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®.