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IDORSIA PHARMACEUTICALS LTD
ALLSCHWIL
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Subcontracting experience
3 records 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 | BACKGROUND KLEBSIELLA PNEUMONIAE (K. PNEUMONIAE, KP) IS A NOTORIOUS PATHOGEN FREQUENTLY RESPONSIBLE FOR NOSOCOMIAL RESPIRATORY TRACT AND INTENSIVE CARE INFECTIONS. IT IS THE SECOND MOST COMMON CAUSE OF GRAM-NEGATIVE BACTEREMIA AND URINARY TRACT INFECTIONS. DRUG RESISTANT ISOLATES ARE ASSOCIATED WITH HIGH MORTALITY (GREATER THAN 50% ACCORDING TO SOME STUDIES), ADD SIGNIFICANTLY TO HOSPITAL STAYS, AND ARE ESPECIALLY PROBLEMATIC IN SUCH MEDICAL AREAS AS ICUS. K. PNEUMONIAE PROPHYLACTIC VACCINATION AGAINST DRUG RESISTANT STRAINS WOULD BE AN EFFECTIVE STRATEGY TO REDUCE THE INCIDENCE OF INFECTIONS AND ANTI-MICROBIAL RESISTANCE. THERE ARE NO APPROVED K. PNEUMONIAE VACCINES AND NO CLEAR EVIDENCE OF ANY ADVANCING IN DEVELOPMENT. IDORSIA BERLIN IS WORKING ON A MULTIVALENT VACCINE TARGETING MULTIPLE STRAINS OF CARBAPENEM RESISTANT K. PNEUMONIAE (CRKP). IDORSIA BERLIN´S PRODUCT IS A MULTI-VALENT O ANTIGEN PROPHYLACTIC VACCINE CURRENTLY IN PRECLINICAL DEVELOPMENT. TARGET COVERAGE IS MORE THAN 90% OF CARBAPENEM RESISTANT STRAINS. UNMET MEDICAL NEED ANTIMICROBIAL RESISTANCE HAS BECOME AN INCREASINGLY SERIOUS PROBLEM IN K. PNEUMONIAE INFECTIONS. CRKP STRAINS ARE THE MOST PROMINENTLY FOUND AMONG THE RESISTANT PATHOGENS, OFTEN CARRYING ADDITIONAL GENES THAT CONFER RESISTANCE TO SEVERAL OTHER CLASSES OF ANTIMICROBIALS. THIS RESULTS IN MORE THAN 40% OF K. PNEUMONIAE ISOLATES SHOWING MULTIDRUG RESISTANCE-PHENOTYPES IN CERTAIN O-ANTIGEN EXPRESSING STRAINS. GIVEN THE LIMITED TREATMENT OPTIONS OF CRKP INFECTIONS, MORTALITY RATES ARE HIGH, VARYING BETWEEN 10% AND 70%, DEPENDING ON THE SITE OF INFECTION. IT IS RECOGNIZED THAT THE PREVENTION OF THE TRANSMISSION FROM CRKP-COLONIZED OR INFECTED INDIVIDUALS REPRESENTS A VERY EFFECTIVE STRATEGY TO REDUCE THE IMPACT OF THE INFECTION IN ACUTE CARE HOSPITALS AND LONG-TERM CARE FACILITIES. WHILE, CURRENT PREVENTIVE RECOMMENDATIONS FOCUS ON BASIC INFECTION PREVENTION PRACTICES, THERE IS AN URGENT UNMET NEED FOR EFFECTIVE INTERVENTION STRATEGIES TO PREVENT TRANSMISSION OF CRKP INFECTIONS. IDORSIA BERLIN´S TECHNOLOGY APPROACH CHALLENGES IN DEVELOPMENT TIMELINES, MANUFACTURING AND QUALITY CONTROL COMPLEXITY STILL BROADLY PERSIST AS EVIDENCED BY THE DISCONTINUATION OF MANY CONJUGATE VACCINE DEVELOPMENT PROGRAMS AND LENGTHY DEVELOPMENT PATHWAYS OF CURRENTLY APPROVED ONES. IDORSIA BERLIN COMPLETED SUCCESSFULLY THE PRECLINICAL DEVELOPMENT OF A C. DIFFICILE SPECIFIC VACCINE WHICH WILL NOW ENTER CLINICAL DEVELOPMENT IN 2024. TECHNOLOGY APPLIED TO K. PNEUMONIAE K. PNEUMONIAE CONSISTS OF CAPSULAR POLYSACCHARIDES (CPS) AND LIPOPOLYSACCHARIDES (LPS) ON ITS OUTER SHELL. THESE CPS AND LPS STRUCTURES ARE