against their own unique tumor cells. In essence, the goal is to stimulate the already existing components of the immune system to do their functions better.  We simply enhance specific functions that assist in cancer antigen recognition and dampen other functions that cancer cells often employ to evade the immune system. We believe that exploiting the already existing, highly-adapted human immune system will be more powerful than choosing individual therapeutic target antigens or artificially stimulating immune system components ex vivo, as others technologies have attempted. 

Below are ongoing clinical trials involving Vigil®.

Clinical Trials
Details
Gradalis Immunotherapy Platform
High Risk Stage III/IV Ovarian Cancer
Phase III
High Risk Stage III/IV Ovarian Cancer
Recruiting

Randomized Phase 2/3 Trial of Maintenance Vigil® for High Risk Stage III/IV Ovarian Cancer

Ewing's Sarcoma
Phase II
Ewing's Sarcoma
Recruiting

Randomized Phase 2b Trial of Vigil® EATC immunotherapy versus gemcitabine + docetaxel for Ewing's Sarcoma

Advanced Breast Cancer
Phase II
Advanced Breast Cancer
Recruiting

Pilot Study of Durvalumab (MEDI4736) in Combination With Vigil® in Advanced Breast Cancer

Advanced Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
Recruiting

Open Label Phase 2 Study of Vigil® + Nivolumab in Advanced Non-Small Cell Lung Cancer

Advanced Melanoma
Advanced Melanoma
Recruiting

Pilot Study of Vigil® + Pembrolizumab for Advanced Melanoma

Gradalis® Clinical Trials