ORG_CITY: ANN ARBOR

ORG_NAME: EVOQ THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE The objective of this project is to develop an effective treatment for myelin oligodendrocyte glycoprotein antibody disease (MOGAD), for which there is no cure. While the current standard of care against MOGAD includes steroids and immunosuppressants, they are associated with systemic immunosuppression with complications and frequent debilitating relapses. Broad B-cell modulating agents have been developed (i.e., rituximab) and showed efficacy in a subset of MOGAD patients; however, it does not confer long-term protection and has risks of deleterious cytokine responses, anaphylactic shock, and increased susceptibility to infections. Thus, there is an urgent need for new targeted treatment options for MOGAD patients. The proposed research will produce a novel vaccine-like strategy for MOGAD, open up avenues to treat other autoimmune diseases, and lead to new strategies to achieve disease control.

PI_NAMEs: DANIEL, WESTON  (contact)

PROGRAM_OFFICER_NAME: RAJAGOPAL, MEENA UMA

PROJECT_TERMS: Address;analytical method;Anaphylaxis;Antibodies;Antibody titer measurement;Antigen Presentation;Antigen Targeting;Antigens;Apolipoprotein A-I;associated symptom;Autoimmune Diseases;Award;B-Lymphocytes;Blindness;Brain;Bystander Suppression;central nervous system demyelinating disorder;Chemistry;Clinical;clinical translation;cytokine;Data;Dendritic Cells;Development;Disease;disorder control;Dose;effective therapy;Encephalomyelitis;Epitopes;Evaluation;Exhibits;Experimental Autoimmune Encephalomyelitis;extracellular;Feedback;first-in-human;Foundations;Goals;good laboratory practice;Granulocyte-Macrophage Colony-Stimulating Factor;Heart;High Density Lipoproteins;Homing;Human;human study;IgG autoantibodies;IL17 gene;Immune;Immune response;Immune System Diseases;Immune Tolerance;Immunologic Factors;Immunosuppression;Immunosuppressive Agents;Immunotherapy;In Vitro;Infection;Inflammation;Inflammatory;Insulin-Dependent Diabetes Mellitus;Interferon Type II;Laboratories;lead candidate;lymph nodes;manufacture;manufacturing process;Mediating;Medical Research;meetings;Membrane;Michigan;Mission;Modification;mouse model;Myelin Sheath;nanodisk;nanoparticle;National Center for Advancing Translational Sciences;Nature;Nerve Degeneration;Neurologic;novel;novel strategies;novel therapeutic intervention;novel vaccines;Oklahoma;oligodendrocyte-myelin glycoprotein;Optic Nerve;Patients;Peptides;peptidomimetics;Peripheral Blood Mononuclear Cell;Phase;Phospholipids;Pre-Clinical Model;pre-Investigational New Drug meeting;Predisposition;Process;process optimization;programmed cell death ligand 1;Rare Diseases;Rattus;Regulatory T-Lymphocyte;Relapse;Reporting;Research;response;Risk;rituximab;Seizures;Small Business Innovation Research Grant;Speed;Spinal Cord;standard of care;Steroids;subcutaneous;Symptoms;T-Cell Proliferation;T-Lymphocyte;targeted treatment;Time;Toxicology;Treatment Efficacy;United States National Institutes of Health;Universities;Whole Blood;Work

PROJECT_TITLE: Novel immunotherapy against MOG antibody disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BBBT-F (10)]


ADMINISTERING_IC: AI

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Natural Products;Urologic Diseases

ORG_CITY: Salt Lake City

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: CURZA INC

ORG_STATE: UT

PHR: Project Narrative This project will lead to the development of the first new class of oral antibiotics in over 40 years to treat infections caused by Gram-negative bacteria, especially life-threatening multidrug-resistant pathogens. The antibiotics to be developed have a novel mechanism of action which should limit the occurrence of resistance and are not expected to encounter cross-resistance to other antibiotic classes. These antibiotics represent an exciting option to address the growing concern of antimicrobial resistance.

