Mapp Inc

MONOCLONAL IMMUNOPROTECTANTS FOR SELECT AGENTS TOXINS (MAB-SAT)

AN ANTIBODY IMMUNOPROTECTANT FOR CATEGORY B TOXINS

AN IMMUNOPROTECTANT FOR ARGENTINE HEMORRHAGIC FEVER

NEW :SERVIR- EASTERN AND SOUTHERN AFRICA W/REGIONAL CENTER FOR MAPPING OF RESOURCES FOR DEV. (RCMRD)

AN IMMUNOPROTECTANT FOR MARBURG VIRUS

MR191_ AN IMMUNOPROTECTANT FOR MARBURG VIRUS

A MONOCLONAL ANTIBODY IMMUNOPROTECTANT FOR EBOLA VIRUS

MONOCLONAL ANTIBODIES IN BIODEFENSE: EBOLA VIRUSES

MONOCLONAL ANTIBODIES FOR ALZHEIMER'S IMMUNOTHERAPY

DEVELOPMENT OF HIGHLY POTENT HUMAN MONOCLONAL FOR RSV IMMUNO-PROPHYLAXIS

AN SEB IMMUNOPROTECTANT

DEVELOPMENT OF A C. DIFFICILE MONOCLONAL-BASED PRODUCT

FUNDAMENTAL RESEARCH TO COUNTER WEAPONS OF MASS DESTRUCTION (C-WMD)

