Gradalis, Inc. Announces Initiation of a Phase 2 Study using Gradalis’ Vigil® Immunotherapy in Combination with Anti-PD-1 Technology to Treat Patients with Advanced Non-Small Cell Lung Cancer

DALLAS, April 26, 2016 (GLOBE NEWSWIRE) — Gradalis Inc., a clinical-stage biopharmaceutical company, today announced the initiation of a Phase 2 study for the treatment of patients with advanced non-small cell lung cancer (NSCLC) using its proprietary, personalized cancer vaccine, Vigil^® in combination with Bristol-Myers Squibb’s  Opdivo^® (nivolumab), a monoclonal antibody against programmed death-1 receptor (PD-1).

This is an open label phase 2 study to evaluate the combination of Vigil and nivolumab in advanced or metastatic NSCLC that is progressive on or after one prior platinum-based systemic therapy. Patients meeting study eligibility criteria will receive Vigil and nivolumab every 2 weeks. The primary end point is objective response rate (ORR) for the combination versus the historical ORR of single-agent nivolumab in this patient population.
Safety and tolerability will also be monitored.   Additionally, patients will be monitored for tumor-specific immune response using sequential IFNγ-ELISPOT (immune activation) assays to assess the functional response of the patient’s circulating immune cells to unmodified patient-specific tumor samples, starting at baseline (pre-treatment) and sequentially after treatment. For more information, please visit ClinicalTrials.gov (Identifier: NCT02639234).

“Our goal is to demonstrate that Vigil, when combined with a PD-1 immune checkpoint inhibitor such as Opdivo, enhances the immune response, leading to more favorable outcomes, particularly in patients expected to be  less responsive to Opdivo,” said John Nemunaitis, M.D., Chief Medical Officer of Gradalis.

Gradalis is also pursuing several other clinical targets for Vigil using the Company’s personalized immunotherapy platform in the treatment of cancer, including Ewing’s sarcoma, advanced melanoma and advanced ovarian cancer.

Bristol-Myers Squibb Company is not sponsoring or is not otherwise a part of this clinical trial.

About Vigil
Vigil is a proprietary, personalized, immunotherapy platform developed by Gradalis. A patient’s tumor cells are engineered 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 is designed to elicit an immune response that is both specifically targeted and broadly relevant to each patient’s unique tumor antigens.

About Gradalis
Gradalis is a clinical-stage biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel proprietary personalized immunotherapies to treat cancer using its Vigil technology platform.  Gradalis operates a cGMP manufacturing facility in Carrolton, Texas.  For more information about Gradalis, Inc. please visit www.gradalisinc.com.

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