DALLAS, Nov. 4, 2016 /PRNewswire/ -- Gradalis, Inc. today announced that the company will participate in the Society for Immunotherapy of Cancer (SITC) meeting. Dr. Luisa Manning, Associate Director of Medical Affairs (Clinical Research), will be presenting a poster titled, "Long Term Follow Up of Vigil® Engineered Autologous Tumor cells (EATC) in Recurrent Metastatic Ewing's Sarcoma (EWS)" on Friday, November 11, 2016.
"Vigil Engineered Autologous Tumor Cell Immunotherapy is an innovative, personalized anticancer therapy that is being explored in a registrational Phase 2b trial in Ewing's sarcoma," said Mr. Sunil Joshi, President and Chief Executive Officer of Gradalis. "We are pleased to participate in this highly important immunotherapy meeting to share the long term follow up from our early clinical experience in Ewing's sarcoma, a rare disease affecting primarily children and young adults."
Dr. Martin Birkhofer, Chief Medical Officer of Gradalis, commented, "We are pleased to present these data summarizing the three-year follow-up of 16 Ewing's sarcoma patients enrolled on our completed Phase I study. The impressive long term survival in the Vigil treated patients vs. matched controls supports our additional clinical exploration of Vigil in the ongoing registrational Phase 2b study."
Dr. Martin Birkhofer and Dr. Luisa Manning will be attending the poster and will be available to answer any questions regarding Vigil EATC technology during and after the poster presentation.
The SITC meeting will be held on November 9- 13, 2016 at the Gaylord National Hotel, National Harbor, Maryland. For additional information about the summit, please visit www.sitcancer.org/2016.
About Vigil® EATC: Vigil® autologous tumor cell therapy is an investigational technology that combines the concepts of genetic engineering with the science of immuno-oncology, to enable an immune response to cancer cells. Patient's own tumor cells are transfected with a DNA plasmid carrying the gene vector for a bifunctional shRNA targeting the knockdown of Furin accompanied with TGF?1 and 2 deletion and a vector for GM-CSF to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the tumor cells as the antigen source, Vigil® EATC is designed to elicit specific immune response targeting each patient's unique and immunogenic tumor antigens. Vigil® EATC was studied in a nonrandomized, open-label Phase 1 trial in over 19 different solid tumor types and is currently 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-1/PD-L1 inhibitors. More information about these studies can be found on www.vigilclinicaltrials.com.
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 www.gradalisinc.com.
Gradalis® and Vigil® are registered trademarks of Gradalis, Inc.
Contact: Beth KriegelChief Financial OfficerGradalis, Inc.(214) 307-8203
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"Vigil Engineered Autologous Tumor Cell Immunotherapy is an innovative, personalized anticancer therapy that is being explored in a registrational Phase 2b trial in Ewing's sarcoma," said Mr. Sunil Joshi, President and Chief Executive Officer of Gradalis. "We are pleased to participate in this highly important immunotherapy meeting to share the long term follow up from our early clinical experience in Ewing's sarcoma, a rare disease affecting primarily children and young adults."
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Dr. Martin Birkhofer, Chief Medical Officer of Gradalis, commented, "We are pleased to present these data summarizing the three-year follow-up of 16 Ewing's sarcoma patients enrolled on our completed Phase I study. The impressive long term survival in the Vigil treated patients vs. matched controls supports our additional clinical exploration of Vigil in the ongoing registrational Phase 2b study."
Dr. Martin Birkhofer and Dr. Luisa Manning will be attending the poster and will be available to answer any questions regarding Vigil EATC technology during and after the poster presentation.
The SITC meeting will be held on November 9- 13, 2016 at the Gaylord National Hotel, National Harbor, Maryland. For additional information about the summit, please visit www.sitcancer.org/2016.
About Vigil® EATC: Vigil® autologous tumor cell therapy is an investigational technology that combines the concepts of genetic engineering with the science of immuno-oncology, to enable an immune response to cancer cells. Patient's own tumor cells are transfected with a DNA plasmid carrying the gene vector for a bifunctional shRNA targeting the knockdown of Furin accompanied with TGF?1 and 2 deletion and a vector for GM-CSF to elicit a systemic T-cell directed immune response when administered to the patient through intradermal injections. By utilizing the tumor cells as the antigen source, Vigil® EATC is designed to elicit specific immune response targeting each patient's unique and immunogenic tumor antigens. Vigil® EATC was studied in a nonrandomized, open-label Phase 1 trial in over 19 different solid tumor types and is currently 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-1/PD-L1 inhibitors. More information about these studies can be found on www.vigilclinicaltrials.com.
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 www.gradalisinc.com.
Gradalis® and Vigil® are registered trademarks of Gradalis, Inc.
Contact: Beth KriegelChief Financial OfficerGradalis, Inc.(214) 307-8203
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SOURCE Gradalis, Inc.
