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Details:

VLA15, an alum-adjuvanted formulation administered intramuscularly, is a vaccine candidate currently undergoing clinical development. It is in Phase III clinical trial studies for the treatment of Lyme disease.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 04, 2023

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VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established MoA for a Lyme disease vaccine that targets the OspA of Borrelia burgdorferi, the bacteria that cause Lyme disease.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 01, 2022

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Proceeds to be primarily used to continue to advance both the company’s Phase 3 Lyme disease, VLA15 and chikungunya vaccine candidates towards marketing approval and to progress preclinical assets.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Goldman Sachs

Deal Size: $99.9 million Upfront Cash: Undisclosed

Deal Type: Public Offering October 04, 2022

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The Company expects to use the net proceeds for the co-development and marketing of its vaccine candidate against Lyme disease (VLA15), to finance the development and marketing of its vaccine candidate against the chikungunya virus (VLA1553), VLA1554 and VLA2112.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Goldman Sachs

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering September 28, 2022

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VLA15 is only Lyme disease vaccine candidate currently in clinical development.uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 08, 2022

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Valneva is planning to use the proceeds to support its contribution to the planned Phase 3 development program for Lyme disease vaccine candidate VLA15. Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: $95.0 million Upfront Cash: Undisclosed

Deal Type: Financing June 23, 2022

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Details:

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A of Borrelia burgdorferi.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 20, 2022

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In pediatric participants (5-17 years old) who received VLA15 in either the two-dose schedule (N=93) or three-dose schedule (N=97), VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: PF-07307405

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2022

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Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and, subject to regulatory approval.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: PF-07307405

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 04, 2022

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VLA15 is the only Lyme disease vaccine in clinical development worldwide while VLA1553 is the only single-shot chikungunya vaccine candidate in Phase 3 clinical trials and VLA2001 the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2021

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VLA15 is the only active Lyme disease vaccine candidate in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for Lyme disease vaccine that targets outer surface protein A (OspA) of Borrelia burgdorferi.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2021

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VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 that enrolls a pediatric population aged 5 years and older.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 19, 2021

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VLA15 will be tested at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg. VLA15 is the only Lyme disease vaccine candidate in active clinical development.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: PF-07307405

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Valneva

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 08, 2021

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Details:

Valneva plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc. (NYSE: PFE), with the planned initiation of study VLA15-221 in the first quarter of 2021, subject to regulatory approval.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 02, 2020

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VLA15 was generally safe across all doses and age groups tested. The tolerability profile including fever rates was comparable to other lipidated recombinant vaccines or lipid containing formulations.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: VLA15

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2020

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Details:

Valneva and Pfizer will work closely together throughout the development of VLA15. The agreement was signed at the end of April 2020 to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: $308.0 million Upfront Cash: $130.0 million

Deal Type: Agreement June 08, 2020

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Details:

Valneva and Pfizer will work closely together to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Pfizer Inc

Deal Size: $308.0 million Upfront Cash: $130.0 million

Deal Type: Collaboration April 30, 2020

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Details:

Valneva will use funds to further advance its leading Lyme and chikungunya development programs and to repay existing debt.


Lead Product(s): VLA15

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Deerfield Management Company

Deal Size: $85.0 million Upfront Cash: $60.0 million

Deal Type: Financing February 03, 2020

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