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INTEGRATED BIOTHERAPEUTICS, LLC
ROCKVILLE, MD, 20850
UnclaimedClaim this profile (free)
Small BusinessSmall Disadvantaged
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 | SAMPLE TESTING 0000904126 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: OH Parent award description: CORRELATE OF PROTECTION (COP) STUDIES TO SUPPORT DEVELOPMENT OF THE CAD3-EBO-S (SUDAN VIRUS) CANDIDATE VACCINE. View parent award on USAspending | 75A50122D00017USAspending | $132,188 | Oct 22, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | STAPHYLOCOCCUS AUREUS (SA), CAUSES SERIOUS DISEASES INCLUDING BLOOD STREAM INFECTION, SEPSIS, ENDOCARDITIS, SURGICAL SITE INFECTIONS (SSI), AND PNEUMONIA. METHICILLIN RESISTANT SA (MRSA) IS CURRENTLY A LEADING CAUSE OF THESE LIFE THREATENING INFECTIONS WITH LIMITED OPTIONS FOR TREATMENT. FOUR VACCINE AND IMMUNOTHERAPEUTIC APPROACHES TARGETING SA SURFACE ANTIGENS HAVE BEEN TESTED IN EFFICACY TRIALS IN HUMANS AND ALL HAVE FAILED. ONE OF THESE VACCINES (V710) CAUSED MULTI-ORGAN FAILURE IN VACCINATED INDIVIDUALS WHO WERE INFECTED WITH SA LEADING TO TRIAL TERMINATION BY FDA. STUDIES IN ANIMALS HAVE ALSO SHOWN THAT VACCINES TARGETING SURFACE ANTIGENS INCREASE THE RISK OF DEATH FROM SA INFECTION. THIS PROPOSAL, SEEKS TO DEVELOP A NOVEL, ENTIRELY TOXOID VACCINE (IBT-V02) FOR PREVENTION OF MRSA INFECTIONS. IBT-V02 CONSISTS OF FIVE COMPONENTS REPRESENTING TOXOIDS FOR SEVEN SA TOXINS. DUE TO CROSS REACTIVITY, THESE TOXOIDS ELICIT PROTECTIVE RESPONSES TO 12-15 SA TOXINS. EFFICACY OF IBT-V02 COMPONENTS HAS BEEN SHOWN IN VARIOUS MOUSE AND RABBIT MODELS OF INFECTION. THIS IS THE FIRST ENTIRELY NON-SURFACE ANTIGEN BASED VACCINE FOR SA DISEASE. THE STUDIES TO BE PERFORMED UNDER CARB-X SUPPORT WILL COMPLETE THE PRE-CLINICAL DEVELOPMENT OF IBT-V02 AND TRANSITIONS THE PROGRAM TO PHASE I CLINICAL TRIAL. FOLLOWING THIS FUNDING PERIOD IBT INTENDS TO TEST THE VACCINE IN PHASE II AND PHASE III CLINICAL TRIALS FOR PREVENTION OF SSI IN ELECTIVE SURGERIES AND SEEK APPROVAL FOR THIS INDICATION.
A TEAM OF EXPERIENCED SCIENTISTS AND PROGRAM MANAGERS AT IBT, AND EMERGENT BIOSOLUTIONS WILL LEAD THE PROGRAM. TWO LEADING RESEARCH LABORATORIES LED BY DR. JEAN C. LEE (BRIGHAM AND WOMEN HOSPITAL) AND DR. BINH DIEP (UCSF) ARE INTIMATELY INVOLVED IN EXECUTION OF ANIMAL STUDIES. THE PROGRAM WILL ALSO HEAVILY COLLABORATE WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) PRECLINICAL AND CLINICAL SERVICES PROGRAM. 4500004358 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 | — | -$85,453 | Oct 31, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | STAPHYLOCOCCUS AUREUS (SA), CAUSES SERIOUS DISEASES INCLUDING BLOOD STREAM INFECTION, SEPSIS, ENDOCARDITIS, SURGICAL SITE INFECTIONS (SSI), AND PNEUMONIA. METHICILLIN RESISTANT SA (MRSA) IS CURRENTLY A LEADING CAUSE OF THESE LIFE THREATENING INFECTIONS WITH LIMITED OPTIONS FOR TREATMENT. FOUR VACCINE AND IMMUNOTHERAPEUTIC APPROACHES TARGETING SA SURFACE ANTIGENS HAVE BEEN TESTED IN EFFICACY TRIALS IN HUMANS AND ALL HAVE FAILED. ONE OF THESE VACCINES (V710) CAUSED MULTI-ORGAN FAILURE IN VACCINATED INDIVIDUALS WHO WERE INFECTED WITH SA LEADING TO TRIAL TERMINATION BY FDA. STUDIES IN ANIMALS HAVE ALSO SHOWN THAT VACCINES TARGETING SURFACE ANTIGENS INCREASE THE RISK OF DEATH FROM SA INFECTION. THIS PROPOSAL, SEEKS TO DEVELOP A NOVEL, ENTIRELY TOXOID VACCINE (IBT-V02) FOR PREVENTION OF MRSA INFECTIONS. IBT-V02 CONSISTS OF FIVE COMPONENTS REPRESENTING TOXOIDS FOR SEVEN SA TOXINS. DUE TO CROSS REACTIVITY, THESE TOXOIDS ELICIT PROTECTIVE RESPONSES TO 12-15 SA TOXINS. EFFICACY OF IBT-V02 COMPONENTS HAS BEEN SHOWN IN VARIOUS MOUSE AND RABBIT MODELS OF INFECTION. THIS IS THE FIRST ENTIRELY NON-SURFACE ANTIGEN BASED VACCINE FOR SA DISEASE. THE STUDIES TO BE PERFORMED UNDER CARB-X SUPPORT WILL COMPLETE THE PRE-CLINICAL DEVELOPMENT OF IBT-V02 AND TRANSITIONS THE PROGRAM TO PHASE I CLINICAL TRIAL. FOLLOWING THIS FUNDING PERIOD IBT INTENDS TO TEST THE VACCINE IN PHASE II AND PHASE III CLINICAL TRIALS FOR PREVENTION OF SSI IN ELECTIVE SURGERIES AND SEEK APPROVAL FOR THIS INDICATION.
A TEAM OF EXPERIENCED SCIENTISTS AND PROGRAM MANAGERS AT IBT, AND EMERGENT BIOSOLUTIONS WILL LEAD THE PROGRAM. TWO LEADING RESEARCH LABORATORIES LED BY DR. JEAN C. LEE (BRIGHAM AND WOMEN HOSPITAL) AND DR. BINH DIEP (UCSF) ARE INTIMATELY INVOLVED IN EXECUTION OF ANIMAL STUDIES. THE PROGRAM WILL ALSO HEAVILY COLLABORATE WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) PRECLINICAL AND CLINICAL SERVICES PROGRAM. 4500004358 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 | — | $110,453 | Sep 28, 2022 | — – — |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Government-sourced data comes from SAM.gov, SBA and USAspending.gov and is attributed to its source. Items marked company-reported were provided by the company and are verified by FedSub only where labeled. FedSub is a private company and is not affiliated with SBA, GSA/SAM.gov, or any government agency.