Lonza and Junshi Biosciences have announced that the first healthy volunteer has been dosed in a Phase I clinical study of JS016 at Huashan Hospital affiliated to Fudan University in China.

JS016 is the first SARS-CoV-2 neutralizing antibody that has entered clinical trials in China and is produced using Lonza’s GS Xceed gene expression system. This follows on from a successful launch of the first PD-1-targeting antibody using GS Xceed last year.

At the start of the COVID-19 outbreak, Junshi Biosciences rapidly launched the R&D program focused on neutralizing antibodies using Lonza's GS Xceed expression system. Within 2 months, the company had completed investigational new drug (IND) enabling preclinical studies, process development and production for GLP toxicity studies, as well as the GMP production of clinical material.

Junshi Biosciences is collaborating with Eli Lilly to co-develop JS016 globally, with Junshi leading clinical development in Greater China and Lilly leading clinical development in the rest of the world.

Lonza’s expression technology platform includes host cell lines, vectors, and access to optimized media and feeds, as well as comprehensive methods and processes. It can express a diverse range of biologic drugs and has an unparalleled track record of successfully taking programs from gene through cell line construction to commercial products.

Together with the technical and regulatory expertise, this expression system is expected to provide valuable support for the JS016 program by helping to improve cell line development timelines and improving yields.

Dr Feng Hui, Chief Operation Officer of Junshi Biosciences said: “Time to market is critical in this campaign against COVID-19. By leveraging Lonza’s GS Xceed gene expression system, Junshi is now successfully advancing JS016 into clinical stage in China. This powerful GS platform enabled us to fast-track chemistry, manufacturing and controls (CMC) development from stable cell line generation to non-GMP Tox material supply to GMP clinical manufacturing."

                                                                                                                  From CPhI Online