PI_NAMEs: TESTA, CHARLES  (contact)

PROGRAM_OFFICER_NAME: XU, ZUOYU

PROJECT_TERMS: absorption;Active Biological Transport;Acute;acute pyelonephritis;Address;Adopted;analog;Animal Model;Anti-Bacterial Agents;Antibiotics;Antimicrobial Resistance;Bacteria;Bacterial Proteins;Binding;Binding Proteins;Biochemical;Biological;Biological Assay;Biological Availability;Caco-2 Cells;candidate selection;Canis familiaris;Cells;Chemicals;Chemistry;Clinical;Cyclic GMP;Cytochrome P450;cytotoxicity;Data;Development;Diffusion;Dose;Dose Fractionation;drug candidate;drug efficacy;Drug Kinetics;Engineering;Enhancers;Escherichia coli;Evaluation;Excretory function;Exhibits;experimental study;Formulation;Frequencies;genotoxicity;Gram-Negative Bacteria;HepG2;improved;In Vitro;in vitro activity;in vivo;indexing;Infection;inhibitor;Intestines;Ions;Klebsiella pneumoniae;Lead;lead candidate;Life;Link;Liver Microsomes;Mammalian Cell;manufacture;manufacturing scale-up;Maximum Tolerated Dose;meetings;Membrane;Metabolic;Metabolism;meter;Minimum Inhibitory Concentration measurement;Mitochondria;Modeling;Multi-Drug Resistance;multi-drug resistant pathogen;Mus;Mutation;natural product inspired;Natural Products;novel;Oral;Oral Administration;passive transport;pathogen;Permeability;Pharmaceutical Chemistry;Pharmaceutical Preparations;Pharmacodynamics;pharmacokinetics and pharmacodynamics;Pharmacologic Substance;Pharmacology;pharmacophore;Phase;Plasma;pre-clinical;programs;Property;Protein Biosynthesis;Protein Isoforms;Rattus;receptor binding;Regimen;Resistance;resistant strain;response;Ribosomes;Route;Safety;scaffold;scale up;screening;Septicemia;Series;Site;Small Business Innovation Research Grant;solute;success;Technology;Testing;Therapeutic;Time;Toxic effect;Toxicology;Urinary tract infection

PROJECT_TITLE: New oral antibiotics focused on treating MDR Gram-negative infections

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-F (12)]


ADMINISTERING_IC: HD

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Eye Disease and Disorders of Vision;Neurosciences;Pediatric;Prevention

ORG_CITY: STANFORD

ORG_DEPT: PEDIATRICS

ORG_NAME: STANFORD UNIVERSITY

ORG_STATE: CA

PHR: Narrative Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with carefully controlled educational interventions and behavioral measurements, to generate a new understanding of how successful intervention shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.

PI_NAMEs: YEATMAN, JASON D (contact)

PROGRAM_OFFICER_NAME: MILLER, BRETT

PROJECT_TERMS: Adult;Affect;Axon;behavior measurement;Biological;Biological Factors;Biological Markers;Brain;brain shape;Cell Density;Child;Computer Models;Development;Diffusion Magnetic Resonance Imaging;Dyslexia;Education;educational atmosphere;Educational Intervention;effective intervention;experience;Eye;Human;Impairment;improved;Individual Differences;individual variation;Infrastructure;Instruction;Intervention;intervention program;Learning;Learning Disabilities;learning outcome;literate;Machine Learning;Magnetic Resonance Imaging;Measurement;Methods;millimeter;Modeling;myelination;neural;neural circuit;neural model;Neuroanatomy;Neurobiology;neuroimaging;neuromechanism;novel;Outcome;personalized approach;post intervention;Predictive Factor;Predisposing Factor;Printing;Process;Property;Reading;remediation;Research;Resolution;response;sample fixation;Series;Shapes;skills;sound;Structure;successful intervention;Time;tool;Translating;Visual;Visual System;Water;white matter;white matter change

PROJECT_TITLE: Neural mechanisms of successful intervention in children with dyslexia


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Biotechnology;Gene Therapy;Genetics;Immunotherapy;Lymphatic Research

ORG_CITY: PHILADELPHIA

ORG_NAME: VELLUM BIOSCIENCES LLC

ORG_STATE: PA

PHR: Narrative This STTR phase 1 proposal lays the groundwork and supportive evidence for an easily transferable GMP- compliant viral vector that can be used to monitor chimeric antigen receptor (CAR) T cell therapies in human patients. We recently developed the underlying technology that uses E. coli dihydrofolate reductase (eDHFR), a small bacterial protein, that can act as a positron emission tomography (PET) imaging tag when paired with a radiolabeled drug, fluorine-18 trimethoprim ([18F]-FTMP). Once enabled, this platform will substantially impact our collective understanding of why a cell therapy product is successful or fails on an individual patient level using non-invasive imaging.

