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Gradalis, Inc. Announces Presentation of Data From a Pilot Study of Vigil (TM) Cancer Vaccine in Ewing’s Sarcoma

20:00 EDT 3 Jun 2015 | Globe Newswire

DALLAS, June 04, 2015 (GLOBE NEWSWIRE) -- Gradalis Inc., a clinical-stage biopharmaceutical company, today announced that data from a pilot study for its proprietary personalized cancer vaccine, Vigil™ (previously FANG), in the treatment of patients with Ewing’s sarcoma were presented in Chicago at the 2015 Annual Meeting of the American Society of Clinical Oncology.

Data were presented in a poster session from a Phase 1 trial of 12 metastatic Ewing’s sarcoma patients who were either multiply recurrent (n=11) or had failed frontline treatment within two years (n=1).  Patients received Vigil™ in doses of 1x106, 4x106, 1x107 or 2.5x107 cells/intradermal injection/month for at least four months.

Patients were followed for safety and clinical response. Additionally, patients were monitored for tumor-specific immune response using sequential IFNγ-ELISPOT (immune activation) assays to assess the functional response of cancer-targeting lymphocytes to unmodified patient-specific tumor samples, starting at baseline (pre-treatment) and sequentially after treatment. Patients were followed for safety and clinical response.

None of the 12 patients (47 doses) developed Grade 2/3/4 drug related toxicity. 

For clinical response, one patient achieved a partial tumor response (38% tumor reduction, RECIST 1.1).  The estimated Kaplan-Meier median survival of these 12 patients at year 1 was 75%.

For patient immune responsiveness, median product release GM-CSF expression was 1858 pg/106 cells; median knockdown of TGFβ1 and TGFβ2 was 100% and 99%, respectively.  Eight patients have been sequentially assessed for peripheral blood mononuclear cell IFNγ-ELISPOT response, all of whom were IFNγ-ELISPOT negative at baseline. In all eight, follow up IFNγ-ELISPOT at month 1 or month 4 (one patient) post-Vigil™ converted to positive (>10 spots/106 cells and >2x baseline).

“These data demonstrate that Vigil™ was well tolerated, elicited a tumor-specific systemic immune response in all patients, and was associated with favorable 1-year survival,” said John Nemunaitis, M.D., Chief Medical Officer of Gradalis.

Gradalis has initiated a Phase 2b study in refractory Ewing’s sarcoma.  The company is also pursuing several other clinical targets for Vigil™ in the Gradalis personalized immunotherapy program including ovarian cancer, and a Phase 1 program in multiple other solid tumors. 

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 in monthly 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 fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel proprietary personalized immunotherapies to treat cancer. Gradalis has its own GMP manufacturing facility in Carrolton, Texas.  For more information about Gradalis, Inc. please visit www.gradalisinc.com.

Beth Kriegel
Chief Financial Officer
(214) 307-8203
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