DEVELOPMENT OF HIGHLY POTENT HUMAN MONOCLONAL FOR RSV IMMUNOPROPHYLAXIS - PROJECT SUMMARY GLOBALLY, RESPIRATORY SYNCYTIAL VIRUS (RSV) CAUSES OVER 3 MILLION HOSPITALIZATIONS OF NEONATES/INFANTS. WHILE THERE ARE LICENSED VACCINES IN THE U.S. FOR USE IN ELDERLY POPULATIONS, THEY ARE NEITHER APPROVED NOR APPROPRIATE FOR USE IN NEONATES/INFANTS WHO HAVE IMMATURE IMMUNE SYSTEMS. PALIVIZUMAB, A PROPHYLACTIC MONOCLONAL ANTIBODY (MAB) MARKETED BY ASTRAZENECA AND SOBI AS SYNAGIS™, HAS BEEN AVAILABLE SINCE 1998, BUT DUE TO HIGH COST AND MODEST EFFICACY, ITS USE HAS BEEN RESTRICTED TO HIGH-RISK INFANTS. THE RECENTLY APPROVED SINGLE DOSE, LONG-ACTING MAB, NIRSEVIMAB (PREVIOUSLY KNOWN AS MEDI8897 AND MARKETED AS BEYFORTUS™ BY SANOFI), HAS IMPROVED EFFICACY COMPARED TO PALIVIZUMAB AND WAS APPROVED FOR USE IN ALL CHILDREN UP TO 24 MONTHS OF AGE. HOWEVER, SEVERE SHORTAGES AND COST BARRIERS HAVE LIMITED ITS AVAILABILITY IN COUNTRIES WHERE IT IS CURRENTLY APPROVED (EU, US, JAPAN, AUSTRALIA, CANADA AND CHINA). IN OCTOBER 2023 THE CDC ISSUED HEALTH ALERT NETWORK CDCHAN-00499 THAT RECOMMENDED LIMITING THE USE OF NIRSEVIMAB TO HIGHER RISK CHILDREN IN THE 2023- 2024 SEASON DUE TO THE SHORTAGES, RESULTING IN MANY ELIGIBLE INFANTS NOT RECEIVING PROPHYLAXIS. IN ADDITION, NIRSEVIMAB IS NOT CURRENTLY AVAILABLE IN ANY LOW- OR MIDDLE-INCOME COUNTRIES (LMICS) AND IS UNAVAILABLE IN 8/10 OF THE MOST POPULOUS COUNTRIES IN THE WORLD. MAPP BIOPHARMACEUTICAL, INC. IS DEVELOPING A FULLY HUMAN MAB PRODUCT, MBP002, THAT LIKE NIRSEVIMAB, CAN BE ADMINISTERED IN A SINGLE DOSE PER RSV SEASON. MAPP’S OBJECTIVE IS TO DRAMATICALLY LOWER THE PRICE AND INCREASE THE GLOBAL AVAILABILITY OF RSV IMMUNOPROPHYLAXIS. FURTHER, UNLIKE NIRSEVIMAB AND MERCK’S PHASE 3 CANDIDATE, MK-1654, MAPP’S PRODUCT IS A TWO MAB COCKTAIL, REDUCING THE RISK NOT ONLY OF CLINICAL DEVELOPMENT OF RESISTANCE, BUT ALSO OF A NATURALLY OCCURRING STRAIN EVADING A SINGLE MAB. INDEED, THIS METHOD OF PRODUCT FAILURE OCCURRED DURING A RECENT PHASE 3 TRIAL WITH REGENERON’S RSV MAB CANDIDATE AND IS THE REASON SEVERAL MAB CANDIDATES LOST THEIR EMERGENCY USE AUTHORIZATION FOR USE AGAINST COVID-19. WHILE NIRSEVIMAB RESISTANT MUTATIONS WERE RARE IN A SURVEY OF 5675 RSV STRAINS BETWEEN 2015 AND 2021, SEVERAL MUTATIONS IN THE NIRSEVIMAB BINDING SITE HAVE INCREASED SINCE 2020, INCLUDING THE RESISTANT RSV-B VARIANT K68N PRESENT IN THE U.S. AND AUSTRALIA. THE IMPACT OF WIDESPREAD USE OF NIRSEVIMAB ON THE FREQUENCY OF RESISTANT VARIANTS IS UNDER CLOSE POST-MARKETING SURVEILLANCE DUE TO THE POTENTIAL FOR SELECTION OF ESCAPE MUTANTS. MAPP HAS SCREENED 70+ RSV CLINICAL STRAINS AND FOUND NEUTRALIZATION RESISTANT STRAINS TO PALIVIZUMAB, NIRSEVIMAB (MEDI8897) AND REGENERON’S CANDIDATE, BUT NO RESISTANT STRAINS TO ONE OF THE MBP002 MABS. IN ADDITION, THE MBP002 MABS ARE DRAMATICALLY MORE POTENT IN VITRO AND IN VIVO THAN PALIVIZUMAB AND HAVE COMPARABLE NEUTRALIZATION AND IN VIVO ACTIVITY TO NIRSEVIMAB. THE REQUESTED SBIR SUPPORT, TOGETHER WITH SIGNIFICANT IN-KIND CONTRIBUTIONS BY MAPP, WILL ALLOW FOR THE ADVANCEMENT OF MBP002 TO IND SUBMISSION (INVESTIGATIONAL NEW DRUG APPLICATION) AND INITIATION OF A PHASE 1 CLINICAL TRIAL.

INFUSING CH4 AND CO2 POINT SOURCE EMISSIONS DATA INTO STAKEHOLDER FRAMEWORKS TO ENABLE MITIGATION AND UNCOVER NEW INSIGHTS

DEVELOPMENT OF A MONOCLONAL IMMUNOPROTECTANT FOR RICIN

MONOCLONAL ANTIBODY SEB IMMUNOPROTECTANT

A HUMAN MONOCLONAL FOR RSV PROPHYLAXIS

DEVELOPMENT OF HIGHLY POTENT HUMAN MONOCLONALS FOR RSV IMMUNOPROPHYLAXIS

22-IDS22-0069 WATERSHEDS WATER QUALITY AND COASTAL COMMUNITIES IN PUERTO RICO (WATER2COASTS): AN INTERDISCIPLINARY ISLAND LANDSCAPE TO COASTAL OCEAN ASSESSMENT WITH SOCIOECONOMIC IMPLICATIONS

AN IMMUNOPROTECTANT FOR MARBURG VIRUS

METHANE AND CARBON DIOXIDE POINT SOURCE EMISSIONS VALIDATION AND ANALYSIS

A MONOCLONAL COCKTAIL FOR CDI

SBIR PHASE I: DYNAMIC ONESOURCE GEOSPATIAL INFORMATION SYSTEM FOR MAXIMIZING AGRICULTURAL YIELDS -THE BROADER/COMMERCIAL IMPACT OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT IS THE CREATION OF A DYNAMIC GEOSPATIAL DATABASE THAT CAN BE MINED TO FURTHER DEVELOP PRECISION MODELS OF SOIL MOISTURE AND FARM PRODUCTIVITY THAT WILL AID SMALL- TO MEDIUM-SIZED FARMS. THESE FARMS COVER ALMOST 75% OF THE OPERATING FARMLAND IN THE U.S. LARGE COMPANIES IN THE AGRICULTURE INDUSTRY BENEFIT FROM THE COLLECTION OF DIGITAL FARM DATA HOWEVER, SMALLER FARMS ARE DISADVANTAGED BY THE INACCESSIBILITY OF AGRICULTURAL DIGITAL INNOVATION SYSTEMS. THE AVAILABILITY OF TIMELY DIGITAL INFORMATION AS INPUTS TO FIELD CONDITIONS WILL HELP SMALL- TO MID-SIZED FARMERS OPTIMIZE THEIR YIELDS AND POTENTIALLY GENERATE GREATER REVENUE. THE PROPOSED DATABASE WILL INTEGRATE MULTISCALE AND MULTIVARIATE IMAGING AND NON-IMAGING GEOSPATIAL AND METEOROLOGICAL DATA INTO A SINGLE SOURCE. THE MERGING OF SATELLITE-BASED GEOSPATIAL DATA WITH AIRBORNE-GEOSPATIAL DATA, A CHALLENGING TASK, WILL IMPROVE THE ACCURACY OF EARTH SCIENCE DATA. POTENTIAL APPLICATIONS OF THE TECHNOLOGY INCLUDE MEDIUM- TO LONG-TERM FOOD SECURITY PLANNING, DROUGHT MITIGATION, SOIL CONSERVATION, DIVERSIFICATION, AND EXPANSION OF CLIMATE-RESILIENT AND SUSTAINABLE FARMING. THIS SBIR PHASE I PROJECT FOCUSES ON DEVELOPING AN INTEGRATED, ONE-SOURCE, DYNAMIC GEOSPATIAL DATABASE AS WELL AS PRECISION SOIL MOISTURE AND FARM PRODUCTIVITY FORECASTING MODELS TO BENEFIT SMALL- AND MEDIUM-SIZE FARMS. THE DATA INPUTS INCLUDE (I) GLOBAL NAVIGATION SATELLITE SYSTEM OBSERVATIONS ON A NEWLY DESIGNED GEODETIC/METEOROLOGICAL NETWORK FOR SIGNIFICANTLY INCREASED ACCURACY; (II) AIRBORNE DIGITAL GEOSPATIAL DATA FROM A FIXED-WING PLATFORM TO CAPTURE HIGH PRECISION AND RESOLUTION NADIR MULTISPECTRAL AND COLOR OBLIQUE IMAGERIES, LIDAR POINT CLOUD DATA, AND DATA FROM UN-MANNED AERIAL SYSTEMS TO CAPTURE SEASONAL HYPERSPECTRAL IMAGERIES; (III) SATELLITE REMOTE SENSING DATA FROM COMMERCIAL SATELLITE HIGH-RESOLUTION IMAGERIES; (IV) WEATHER SATELLITE DATA FOR HOURLY GLOBAL PRECIPITATION MEASUREMENTS (GPM) FUSED WITH MULTI-SATELLITE RETRIEVALS FOR GLOBAL PRECIPITATION MEASUREMENT MISSION (GPM); AND (V) TERRESTRIAL DATA FROM EXISTING GEOGRAPHIC INFORMATION SYSTEMS AND METEOROLOGICAL STATIONS. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.- SUBAWARDS ARE PLANNED FOR THIS AWARD.