PI_NAMEs: MILLER, DEREK  (contact);SELLMYER, MARK A

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Acceleration;adeno-associated viral vector;Affinity;Animal Model;Animals;Antibiotics;arm;Bacterial Proteins;Binding;Biodistribution;Biological Assay;Biological Sciences;bioluminescence imaging;Blood - brain barrier anatomy;Bone Marrow;CAR T cell therapy;Cell Culture Techniques;Cell Physiology;Cell Therapy;Cells;Cellular immunotherapy;chimeric antigen receptor;chimeric antigen receptor T cells;Clinic;Clinical;Clinical Management;clinical practice;Clinical Protocols;Clinical Research;clinical translation;Collaborations;commercialization;Contracts;Data;Development;Dihydrofolate Reductase;Disadvantaged;drug development;Drug Kinetics;early phase trial;Engineering;Epithelium;Escherichia coli;evidence base;first-in-human;Fluorine;FOLH1 gene;Future;gene therapy;Genetic;Genetic Medicine;Goals;Grant;Herpesvirus 1;Human;IL18 gene;Image;imaging approach;imaging biomarker;imaging platform;imaging study;Immune;Immunocompetent;immunogenicity;In Situ;In Vitro;in vitro Assay;in vivo;in vivo Model;individual patient;Injections;Lentivirus;Lentivirus Vector;Ligands;Literature;Location;Lymphoma;Mammalian Cell;manufacture;Measurement;Measures;Mediating;Messenger RNA;Methods;molecular imaging;Monitor;mouse model;new technology;non-invasive imaging;novel therapeutics;off-target site;Organ;Pathologic;patient response;Patients;Pattern;Pennsylvania;Pharmaceutical Preparations;Pharmacologic Substance;Phase;plasmid DNA;Plasmids;Positron-Emission Tomography;preclinical study;Process;Production;Prostate;protein expression;Proteins;Protocols documentation;Publishing Peer Reviews;Quality Control;quantitative imaging;Radiolabeled;radiotracer;receptor expression;Refractory;Reporter Genes;Research;Research Personnel;Rodent;SLC5A5 gene;Small Business Technology Transfer Research;small molecule;Specificity;Splenocyte;Stress Tests;System;T-Lymphocyte;Technology;technology platform;Testing;Therapeutic;therapeutic biomarker;thymidine kinase 1;Thyroid Gland;Time;Tissues;Toxic effect;trafficking;Triage;Trimethoprim;tumor;Universities;uptake;Validation;vector;Viral Vector;Vision

PROJECT_TITLE: The development of a GMP eDHFR vector to monitor investigational CAR T cell therapies


NIH_SPENDING_CATS: Behavioral and Social Science;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Racial and Ethnic Minority Health Research;Sexually Transmitted Infections;Social Determinants of Health;Women's Health Research

ORG_CITY: DURHAM

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: PROJECT NARRATIVE Young Black men who have sex with men (YBMSM) and transwomen in the southern United States (US) are at a disproportionately higher risk of HIV due to lower rates of viral suppression among HIV positive men and of pre-exposure prophylaxis (PrEP) among HIV-negative men, but current recommendations for PrEP do not take into account important social and economic barriers. Much of YBMSM's elevated risk is mediated through their sociosexual network, where higher rates of uncontrolled HIV and co-circulating sexually transmitted infections influence the risk of HIV acquisition, although the factors leading to acquisition and the factors indicating this risk are often not addressed in that context. In this project, we aim to address this issue by quantifying the additional risks of HIV for YBMSM as measured through the sociosexual network, developing a model that can be applied at the time of public health interview to predict HIV seroconversion within 3 years, and comparing methods to scale up to the underlying transmission network using the subset of relationships observed during public health interactions.

