VALN Valneva SE

35.35
-2.31  -6%
Previous Close 37.66
Open 36.11
52 Week Low 24.1573
52 Week High 67.84
Market Cap $1,857,039,783
Shares 52,532,950
Float 52,532,950
Enterprise Value $1,614,486,888
Volume 82,625
Av. Daily Volume 88,028
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Upcoming Catalysts

Drug Stage Catalyst Date
VLA2001-304 + alum and CpG 1018
COVID-19 vaccine
Phase 3
Phase 3
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VLA1553
Chikungunya Virus Infection
Phase 3
Phase 3
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VLA1553-302
Chikungunya Vaccine
Phase 3
Phase 3
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VLA15-221
Lyme disease pediatric and adult vaccine
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
VLA2001-201
Booster shot COVID-19 vaccine
Phase 1/2
Phase 1/2
Phase 1/2 trial commenced enrollment and provided boosters to volunteers September 23, 2021. Phase 1/2 data reported that antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels, and were four-fold higher compared to two weeks after primary immunization, noted December 16, 2021. Additional data reported that 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, noted January 19, 2022. Phase 3 trial planned for 2022.
VLA2001-301 + alum and CpG 1018 (COV-COMPARE)
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 top-line data reported that trial met both co-primary endpoints, noted October 18, 2021.
VLA15-202
Lyme disease
Phase 2
Phase 2
Phase 2 18 month data reported trial met primary endpoint, however antibody decline confirmed a need for boosters. Booster data yielded a 2.9-fold to 4.2-fold increase in anti-OspA IgG antibody titers compared with titers observed after primary immunization, noted September 28, 2021. Phase 3 trial planned for 2022.

Latest News

    • Preliminary laboratory studies demonstrate that three doses of Valneva's inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B.1.1.529 lineage) 
    • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

    Saint Herblain (France), January 19, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva's inactivated 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…

    • Preliminary laboratory studies demonstrate that three doses of Valneva's inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B.1.1.529 lineage) 

    • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

    Saint Herblain (France), January 19, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva's inactivated 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.

    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, "We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our inactivated, adjuvanted whole virus vaccine and its ability to address currently circulating variants of concern. These results add to earlier findings from our Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and a broad T-cell response. We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can."

    Valneva is continuing to provide data to the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency, and the National Health Regulatory Authority in Bahrain (NHRA) as 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 2022.1

    Valneva announced in November 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years – including 24.3 million doses in 20222. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the EMA. Valneva also announced in December 2021 that it had signed an agreement to supply one million doses of VLA2001 to the Kingdom of Bahrain, with deliveries planned in the first quarter of 2022 subject to approval from the Bahraini NHRA.3

    About Valneva's Cross-Neutralization Laboratory Studies

    Neutralization of the currently circulating variants of concern, Delta and Omicron, induced by vaccination with VLA2001 was tested using a pseudovirus neutralization assay. The tested sera were collected from participants in Valneva's Phase 1/2 trial, VLA2001-201, two to four weeks after receiving a booster dose of VLA2001. The booster dose had been administered seven to eight months after the second dose of the priming schedule.

    To assess neutralization, pseudoviruses expressing the spike (S) protein from either the ancestral SARS-CoV-2 virus, the Delta variant, or the Omicron variant were pre-incubated with serial dilutions of individual serum samples and then used to infect target cells. Neutralization was calculated from the reduction of infection efficiency at different serum dilutions compared to a no serum control. The assays and analyses were performed by the German Primate Center (Deutsches Primatenzentrum).4

    About VLA2001

    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 and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with 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, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    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 need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials of VLA2001 and with respect to possible regulatory approval of VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva Confirms Clinical Trial and Regulatory Submission Timelines for its Inactivated COVID-19 Vaccine Candidate VLA2001

    2 Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001

    3 Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001

    4 For further details of the method, please see Hoffmann et al, Cell 2021 Apr 29; 184(9):2384-2393.

     

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  1. Saint Herblain (France), January 6, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.

