2021/11/11 Clinical Development Updates on Medigen's MVC-COV1901 in COVID-19 Solidarity Trial Vaccines

TAIPEI, 11 November 2021 - Medigen Vaccine Biologics Corp (MVC), a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars, today provided an update on the clinical development status of its COVID-19 vaccine candidate, MVC-COV1901. MVC-COV1901 is one of two current vaccine candidates included in WHO's Solidarity Trial Vaccines (STV), a multi center, multi vaccine, adaptive, shared placebo, event driven, individually randomized controlled Phase 3 clinical trial. Recruitment for STV has begun at more than 40 sites across three countries, Colombia, Mali and the Philippines. To date, more than 4,000 participants have been enrolled for the trial.
The global COVID-19 pandemic has not yet been effectively controlled. According to Reuters COVID-19 Tracker, there have been 251 million confirmed cases and 5 million coronavirus-related deaths worldwide since the pandemic began and there are around 2000 new COVID-19 infections reported on average each day in participating sites in both Colombia, and the Philippines. The STV is conducted across three continents to obtain data related to safety and protection against a broad range of COVID-19 variants with the goal to “accelerate the evaluation of multiple promising candidate COVID-19 vaccines, contributing to the creation of a larger portfolio of vaccines needed to protect people from COVID-19 around the world.”
Charles Chen, Vice Chairman & CEO of MVC said, “Medigen is honored to be a part of the Solidarity Trial Vaccines and thankful towards the more than 4,000 participants having already enrolled in this meaningful clinical trial towards equitable access. Seeing promising results thus far, we are pleased to share the recent progress and it is our hope to have preliminary safety, immunogenicity and efficacy data in the first half of 2022.”
About MVC-COV1901
MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). CpG 1018 is developed and produced by Dynavax Technologies. Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and clinical studies, MVC-COV1901 has shown robust safety and promising immunogenicity responses. MVC-COV1901 has been granted emergency use authorization in Taiwan with vaccinations commencing Aug 23, 2021. MVC continues to pursue global regulatory recognition. MVC-COV1901 has been selected by an independent vaccine prioritization advisory group composed of leading global scientists and experts to be included in WHO Solidarity Trial Vaccines.
About Medigen Vaccine Biologics Corp. (MVC)
MVC is a biopharmaceutical company using cell-based technologies to develop novel 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 enterovirus EV71 vaccine, dengue vaccine, influenza quadrivalent vaccine which all have entered late clinical stage. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s 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: 65470.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidate, MVC-COV1901, 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 and 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.
Medigen Contact:
Paul Torkehagen
Director, International Business Development
Investor Relations:

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