PI_NAMEs: PASQUALE, DANA KRISTINE (contact)

PROGRAM_OFFICER_NAME: DEJLI, JAMAL

PROJECT_TERMS: Accounting;Address;Affect;aged;AIDS prevention;antiretroviral therapy;Area;Attitude;barrier to care;Behavior;black men;black men who have sex with men;cisgender;Clinical;cohort;Communicable Diseases;Communities;Contact Tracing;Data;demographics;Diagnosis;Disparity;Economics;effective therapy;Epidemic;Failure;Future;Genes;Guidelines;high risk;high risk population;High Risk Woman;HIV;HIV anti-retroviral;HIV risk;HIV Seronegativity;HIV Seropositivity;improved;Incidence;Individual;Infection;infection risk;Intervention;Interview;Investigation;Joints;Lead;Learning;Link;Measures;Mediating;Medicaid;member;men;men of color;Methods;Modeling;Molecular;network models;Newly Diagnosed;North Carolina;Pathway Analysis;Pattern;Persons;Population;Populations at Risk;pre-exposure prophylaxis;Prevalence;prevent;Prevention;prevention service;Process;Prophylactic treatment;Public Health;Race;Recommendation;Recording of previous events;Regimen;Resources;Risk;Risk Factors;scale up;seroconversion;Services;Sexually Transmitted Diseases;simulation;social;sociodemographic group;Syphilis;Testing;Time;tool;transgender women;transmission process;United States;United States Public Health Service;Viral;Viral Load result;young man

PROJECT_TITLE: Increasing the yield of HIV contact tracing for prevention using network models

STUDY_SECTION: PPAH

STUDY_SECTION_NAME: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH]


NIH_SPENDING_CATS: Brain Disorders;Clinical Research;HIV/AIDS;Infectious Diseases;Neurosciences;Rare Diseases;Sexually Transmitted Infections

ORG_CITY: BALTIMORE

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: The best management approach for people with HIV (PWH) experiencing syphilis serologic non-response or failure is uncertain, mainly because data on long-term symptomatic neurosyphilis outcomes in these patients are lacking. We propose to leverage a well characterized clinical cohort of PWH followed from 1990-2024 to: 1. Compare symptomatic neurosyphilis incidence over time in those with appropriate syphilis serologic response compared to those with serologic non-response or failure and 2. Determine whether additional interventions in those with syphilis serologic non-response or failure are associated with improved outcomes. The results of this study have the potential to change national policy, reducing unnecessary lumbar punctures and antibiotic treatment in PWH with serologic non-response or even serologic failure after initial syphilis treatment.

PI_NAMEs: TUDDENHAM, SUSAN ANNE (contact)

PROGRAM_OFFICER_NAME: HUEBNER, ROBIN E

PROJECT_TERMS: Acute;Address;Affect;Aftercare;Antibiotic Therapy;Antibiotics;Antibodies;Antibody titer measurement;Benign;Benzathine Penicillin;CD4 Lymphocyte Count;Central Nervous System Infections;Clinical;cohort;Confusion;cost;Data;Development;Diagnostic Procedure;Dose;Exhibits;experience;Failure;follow-up;Goals;Guidelines;Healthcare;high risk;HIV;HIV Infections;HIV Seronegativity;improved;improved outcome;Incidence;Individual;Infection;Intervention;Latent Syphilis;Lead;Measures;Monitor;Neurologic;Neurosyphilis;Outcome;Participant;Patients;Penicillin G;Penicillins;Persons;Policies;prospective;Recommendation;Relapse;response;Risk;Serology;Serum;Spinal Puncture;Syphilis;Time;treatment guidelines;treatment response;Viral

PROJECT_TITLE: The long-term risk of neurosyphilis in people with HIV experiencing syphilis serologic nonresponse or failure

STUDY_SECTION: HCAC

STUDY_SECTION_NAME: HIV Coinfections and HIV Associated Cancers Study Section[HCAC]


ADMINISTERING_IC: MH

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Mental Health;Pediatric;Pediatric - AIDS;Prevention;Social Determinants of Health

ORG_CITY: BIRMINGHAM

ORG_NAME: UNIVERSITY OF ALABAMA AT BIRMINGHAM

ORG_STATE: AL

PHR: NARRATIVE Incidence of HIV is increasing in Brazil among sexual and gender minority youth aged 15-24 years (SGM youth), who face barriers in accessing preventive care at health facilities. The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which SGM youth will be integrated into SGM-affirming health care teams and trained to deliver HIV pre-exposure prophylaxis (PrEP) to their peers. The project will provide evidence on whether PrEP delivery by peer lay workers can increase PrEP uptake, adherence, and persistence among SGM youth and will be used by our collaborators at the National HIV Program in Brazil to guide programming for this population.

