Step 1: Tumor Tissue Collection & Processing
The process begins with the surgical removal of the patient’s tumor tissue, a standard procedure in treating most advanced cancers. The fresh tissue is immediately shipped to our cGMP manufacturing facility, where it undergoes a proprietary two-day genetic modification process.
During this time, the patient’s cancer cells are altered to enhance immune visibility and response. Up to 12 doses of Vigil immunotherapy are produced for each patient.
Step 2: Genetic Modification of Cancer Cells
Vigil’s innovative approach employs two critical genetic modifications, facilitated by a proprietary gene plasmid. The first modification involves bifunctional shRNA, which targets and reduces the expression of Furin—an enzyme responsible for activating the immunosuppressive proteins TGFβ1 and TGFβ2. This downregulation of immunosuppression enables the patient’s immune system to more effectively detect and attack cancer cells.
The second modification introduces Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), a potent immune system stimulator. GM-CSF increases surface antigen expression on cancer cells, making them more visible to the immune system. It also recruits antigen-presenting cells (APCs), such as dendritic cells, further amplifying the immune response and enhancing the immune system’s ability to identify and destroy cancer cells.
Step 3: Irradiation, Reintroduction & Administration
Following genetic modification, the tumor cells are irradiated to arrest cell growth and cryogenically stored prior to being reintroduced into the same patient (autologous) via intradermal injection into the upper arm.
Administered once a month, on a 3- or 4-week cycle, Vigil ensures stimulation of the immune system, with each injection activating T-cells to target and destroy remaining cancer cells. This immunotherapy works in tandem with traditional treatments like surgery, chemotherapy, and radiation.
Step 4: Durable Immune System Activation & Response
Upon reintroduction, the modified tumor cells stimulate APCs to sample the tumor antigens and migrate to nearby lymph nodes. Here, the APCs activate T-cells against the patient’s specific cancer neoantigens.
These activated T-cells then circulate through the body, seeking out and destroying cancer cells, providing precise and sustained immune support. By inducing long-term immune memory, Vigil offers a durable defense, with reports of extended survival outcomes.