Medigen, Dynavax COVID-19 Vaccine Receives Taiwan, China Government Subsidy

Medigen Vaccine Biologics and Dynavax Technologies announced that MVC has obtained a Taiwan, China government subsidy for successfully initiating a Phase 1 clinical trial in Taiwan, China Region of China. The first participant in MVC's Phase 1 clinical trial was dosed with MVC's COVID-19 vaccine combined with Dynavax's CpG 1018 adjuvant at National Taiwan, China University Hospital in early October. The subsidy will be released at agreed upon milestones in the total amount of up to NT$ 472 million (US$ 16.4 million). The grant received by MVC was earmarked by the Taiwan, China government for purposes of research and development of a locally produced COVID-19 vaccine.

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 Charles Chen, Chief Executive Officer of MVC. "We are pleased with the pre-clinical data and the potential to demonstrate clinical benefit and have a positive impact fighting this global pandemic motivates our team to undertake the clinical development ahead."

"Dynavax is proud to be working with MVC as they begin the Phase 1 trial for an adjuvanted vaccine candidate to help prevent COVID-19," said Ryan Spencer, Chief Executive Officer of Dynavax. "Based on the preclinical studies the combination of S-2P and CpG 1018 plus alum has the potential to provide critical enhancements to the immune response to drive increased protection for adults, especially those who are traditionally less responsive to vaccination and are at greatest risk for severe disease from COVID-19."

MVC's subunit vaccine is based on the stable prefusion form of the SARS-CoV2 recombinant spike protein with global technology license from the U.S. Vaccine Research Center at National Institutes of Health (NIH).

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.

CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.