Medigen Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan

TAIPEI, Taiwan and EMERYVILLE, CA, USA I January 25, 2021 I Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO) a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901.  MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax.

MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance.

"MVC is delighted to receive the Phase 2 clinical trial IND approval by Taiwan FDA for MVC-COV1901 vaccine" said Charles Chen, Chief Executive Officer at Medigen. "We would like to express our deepest gratitude to all the volunteers, partners and Dynavax for the continued support.  MVC will continue with our best efforts to bring MVC-COV1901 vaccine to market to meet our commitment to help the global community in the fight against COVID-19."

"Dynavax is proud to collaborate with MVC and support their commitment to help the global fight against COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We are pleased with the results of Phase 1 clinical testing, where the combination of S-2P and CpG 1018 plus alum induced neutralizing antibody levels higher than human convalescent sera and was well tolerated, allowing for the continued development on the path to bringing this product to market to address the global demand for coronavirus vaccines."

About MVC-COV1901
MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by 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).  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 phase 1 clinical study data, MVC-COV1901 showed robust safety and promising immunogenicity responses and as a result entered Phase 2 clinical trial in 2020.

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.

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 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.

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.  Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships.   Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit https://www.dynavax.com and follow the company on LinkedIn.

SOURCE: Dynavax

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