    The Company also announced positive homologous booster results…

    Saint Herblain (France), January 6, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.

    The Company also announced positive homologous booster results at the end of December 20213. The data showed an excellent immune response after a third dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. Valneva is also evaluating the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with licensed COVID-19 vaccines or following natural COVID-19 infection.

    VLA2001 is also being evaluated in elderly and adolescent volunteers. The Company expects to report topline data for the elderly trial in the coming weeks.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "In recent weeks, we have been receiving even more messages every day from people around the world who would like to be vaccinated with an inactivated vaccine and want to know more about VLA2001. We continue to believe that our inactivated vaccine candidate could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can. We look forward to sharing further data in due course."

    Valneva announced in November 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years – including 24.3 million doses in 20224. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the EMA.

    About VLA2001

    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 and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with 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, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    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 need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001

    2 Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

    3 Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

    4 Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001

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  2. Saint Herblain (France), December 23, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it is in advanced discussions, with Scottish Enterprise, for a multi-million pound grant which will enable it to fully complete its strategic manufacturing site in Livingston, Scotland.

    Following the termination of the supply agreement with the UK Government (HMG) for Valneva's inactivated COVID-19 vaccine candidate, VLA2001, Valneva paused its site plans. Valneva and Scottish Enterprise have since engaged in a highly constructive dialogue, and under the proposed grant, the Livingston site will be fully developed as a key vaccine production site for the long term.

    Both Valneva and Scottish Enterprise would invest…

    Saint Herblain (France), December 23, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it is in advanced discussions, with Scottish Enterprise, for a multi-million pound grant which will enable it to fully complete its strategic manufacturing site in Livingston, Scotland.

    Following the termination of the supply agreement with the UK Government (HMG) for Valneva's inactivated COVID-19 vaccine candidate, VLA2001, Valneva paused its site plans. Valneva and Scottish Enterprise have since engaged in a highly constructive dialogue, and under the proposed grant, the Livingston site will be fully developed as a key vaccine production site for the long term.

    Both Valneva and Scottish Enterprise would invest in the plant. Scottish Enterprise's contribution is expected to be through a series of grants totalling £10-20 million to enable Valneva to commence production at the plant. Discussions between the Company and the Scottish Government also include potential supply of VLA2001 for Scotland in the future, subject to regulatory approval. Valneva has also offered to make up to 25,000 doses of VLA2001 available for primary immunisation, free of charge, to National Health Service and frontline workers in Scotland, subject to regulatory approval. The grant is subject to contract and final due diligence and is expected to include commitments to jobs for the future in Livingston.

    Commenting, David Lawrence, Acting Chief Financial Officer, said "We're pleased that we've been able to advance discussions with Scottish Enterprise quickly, following the UK Government's unexpected decision to terminate our supply agreement with them. We've reported excellent Phase 3 data and homologous booster data in the past couple of months, underlining the potential importance of VLA2001 – our inactivated, adjuvanted whole virus vaccine. Subject to regulatory approval we want to make VLA2001 available to people who need it, as soon as we can. We already have some vaccine stock available for distribution, upon approval. The grant will be very welcome and, subject to contract, will ensure that Livingston becomes a strategic vaccine manufacturing site for the future, successfully completing the work we began with HMG".

    Ivan McKee, Scottish Government Minister for Business, Trade, Tourism and Enterprise, said "Valneva is a valued contributor to our life sciences sector and the Livingston facility is an important asset, developing vaccines for the treatment of several important infectious diseases and supporting high quality jobs. Ministers and Scottish Enterprise are in advanced discussions with the company to agree a package of support which would underpin the company's operations in Scotland."