PI_NAMEs: BRUXVOORT, KATIA  (contact)

PROGRAM_OFFICER_NAME: KAMATH, SUSANNAH M A

PROJECT_TERMS: Adherence;Adolescent;Adolescent Medicine;aged;arm;Articulation;authority;Behavioral Sciences;Brazil;Caring;clinical care;Clinical Trials;Communities;community intervention;community setting;Consolidated Framework for Implementation Research;COVID-19 pandemic;Data;effective intervention;Eligibility Determination;Ensure;Epidemic;Epidemiology;Evaluation;experience;Foundations;gender minority youth;General Population;Goals;Health care facility;Health Personnel;Health Services Accessibility;Health system;HIV;HIV Infections;implementation science;Incidence;innovation;interest;Intervention;Interview;Latin America;Libido;Link;Medical Care Team;member;men;men who have sex with men;Modification;Monitor;Municipalities;navigator intervention;Nurses;participant safety;peer;personalized approach;Physicians;Policy Maker;Population;Positioning Attribute;pre-exposure prophylaxis;Prevalence;Prevention;Prevention approach;Preventive care;Primary Care;primary outcome;Process Assessment;programs;Provider;Randomized;randomized trial;Randomized, Controlled Trials;Reach, Effectiveness, Adoption, Implementation, and Maintenance;recruit;Reporting;Research;Research Personnel;scale up;secondary outcome;Series;Services;Sexual and Gender Minorities;sexual minority youth;Social Sciences;social stigma;sound;standard care;Structure;Testing;Training;transgender women;trend;United Nations;Update;uptake;Work;young men who have sex with men

PROJECT_TITLE: "Determining the impact of peer-led community-based PrEP delivery among sexual and gender minority youth in Brazil: A randomized controlled trial"


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Assistive Technology;Bioengineering;Diabetes;Wound Healing and Care

ORG_CITY: EVANSTON

ORG_NAME: RHAEOS, INC.

ORG_STATE: IL

PHR: PROJECT NARRATIVE Nonhealing wounds affect >8 million Medicare beneficiaries in the United States, costing the system up to ~$97 billion, with challenges particularly acute in older adults. Nonhealing characterization and treatment are highly subjective and based largely on the experience of the treating clinician. In the proposed work, will develop wearable devices for the precise, real-time, continuous monitoring of wound healing through dressing layers with miniaturized, wireless, wearable conformal thermal sensors.

PI_NAMEs: WEBB, RICHARD CHAD (contact)

PROGRAM_OFFICER_NAME: TSAP, LEONID V

PROJECT_TERMS: Acute;adverse outcome;Affect;Amputation;angiogenesis;Animal Model;Architecture;Bacterial Infections;Beds;beneficiary;Biological;Biological Markers;Biological Models;Biophysics;Biopsy;Blood;Blood flow;blood perfusion;Blood Vessels;Bluetooth;Caring;Chemotaxis;Chronic;chronic wound;Clinical;Complex;cost;Country;cytokine;Data;data exchange;db/db mouse;Debridement;Decision Making;decubitus ulcer;Deposition;Dermal;Development;Devices;Diabetes Mellitus;diabetic;Diabetic Foot Ulcer;diabetic ulcer;Ensure;Equilibrium;experience;Extracellular Matrix;Exudate;Friction;Frustration;Geometry;healing;Human;Hydration status;Hyperglycemia;Hypoxia;imaging modality;Immobilization;in vivo;Inpatients;insight;Intervention;Laboratories;Leg Ulcer;Magnetic Resonance Imaging;Malignant Neoplasms;manufacturability;Measurement;Mediating;Medical;Medicare;Metabolic Diseases;Methods;Microfluidics;miniaturize;Modality;Modeling;non-healing wounds;non-invasive monitor;Nursing Homes;older adult;older patient;Outcome;Outpatients;Patients;Pattern;Performance;Perfusion;Physicians;pre-clinical;pressure;Prevalence;Process;Property;rechargeable battery;remote monitoring;Reperfusion Therapy;Risk;Rodent Model;Roentgen Rays;Safety;Sampling;sensor;Sepsis;Silicones;Site;Skin;skin wound;smartphone application;software development;Splint Device;Sterile coverings;Structure;Survival Rate;System;Technology;Technology Assessment;technology validation;Telemetry;Temperature;Testing;Time;Tissues;United States;Validation;Vascularization;Venous;wearable device;wearable sensor technology;Weight;wireless;wireless data transmission;Work;Workload;wound;wound care;wound dressing;wound environment;wound healing

