SONGDO, South Korea and SAN FRANCISCO—Samsung Biologics Co., Ltd. and Vir Biotechnology, Inc. have reported 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 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.
“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, chief executive officer 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.”
Under the deal, which is valued at approximately $362 million, Samsung Biologics is expected to begin manufacturing as early as October with the first engineering run. Potential commercial batches will be manufactured starting in 2021, in Plant 3. Vir and Samsung Biologics will continue to negotiate additional terms in a definitive agreement, and expect to execute a definitive agreement before July 31, 2020.
“Given the trajectory of the COVID-19 pandemic, our expectation is that there will be a significant need around the world for antibody therapies. 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,” added George Scangos, Ph.D., chief executive officer of Vir. “We are pleased to partner with Samsung Biologics who share our commitment to work with exceptional speed to address this pandemic.”
Vir has been quite busy with the dealmaking of late, creating or expanding other agreements with four other companies in the last few weeks alone.
On April 6, Vir and GlaxoSmithKline plc (GSK) signed a binding agreement for a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. The collaboration plans to use Vir’s proprietary monoclonal antibody platform technology to accelerate existing anti-viral antibodies, and to identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. To gain access to Vir’s technology, GSK is making a $250 million equity investment in Vir.
The companies will use GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. Vir and GSK will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
Due to the urgent patient need for COVID-19 solutions, the initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform — VIR-7831 and VIR-7832. Subject to regulatory review, the companies plan to proceed directly into a Phase 2 clinical trial within the next three to five months.
Vir and GSK have also agreed to conduct research into SARS-CoV-2 and other coronavirus vaccines by coupling GSK’s vaccines technologies and expertise with Vir’s ability to identify neutralizing epitopes that are present across entire viral families. These efforts will be additive to other initiatives GSK is advancing to develop a potential vaccine for COVID-19.
Also, on April 2, Vir and Alnylam Pharmaceuticals, Inc. expanded their existing collaboration for the development and commercialization of RNAi therapeutics in order to focus on three targets focused on host factors for SARS-CoV-2.
The two named targets include angiotensin converting enzyme-2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2). ACE2 is known to be the viral entry receptor for SARS-CoV-2 and other coronaviruses, while TMPRSS2 is believed to cleave the SARS-CoV-2 spike protein to facilitate cellular attachment. The third target is expected to emerge from Vir’s ongoing functional genomics efforts to identify novel host factors pertinent to coronaviral infection and targetable by siRNA, mAbs or small molecules.
On March 30, Generation Bio Co. and Vir announced a collaborative research agreement for Generation Bio’s non-viral gene therapy platform to extend the impact and reach of Vir’s current or future mAbs against SARS-CoV-2.
Generation Bio’s technology has the potential to deliver genetic information directly to cells without the use of adeno-associated viruses, in effect instructing the patient’s body to produce the antibody itself. The companies believe that this, coupled with Vir’s potent neutralizing antibodies, has the potential to provide effective, long-lasting protection against SARS-CoV-2.
Vir’s leading antibody was isolated from a SARS-CoV-1 recovered patient and potently neutralizes SARS-CoV-2. Vir believes that this approach can potentially provide broad and longer-lasting protection.
And March 12 brought word that Vir had signed the aforementioned letter of intent with Biogen for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19.
Because of the urgency of the situation, the companies have begun work while a Clinical Development and Manufacturing Agreement is being negotiated. Subject to the completion of a definitive agreement, Biogen will continue cell line development, process development and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies.
Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2, which were isolated from individuals who had survived a severe acute respiratory syndrome (SARS) infection. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.