    Hannah Bardell, MP for Livingston, added "I am delighted that the Scottish Government and Scottish Enterprise have listened to my constituency colleagues and I by agreeing to invest in Valneva's vaccine manufacturing site in Livingston. This funding will enable Valneva to complete its expansion, boosting vital production capacity and protecting skilled jobs. It has been a pleasure to work with all involved in securing this agreement and I can only hope the UK Government will see the faith that we in Scotland have in Valneva."

    Valneva is continuing to try to reach an amicable resolution with HMG regarding its termination of the supply agreement and performance of the ongoing clinical trial agreement. The Company continues to reserve all rights in the event that an amicable outcome is not achieved.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials 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 and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with 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, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    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 need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investors Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

      

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, relating to regulatory approval of product candidates, and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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  3. Saint Herblain (France), December 21, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.

    Lot-to-lot trials demonstrate manufacturing consistency, one of the standard requirements for vaccine licensure. The trial, which included 408 participants aged 18 to 45 years, confirmed the excellent immunogenicity profile demonstrated in the pivotal Phase 3 trial, VLA1553-301…

    Saint Herblain (France), December 21, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.

    Lot-to-lot trials demonstrate manufacturing consistency, one of the standard requirements for vaccine licensure. The trial, which included 408 participants aged 18 to 45 years, confirmed the excellent immunogenicity profile demonstrated in the pivotal Phase 3 trial, VLA1553-301. All three lots were equally well tolerated and the safety profile was consistent with results in the pivotal Phase 3 trial. Study VLA1553-302 therefore confirmed clinical equivalence as well as manufacturing consistency of the three lots.

    Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, "We are extremely pleased with these lot-to-lot Phase 3 data, which come in addition to the compelling pivotal Phase 3 results we reported in August. The lot-to-lot data will be part of our submission with the US Food and Drug Administration (FDA), which we plan to start in 2022. Chikungunya is a major, growing and unmet public health threat, yet no vaccine or specific treatment is currently available to prevent this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible."

    The lot-to-lot trial will continue towards final six-month analysis with final trial results expected in the second quarter of 2022.

    Valneva's chikugunya program was awarded Breakthrough Therapy Designation by the US FDA in July 2021. This new milestone followed the US FDA's Fast Track designation and the European Medicines Agency (EMA)'s PRIME designation which the Company received in December 2018 and in October 2020, respectively. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV) 1.

    About Chikungunya

    Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there were more than 3 million reported cases in the Americas2 and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

    About VLA1553

    VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to more than 100 countries. It has been designed by deleting a part of the chikungunya virus genome.

    In August 2021, Valneva reported positive topline results for pivotal Phase 3 clinical trial, VLA1553-301. In this double-blind, multi-center, randomized Phase 3 clinical trial, 4,115 participants aged 18 years and above were randomized 3:1 into two groups to receive either 0.5mL of VLA1553 or a placebo. The trial met its primary endpoint, inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.2-99.6). The seroprotective titer was agreed with the FDA to serve as a surrogate of protection that can be utilized in a submission for approval of VLA1553 under the accelerated approval pathway. VLA1553 was highly immunogenic, with a GMT of approximately 3,270.

    VLA1553 was generally well tolerated among the 3,082 subjects evaluated for safety. An independent Data Safety Monitoring Board, or DSMB, continuously monitored the study and identified no safety concerns. The majority of solicited adverse events were mild or moderate and resolved within 3 days.

    Additionally, VLA1553 was highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as an equally good safety profile.

    VLA1553-301 will continue towards final analysis including the 6-month safety data. The Company expects to report final trial results in early 2022.

    VLA1553 would expand Valneva's existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for chikungunya vaccines is estimated to exceed $500 million annually by 20323.

    To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA15534. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 20195, which provides funding of up to $23.4 million with support from the European Union's Horizon 2020 program.