A NOVEL COST-EFFECTIVE MULTISPECIFIC THERAPEUTIC FOR DENGUE - PROJECT SUMMARY DENGUE REMAINS A MAJOR GLOBAL HEALTH CONCERN FOR WHICH EFFECTIVE PROPHYLACTIC AND THERAPEUTIC OPTIONS ARE URGENTLY NEEDED. THE HEIGHTENED DENGUE BURDEN IS DRIVEN BY SEVERAL FACTORS INCLUDING INCREASED URBANIZATION, WORLD POPULATION GROWTH, INCREASED INTERNATIONAL TRADE AND TRAVEL, AND CHANGES IN HUMAN BEHAVIOR THAT INCREASE MOSQUITO BREEDING SITES. AFTER MALARIA, DENGUE IS THE SECOND MOST FREQUENT MOSQUITO-BORNE DISEASE THAT AFFECTS HUMANS. TO DATE, TRADITIONAL STRATEGIES HAVE FAILED TO GENERATE AN EFFECTIVE VACCINE, AND IN SOME INSTANCES, VACCINATION RESULTED IN ENHANCED DISEASE. DENGVAXIA IS THE ONLY AVAILABLE DENGUE VACCINE IN THE US AND IS ONLY RECOMMENDED TO PREVENT DENGUE IN CHILDREN AGED 9-16 YEARS WITH LABORATORY-CONFIRMED PREVIOUS DENGUE INFECTION. A SAFETY SIGNAL IN DENGUE SERONEGATIVE VACCINE RECIPIENTS AND IN CHILDREN 2-5 YEARS OLD HIGHLIGHTED INCREASING EVIDENCE OF A DETRIMENTAL EFFECT OF VACCINATION IN CERTAIN POPULATIONS 1. FURTHERMORE, NO DENGUE THERAPEUTIC PRODUCT IS APPROVED FOR INTERVENTION TO CONTROL A DENGUE OUTBREAK. MAPP BIOPHARMACEUTICAL, INC. (SAN DIEGO, CA), IS DEVELOPING A MULTI-SPECIFIC ANTIBODY-DERIVED THERAPEUTIC PRODUCT THAT SYNERGISTICALLY COMBINES THE EFFICACY OF TWO BROADLY NEUTRALIZING ANTIBODIES INTO ONE HALF-LIFE EXTENDED MOLECULE. WITH HIGHER POTENCY (I.E. LOWER DOSE), A SINGLE DOSE DUE TO THE EXTENDED SERUM HALF-LIFE, AND MANUFACTURING IN MICROBIAL HOST CELLS, MAPP'S OBJECTIVE IS TO DEVELOP A COST-EFFECTIVE DENGUE IMMUNOTHERAPEUTIC THAT WILL BE GLOBALLY ACCESSIBLE. MAPP'S PRODUCT CANDIDATE IS A TRI-SPECIFIC ANTIBODY FRAGMENT MOLECULE DESIGNED TO ENHANCE THERAPEUTIC EFFICACY AGAINST DENGUE VIRUS INFECTION BY TARGETING TWO DISTINCT EPITOPES OF THE ENVELOPE PROTEIN. THIS DESIGN AIMS TO BROADEN COVERAGE AND MITIGATE THE RISK OF ESCAPE MUTANTS. ADDITIONALLY, ONE ARM OF THE MOLECULE IS DESIGNED TO BIND HUMAN SERUM ALBUMIN, EXTENDING THE THERAPEUTIC'S HALF-LIFE. EXCLUDING THE FE REGION OF THE ANTIBODY PREVENTS ANTIBODY-DEPENDENT ENHANCEMENT OF INFECTION, A SERIOUS COMPLICATION LINKED TO THE FE REGION, AND ALLOWS PRODUCTION IN MICROBIAL HOST CELLS, SIGNIFICANTLY REDUCING COSTS. MAPP HAS ALREADY DEVELOPED A PLATFORM TO OPTIMIZE THE DESIGN, PRODUCTION, AND CHARACTERIZATION OF THE TRISPECIFIC MOLECULES. CONSIDERING THE PREVALENCE AND THE AVAILABILITY OF PUBLISHED POTENT ANTI-DENGUE VIRUS ANTIBODIES, MAPP IS STRATEGICALLY INVESTING IN DEVELOPING NOVEL FORMATS THAT ADDRESS THE SPECIFIC NEEDS OF THE DENGUE DISEASE BURDEN: POTENCY, SAFETY, AND ACCESS. PHASE I OF THIS FAST-TRACK SBIR PROPOSAL AIMS TO IDENTIFY, MANUFACTURE, AND CHARACTERIZE ANTI-DENGUE THERAPEUTICS WITH A SYNERGISTIC MODE OF ACTION. PHASE II WILL INVOLVE EVALUATING THE MOST PROMISING THERAPEUTIC CANDIDATES IN MURINE AND NON-HUMAN PRIMATE (NHP) MODELS OF DENGUE CHALLENGE AND INITIATING IND ENABLING STUDIES OF THE LEAD CANDIDATE.

