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US-based Dynavax Technologies has partnered with Taiwan-based Medigen Vaccine Biologics to develop an adjuvanted Covid-19 vaccine candidate.
The partners will leverage Medigen’s stable prefusion form of the SARS-CoV2 recombinant spike protein in combination with Dynavax’s advanced adjuvant CpG 1018.
Medigen’s subunit vaccine is based on the technology licence from the US Vaccine Research Center at National Institutes of Health (NIH). In preclinical studies, this adjuvanted vaccine candidate was observed to produce ‘strong’ immune responses.
Medigen Vaccine Biologics CEO Charles Chen said: “In preclinical testing, the combination of Dynavax’s proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralising antibody responses and cellular immunity.
“These results support advancing evaluation of the combination into Phase I human testing, which we expect to begin in September of this year.”
Dynavax developed CpG 1018 to enable an enhanced vaccine immune response.
Data from pre-clinical and clinical studies showed that the addition of the adjuvant boosts antibody concentrations induces CD4+ and CD8+ T-cell populations and produces T and B-cell memory responses.
Dynavax expects its adjuvant to speed-up the development and large-scale production of a Covid-19 vaccine.
After completion of on-going scale up, the existing equipment capacity for CpG 1018 is estimated to be 600 million to 1.2 billion doses per year, based on final dose selected.
Dynavax Technologies CEO Ryan Spencer said: “CpG 1018 is expected to enhance the immune response and may play an important role in developing an effective vaccine, especially for populations traditionally less responsive to vaccination such as older adults who are at greatest risk for severe disease from Covid-19.”
In March, Dynavax partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) to create a vaccine against Covid-19.
As part of the alliance, the company agreed to provide access to CpG 1018, used in HEPLISAV-B, a US Food and Drug Administration (FDA)-approved hepatitis B vaccine for adults.