Junshi Completes Enrollment for Phase 1 Trial of COVID-19 Antibody

Shanghai-based Junshi Biosciences announced that it has finished enrolling participants in a phase 1 trial of JS016, its COVID-19 neutralizing antibody.

The randomized, double-blind, placebo-controlled phase 1 trial is evaluating the safety and tolerability of JS016 intravenous injection in 40 healthy subjects. The candidate is the first COVID-19 neutralizing antibody to enter clinical trials in China.

The antibody was made using Swiss-based Lonza’s gene expression technology, GS Xceed, a platform the companies previously used to develop China’s first anti-PD-1 cancer therapy launched in 2018.

The gene expression system “is expected to provide valuable support for the JS016 program by helping to improve cell line development timelines and improving yields,” Lonza said. Within just two months, Junshi completed preclinical studies, process development and production for good laboratory practice toxicity studies, as well as the good manufacturing practice production of clinical material, Lonza said.

Junshi is co-developing the neutralizing antibody with Eli Lilly. The Shanghai company is spearheading clinical development in China while Eli Lilly leads clinical development internationally.

Lonza has also penned a massive, decade-long manufacturing deal with Moderna. Under the agreement, Lonza anticipates expanding its capabilities to enable the production of up to one billion doses of Moderna’s vaccine candidate annually. The first batches are expected to be manufactured at Lonza’s U.S. facilities this month (DID, May 4). — James Miessler