Dynavax Technologies Corporation, a biopharmaceutical company, announced that Valneva SE reported positive topline results from the phase 3 pivotal trial of VLA2001, their inactivated Covid-19 vaccine candidate using Dynavax's CpG 1018 adjuvant.

Valneva reported that the phase 3 COV-COMPARE trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 (ChAdOx1-S), in terms of geometric mean titer for neutralization antibodies (GMT ratio=1.39, p<0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48, 862.59)), (AZD1222(ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older.  VLA2001 was generally well-tolerated. The tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine. Participants 30 years and older reported significantly fewer solicited adverse events up to seven days after vaccination, both with regards to injection site reactions and systemic reactions (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001) and systemic reactions (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001). No unsolicited treatment-related serious adverse events (SAE) have been reported. Less than 1% reported an adverse event of special interest in both treatment groups. Participants in the younger age group vaccinated with VLA2001 showed an overall safety profile comparable to the older age group.

Ryan Spencer, chief executive officer of Dynavax commented, "With these results announced by Valneva,  our CpG 1018 adjuvant has now been shown to help drive a robust immune response while maintaining a favorable  tolerability profile in multiple phase 3 trials across different vaccine platforms. This data further supports the value of CpG 1018 in the global response to the pandemic and as a platform for developing new and improved vaccines. We look forward to continuing to support Valneva in the development and approval of their inactivated COVID-19 vaccine to make it available to those in need."

Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in 4,012 adults and 660 adolescents. Co-Primary immunogenicity endpoints are superiority of GMT ratio of VLA2001 compared to AZD1222 (ChAdOx1-S) as well as non-inferiority of seroconversion rates of neutralizing antibodies administered in a two-dose immunization schedule four weeks apart, measured at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It also evaluates the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults and adolescents aged 12 years and older. The trial is being conducted at 26 sites across the UK 2,972 participants 30 years of age and older were randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=1,977) or AZD1222 (ChAdOx1-S) (n=995) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from 990 participants (492 vaccinated with VLA2001, 498 vaccinated with AZD1222 (ChAdOx1-S)) who tested sero-negative for SARS-CoV-2 at screening were analyzed. 1,040 participants that are under 30 years of age were recruited in a non-randomized treatment group and received VLA2001 28 days apart. Safety data on those participants aged 18-29 years of age are analyzed in parallel to the adults aged 30 years and above. Recently, the trial commenced enrolling the first adolescent participants.

CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an enhanced vaccine immune response, which has been demonstrated in HEPLISAV-B and in multiple Covid-19 vaccine candidates. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, supporting development and large-scale manufacturing of a Covid-19 vaccine.

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines.