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VAXDYN SOCIEDAD LIMITADA
SEVILLA, 41013
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Subcontracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | THE SPANISH BIOTECHNOLOGY COMPANY VAXDYN HAS DEVELOPED PROPRIETARY TECHNOLOGY ENABLING THE EXPRESSION AND PRESENTATION OF HETEROLOGOUS ANTIGENS ON THE SURFACE OF DETOXIFIED BACTERIAL CELLS. THIS TECHNOLOGY FACILITATES THE DEVELOPMENT OF MULTI-ANTIGEN BACTERIAL VACCINES, PRESENTING KEY ANTIGENS IN THEIR NATIVE CONFORMATION TO CELLS OF THE HOST IMMUNE SYSTEM. IT HAS BEEN VALIDATED DURING THE PROJECT THROUGH THE DELIVERY OF VACCINE CANDIDATES TARGETING EITHER KLEBSIELLA PNEUMONIAE OR PSEUDOMONAS AERUGINOSA. IMMUNITY IS DIRECTED TOWARDS MULTIPLE OUTER-MEMBRANE PROTEIN (OMP) ANTIGENS, WHICH ARE HIGHLY CONSERVED AMONG ALL CIRCULATING CLINICAL ISOLATES OF A PARTICULAR TARGETED PATHOGEN. THIS PROPERTY ENABLES THE ACHIEVEMENT OF EXTENSIVE STRAIN COVERAGE, INCLUDING STRAINS CIRCULATING IN DIFFERENT REGIONS OF THE WORLD. THEREFORE, A SINGLE PRODUCT CAN PROVIDE GLOBAL PROTECTION. THIS ASPECT REPRESENTS A KEY COMPETITIVE ADVANTAGE OF THE TECHNOLOGY. THIS PROJECT AIMS TO ADVANCE THE DEVELOPMENT OF K-VAX, A PROPHYLACTIC VACCINE FOR THE PREVENTION OF INVASIVE DISEASES CAUSED BY KLEBSIELLA PNEUMONIAE IN VARIOUS AT-RISK POPULATIONS, THROUGH CLINICAL PHASE 1. KLEBSIELLA PNEUMONIAE WAS THE SECOND LEADING CAUSE OF DEATH ASSOCIATED WITH ANTIBIOTIC RESISTANCE IN 2019. LOW AND MIDDLE-INCOME COUNTRIES (LMICS) ARE SEVERELY AFFECTED BY K. PNEUMONIAE, CURRENTLY THE LEADING CAUSE OF NEONATAL SEPSIS. K. PNEUMONIAE IS PARTICULARLY PROBLEMATIC IN PATIENTS WITH CHRONIC RESPIRATORY DISEASES AND OTHER COMORBIDITIES WEAKENING THE IMMUNE SYSTEM. IT IS ALSO THE SECOND LEADING CAUSE OF URINARY TRACT INFECTIONS. THE GLOBAL PROLIFERATION OF HYPERVIRULENT AND ANTIBIOTIC-RESISTANT STRAINS OF K. PNEUMONIAE IS ALREADY CAUSING SIGNIFICANT INVASIVE SOFT TISSUE INFECTIONS IN IMMUNOCOMPETENT INDIVIDUALS. REGARDING THE PROTECTION OF NEONATES BY MATERNAL IMMUNIZATION, IT HAS BEEN REPORTED THAT A MATERNAL K. PNEUMONIAE VACCINE WITH THE SAME POPULATION COVERAGE AS THE TETANUS VACCINE PROGRAM IN LMICS COULD PREVENT 400,000 NEONATAL DEATHS. THUS, THE SUCCESSFUL DEVELOPMENT OF A PROPHYLACTIC VACCINE AGAINST K. PNEUMONIAE COULD SIGNIFICANTLY ENHANCE THE CLINICAL MANAGEMENT OF MULTIDRUG-RESISTANT INFECTIONS CAUSED BY THIS PATHOGEN." THE REMAINING ACTIVITIES THAT WILL BE CARRIED OUT DURING THIS PROJECT INCLUDE THE FOLLOWING: 1. FINAL DEVELOPMENT OF MANUFACTURING PROTOCOL FOR K-VAX, INCLUDING DELIVERY OF ANALYTICAL METHODS, RELEASE ASSAY, AND FINAL DEFINITION AND ANALYSIS OF CONSISTENCY OF CRITICAL QUALITY ATTRIBUTES. 2. ANALYSIS OF PROTECTION IN A MURINE SEPSIS MODEL AND ROLE OF ADJUVANT ALUMINUM HYDROXIDE. 3. ANALYSIS OF PROTECTION IN A MURINE PNEUMONIA MODEL. 4. ANALYSIS OF POTENTIAL OF K-VAX FOR MATERNAL IMMUNIZATION TO PROTECT NEONATES. 5. QUANTITATIVE ANALYSIS OF FUNCTIONAL ANTIBODIES IN THE SERA OF VACCINATED ANIMALS. 6. ANALYSIS OF STRAIN COVERAGE. 7. MANUFACTURING OF BATCH FOR GLP-TOX STUDIES. 8. GLP-TOXICITY PACKAGE IN RABBITS. 9. GMP-MANUFACTURING OF THE CLINICAL BATCH. 10. REGULATORY SCIENTIFIC ADVICE AND PRE-CLINICAL TRIAL APPLICATION MEETINGS WITH THE PAUL EHRLICH INSTITUTE. 11. FILING AND ACCEPTANCE OF THE CLINICAL TRIAL APPLICATION. 12. RECRUITMENT AND COMPLETION OF A PHASE I CLINICAL TRIAL IN ORDER TO ASSESS VACCINE SAFETY AND PRELIMINARY STUDIES ON IMMUNOGENICITY IN HUMANS. THE FOLLOWING INSTITUTIONS WILL PARTICIPATE AS PROJECT PARTNERS: NATIONAL CENTER OF MICROBIOLOGY OF THE HEALTH INSTITUTES “CARLOS III” OF SPAIN (MADRID); THE INSTITUTE OF BIOMEDICINE OF A CORUÑA (RUN BY THE PROFESSOR NOVOA SANTOS FOUNDATION, FPNS, OF THE UNIVERSITY OF A CORUÑA, SPAIN); LABORATORIOS REIG-JOFRÉ (BARCELONA); QUEEN’S UNIVERSITY OF BELFAST (UK); VIVEXIA (DIJON, FRANCE); BIODEXTRIS (CDMO; LAVAL, QUEBEC, CANADA); INTRAVACC (UTRECHT, THE NETHERLANDS); LEADS TO DEVELOPMENT (PARIS); HOFFMANN-EITLE (MADRID); PHARMALEX (MUNICH, GERMANY); AND UNIVERSITY HOSPITAL VIRGEN DEL ROCÍO OF SEVILLE (SPAIN). KC3460 Parent award context Parent award agency: Department of Health and Human Services · Office of Assistant Secretary for Preparedness and Response Parent award NAICS: 541714 Parent award performance state: MA Parent award description: CARB-X GLOBAL ANTIBACTERIAL ACCELERATOR OTA View parent award on USAspending | — | $2,039,117 | Jan 23, 2023 | — – — |
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