Medigen's COVID-19 Vaccine Combined with Dynavax's CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October
MVC's Phase 1 study is an open-label, single-center, staggered dose-escalation study intended to assess the safety and immunogenicity of the stable prefusion form of SARS-CoV-2 recombinant spike protein S-2P at three dose levels (low, medium and high) adjuvanted with CpG 1018 plus alum, in approximately 45 healthy subjects 20 to 50 years of age. The vaccination schedule consists of two doses for each study participant, administered via intramuscular (IM) injection 28 days apart, on Day 1 and Day 29.
"The pre-clinical study results demonstrated that the combination of our S-2P vaccine candidate and CpG 1018 plus alum provided safety and immunogenicity sufficient to advance to Phase 1 development," said
MVC's subunit vaccine is based on the stable prefusion form of the SARS-CoV2 recombinant spike protein with global technology license from the
About Vaccine Adjuvants
An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the
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 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 and GMP requirements. For more information, visit www.medigenvac.com.
About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)
SARS-CoV-2 is a new coronavirus identified in late 2019 which belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus causes a disease named COVID-19. Since this outbreak was first reported in late 2019, the virus has infected over 19.9 million people and has caused over 732,000 reported deaths (as of
Dynavax Forward-Looking Statements
This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 plus aluminum combined with MVC's subunit vaccine will prove to be beneficial in clinical trials, , whether and when the vaccine will be approved for use, and whether sufficient quantities of CpG 1018 will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
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