Walvax Biotech Launches Phase IIIb Clinical Trial of ARCoVaX mRNA COVID-19 Booster Vaccine

Source: PharmaCube Info

Author: Sunshine

On November 24, the website of the Chinese Clinical Trial Registry showed that Walvax registered a Phase IIIb clinical trial (Registration No.: ChiCTR2100053551) to evaluate the immunogenicity and safety of the booster dose of the mRNA vaccine (ARCoVaX) against the novel coronavirus in people aged 18-59 and 60 years or older who have received the inactivated COVID-19 vaccine. ARCoVaX is also the first domestically produced mRNA vaccine in China to enter Phase III clinical trials.

ARCoVaX is an mRNA vaccine jointly developed by Abogen, Walvax, and the Academy of Military Medical Sciences to prevent COVID-19 caused by SARS-CoV-2 infection. It is encapsulated by lipid nanoparticles (LNPs) and targets the RBD region of the SARS-CoV-2 spike protein. A 100μg dose can induce high levels of neutralizing antibodies, while a 1000μg dose shows no significant adverse reactions. Single or two-dose immunization with ARCoV elicits robust antibody and T-cell responses against various prevalent SARS-CoV-2 strains in mice and non-human primates. Preclinical study results have been published in the journal Cell.

According to the information disclosed by Abogen, the protection rate of ARCoVaX is comparable to that of marketed vaccines. Its biggest advantage is that it does not require frozen storage and can be stored at 2°C-8°C for at least 7 months.

On May 11, 2020, Walvax and Abogen signed the "Technology Development Cooperation Agreement" to jointly collaborate on the research and development as well as commercial production of the COVID-19 mRNA vaccine. According to the terms of the agreement, Abogen is primarily responsible for the preclinical research of the COVID-19 mRNA vaccine, while Walvax mainly focuses on the QA, QC, IND, clinical research, NDA, and commercial production of the vaccine. After the approval and market launch of the COVID-19 mRNA vaccine, Walvax will pay Abogen a total of 80 million RMB in development and clinical milestone fees.