Taipei, TAIWAN, June 5, 2022 -- Medigen Vaccine Biologics Corporation (MVC) today announced the completion of enrollment and dosing of the last subject in the company’s first-in-human (FIH) clinical study of its next-generation COVID-19 vaccine candidate (Beta) at Tri-Service General Hospital and Taipei Medical University Hospital; and the trial is in progress according to the target schedule. The animal challenge data of MVC next-generation beta vaccine has also been reviewed and published by the internationally renowned journal "Journal of Infectious Diseases" (JID):
https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiac153/6572278
Constructing a broad-spectrum cross-protective COVID-19 vaccine booster with genetic modification of beta variant is one of the research and development trends that many vaccine manufacturers are currently investing in. MVC’s project on the next-generation COVID-19 vaccine has found that the vaccine using the beta variant can produce a higher level of neutralizing antibodies against the current major variants and effectively reduce the lung viral loads of hamsters.
In this JID-published study, the research team used hamsters as the animal model, and inoculated hamsters with 2- or 3-dose with SARS-CoV-2 vaccines constructed from stabilized prefusion spike proteins (S-2P) of Wuhan or beta variants, to evaluate the neutralizing antibody titers against different SARS-CoV-2 variants in each vaccine group. Then the team challenged hamsters with the delta variant to observe lung live virus titer and pathology of the hamsters.
The study results show that in all treatment groups, 2 doses of Wuhan S-2P followed by a third dose of a booster of beta S-2P induced the highest neutralizing antibody titer against live SARS-CoV-2 viruses such as Alpha, Beta, Gamma, and Delta. Also, the group enhanced 3.8-folder neutralization of omicron variant pseudovirus compared to 3 doses of Wuhan S-2P. Furthermore, all treatment groups reduced lung live virus titer and pathology, suggesting that all vaccination regimens protect hamsters from SARS-CoV-2 infection. Therefore, the third dose of a booster of the next-generation COVID-19 vaccine (Beta) can protect against current different variants of concern and produce a broader and more efficient antibody neutralization response.
As the global COVID-19 pandemic and the mutation of SARS-CoV-2 continue, the long-term trend of the COVID-19 is inevitable. MVC will carry on with the evaluation of the next-generation potential vaccine and accelerate to obtain the human trial data of the beta-strain next-generation vaccine as the third and fourth shots, hoping to provide more scientific evidence for the global to be as a tool fight against the COVID-19 pandemic.
About Medigen Vaccine Biologics (MVC) Corporation
MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC’s pipeline includes COVID-19 vaccine (MVC-COV1901), enterovirus EV71 vaccine, dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. MVC-COV1901 vaccine's clinical study data has shown robust safety and promising immunogenicity responses and has as a result obtained Taiwan's EUA approval on July 19th, 2021, and Paraguay’s EUA approval on February 14th, 2022. MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19. MVC will continue to collaborate with international partners to develop promising COVID-19 vaccines and assist the global community in its fight against the ongoing pandemic. MVC’s large-scale production facility is state of the art and adherent to international PIC/s and GMP requirements. For more information, visit www.medigenvac.com.
MVC's Forward Looking Statements
This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 6547.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidates, MVC-COV1901 and jointly developed BW-1019, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC's COVID19 vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.