Clinical validation of an antibiotic-resistant bacteria global vaccine platform through the first vaccine against Klebsiella pneumoniae

Grant number: 101189068

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Key facts

  • Disease

    Bacterial infection caused by Klebsiella pneumonia
  • Start & end year

    2025
    2026
  • Known Financial Commitments (USD)

    $2,603,270.57
  • Funder

    European Commission
  • Principal Investigator

    INFANTE Juan Jose
  • Research Location

    Spain
  • Lead Research Institution

    VAXDYN SL
  • Research Priority Alignment

    N/A
  • Research Category

    Vaccines research, development and implementation

  • Research Subcategory

    N/A

  • Special Interest Tags

    N/A

  • Study Type

    Non-Clinical

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

Abstract

VAXDYN, a Spanish biotech startup, is leading innovation with a novel vaccine platform targeting antimicrobial-resistant (AMR) infections, a critical global health threat. With projections indicating a potential cost of USD 100 trillion and over 10 million deaths by 2050 due to AMR, VAXDYN's work is of paramount importance. Their patented technology focuses on the most dangerous AMR bacteria, developing vaccines for four out of the six most urgent bacterial pathogens, which are responsible for 73% of AMR-related deaths worldwide. VAXDYN's vaccine platform stands out for its utilization of full Outer-Membrane Protein bacterial antigens with a safe carrier cell to stimulate immunity. This unique strategy has earned approval from European regulators and prestigious backers such as the CARB-X accelerator, funded by entities including the Bill and Melinda Gates Foundation and the Wellcome Trust. The company's lead vaccine, K-VAX, targets Klebsiella pneumoniae, the third leading cause of AMR deaths, claiming 700,000 lives annually. There are no current vaccines against this pathogen, which has a mortality rate exceeding 50%. VAXDYN's K-VAX aims to serve both the global elderly population and prevent neonatal sepsis in low-and middle-income countries, addressing a potential $6 billion market by 2035. VAXDYN is advancing K-VAX through Phase 1A trials, supported by CARB-X and private investors. The next steps involve Phase 1B and Phase 2 trials to determine the final formulation and efficacy, for which EIC funds are crucial. Post-trials, VAXDYN plans to license K-VAX, continuing the development of its second vaccine, P-VAX, for Pseudomonas aeruginosa infections in patients with chronic respiratory conditions. This strategic move underscores VAXDYN's commitment to addressing urgent health crises and leading in the AMR vaccine domain.