    About Phase 3 study VLA1553-302

    VLA1553-302 clinical lot-to-lot consistency Phase 3 study is a prospective, multicenter, randomized, pivotal Phase 3 study including 408 participants aged 18 to 45 years. Lyophilized VLA1553 are administered as a single intramuscular immunization. Equivalence of immune responses will be determined based on neutralizing antibody titers. The primary objective of the study is to evaluate a pair-wise comparison of the 95% Confidence Interval (CI) on the ratio of GMTs on Day 29 after vaccination in the three vaccine lots. The two-sided 95% CI on the GMT ratio should be within 0.67 and 1.5 in order to demonstrate consistency.

    Study volunteers will be followed for six months after vaccination. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04786444).

    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 need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. Valneva has leveraged its expertise and capabilities to successfully commercialize two wholly owned vaccines and rapidly advance multiple vaccine candidates into late-stage clinical development, including candidates against Lyme disease (partnered with Pfizer), the chikungunya virus and COVID-19.

    Media & Investors Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, PhD

    VP Global Investor Relations

    M +001 917 815 4520

      

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 https://priorityreviewvoucher.org/

    2 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 13 Oct 2020.

    3 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020

    4 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries

    5 CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine

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    • Initial results show excellent immune response after third dose of VLA2001 administered 7 to 8 months after the second dose of primary vaccination
    • Antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels
    • Antibody titers four-fold higher compared to two weeks after primary immunization
    • Evaluating sera from boosted participants for cross-neutralization against Variants Of Concern, including Omicron

    Saint Herblain (France), December 16, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity…

    • Initial results show excellent immune response after third dose of VLA2001 administered 7 to 8 months after the second dose of primary vaccination
    • Antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels
    • Antibody titers four-fold higher compared to two weeks after primary immunization
    • Evaluating sera from boosted participants for cross-neutralization against Variants Of Concern, including Omicron

    Saint Herblain (France), December 16, 2021 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination.

    77 of the 153 original Phase 1/2 study participants, aged 18-55 years, received a booster dose seven to eight months after completion of their primary immunization with either a low, medium or high dose of VLA2001. All participants received a single booster vaccination with VLA2001 at the same (high) dose level used in the pivotal Phase 3 "Cov-Compare" trial.1 IgG antibody titers (spike protein-based) were measured at the time of the booster as well as two weeks after the booster dose. 45 of the 77 boosted participants were included in the final analysis.2

    A third dose of VLA2001 elicited an excellent anamnestic response, with similar antibody levels observed whether participants were initially vaccinated with a low, medium or high dose (GMT 9699.3 (95%CI: 8497.76, 11070.71)). This represents a strong boosting effect, increasing levels of antibodies against the Wuhan virus 42- to 106-fold, depending on the pre-boosting levels of antibodies.

    Antibody levels measured two weeks after the booster dose were approximately four-fold higher compared to those observed two weeks after primary immunization.

    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented: "We are extremely pleased to report our first booster data, confirming that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination and regardless of the initial neutralizing antibody level at the time of boosting. Boostering several months, typically six months or more, after primary immunisation is generally effective for inactivated, adjuvanted vaccines. Our teams are working diligently on our rolling review regulatory submissions so that we can quickly deploy our vaccine and ensure it reaches the people who need it. I would like to thank again the trial investigators, participants and collaborators, especially the National Institute for Health Research and the clinical teams within the NHS Research Centres."

    In addition to these initial booster data, Valneva expects to report further homologous booster data from the Phase 3 Cov-Compare study. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with other vaccines or following natural infection. This study is expected to commence in early 2022.

    Valneva will also evaluate the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron.

    About Phase 1/2 Trial VLA2001-201

    VLA2001-201 is a randomized, dose-finding trial to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 trial evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years were recruited in the trial. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).

    77 subjects from the 153 study participants originally included in the Phase 1/2 trial received a booster dose approximately 7-8 months after completion of their primary vaccination series.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials 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 and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with 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, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    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 need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

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    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, relating to regulatory approval of product candidates, and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

    2 27 of the remaining participants who were not included in the final analysis had also received another COVID-19 vaccine, and five experienced a COVID-19 infection during the study.

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