Biopharmaceutical company Dynavax Technologies Corporation (Nasdaq:DVAX) on Monday provided an update from Valneva SE's positive topline results from the Phase 3 pivotal trial of the inactivated COVID-19 vaccine candidate VLA2001 using Dynavax's CpG 1018 adjuvant.
The Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in 4,012 adults and 660 adolescents. The trial is being conducted at 26 sites across the UK. About 2,972 participants 30 years of age and older were randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 or AZD1222 at the recommended dose level, 28 days apart.
Additionally, 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 well- developed technology and safety database, supporting development and large-scale manufacturing of a COVID-19 vaccine.
According to the company, VLA2001 successfully met both co-primary endpoints. Its superior neutralizing antibody titer levels were compared to active comparator vaccine, AstraZeneca's AZD1222 (ChAdOx1-S). Its neutralizing antibody seroconversion rate was above 95%. VLA2001 was well-tolerated, demonstrating a statistically significant better tolerability profile compared to active comparator vaccine.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA