What is Vigil®?

Vigil® is an investigational cellular immunotherapy technology that marries the advances in genetic engineering with the science of immunotherapy, with the goal of enabling an immune response to cancer cells.  The technology consists of a DNA plasmid encoding both a gene for recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) and a gene for bifunctional short hairpin RNA (bi-shRNAFurin) targeting Furin.

How is Vigil® designed to work?

The investigational Vigil® technology is designed to modify a patients own tumor cells into Engineered Autologous Tumor Cells or EATCs, EATCs are designed to do three things:

  • present the full profile of cancer cell antigens to the body's immune system,
  • produce bi-shRNA Furin, a substance which blocks the production of certain active forms of TGF-β, a substance that is known to prevent the body’s immune cells from recognizing the tumor cell, and,
  • produce rhGM-CSF, a substance that is known to help the body’s immune cells recognize and become aware of the tumor.

In the Vigil® Clinical Trials, Gradalis, Inc. is evaluating whether these transformed cells, when re-introduced into the patient's body, enable the immune system to "recognize" the cancer cells and generate an immune response to them.

Process of Creating Engineered Autologous Tumor Cells

The process of creating Engineered Autologous Tumor Cells and administration works as follows:

  • A patient undergoes surgery to remove a piece of tumor tissue
  • This tumor tissue is sent in a refrigerated container to Gradalis manufacturing site in Carrolton, TX
  • Once the tissue arrives at our site in Carrolton, the tissue is removed for processing.  
  • The tumor cells are separated using a proprietary process, and transfected with Vigil® plasmid using electroporation
  • The transfected cells are incubated for a specific period of time to allow turning off of the targeted protein and expression of GM-CSF
  • The cells are then tested for Furin and TGFβ 1, 2 turn off, and GM-CSF expression
  • The cells are then irradiated to block their ability to growth
  • The cells are then diluted to a density of 10 million cells per milliliter, and distributed into vials in 1.2ml quantity
  • These vials are then frozen until such time as the patient needs them
  • A few days before the patient is to be administered Vigil® EATCs, a frozen vial is shipped to the hospital/clinical trial site
  • On the day of administration, a pharmacist draws 1ml quantity of Vigil® EATCs into a syringe, which is then administered to the patient intra-dermally over the course of a few minutes.