Specialty vaccine company Valneva SE (VALN:NASDAQ; VLA:FRA), which focuses on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need, today announced "positive topline results from the Phase 3 pivotal trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001."
"Our COVID vaccine as good or better than AstraZeneca's" - Valneva
The firm indicated that approximately 4,000 individuals 18 years of age and above were enrolled in the Phase 3 Cov-Compare study in 26 locations in the U.K. and stated that VLA2001 successfully met both co-primary endpoints in the trial. The company highlighted that with a neutralizing antibody seroconversion rate above 95%, VLA2001 demonstrated "superior neutralizing antibody titer levels compared to active comparator vaccine, AstraZeneca's AZD1222 (ChAdOx1-S)." In addition, Valneva stated that "VLA2001 was shown "to induce broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S (74.3%), M (20.3%) and N (45.9%) proteins."
The firm said that VLA2001 was generally well tolerated in the study and significantly outperformed compared to the active comparative vaccine. The company noted that no severe COVID-19 cases were recorded in the trial which it believes may imply that both vaccines administered in the trial acted well to prevent severe COVID-19 caused by the current virus and variants including the Delta variant.
The Phase 3 Cov-Compare Trial's Chief Investigator, Adam Finn, Professor of Pediatrics, University of Bristol, commented, "The low levels of reactogenicity and high functional antibody responses alongside broad T-cell responses seen with this adjuvanted inactivated whole virus vaccine are both impressive and extremely encouraging. This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic."
Valneva' CEO Thomas Lingelbach remarked, "These results confirm the advantages often associated with inactivated whole virus vaccines. We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the COVID-19 pandemic. We are keen to propose an alternative vaccine solution for people who have not yet been vaccinated."
"VLA2001 is the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe."
The company's Chief Medical Officer Juan Carlos Jaramillo, M.D., added, "I would like to thank the trial investigators as well as all trial participants and collaborators, especially the National Institute for Health Research and the clinical teams within the NHS Research Centres as well as Public Health England…We will continue to work very closely with the MHRA to complete our rolling submission for approval."
The company stated that "it commenced rolling submission for initial approval with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and is preparing to commence rolling submission for conditional approval with the European Medicines Agency (EMA).
The firm stated that it is now moving forward with its efforts for clinical trials to evaluate potential use of VLA2001 in children between 5 and 12 years of age. In addition, it plans to initiate a VLA2001 booster to determine the efficacy in individuals who may be in need or benefit from a booster shot.
The company mentioned that the Phase 3 Cov-Compare (VLA2001-301) trial is a randomized study conducted in 4,012 adults and 660 adolescents. The trial is designed to evaluate immunogenicity endpoints measuring the superiority of GMT ratio of its VLA2001 versus AstraZeneca Plc.'s (AZN:NASDAQ; AZN:LON) AZD1222 (ChAdOx1-S) vaccine. In addition, the study is said to be evaluating "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 in adults aged 30 years and older."
The company pointed out that presently, "VLA2001 is the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe."
Valneva is a specialty vaccine company headquartered in Saint Herblain, France that is engaged in targeted development and commercialization of preventative vaccines for infectious diseases. The firm noted that it has already been successful in commercializing two vaccines for preventing Japanese encephalitis and cholera and is leveraging that experience to advance a broad range of additional vaccine candidates into and through clinical development. The company is now investigating vaccine candidates to address Lyme disease, the chikungunya virus, COVID-19, Clostridium difficile (c diff.) and the Zika virus.
Valneva started the day with a market cap of around $1.39 billion with approximately 49.95 million shares outstanding. VALN shares opened almost 34% higher today at $37.51 (+$9.46, +33.73%) over Friday's $28.05 closing price. The company's U.S.-ADR shares have traded today between $36.32 and $40.8541 per share and closed for trading at $39.21 (+$11.16, +39.79%).
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