MACRO BIOLOGICS, INC.

CARLSBAD, CA, 92010

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	INFECTION IS A PROGRESSION, BEST STOPPED EARLY. DANGEROUS MICROBES REACH VULNERABLE TISSUES BY PASSING THROUGH “GATEWAYS”, SUCH AS SURGICAL & TRAUMATIC WOUNDS, THROAT & UPPER AIRWAY, AND URINARY TRACT. A FOCAL INFECTION, LIKE A SURGICAL SITE INFECTION OCCURS, AND CAN LEAD TO SEPSIS. WORLDWIDE, SEPSIS IS RESPONSIBLE FOR 1/5 OF DEATHS, WHICH IS OVER 30,000 PER DAY. IN THE US, SEPSIS IS A LEADING CAUSE OF HOSPITAL-BASED DEATHS (1 EVERY 90 SECONDS) AND RESPONSIBLE FOR OVER $50 BILLION IN HEALTHCARE COSTS. FURTHER, 1 IN 2 OF THOSE WHO SURVIVE SEPSIS HAVE SIGNIFICANT LONG-TERM HEALTH COMPLICATIONS, WHICH OFTEN REQUIRE ADDITIONAL HOSPITAL ADMISSIONS AND SUPPORTIVE CARE AT HOME. AMICIDIN-SS IS PURPOSE-BUILT FOR TOPICAL APPLICATION TO CONTAMINATED, COLONIZED, AND INFECTED TISSUES AND IMPLANTS. ALONE, OR AS A COMPLEMENT TO SYSTEMIC ANTIBIOTICS, AMICIDIN-SS SHOULD HELP CLEANSE TISSUES, REDUCE MICROBIAL BURDEN, AND STOP INFECTIONS BEFORE THEY BECOME LIFE-THREATENING. AMICIDIN-SS IS A LARGE MOLECULE BIOLOGIC MADE FROM JUST TWO AMINO ACIDS (MW 12.5-16.5 KDA) AND ITS ENGINEERED ARCHITECTURE IMPARTS A DUAL MODE OF ACTION (MOA): SURFACTANT TO CLEANSE AND MICROBICIDE TO KILL. AMICIDIN-SS IS BROADLY ACTIVE AGAINST GRAM-POSITIVE AND GRAM-NEGATIVE BACTERIA, INCLUDING ALL MULTIDRUG-RESISTANT ORGANISMS (MDROS) TESTED TO DATE, AS WELL AS CANDIDA SPP. FURTHER, AMICIDIN-SS’S MOLECULAR SIZE AND ARCHITECTURE PROMOTE LOCAL TISSUE RETENTION FOR ENHANCED EFFECTIVENESS AND LIMIT ABSORPTION OF INTACT MOLECULES INTO THE BLOODSTREAM FOR ENHANCED SYSTEMIC SAFETY. AMICIDIN-SS TOPICAL SOLUTION IS A CLEAR COLLOIDAL SOLUTION OF AMICIDIN-SS IN WATER AT 10 MG/ML CONCENTRATION. IN NONCLINICAL STUDIES, EFFICACY AND SAFETY WERE DEMONSTRATED IN MULTIPLE MODELS IN VITRO AND IN VIVO. FOR THE UPCOMING CLINICAL TRIAL (SEE BELOW) IT IS PROVIDED IN 50 ML PREFILLED SYRINGES THAT ARE TERMINALLY STERILIZED BY AUTOCLAVE. EXCELLENT SHELF STABILITY AND LONG-TERM STERILITY HAVE BEEN DEMONSTRATED. ANTICIPATED CLINICAL STORAGE IS AT ROOM TEMPERATURE. THIS DRUG PRODUCT FORMAT ENABLES EASY APPLICATION TO A VARIETY OF TISSUES, INCLUDING SURGICAL INCISIONS AND TRAUMATIC WOUNDS. RECENTLY, AN IND APPLICATION FOR A PHASE 1 CLINICAL TRIAL WAS FILED WITH THE FDA AND THE SPONSOR, MACRO BIOLOGICS, INC. RECEIVED A “SAFE TO PROCEED” LETTER. AS SUCH AMICIDIN-SS TOPICAL SOLUTION IS NOW EXPECTED TO ENTER ITS FIRST-IN-PATIENT TRIAL, WHICH IS ENTITLED, “A PHASE 1 STUDY TO ASSESS SAFETY AND TOLERABILITY OF AMICIDIN-SS TOPICAL SOLUTION IN ADULT PATIENTS UNDERGOING INTERVENTIONAL MANAGEMENT OF A SURGICAL OR TRAUMATIC WOUND INFECTION”. THE STUDY IS EXPECTED TO INCLUDE 40 ADULT PATIENTS AND OCCUR AT SEVERAL MAJOR HOSPITALS IN THE UNITED STATES. GIVEN FAVORABLE PHASE 1 SAFETY DATA, LATER STAGE CLINICAL STUDIES WILL BE PERFORMED IN THE SAME PATIENT POPULATION. IN ADDITION, PARALLEL DEVELOPMENT IS EXPECTED TO OCCUR IN PATIENTS UNDERGOING SURGICAL MANAGEMENT OF ORTHOPEDIC HARDWARE-RELATED INFECTION (OHRI), INCLUDING PROSTHETIC JOINT INFECTIONS (PJI) AND INFECTED OSTEOSYNTHESIS SITES (BONE FRACTURES REPAIRED WITH HARDWARE). IF SUCCESSFULLY DEVELOPED, AMICIDIN-SS TOPICAL SOLUTION SHOULD DRAMATICALLY REDUCE THE TREATMENT FAILURE OF SURGICAL AND TRAUMATIC WOUND INFECTIONS. IN ADDITION, IT SHOULD REDUCE THE OVERALL USE OF ANTIBIOTICS, HELP STEM THE RISING TIDE OF ANTIBIOTIC RESISTANCE, AND SIGNIFICANTLY REDUCE HEALTHCARE COSTS. MOST IMPORTANTLY, AMICIDIN-SS TOPICAL SOLUTION SHOULD SAVE LIVES KC3376 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	—	$1,241,243	Nov 7, 2022	— – —

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