Benzinga | Apr 6, 2021 06:03AM EDT

Dynavax Announces Valneva SE Reported Results From Part A Of Phase 1/2 Trial Of Its COVID-19 Vaccine Using Dynavax's CpG 1018 Adjuvant; Valneva Plans To Commence Phase 3 Trial By End Of Apr.

Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Valneva SE reported positive initial results for Part A of the Phase 1/2 clinical trial of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, using Dynavax's CpG 1018(tm) adjuvant in 153 healthy adults aged 18 to 55 years. Based on these results, Valneva plans to commence a pivotal Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

In their press release issued April 6th, 2021 (available here), Valneva reported that VLA2001 was generally safe and well tolerated across all dose groups tested and was highly immunogenic with a seroconversion rate for S-protein binding IgG antibodies of 100% in the high dose group. The IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay. The geometric mean titer of neutralizing antibodies measured two weeks after completion of the two-dose schedule in this group was at or above levels for a panel of convalescent sera.

Ryan Spencer, Chief Executive Officer Dynavax, said, "We are excited to see the positive results Valneva has generated with their inactivated vaccine using Dynavax's CpG 1018 adjuvant. We believe the effect delivered by our CpG 1018 adjuvant combined with Valneva's existing manufacturing process for whole virus inactivated vaccines will result in an important option in the global fight against COVID-19. This platform has potential to allow rapid modifications to the vaccine as needed to address variants using Valneva's existing manufacturing process."

Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial with the high dose formulation by the end of April 2021. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.