The pilot study is evaluating the combination of Vigil engineered autologous tumor cells (EATCs) and durvalumab on advanced or metastatic triple negative breast cancer (TNBC).
"The combination of Vigil EATC immunotherapy and durvalumab is designed to overcome TGFB and PD-L1 based suppression of the immune response to the cancer," Principal Investigator Dr. Minal Barve said. "We hope to demonstrate that the two therapies can be safely combined to generate an immune response to the patient's tumor neo-antigens."
Vigil EATC adds a plasmid to the patient's own tumor cells to encourage a T-cell response. The patient receives intradermal injections containing the engineered cells. This causes an immune response to the specific cancer cells in the patient's body. Combined with durvalumab, which is a monoclonal antibody that blocks tumor immune-evading mechanisms, the treatment encourages the body's T-cells to attack and destroy the cancer cells.
"There is strong scientific rationale for combining Vigil EATC immunotherapy with durvalumab, by sensitizing the immune system to the patient's own tumor neo-antigens while simultaneously taking the brakes off the activated immune system," Gradalis CEO Sunil Joshi said. "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 pilot study is still recruiting participants at Mary Crowley Cancer Research, 7777 Forest Lane, Suite 707, Dallas, Texas.