IMMUNOGENIC AND ARE RECOGNIZED BY THE IMMUNE SYSTEM UPON INFECTIONS, EITHER CAUSING IMMUNITY NATURALLY, OR BY VACCINES SPECIFICALLY TARGETING CPS- OR LPS-ANTIGENS. FOR K. PNEUMONIAE, THE LIMITED VARIATION IN LPS-ANTIGENS WHEN COMPARED TO CPS ANTIGENS, MAKES THEM MORE SUITABLE TARGETS FOR VACCINE DEVELOPMENT. HOWEVER, PRODUCTION OF LPS-BASED VACCINES IS EXTREMELY CHALLENGING DUE TO TOXIC COMPONENTS THAT ATTACH THE LPS TO THE OUTER MEMBRANE OF BACTERIA. LPS DETOXIFIED MOLECULES ARE VIRTUALLY IMPOSSIBLE TO ISOLATE AND PURIFY, SO FAR PREVENTING DEVELOPMENT OF SUCH VACCINES. IDORSIA BERLIN EMPLOYS AN ALTERNATIVE APPROACH: THE SYNTHESIS OF LPS O-ANTIGENS WHICH AMONG OTHER ADVANTAGES OF SYNTHETIC GLYCAN CHEMISTRY ELIMINATES THE POTENTIAL CONTAMINATION RISKS OF THE LPS. IDORSIA BERLIN HAS IDENTIFIED THE LEAD ANTIGENS AND WILL COMPLETE PRECLINICAL CHARACTERIZATION OF THE MULTIVALENT VACCINE IN Q1/2024. 4500004575 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 | — | -$60,584 | Dec 14, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | BACKGROUND KLEBSIELLA PNEUMONIAE (K. PNEUMONIAE, KP) IS A NOTORIOUS PATHOGEN FREQUENTLY RESPONSIBLE FOR NOSOCOMIAL RESPIRATORY TRACT AND INTENSIVE CARE INFECTIONS. IT IS THE SECOND MOST COMMON CAUSE OF GRAM-NEGATIVE BACTEREMIA AND URINARY TRACT INFECTIONS. DRUG RESISTANT ISOLATES ARE ASSOCIATED WITH HIGH MORTALITY (GREATER THAN 50% ACCORDING TO SOME STUDIES), ADD SIGNIFICANTLY TO HOSPITAL STAYS, AND ARE ESPECIALLY PROBLEMATIC IN SUCH MEDICAL AREAS AS ICUS. K. PNEUMONIAE PROPHYLACTIC VACCINATION AGAINST DRUG RESISTANT STRAINS WOULD BE AN EFFECTIVE STRATEGY TO REDUCE THE INCIDENCE OF INFECTIONS AND ANTI-MICROBIAL RESISTANCE. THERE ARE NO APPROVED K. PNEUMONIAE VACCINES AND NO CLEAR EVIDENCE OF ANY ADVANCING IN DEVELOPMENT. IDORSIA BERLIN IS WORKING ON A MULTIVALENT VACCINE TARGETING MULTIPLE STRAINS OF CARBAPENEM RESISTANT K. PNEUMONIAE (CRKP). IDORSIA BERLIN´S PRODUCT IS A MULTI-VALENT O ANTIGEN PROPHYLACTIC VACCINE CURRENTLY IN PRECLINICAL DEVELOPMENT. TARGET COVERAGE IS MORE THAN 90% OF CARBAPENEM RESISTANT STRAINS. UNMET MEDICAL NEED ANTIMICROBIAL RESISTANCE HAS BECOME AN INCREASINGLY SERIOUS PROBLEM IN K. PNEUMONIAE INFECTIONS. CRKP STRAINS ARE THE MOST PROMINENTLY FOUND AMONG THE RESISTANT PATHOGENS, OFTEN CARRYING ADDITIONAL GENES THAT CONFER RESISTANCE TO SEVERAL OTHER CLASSES OF ANTIMICROBIALS. THIS RESULTS IN MORE THAN 40% OF K. PNEUMONIAE ISOLATES SHOWING MULTIDRUG RESISTANCE-PHENOTYPES IN CERTAIN O-ANTIGEN EXPRESSING STRAINS. GIVEN THE LIMITED TREATMENT OPTIONS OF CRKP INFECTIONS, MORTALITY RATES ARE HIGH, VARYING BETWEEN 10% AND 70%, DEPENDING ON THE SITE OF INFECTION. IT IS RECOGNIZED THAT THE PREVENTION OF THE TRANSMISSION FROM CRKP-COLONIZED OR INFECTED INDIVIDUALS REPRESENTS A VERY EFFECTIVE STRATEGY TO REDUCE THE IMPACT OF THE INFECTION IN ACUTE CARE HOSPITALS AND LONG-TERM CARE FACILITIES. WHILE, CURRENT