Valneva SE is trading significantly higher Wednesday following results from an initial laboratory study. Which demonstrated that serum antibodies induced by three doses of Valneva’s COVID-19 vaccine candidate, VLA2001, neutralize the omicron variant.
Sera from 30 participants in the Phase 1/2 trial VLA2001-201 were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the Delta and Omicron variants.
All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant. The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron.
Valneva said 100% of participants showed neutralizing antibodies against the ancestral virus and delta variant. While 87% showed neutralizing antibodies against the omicron variant.
“We are extremely pleased with these results,” said Chief Medical Officer Juan Carlos Jaramillo in a statement, noting that these added to an earlier Phase III trial that showed improved immune response with two doses of the VLA2001 candidate.
Valneva said it is continuing to provide data to the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency. The National Health Regulatory Authority in Bahrain is part of the rolling submissions process for initial approval of VLA2001. The company continues to expect to complete these submissions in time to receive potential regulatory approvals in the first quarter of 2022.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic. It potentially later for routine vaccination including addressing new variants.
VLA2001 may also be suited for boosting. It is as repeat booster vaccinations have been shown to work well with the whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine.
The stock was up 6% to $34.83 at 12:30 p.m. ET, after trading down as low as $30.26 earlier in the session as concerns mounted over the commercial prospects of its coronavirus vaccine candidate.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needs. The Company takes a highly specialized and targeted approach to vaccine development. Then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases.
Valneva has leveraged its expertise and capabilities to successfully commercialize two vaccines. To rapidly advance a broad range of vaccine candidates into and through the clinic. It includes candidates against Lyme disease, the chikungunya virus, and COVID-19.