Samsung Biologics and Vir Biotechnology, Inc. today announced a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody (mAb) program.
“We are proud to be working as a partner with Vir in their response to the global COVID-19 pandemic,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “With millions of people being impacted by this virus, accessibility to effective treatment is paramount. Vir’s candidate molecules supported by Samsung Biologics’ production scale have the potential to bring hope to countless lives across nations suffering from COVID-19.”
Vir’s lead SARS-CoV-2 mAb development candidates, VIR-7831 and VIR-7832, have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays. Vir plans to proceed directly into a phase 2 clinical trial within the next three to five months.
Today’s agreement builds on Vir’s previously announced manufacturing agreement with WuXi Biologics and its letter of intent with Biogen, Inc..
“Given the trajectory of the COVID-19 pandemic, our expectation is that there will be a significant need around the world for antibody therapies,” said George Scangos, Ph.D., CEO, Vir. “Accordingly, we are taking proactive steps to reserve large scale manufacturing capacity to be ready to move quickly with any of our antibody candidates that prove to be clinically safe and effective. We are pleased to partner with Samsung Biologics who share our commitment to work with exceptional speed to address this pandemic.”
Under the deal valued at approximately $362 million, Samsung Biologics is expected to commence its manufacturing as early as October with the first engineering run, with potential commercial batches to be manufactured starting in 2021 in Plant 3. The parties will continue to negotiate additional terms in a definitive agreement and will use best efforts to execute a definitive agreement before July 31, 2020.