PREVENTIVE RECOMMENDATIONS FOCUS ON BASIC INFECTION PREVENTION PRACTICES, THERE IS AN URGENT UNMET NEED FOR EFFECTIVE INTERVENTION STRATEGIES TO PREVENT TRANSMISSION OF CRKP INFECTIONS. IDORSIA BERLIN´S TECHNOLOGY APPROACH CHALLENGES IN DEVELOPMENT TIMELINES, MANUFACTURING AND QUALITY CONTROL COMPLEXITY STILL BROADLY PERSIST AS EVIDENCED BY THE DISCONTINUATION OF MANY CONJUGATE VACCINE DEVELOPMENT PROGRAMS AND LENGTHY DEVELOPMENT PATHWAYS OF CURRENTLY APPROVED ONES. IDORSIA BERLIN COMPLETED SUCCESSFULLY THE PRECLINICAL DEVELOPMENT OF A C. DIFFICILE SPECIFIC VACCINE WHICH WILL NOW ENTER CLINICAL DEVELOPMENT IN 2024. TECHNOLOGY APPLIED TO K. PNEUMONIAE K. PNEUMONIAE CONSISTS OF CAPSULAR POLYSACCHARIDES (CPS) AND LIPOPOLYSACCHARIDES (LPS) ON ITS OUTER SHELL. THESE CPS AND LPS STRUCTURES ARE IMMUNOGENIC AND ARE RECOGNIZED BY THE IMMUNE SYSTEM UPON INFECTIONS, EITHER CAUSING IMMUNITY NATURALLY, OR BY VACCINES SPECIFICALLY TARGETING CPS- OR LPS-ANTIGENS. FOR K. PNEUMONIAE, THE LIMITED VARIATION IN LPS-ANTIGENS WHEN COMPARED TO CPS ANTIGENS, MAKES THEM MORE SUITABLE TARGETS FOR VACCINE DEVELOPMENT. HOWEVER, PRODUCTION OF LPS-BASED VACCINES IS EXTREMELY CHALLENGING DUE TO TOXIC COMPONENTS THAT ATTACH THE LPS TO THE OUTER MEMBRANE OF BACTERIA. LPS DETOXIFIED MOLECULES ARE VIRTUALLY IMPOSSIBLE TO ISOLATE AND PURIFY, SO FAR PREVENTING DEVELOPMENT OF SUCH VACCINES. IDORSIA BERLIN EMPLOYS AN ALTERNATIVE APPROACH: THE SYNTHESIS OF LPS O-ANTIGENS WHICH AMONG OTHER ADVANTAGES OF SYNTHETIC GLYCAN CHEMISTRY ELIMINATES THE POTENTIAL CONTAMINATION RISKS OF THE LPS. IDORSIA BERLIN HAS IDENTIFIED THE LEAD ANTIGENS AND WILL COMPLETE PRECLINICAL CHARACTERIZATION OF THE MULTIVALENT VACCINE IN Q1/2024. 4500004575 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 | — | $60,584 | Nov 16, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | BACKGROUND
KLEBSIELLA PNEUMONIAE (K. PNEUMONIAE, KP) IS A NOTORIOUS PATHOGEN FREQUENTLY RESPONSIBLE FOR NOSOCOMIAL RESPIRATORY TRACT AND INTENSIVE CARE INFECTIONS. IT IS THE SECOND MOST COMMON CAUSE OF GRAM-NEGATIVE BACTEREMIA AND URINARY TRACT INFECTIONS. DRUG RESISTANT ISOLATES ARE ASSOCIATED WITH HIGH MORTALITY (GREATER THAN 50% ACCORDING TO SOME STUDIES), ADD SIGNIFICANTLY TO HOSPITAL STAYS, AND ARE ESPECIALLY PROBLEMATIC IN SUCH MEDICAL AREAS AS ICUS.
K. PNEUMONIAE PROPHYLACTIC VACCINATION AGAINST DRUG RESISTANT STRAINS WOULD BE AN EFFECTIVE STRATEGY TO REDUCE THE INCIDENCE OF INFECTIONS AND ANTI-MICROBIAL RESISTANCE. THERE ARE NO APPROVED K. PNEUMONIAE VACCINES AND NO CLEAR EVIDENCE OF ANY ADVANCING IN DEVELOPMENT. VAXXILON IS WORKING ON A MULTIVALENT VACCINE TARGETING MULTIPLE STRAINS OF CARBAPENEM RESISTANT K. PNEUMONIAE (CRKP).
VAXXILON€„¢S PRODUCT IS A MULTI-VALENT O ANTIGEN PROPHYLACTIC VACCINE CURRENTLY IN PRECLINICAL DEVELOPMENT. TARGET COVERAGE OF THE VALENCIES IS MORE THAN 80% OF CARBAPENEM RESISTANT STRAINS.
