– The open-label trial will measure progression free survival of participants from date of randomization until first disease progression in the study –

– The trial will use product produced from Gradalis’ recently-upgraded cGMP Carrollton facility –

DALLAS, Aug. 28, 2018 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced the initiation of its Phase 3 clinical trial of Vigil for individuals with Ewing’s sarcoma using product produced from Gradalis’ recently upgraded current Good Manufacturing Practice (cGMP) Carrollton facility.

Gradalis is also pursuing several other clinical targets for Vigil using the Company’s personalized immunotherapy platform in the treatment of cancer, including combination studies with checkpoint inhibitors targeting advanced gynecological and other women’s cancers.

The trial is a Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination with Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's sarcoma.

“We are pleased to initiate our Phase 3 trial in Ewing’s sarcoma,” said David Shanahan, Founder, Chairman and Chief Executive Officer of Gradalis. “The initiation of this trial demonstrates Gradalis' continued investment and advancement of Vigil, our innovative, personalized immunotherapy which we believe has the potential to transform the way cancer is treated.”

According to National Cancer Institute, Ewing’s sarcoma (“EWS”) is a rare, pediatric cancer that forms in bone or soft tissue.  EWS is caused by genetic mutation and is most common in adolescents and young adults, affecting an estimated 1,000 individuals globally every year. Given its rare occurrence, doctors often prescribe chemotherapy, surgery and/or radiation to minimize the spread of the disease.

“For patients affected by Ewing’s sarcoma, our most recent trial has shown positive results with minimal side effects,” said John Nemunaitis, Chief Medical Officer at Gradalis.  “We believe Gradalis’ approach of exploiting the patient's existing, highly-adapted immune system by presenting the entire neoantigen matrix and induced T-cell responses against their cancer has great promise.”

For more information about these clinical trials, please visit http://www.clinicaltrials.gov and search for NCT03495921.

About Vigil Vigil is a proprietary, investigational cellular immunotherapy technology that combines genetic engineering with the science of immuno-oncology.  Vigil is intended to stimulate and enhance the body’s natural mechanism for recognizing and killing cancer cells. It utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy. By utilizing the patient's own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor antigens.  Vigil is being studied in Ewing's sarcoma, in gynecological cancer and advanced women’s cancer in combination with PD-L1 inhibitors, and ovarian cancer as a single agent.

About Gradalis, Inc. Gradalis is a late stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. We are developing Vigil, our proprietary immunotherapy platform in multiple advanced cancer indications with the lead program for the treatment of patients with Ewing's sarcoma.

For additional information, please visit  http://www.gradalisinc.com

Forward-Looking Statements   All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Gradalis cautions investors not to rely too heavily on the forward-looking statements the company makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Gradalis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Media and Investor Inquiries: Walter Chen Vice President – Corporate Development Gradalis, Inc. 214-442-8100 wchen@gradalisinc.com