PROJECT_TITLE: Development of wearable sensors for continuous wound monitoring

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (11)]


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Depression;Health Services;Mental Health;Pediatric

ORG_NAME: 3-C INSTITUTE FOR SOCIAL DEVELOPMENT

PHR: Project Narrative Youth mental health rates have nearly doubled over the past several years creating a significant public health crisis. Schools are the primary mental health (MH) service setting for youth, and as prevalence rates have climbed, school mental health (SMH) providers are struggling to meet the needs of the youth they serve. This SBIR will create and test Assist-MH, a new interactive digital support system of innovative treatment planning and intervention tools that will enhance SMH providers’ ability to address the emotional and behavioral health needs of their students more efficiently and effectively.

PI_NAMEs: DEROSIER, MELISSA E. (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: 17 year old;Address;Administrator;Age;age group;Anxiety;anxiety symptoms;Area;barrier to care;behavioral health;care outcomes;Caring;Clinical;Collaborations;commercial application;commercialization;Computer software;cost;COVID-19 pandemic;Data;depressive symptoms;design;Development;digital;digital technology;Disease;Emotional;exhaustion;experience;Failure;Feedback;Focus Groups;Foundations;Goals;Health Personnel;Health Planning;improved;Individual;Infrastructure;innovation;Intervention;Learning;Letters;Mental Depression;Mental disorders;Mental Health;Mental Health Services;Monitor;Outcome;Pain;pandemic disease;Participant;Persons;Phase;Population;Prevalence;Primary Schools;Problem behavior;prototype;Provider;Psyche structure;Public Health;public health emergency;Random Allocation;Recommendation;recruit;Reporting;Research;Risk;Risk Behaviors;Schools;Self Efficacy;service delivery;service engagement;Service setting;Services;Small Business Innovation Research Grant;social stigma;Software Design;software development;Students;substance use;Suggestion;Support System;Surgeon;Surveys;Symptoms;System;Technology;Testing;Time;tool;Trauma;Treatment outcome;treatment planning;treatment strategy;usability;virtual;Voice;web app;Work;Youth

PROJECT_TITLE: Assist-MH digital technologies to support school mental health care

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-D (10)]


ADMINISTERING_IC: GM

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: FORT COLLINS

ORG_DEPT: BIOLOGY

ORG_NAME: COLORADO STATE UNIVERSITY

ORG_STATE: CO

PHR: PROJECT NARRATIVE This administrative supplement will be used to replace a centrifuge that is essential to the project funded by the parent award on mechanisms of mitochondrial mutation rate variation. This equipment experienced unforeseen damages that rendered it inoperable.

PI_NAMEs: SLOAN, DANIEL BENJAMIN (contact)

PROGRAM_OFFICER_NAME: MACARTHUR, LINDA

PROJECT_TERMS: Administrative Supplement;Centrifugation;Chloroplasts;Equipment;Eukaryota;experience;Funding;Goals;Mitochondria;Mutation;parent project;Speed;Tissues;United States National Institutes of Health;Variant

PROJECT_TITLE: Mechanisms of mitochondrial mutation rate variation across eukaryotes

STUDY_SECTION: MRAA

STUDY_SECTION_NAME: Maximizing Investigators? Research Award A Study Section[MRAA]


ORG_CITY: IOWA CITY

ORG_NAME: HALIDE BIOLOGICS, INC.

ORG_STATE: IA

PHR: Project Narrative For many challenging medical conditions (e.g., metabolic diseases, hematologic diseases, and cancer), the best treatment option is the injection of the missing or dysfunctional protein into the bloodstream. Unfortunately, even after four decades, these special recombinant protein therapeutics remain expensive to produce and challenging and inconvenient to administer. For this multi-phase SBIR project, we propose to address this issue by designing, validating, and commercializing next-generation proteins that work better (and/or last longer)—thereby greatly benefitting the health of millions who suffer from a broad range of ailments and conditions in the U.S. and worldwide.

