Saint-Gobain (Aurora, OH), a supplier of polymer components and associated technologies for the biopharmaceutical, pharmaceutical, and medical industries, has entered into an agreement with Argos Therapeutics (Durham, NC) to design, integrate, and scale production of a range of plastic disposables for use in the automated manufacturing of its AGS-003 personalized immunotherapy product.
Based on Argos' Arcelis technology platform, AGS-003 has been developed to treat metastatic renal cell carcinoma. It is currently being tested in a phase III clinical trial.
The Arcelis process uses only a small tumor or blood sample and the patient's own dendritic cells, which are collected and optimized through a single procedure. RNA isolated from the patient's disease sample is used to program dendritic cells to target disease antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.
The personalized immunotherapy technology is potentially applicable to a range of cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have plagued other personalized immunotherapeutic approaches. In addition to AGS-003, which is the company's leading product candidate, AGS-004 currently is in a phase 2 clinical trial for the treatment of HIV. It is being evaluated in combination with a latency reversing drug for HIV eradication in adult patients.
The agreement with Saint-Gobain "positions us to maximize throughput while processing biomaterials from multiple patients simultaneously in the same automated manufacturing suite," said Argos President and CEO Jeff Abbey in a prepared statement.
For its part, Saint-Gobain is excited to play a part in the rollout of this technology, which has the potential to "change the future of patient care in cancer and infectious diseases," said Steve Maddox, General Manager of Saint-Gobain Performance Plastics' Life Sciences business unit. "We believe our capabilities in design, component manufacturing, and custom fluid transfer assemblies, as well as testing and validation, are ideally suited to this cell therapy manufacturing automation project," said Maddox.