UNMET MEDICAL NEED
ANTIMICROBIAL RESISTANCE HAS BECOME AN INCREASINGLY SERIOUS PROBLEM IN K. PNEUMONIAE INFECTIONS. CRKP STRAINS ARE THE MOST PROMINENTLY FOUND AMONG THE RESISTANT PATHOGENS, OFTEN CARRYING ADDITIONAL GENES THAT CONFER RESISTANCE TO SEVERAL OTHER CLASSES OF ANTIMICROBIALS. THIS RESULTS IN MORE THAN 17% OF K. PNEUMONIAE ISOLATES SHOWING MULTIDRUG RESISTANCE-PHENOTYPES. GIVEN THE LIMITED TREATMENT OPTIONS OF CRKP INFECTIONS, MORTALITY RATES ARE HIGH, VARYING BETWEEN 10% AND 70%, DEPENDING ON THE SITE OF INFECTION. IT IS RECOGNIZED THAT THE PREVENTION OF THE TRANSMISSION FROM CRKP-COLONIZED OR INFECTED INDIVIDUALS REPRESENTS A VERY EFFECTIVE STRATEGY TO REDUCE THE IMPACT OF THE INFECTION IN ACUTE CARE HOSPITALS AND LONG-TERM CARE FACILITIES. WHILE, CURRENT PREVENTIVE RECOMMENDATIONS FOCUS ON BASIC INFECTION PREVENTION PRACTICES, THERE IS AN URGENT UNMET NEED FOR EFFECTIVE INTERVENTION STRATEGIES TO PREVENT TRANSMISSION OF CRKP INFECTIONS.
VAXXILON€„¢S TECHNOLOGY APPROACH
CHALLENGES IN DEVELOPMENT TIMELINES, MANUFACTURING AND QUALITY CONTROL COMPLEXITY STILL BROADLY PERSIST AS EVIDENCED BY THE DISCONTINUATION OF MANY CONJUGATE VACCINE DEVELOPMENT PROGRAMS AND LENGTHY DEVELOPMENT PATHWAYS OF CURRENTLY APPROVED ONES. TO DEMONSTRATE THE TECHNOLOGY€„¢S POTENTIAL, VAXXILON CONDUCTED SUCCESSFUL PROOF OF CONCEPT (POC) STUDIES WITH TWO PROPRIETARY SEMI-SYNTHETIC VACCINES: ONE AGAINST S. PNEUMONIAE SEROTYPE 3 (ST3) AND THE OTHER AGAINST H. INFLUENZAE TYPE B (HIB). THE APPROACH RELIES ON THE IDENTIFICATION OF EFFECTIVE ANTIGENS AND THE CREATION OF CONJUGATE VACCINE CANDIDATES.
TECHNOLOGY APPLIED TO K. PNEUMONIAE
K. PNEUMONIAE CONSISTS OF CAPSULAR POLYSACCHARIDES (CPS) AND LIPOPOLYSACCHARIDES (LPS) ON ITS OUTER SHELL. THESE CPS AND LPS STRUCTURES ARE IMMUNOGENIC AND ARE RECOGNIZED BY THE IMMUNE SYSTEM UPON INFECTIONS, EITHER CAUSING IMMUNITY NATURALLY, OR BY VACCINES SPECIFICALLY TARGETING CPS- OR LPS-ANTIGENS. FOR K. PNEUMONIAE, THE LIMITED VARIATION IN LPS-ANTIGENS WHEN COMPARED TO CPS ANTIGENS, MAKES THEM MORE SUITABLE TARGETS FOR VACCINE DEVELOPMENT. HOWEVER, PRODUCTION OF LPS-BASED VACCINES IS EXTREMELY CHALLENGING DUE TO TOXIC COMPONENTS THAT ATTACH THE LPS TO THE OUTER MEMBRANE OF BACTERIA. LPS DETOXIFIED MOLECULES ARE VIRTUALLY IMPOSSIBLE TO ISOLATE AND PURIFY, SO FAR PREVENTING DEVELOPMENT OF SUCH VACCINES.
VAXXILON EMPLOYS AN ALTERNATIVE APPROACH: TO THE SYNTHESIS OF LPS O-ANTIGEN WHICH ELIMINATES THE POTENTIAL CONTAMINATION RISKS OF THE LPS. VAXXILON HAS ALREADY IDENTIFIED THE LEAD ANTIGENS USING THIS APPROACH AND IS ADVANCING THE MULTIVALENT VACCINE INTO FULL PRECLINICAL DEVELOPMENT. 4500004575 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 | — | $25,000 | Jan 29, 2023 | — – — |
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