Since this outbreak was first reported in late-2019, the 2019-nCov virus has so far infected thousands of people and has caused over one hundred reported deaths (as of January 28, 2020). The epidemic currently appears to be in an exponential phase.
Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, 2019-nCoV is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of 2019-nCoV is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry. Symptoms in infected patients include fever, coughing and breathing difficulties, and it can be fatal.
Clover is using its patented Trimer-Tag© technology to construct a recombinant 2019-nCoV S protein subunit-trimer vaccine (S-Trimer) and will produce it via a rapid mammalian cell-culture based expression system. Clover expects to obtain highly purified S-Trimer vaccine for further preclinical safety and analysis within the next 6-8 weeks. Having its own in-house cGMP biomanufacturing capabilities, Clover would potentially be able to rapidly scale-up and produce large-quantities of a coronavirus vaccine, if a successful vaccine candidate is able to be identified.
Clover has previously developed recombinant subunit-trimer vaccines for HIV, RSV and Influenza viruses utilizing its Trimer-Tag© technology and has demonstrated that they are able to evoke protective neutralizing antibody responses in multiple animal models.
“Upon knowing the genomic DNA sequence of this newly identified 2019-nCoV last week, we immediately started designing the vaccine construct and initiated its gene synthesis. Using our proprietary Trimer-Tag© protein trimerization technology, we plan to complete constructing the expression vector for S-Trimer vaccine and produce it for further evaluation within weeks,” said Dr. Peng Liang, co-founder, Chairman and President of Clover. “We believe that S-Trimer utilizing Trimer-Tag© technology will be faster to produce and potentially safer and more effective than vaccines produced via traditional approaches that involve lengthy live viral propagation, amplification, purification and heat/chemical attenuation or inactivation processes.”
“We are excited to initiate development of the S-Trimer vaccine candidate for 2019-nCoV and hope that by leveraging our proprietary Trimer-Tag© technology and cGMP biomanufacturing capabilities, we can help support global efforts to fight the growing 2019-nCoV epidemic,” said Joshua Liang, Chief Strategy Officer and Board Director at Clover. “To this end, we recognize that collaboration will be critical to accelerating the development of a successful vaccine, and we invite any interested regulatory, academic or industry parties to contact and collaborate with us.”
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. Having raised more than US$ 100 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit our website: www.cloverbiopharma.com. www.cloverbiopharma.com.
About Trimer-Tag© Technology
Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using Trimer-Tag technology to create trimerized fusion proteins that are able to effectively target these previously undruggable pathways.
About Wuhan Coronavirus 2019-nCoV
The new coronavirus identified in late-2019 was officially named by WHO as 2019-nCoV on January 12, 2020. Coronavirus is a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. 2019-nCoV has never before been found in human and has infected thousands and caused over one hundred deaths (as of January 28, 2020). Currently there are no vaccines or safe and effective treatments available for the virus.