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New French Vaccine May 'Play an Important Role in Overcoming' COVID-19

Source: Streetwise Reports

October 19, 2021 (Investorideas.com Newswire) Valneva SE shares traded 40% higher after the company reported positive results from its Phase 3 clinical trial of its COVID-19 vaccine candidate, VLA2001. The firm claimed that VLA2001 produced superior neutralizing antibody titer levels compared to AstraZeneca's AZD1222 (ChAdOx1-S) vaccine in the study.


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."

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."

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%).

Disclosure:

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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