Covid-19 – Valneva vaccine shows robust immune response in trial.

Valneva has reported that initial results from Part A of the Phase I/II clinical trial of its inactivated Covid-19 vaccine candidate, VLA2001 demonstrated to be highly immunogenic in 153 healthy adults aged 18 to 55 years.
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VLA2001 has inactivated whole virus particles of SARS-CoV-2 with high S-protein density along with two adjuvants, alum and Dynavax’s CpG 1018.

As per the initial data, the vaccine demonstrated to be generally safe and well-tolerated in all dose groups and was also highly immunogenic with a 100% seroconversion rate for S-protein binding IgG antibodies in high dose group.

Two weeks after a two-dose regimen in the high dose group, the geometric mean titer of neutralising antibodies was similar or above the levels for a panel of convalescent sera.

Valneva CEO Thomas Lingelbach said: “Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play.

“This includes potential modifications to the vaccine to address variants, using our existing manufacturing process.”

On obtaining regulatory approval, Valneva anticipates initiating a pivotal, comparative immunogenicity Phase III trial with the high dose formulation by this month-end.

In a separate development, Ampio Pharmaceuticals has reported results from a pre-clinical study showing that its lead drug candidate, Ampion, hinders a vital pro-inflammatory pathway in the types of immune cells implicated in Covid-19 and lupus nephritis.

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