VLA2001

Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate

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Tuesday, March 26, 2024
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Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the

Key Points: 
  • Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the
    the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).
  • The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States.
  • Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules2.
  • This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.

Valneva Provides Clinical and Regulatory Updates for its COVID-19 Vaccine VLA2001

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Thursday, March 2, 2023
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Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001.
  • As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a new partnership1.
  • It is, however, completing remaining clinical studies and submissions as agreed with regulators.
  • The T-cell response against the spike protein elicited upon vaccination with VLA2001 was in the same range as for the active comparator.

Valneva Reports Further Heterologous Booster Data for its inactivated COVID-19 vaccine

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Friday, December 30, 2022
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Saint-Herblain (France), December 30, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further heterologous booster data from an exploratory, small clinical study for its inactivated COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint-Herblain (France), December 30, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further heterologous booster data from an exploratory, small clinical study for its inactivated COVID-19 vaccine, VLA2001.
  • The data show that a booster dose of VLA2001 was well tolerated in previously BNT162b2 (Pfizer/BioNTech)- or mRNA 1273 (Moderna)-vaccinated participants, confirming the favorable safety profile of VLA2001 seen across all studies – including in homologous or heterologous booster settings2.
  • The Company previously reported positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca) in August 20223 and positive homologous booster results at the end of December 20214.
  • Valneva is currently seeking regulatory approval for VLA2001 as a homologous booster as well as heterologous booster in ChAdOx1-S (AstraZeneca) primed individuals which may support the Company in deploying its inventory in international markets5.

Valneva Hosts Investor Day in New York City

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Tuesday, December 6, 2022
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Saint-Herblain (France), December 06, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an in-person investor day today in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions.

Key Points: 
  • Saint-Herblain (France), December 06, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an in-person investor day today in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions.
  • While completion of the BLA submission is expected by year end, Valneva is focused on pre-commercial and market access preparations.
  • Valneva successfully generated a stabilized pre-fusion F protein antigen, which forms the basis of the proprietary vaccine candidate VLA1554.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva Provides Further Update on its COVID-19 Activities

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Monday, September 26, 2022
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Saint-Herblain (France), September 26, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.

Key Points: 
  • Saint-Herblain (France), September 26, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.
  • The Company is in active discussions with a prospective partner for potentially funding the development of a second-generation COVID-19 vaccine.
  • Valneva currently has agreements to supply VLA2001 to certain EU Member States2 and the Kingdom of Bahrain6.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration

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Friday, September 16, 2022
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As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT.

Key Points: 
  • As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • IDT Biologika is an innovative biotech company with a successful history dating back 100 years.
  • In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.

Valneva Announces Publication of its COVID-19 Vaccine Phase 3 Data in The Lancet Infectious Diseases

Retrieved on: 
Tuesday, September 6, 2022
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Saint-Herblain (France), September 6, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that The Lancet Infectious Diseases (The Lancet ID), a peer-reviewed medical journal, has published the Companys pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint-Herblain (France), September 6, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that The Lancet Infectious Diseases (The Lancet ID), a peer-reviewed medical journal, has published the Companys pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.
  • Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, This Lancet publication is a strong scientific and developmental validation of the work that has been accomplished at Valneva.
  • The Company published safety and immunogenicity data from the Phase 1/2 trial of VLA2001 in the Journal of Infection3 in June 2022.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva Reports Further Positive Phase 3 Immunogenicity and the First Heterologous Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine VLA2001

Retrieved on: 
Monday, August 29, 2022
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Saint-Herblain (France), August 29, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 results for its inactivated, adjuvanted COVID-19 vaccine VLA2001.

Key Points: 
  • Saint-Herblain (France), August 29, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 results for its inactivated, adjuvanted COVID-19 vaccine VLA2001.
  • Additional readouts from the Companys pivotal VLA2001-301 Cov-Compare trial showed persistent immunogenicity and first positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca).
  • The safety profile of VLA2001 continues to be favorable and the vaccine was well tolerated up to Day 208.
  • This complements the positive homologous booster data weve generated in our Phase 1/2 and this Phase 3.

Valneva Confirms WHO Recommendations for its Inactivated COVID-19 Vaccine

Retrieved on: 
Tuesday, August 23, 2022
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Saint-Herblain (France), August 23, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Companys inactivated COVID-19 vaccine.

Key Points: 
  • Saint-Herblain (France), August 23, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Companys inactivated COVID-19 vaccine.
  • WHO may further update its interim recommendations to include additional uses of Valnevas COVID-19 vaccine as new data are made available.
  • Valneva currently has agreements to supply VLA2001 to certain EU Member States2 and the Kingdom of Bahrain3.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva’s Inactivated COVID-19 Vaccine

Retrieved on: 
Monday, August 1, 2022
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Under this amendment, the Member States purchases of VLA2001, Valnevas inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.

Key Points: 
  • Under this amendment, the Member States purchases of VLA2001, Valnevas inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.
  • The Company expects to deliver the first vaccine doses to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.