Platform & Pipeline

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The Gradalis platform, 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. Our lead program focuses on the adjuvant treatment of patients with Stage III/IV ovarian cancer following primary surgery and chemotherapy.

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 T-cells against their own unique tumor cells.

We believe that Vigil® has several key features and advantages which differentiate it from other cancer immunotherapies.

  • We use the entire compliment of antigens present in an individual patient’s cancer by using whole cells from their cancer. The goal is to stimulate a robust immune response (T-cell activation) against a heterogeneous mix of cancer antigens specific to that patient.
  • With gene modification, we specifically down-regulate an immune suppression function of the cancer cells; and at the same time, up-regulate an immune stimulation function of those same cells. When those cells are reintroduced back into the patient, these two modifications are designed to work in tandem to help activate the immune system to detect and kill any cancer cells that may remain.

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.

We believe that our approach to harness an individual’s already existing immune system against their cancer has great promise.