Gradalis begins dosing in Phase I breast cancer trial of Vigil EATCs and durvalumab

30th August 2016 (Last Updated August 30th, 2016 18:30)

US-based clinical-stage biopharmaceutical company Gradalis has dosed the first patient in its pilot Phase I trial of a combination of Vigil Engineered Autologous Tumor Cells (EATCs) and durvalumab to treat advanced breast cancer.

US-based clinical-stage biopharmaceutical company Gradalis has dosed the first patient in its pilot Phase I trial of a combination of Vigil Engineered Autologous Tumour Cells (EATCs) and durvalumab to treat advanced breast cancer.

Vigil is an investigational, cellular immunotherapy technology based on a combination of genetic engineering concepts with the science of immuno-oncology to induce an immune response to cancer cells.

A patient's tumour cells are engineered with a plasmid carrying the gene vector for shRNA Furin and GMCSF, to issue a systemic, T-cell directed immune response administered to the patient through intradermal injections.

The Vigil EATC is therefore designed to elicit immune response using patient's own tumour as the antigen source.

Durvalumab is a human monoclonal antibody under investigation, designed to work against programmed death ligand-1 (PD-L1).

PD-L1 expression helps the tumours avoid being detected by the immune system through binding to PD-1 on cytotoxic T lymphocytes.

Durvalumab inhibits the bonding with both PD-1 and CD80 on T-cells, thereby preventing the tumour's immune-evading tactics.

The open-label, investigator-sponsored Phase I trial intends to test the safety, tolerability, and efficacy of the combination of Vigil EATCs immunotherapy and durvalumab in treating locally advanced or metastatic triple negative breast cancer (TNBC), which has aggravated after two prior therapies.

"Triple negative breast cancer remains a disease of high unmet medical need and Gradalis is pleased to provide support to explore the potential of this combination."

The trial is divided into two parts, in which the first part will determine an appropriate dose of Vigil EATC immunotherapy combined with durvalumab every four weeks.

The second part will administer Vigil EATC immunotherapy at the recommended expansion dose combined with durvalumab to patients with no PD-L1 expression.

Gradalis CEO Sunil Joshi said: "There is strong scientific rationale for combining Vigil EATC immunotherapy with durvalumab, by sensitising the immune system to the patient's own tumour neo-antigens while simultaneously taking the brakes off the activated immune system.

"Triple negative breast cancer remains a disease of high unmet medical need and Gradalis is pleased to provide support to explore the potential of this combination."


Image: Gradalis doses first patient with advanced breast cancer. Photo: courtesy of PRNewsFoto/Gradalis, Inc., Shutterstock.