Vigil is a fully personalized cellular immunotherapy being investigated for the treatment of advanced cancers.

Being developed by Gradalis, Vigil combines genetic engineering with immuno-oncology to stimulate an immune response against cancer cells.

How Vigil works

Vigil is a personalized cellular immunotherapy, which means that patient’s own cancer cells are used to treat their cancer.

Vigil therapy begins when part of the patient’s tumor is removed by a surgeon. The cells from the tumor are then genetically modified in two ways. First, they are modified to inhibit the production of furin – a protein that makes it difficult for the immune system to detect cancer cells. Second, they are modified to produce a protein called granulocyte macrophage colony stimulating factor (GM-CSF). GM-CSF is a potent stimulator of the immune system that has been found to make cancer cells more visible to the immune system.

Once modified, the cancer cells are injected back into the patient. There, the two modifications work in tandem: GM-CSF production activates the immune system and furin inhibition allows the immune system to detect cancer cells. This process is intended to result in better recognition and killing of cancer cells.

Vigil in clinical trials

A open-label pilot study (NCT02574533) examined the combination of Vigil and Keytruda (pembrolizumab) in inducing cancer-specific T-cell immunity in patients with incurable locally advanced or metastatic melanoma. Keytruda is a humanized monoclonal antibody, which activates T-cell-mediated immune responses against tumor cells. The results of the study do not appear to have yet been published.

Vigil is also being investigated as a maintenance therapy in patients with high-risk stage 3b-4 ovarian cancer in a multicenter, randomized, double-blind, placebo-controlled, Phase 2/3 clinical trial (NCT02346747). Also known as VITAL, this study involves more than 80 patients diagnosed with stage 3B, 3C or 4 high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube, or primary peritoneal cancer. Patients are randomized to receive either Vigil or placebo injected into the skin monthly for a minimum of four and a maximum of 12 months. Its main goal is to determine patients’ recurrence-free survival (RFS); their overall survival (OS) rate will also be examined.

Phase 2 of the VITAL trial concluded and results in 42 cancer patients were published in the scientific journal Gynecologic Oncology. It covered the safety, immunogenicity (ability to trigger an immune response), and efficacy of Vigil. Findings demonstrated that the use of Vigil is safe, leads to T-cell activation, and improves RFS.

Another Phase 2 crossover study (NCT03073525) is evaluating the safety and anti-tumor activity of Vigil in women diagnosed with advanced gynecological cancers, such as cancer of the ovaries, cervix, and uterus. In this study, Vigil’s safety and anti-tumor activity, in combination with the immune checkpoint inhibitor Tecentriq (atezolizumab), by Genentech, are being evaluated. Biomarkers are being used to measure anti-tumor systemic immune response generated either by Vigil alone, Tecentriq alone, or the combination of the two agents.

This study, which is currently recruiting participants at different locations in the U.S., is expected to be completed by April 2019.

A pilot study (NCT02725489) evaluating the safety, tolerability, and efficacy of the combination of Vigil immunotherapy and Imfinzi (durvalumab), a PDL1 inhibitor, in women diagnosed with different types of advanced cancers  — such as breast, ovarian, cervical, uterine, fallopian, primary peritoneal, and endometrial cancer — is currently recruiting patients at a single site in Dallas. The main purpose of the study is to investigate the effects the combination treatment may have on patients, and whether or not the combination helps in slowing down the progression of the disease.

The safety of Vigil immunotherapy in combination with other drugs is also being evaluated in a Phase 2b clinical trial (NCT02511132) involving patients with metastatic Ewing’s sarcoma that could not be treated with at least one prior line of systemic chemotherapy.


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