DALLAS, October 3, 2018 – Gradalis, Inc., a Dallas-based, clinical-stage, vertically-integrated immunotherapy company, announced today it has successfully implemented and launched L7’s Enterprise Science Platform (“ESP”). L7 Informatics, Inc., is the leading software and analytics company for life science research and manufacturing companies.
Gradalis recently upgraded its Carrollton, TX manufacturing facility to support the launch of a Phase 3 registration trial of Vigil in Ewing’s sarcoma. Gradalis’ vertically integrated research, clinical and manufacturing business model creates complex master batch record (“MBR”) requirements that few technology providers can support.
Enter L7’s ESP.
L7’s ESP next-generation life sciences platform provides a secure, flexible and scalable technology solution to support cell and CAR-T therapy companies processes and data. ESP’s open architecture supports electronic record needs by managing all mission-critical workflows for research, clinical and manufacturing operations and integrations to process equipment and instrumentation in single platform.
For Gradalis, L7’s ESP serves as the technology hub for its integrated bench-to-bedside operations, and ESP automates Gradalis’ manufacturing records, ensuring its cancer vaccine meets or exceeds regulatory, clinical, manufacturing, provider and study participant needs.
“Our Phase 3 trial in Ewing’s sarcoma is a major milestone for our company and the Ewing’s sarcoma community. Given the rare occurrence of this pediatric cancer, families have limited treatment options, therefore, it is imperative we execute flawlessly to serve these patients,” said Ernest Bognar, Gradalis’ Chief Operating Officer. “We implemented L7’s platform in a phased approach with results rarely seen with technology projects: ‘on time’, ‘on functionality’, and ‘on budget’. By running our manufacturing operations on L7’s ESP platform, we remove major risk factors and improve visibility and accountability. Our quality assurance team views the batch procress in real time and provides in-process approvals or interventions as the situation requires. The company can see the status of each batch of Vigil manufactured in L7’s operational dashboard. Because of its open architecture and intuitive design, we are adding new apps and workflows to the ESP platform with minimal technical resources.”
“We developed ESP to minimize manufacturing and clinical risk so gene and cell therapy companies like Gradalis can successfully deliver immunotherapy treatments to patients. In the case of Ewing’s sarcoma, we are talking about children and young adults fighting an aggressive cancer. ESP provides end-to-end visibility for Gradalis to achieve its mission,” said Vasu Rangadass, CEO at L7 Informatics. “L7 is humbled and energized to partner with companies like Gradalis who are bringing innovative personalized immunotherapies to market.”
For more information about Gradalis and its Ewing’s sarcoma clinical trial, go to FDA’s Clinical Trials portal please visit https://clinicaltrials.gov/ct2/show/NCT03495921.
Researchers, clinicians, manufacturing executives and technology partners, please go to L7’s ESP platform digital home at http://www.L7informatics.com to discover how leading biotech, research institutes and pharmaceutical companies are using the platform.
About Gradalis, Inc.
Gradalis is a late clinical 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
About Vigil by Gradalis
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 L7 Informatics
Our mission is to revolutionize scientific information management in order to accelerate discoveries and drive higher quality of healthcare. Our end-to-end solutions and services yield efficiencies that enable researchers to make more breakthroughs and healthcare companies to provide superior care. To learn more about L7’s Enterprise Science Platform, go to https://www.L7informatics.com/esp/
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