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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Posted on: 29 Aug 16

DALLAS, Aug. 29, 2016 /PRNewswire/ -- Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy. 

"The combination of Vigil EATC immunotherapy and durvalumab is designed to overcome TGFβ and PD-L1 based suppression of the immune response to the cancer.  We hope to demonstrate that the two therapies can be safely combined to generate an immune response to the patient's tumor neo-antigens," said Dr. Minal Barve, MD, the trial's Principal Investigator. This pilot is a two-part study.  In part one, an appropriate dose of Vigil EATC immunotherapy in combination with durvalumab 1500 mg IV every 4 weeks will be determined.  In part two, patients with no PD-L1 expression (defined as < 1% membranous PD-L1 staining using the SP263 anti-PD-L1 assay (Ventana, Tucson, AZ)) will receive Vigil EATC immunotherapy at the recommended expansion dose, in combination with durvalumab.

"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," said Sunil Joshi, CEO, Gradalis.  "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 phase I breast cancer clinical trial is enrolling patients at Mary Crowley Cancer Research, located at 7777 Forest Lane, Suite 707, in Dallas, Texas.

About Vigil EATC: Vigil is an investigational cellular immunotherapy technology that combines the concepts of genetic engineering with the science of immuno-oncology, to enable an immune response to cancer cells. A patient's tumor cells are engineered with a plasmid carrying the gene vector for shRNA Furin and GMCSF to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the patient's own tumor as the antigen source, Vigil EATC is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor antigens.  Vigil EATC is being studied in Ewing's sarcoma and ovarian cancer as a single agent, and in breast cancer, non-small cell lung cancer and melanoma in combination with PD-L1 inhibitors.  More information about these studies can be found on

About Durvalumab: Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 expression enables tumours to evade detection from the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks PD-L1 interaction with both PD-1 and CD80 on T cells, countering the tumor's immune-evading tactics. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination, in NSCLC, bladder, head and neck, gastric, pancreatic, HCC, and blood cancers.

About Gradalis: Gradalis is a fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel proprietary personalized cellular immunotherapies to treat cancer. Gradalis operates a cGMP manufacturing facility in Carrolton, Texas. For more information about Gradalis, Inc. please visit

About Mary Crowley Cancer Research Center: Operating in compliance with the Food and Drug Administration (FDA) guidelines, the Mary Crowley non-profit research center has been conducting clinical trials for approximately 20 years with a mission to expand treatment options for all cancer patients through investigational vaccine and targeted therapies.

For more information, patients may contact 1-866-90CANCER (1-866-902-2623) or email:

Gradalis® and Vigil® are registered trademarks of Gradalis, Inc.

Gradalis Contact:
Beth Kriegel
Chief Financial Officer
(214) 307-8203

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SOURCE Gradalis, Inc.

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Editor's Details

Mike Wood

Last updated on: 29/08/2016

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