SYNTIRON LLC

SAINT PAUL, MN, 55114

Unclaimed

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	URINARY TRACT INFECTIONS (UTI) RESULT IN BILLIONS OF DOLLARS IN MEDICAL COSTS AND LOST REVENUE ANNUALLY, AND ACCOUNT FOR AN ENORMOUS AMOUNT OF ANTIMICROBIAL USE. ALTHOUGH THEY AFFECT BOTH MEN AND WOMEN, THEY DISPROPORTIONATELY IMPACT WOMEN AT EVERY AGE ACROSS THE GLOBE. UTI CAN LEAD TO OTHER SERIOUS INFECTIONS, SUCH AS SEPSIS. NEONATAL SEPSIS (NNS) IS OF GROWING CONCERN GLOBALLY, PARTICULARLY IN LOW AND MIDDLE INCOME COUNTRIES (LMICS), AS ANTIMICROBIAL RESISTANCE INCREASES. NNS IS A SYSTEMIC IMMUNE DYSREGULATION RESULTING FROM BLOODSTREAM INFECTION IN BABIES LESS THAN 28 DAYS OLD. NNS IS OFTEN CAUSED BY BACTERIA AND IS STRONGLY ASSOCIATED WITH MATERNAL UTI. PREGNANT WOMEN ARE AT INCREASED RISK FOR UTI DUE TO CHANGES IN IMMUNOLOGY, URINE COMPOSITION AND THE URINARY TRACT THAT CREATE MORE HOSPITABLE CONDITIONS FOR UROPATHOGENS. MATERNAL UTI CAN QUICKLY PROGRESS TO PYELONEPHRITIS, WHICH IS THE MOST COMMON SERIOUS MEDICAL CONDITION SEEN DURING PREGNANCY AND THE MOST COMMON CAUSE OF SEPTIC SHOCK IN PREGNANT WOMEN. MATERNAL UTI AND ASYMPTOMATIC COLONIZATION OF THE BLADDER OCCUR IN 50-75% OF PREGNANT WOMEN IN LMICS, RESULTING IN AS MUCH AS A FIVE-FOLD INCREASE IN THE RISK OF NNS. MATERNAL UTI ALSO INCREASES THE RISK OF PRETERM LABOR AND PREMATURE DELIVERY, BUT MANY UTIS ARE NOT DIAGNOSED, AND MANY ANTIMICROBIALS ARE NOT SAFE FOR USE IN PREGNANT WOMEN. IT IS IMPOSSIBLE TO VACCINATE A NEONATE SUFFICIENTLY EARLY TO PROTECT AGAINST NNS, AND PROGRESSION TO SYSTEMIC IMMUNE DYSREGULATION IS OFTEN TOO RAPID TO ENABLE ANTIMICROBIAL THERAPY. A LICENSED VACCINE TO PREVENT UTI WOULD SUBSTANTIALLY IMPROVE MEDICAL CARE AND REDUCE INDISCRIMINATE ANTIMICROBIAL USE INTENDED TO KEEP UTI AT BAY. A MATERNAL VACCINE WOULD PROTECT BOTH MOTHERS AND INFANTS DURING THIS CRITICAL PERIOD, BUT THERE ARE CURRENTLY NO LICENSED VACCINES TO PREVENT MATERNAL UTI/NNS. A MATERNAL VACCINE TARGETING THE COMMON UROPATHOGENS ASSOCIATED WITH NNS IS URGENTLY NEEDED. SYNTIRON’S SYN-001 VACCINE TARGETS MULTIPLE PATHOGENS ASSOCIATED WITH UTI/NNS COULD SUBSTANTIALLY IMPROVE WOMEN’S HEALTH, INCLUDING MATERNAL AND INFANT HEALTH BY REDUCING MATERNAL UTI AND NEONATAL SEPSIS INFECTIONS. SYNTIRON’S VACCINE TARGETS ALL STRAINS OF E. COLI AND KLEBSIELLA PNEUMONIAE, UROPATHOGENS THAT ARE THE MOST COMMON CAUSES OF BOTH UTI AND NNS. DURING THE FUNDING PROGRAM, THE VACCINE WILL BE EVALUATED IN THREE PHASES, ONE OF WHICH IS ALREADY COMPLETE: 1) DURING LEAD OPTIMIZATION, THE VACCINE FORMULATION WAS EVALUATED AND OPTIMIZED FOR ITS POTENTIAL TO ELICIT AN APPROPRIATE IMMUNE RESPONSE IN PREGNANT ANIMALS AND THEIR OFFSPRING; 2) DURING PRECLINICAL DEVELOPMENT, THE PRECLINICAL DATA PACKAGE WILL BE STRENGTHENED AND THE PROTEIN ANTIGEN WILL BE MANUFACTURED IN ACCORDANCE WITH CGMP AND TESTED FOR SAFETY AND TOXICITY; 3) DURING CLINICAL DEVELOPMENT, THE IMMUNE RESPONSE OF HEALTHY VOLUNTEERS AGED 18-59 YEARS OLD WILL BE EVALUATED IN THE FIRST-IN-HUMAN VACCINE SAFETY TRIAL; MEANWHILE, PREGNANT ANIMALS WILL BE IMMUNIZED TO ASSESS SAFETY AND TOXICITY OF THE VACCINE IN PREPARATION FOR A MATERNAL VACCINATION TRIAL. KC3639 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	—	$356,706	Dec 11, 2023	— – —

Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.