DIRECT SEQUENCING OF SERUM ANTIBODIES AFTER INFECTION

PSEUDOMONAS ANTIBODIES WITH DESIGNED GLYCANS

NOVEL IMMUNOTHERAPY FOR BRAIN CANCER

1:24,000 SCALE SURFICIAL GEOLOGIC MAPS OF THE MANLIUS QUADRANGLE...

RAPID RESPONSE AGENTS AGAINST FILOVIRUS OUTBREAKS USING VECTORED IMMUNOPROPHYLAXIS

DIRECT SEQUENCING OF ANTIBODIES OF THE INFLUENZA IMMUNE RESPONSE

EO14042 OCEAN COMMUNITY ENGAGEMENT AND AWARENESS USING NASA OBSERVATIONS AND SCIENCE FOR LOW-INCOME HISPANIC/LATINOSTUDENTS (OCEANOS)

A SCALABLE FRAMEWORK FOR ASSESSING VARIABILITY IN CO2 POINT SOURCES USING MULTIPLE SATELLITE INSTRUMENTS.

7TH ANNUAL WORLD CONGRESS OF IBMISPS ON BRAIN MAPPING AND IMAGE GUIDED THERAPY

TO SUPPORT THE DEVELOPMENT AND PRESENTATION OF "HOLOSCENES" AND "/PEH-LO-TAH/," MULTIDISCIPLINARY WORKS.

TO SUPPORT THE CREATION AND TOURING OF MULTIDISCIPLINARY PERFORMANCE WORKS.

TO SUPPORT THE "AMERICA PROJECT."

TO SUPPORT THE FINAL PRODUCTION PHASE AND PREMIERE OF "HOLOSCENES," A MULTIDISCIPLINARY PERFORMANCE INSTALLATION, CONCEIVED AND DIRECTED BY LARS JAN.

TO SUPPORT THE DEVELOPMENT AND PRODUCTION OF THE NEW WORKS "CIPHER" AND PHASE 2 AND 3 OF "HOLOSCENES."

TO SUPPORT THE DEVELOPMENT AND TOUR OF "RED BLACK AND GREEN: A BLUES(RBGB) " IN CONSORTIUM WITH YOUTH SPEAKS.

6TH ANNUAL WORLD CONGRESS OF IMBISPS ON BRAIN MAPPING AND IMAGE GUIDED THEORY CONFERENCE

CONFERENCE 2008 WORLD CONGRESS FOR IMAGE GUIDED THERAPY AND SURGERY

NHD SUPPORT LANCASTER PILOT

TO SUPPORT THE PRODUCTION OF MIRIAM BY CHOREOGRAPHER NORA CHIPAUMIRE, SOUL PROJECT BY CHOREOGRAPHER DAVID ZAMBRANO, AND THE DANCE PROGRAM VOICES OF S

TO SUPPORT THE CREATION, PRODUCTION, AND TOURING OF MULTIDISCIPLINARY PERFORMANCE WORKS.