(San Diego, CA; Durham, NC; and Melbourne, Australia; Nov. 11, 2010) – Invetech and Argos Therapeutics today announced the delivery of custom designed cell therapy automation units to Argos to facilitate the manufacturing of Argos’ personalized RNA-loaded dendritic cell immunotherapies for cancer, HIV and other infectious diseases at commercial scale.
Argos recently announced positive interim results from a Phase II clinical study of its Arcelis™ immunotherapy, in combination with sunitinib, for the treatment of renal cell carcinoma (RCC) at the Ninth International Kidney Cancer Symposium. The company plans to move forward with a Phase III clinical trial in RCC in mid-2011 and implement the automation units prior to commercialization.
“The technology we have developed together is a marriage of science and engineering that will make immunotherapies accessible to many more patients,” said Dr. Fred Davis, President of Invetech. “The closed system approach employed by Invetech enables significant improvements to quality and requires fewer human resources, lowering the cost of the therapy. Use of advanced technology eliminates common human errors, making results repeatable, cost effective and scalable. With closed system based automation, you don’t need a facility with 100 clean rooms to produce commercial-scale personalized therapies. Employing this cutting-edge technology avoids the need to hire and maintain a building full of expensive professionals with advanced biotech degrees.”
“Our engineering team has worked closely with Argos to take their laboratory scale cell therapy process and turn it into a commercial scale system capable of creating life-changing treatments for cancer and HIV,” added Davis.
Jeff Abbey, President and Chief Executive Officer of Argos, said “The Arcelis immunotherapy is the first and only fully automated process that lowers labor and production costs while benefiting from economies of scale. With virtually no risk of process inconsistency and contamination due to the use of robotics in a closed, airtight system, Arcelis addresses the manufacturing challenges of personalized immunotherapies, including meeting the needs of large patient populations in cancer and infectious diseases.”
Cell therapy involves the process of introducing specific cells into a patient in order to treat a disease. It has the potential to be highly effective in the emerging field of personalized medicine, allowing treatment of diseases not satisfactorily addressed by conventional therapies. However, to be a practical treatment for widely prevalent diseases, cell therapy must be commercially viable, allowing enough patients to be treated in a realistic timeframe without excessive costs. Traditional cell therapy processes include centrifugation, incubation, media addition, cell selection, cell washing and final fill and finish. These are labor intensive, require highly skilled operators and must be completed in a BioSafety cabinet hosted in a clean room environment to ensure that the product is free of contamination. The manual process is complex and costly, which has inhibited the advance of personalized medicine.
Invetech scientists and engineers from many disciplines worked with Argos’ process development team for more than two years to design and engineer the Arcelis immunotherapy automation platform. Arcelis only requires one production run to produce five years’ worth of doses for patient treatment, and these doses can be frozen for years instead of requiring immediate use.
The complete automated process involves three separate stand-alone units: A ribonucleic acid (RNA) processing unit to isolate and amplify antigen and two cellular units designed to perform the various cellular and plasma processing steps to generate the immunotherapeutic product in functionally closed disposable vessels.
Moving forward, Argos is in the process of securing funding to begin a Phase 3 trial in RCC in mid-2011. If Argos is successful in obtaining regulatory approval for its Arcelis immunotherapy in RCC, the automated manufacturing process will provide Argos with the potential to immediately address the entire targeted RCC patient population.