Samsung Biologics and Vir Biotechnology, Inc announced April 9th a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody (mAb) program.
“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.” said Dr. Tae Han Kim, CEO of Samsung Biologics.
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.
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. The parties expect to execute a definitive agreement before July 31, 2020.
Established in 2011 and headquartered in Songdo, South Korea, Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. www.samsungbiologics.com.
Vir Biotechnology, Inc. (Nasdaq: VIR) is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. visit www.vir.bio.