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

Retrieved on: 
Wednesday, December 8, 2021
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Saint-Herblain (France), December 8, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Companys inactivated COVID-19 vaccine candidate VLA2001.

Key Points: 
  • Saint-Herblain (France), December 8, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Companys inactivated COVID-19 vaccine candidate VLA2001.
  • This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.
  • Last month, Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA20011.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe.

Valneva Comments on COV-Boost Clinical Trial Data

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Friday, December 3, 2021
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The Company has already begun generating data to inform any regulatory discussions regarding a potential booster indication for VLA2001.

Key Points: 
  • The Company has already begun generating data to inform any regulatory discussions regarding a potential booster indication for VLA2001.
  • The first data from a continuation of existing clinical trials (homologous) are expected in the first quarter of 2022.
  • Additionally, Valneva is in the process of setting up a dedicated heterologous booster trial.
  • On October 18, 2021, Valneva announced positive topline results from Cov-Compare, the pivotal Phase 3 comparative immunogenicity trial of VLA2001.

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

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Thursday, December 2, 2021
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Saint-Herblain (France), December 2, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (EMA) has started a rolling review of VLA2001, its whole-virus inactivated, adjuvanted COVID-19 vaccine candidate.

Key Points: 
  • Saint-Herblain (France), December 2, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (EMA) has started a rolling review of VLA2001, its whole-virus inactivated, adjuvanted COVID-19 vaccine candidate.
  • Valneva remains focused on achieving regulatory approvals of VLA2001 following its positive Phase 3 trial results.
  • Valneva is also providing an update on VLA2001 in the context of the emergence of the Omicron variant.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.

OSE Immunotherapeutics Provides an Update on the First Positive Results and Clinical Development of CoVepiT, its Multi-Target T-cell Anti-COVID Vaccine

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Tuesday, November 30, 2021
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Promising preclinical efficacy signals guide development in immunocompromised patients with poor antibody response to present registered anti-COVID vaccines.

Key Points: 
  • Promising preclinical efficacy signals guide development in immunocompromised patients with poor antibody response to present registered anti-COVID vaccines.
  • Results on the 6-month long-term memory T response, expected in the first quarter of 2022, will be a key element in further clinical development.
  • OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases.
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Valneva and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001

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Monday, November 29, 2021
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Saint-Herblain (France) and Dessau-Rolau (Germany), November 29, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced their collaboration for the production of Valnevas inactivated COVID-19 vaccine candidate VLA2001.

Key Points: 
  • Saint-Herblain (France) and Dessau-Rolau (Germany), November 29, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced their collaboration for the production of Valnevas inactivated COVID-19 vaccine candidate VLA2001.
  • Dr. Jrgen Betzing, Chief Executive Officer of IDT Biologika, added, This is great news for our company.
  • Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe.

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

Retrieved on: 
Tuesday, November 23, 2021
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Saint-Herblain (France), November 23, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years.

Key Points: 
  • Saint-Herblain (France), November 23, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years.
  • Thomas Lingelbach, Chief Executive Officer of Valneva, said, We are extremely pleased that the European Commission and the Member States have completed this purchase agreement and are eager to help address the ongoing pandemic.
  • We continue to receive messages from people across the world requesting access to an inactivated vaccine.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe.

Valneva Reports Nine-Month 2021 Revenue and Cash

Retrieved on: 
Thursday, November 18, 2021
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Saint Herblain (France), November 18, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its revenue and cash balance for the first nine months of the year 2021.

Key Points: 
  • Saint Herblain (France), November 18, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its revenue and cash balance for the first nine months of the year 2021.
  • Valnevas total revenues were 69.8 million in the first nine months of 2021 compared to 58.8million in the first nine months of 2020.
  • Liquid funds increased to 247.9 million as of September 30, 2021 compared to 156.2 million as of December 31, 2020.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

OSE Immunotherapeutics and the FoRT Foundation Announce First Patient Randomized in Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Opdivo® (nivolumab) in Non-Small Cell Lung Cancer

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Wednesday, November 17, 2021
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Clinical trial sponsored and conducted by the Italian Oncology Foundation FoRT and supported by Bristol Myers Squibb and OSE Immunotherapeutics.

Key Points: 
  • Clinical trial sponsored and conducted by the Italian Oncology Foundation FoRT and supported by Bristol Myers Squibb and OSE Immunotherapeutics.
  • A strategy of combining Opdivo, a PD-1 targeted checkpoint inhibitor, with Tedopi as a second-line treatment in patients with metastatic non-small cell lung cancer after first-line chemo-immunotherapy.
  • The clinical trial, sponsored and conducted by the Italian oncology foundation FoRT, is designed to enroll 105 patients.
  • In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.

OSE Immunotherapeutics Presented New Translational Data on Tedopi® and Preclinical Data on PD-1/IL-7 Bifunctional Program BiCKI®-IL-7

Retrieved on: 
Tuesday, November 16, 2021
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Both products aim at addressing the high unmet clinical needs of patients suffering from immune escape following checkpoint inhibitor treatments.

Key Points: 
  • Both products aim at addressing the high unmet clinical needs of patients suffering from immune escape following checkpoint inhibitor treatments.
  • This progress further reinforces the Companys leading position in immuno-oncology by pushing forward these high potential promising assets.
  • OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases.
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Valneva to Present its Chikungunya Vaccine Candidate at the ASTMH 2021 Annual Meeting

Retrieved on: 
Monday, November 15, 2021
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Saint-Herblain (France), November 15, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present its Chikungunya vaccine candidate, VLA1553, on November 18 and 19, 2021 during the American Society of Tropical Medicine & Hygiene (ASTMH) 2021 Annual Meeting.

Key Points: 
  • Saint-Herblain (France), November 15, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present its Chikungunya vaccine candidate, VLA1553, on November 18 and 19, 2021 during the American Society of Tropical Medicine & Hygiene (ASTMH) 2021 Annual Meeting.
  • At the beginning of August 2021, Valneva announced positive topline results for the Phase 3 pivotal trial of VLA1553.
  • TropMed21, the ASTMH 2021 Annual Meeting, is the premier international forum for the exchange of scientific advances in tropical medicine, hygiene and global health and will be 100% virtual this year.
  • VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to more than 100 countries.