Samsung Biologics, Vir in $362-M Mfg Pact for COVID-19 mAbsBy
Samsung Biologics, a contract biologics manufacturer, and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have formed a manufacturing agreement, valued at $362 million, under which Samsung Biologics will provide large-scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody (mAb) program. SARS-CoV-2 is the virus that causes the novel coronavirus (COVID-19).
Vir’s SARS-CoV-2 mAb development candidates, VIR-7831 and VIR-7832, have shown high affinity for the SARS-CoV-2 spike protein and are used in neutralizing SARS-CoV-2 in live-virus cellular assays, according to information from Vir Biotechnology. Vir says it plans to proceed directly into a Phase II clinical trial within the next three to five months (as reported on April 10, 2020). This pact builds on Vir’s previously announced manufacturing agreement with WuXi Biologics announced in February 2020 for potential COVID-19 treatments and its letter of intent signed with Biogen last month (March 2020) for clinical manufacturing of potential COVID-19 treatments.
Under the deal valued at approximately $362 million, Samsung Biologics is expected to commence its manufacturing as early as October (October 2020) with the first engineering run, with potential commercial batches to be manufactured starting in 2021. The parties say they will continue to negotiate additional terms in a definitive agreement and will use best efforts to execute a definitive agreement before July 31, 2020.