PI_NAMEs: INFIELD, DANIEL T (contact)

PROGRAM_OFFICER_NAME: SURPRIS, MARIPIERRE PAYEN

PROJECT_TERMS: Address;Alpha-galactosidase;Amino Acids;analog;Area;Biochemical;Biological;Biological Assay;Biological Products;Biology;Blood Circulation;Caregivers;Cell Line;Chemicals;Clinical;clinical development;clinical efficacy;Code;Combined Modality Therapy;commercialization;Complex;Cost efficiency;Cyclic GMP;Data;design;Disease;DNA;Dose;Engineering;enzyme replacement therapy;Enzymes;Evaluation;experimental study;Fabry Disease;Fibroblasts;Foundations;Funding;Future;Glucan 1,4-alpha-Glucosidase;Glycogen storage disease type II;Goals;Government;Growth;Health;Health Benefit;Health Professional;Hematological Disease;Human;improved;In Vitro;in vivo;Inborn Errors of Metabolism;Industry;Infusion procedures;Injectable;Injections;interest;International;Intravenous;invention;Investments;Iowa;Licensing;Malignant Neoplasms;Mammalian Cell;manufacture;manufacturing process;Marketing;Mass Spectrum Analysis;Medical;Metabolic Diseases;Methods;Modeling;multidisciplinary;National Institute of Child Health and Human Development;next generation;novel;Oregon;Ownership;Patients;Peptides;Performance;Personal Satisfaction;Persons;Pharmaceutical Chemistry;pharmacologic;Pharmacology;Phase;Phenylalanine;phenylalanine analog;Physiological;Plasmids;Private Sector;Production;Property;Protein Secretion;Proteins;Recombinant Proteins;Recombinants;research and development;Residual state;Resources;RNA;Safety;Site;Small Business Innovation Research Grant;small molecule;stable cell line;standard of care;success;Suspensions;System;Techniques;Technology;Temperature;Therapeutic;therapeutic protein;therapeutic target;Therapeutic Uses;Thermodynamics;tool;Transfection;Triplet Multiple Birth;United States National Institutes of Health;Universities;Variant;Work

PROJECT_TITLE: Targeted fluorination for improved pharmacology of enzyme replacement therapies

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Dental, Oral, and Craniofacial Disease

ORG_CITY: AUSTIN

ORG_NAME: CALLENTIS CONSULTING GROUP LLC

ORG_STATE: TX

PHR: NARRATIVE  As per statistics from NIDCR, nearly 90% of adults ages 20 to 64 years have had decay (dental caries) in their teeth, a percentage that has not changed significantly between the 1999–2004 and 2011–2016 NHANES (National Health and Nutrition Examination Survey) cycles. The most common dental restorative materials that are used to address this issue are BPA-derived Bis-GMA resin-based composites, which expose human body to BPA leaching that may cause male reproductive abnormalities, and increased risk of heart disease and diabetes. In this project, Callentis Consulting Group, in collaboration with University of Colorado and New Mexico State University are aiming to develop novel high-performance, BPA-free, functional, and durable dental composites with remineralization capabilities that will replace Bis-GMA in dental restoration applications.

PI_NAMEs: STANSBURY, JEFFREY W. (contact)

PROGRAM_OFFICER_NAME: LOPEZ, ORLANDO

PROJECT_TERMS: Address;Adopted;Adult;Age;Allergic Reaction;Barium;biomaterial compatibility;Bisphenol A-Glycidyl Methacrylate;Clinical;clinical application;Collaborations;Colorado;commercialization;composite restoration;cost;cytotoxicity;cytotoxicity test;Data;Degree Completion;density;Dental;Dental Care;Dental caries;Dental Enamel;Dental Materials;dental resin;Diabetes Mellitus;Dryness;Esthetics;Evaluation;Exhibits;exposed human population;Failure;Filler;fluorapatite;Formulation;Fracture;Glass;Goals;Hardness;Health;heart disease risk;Heart Diseases;Human body;Hydroxyapatites;improved;innovation;Institution;invention;Legal patent;Life;Longevity;male;Manufacturer;Marketing;Measures;mechanical behavior;mechanical properties;Mechanics;Methacrylates;methacrylic acid;microCT;mineralization;Minerals;Modeling;Modulus;monomer;Morphology;National Health and Nutrition Examination Survey;National Institute of Dental and Craniofacial Research;New Mexico;novel;Oral cavity;particle;Particle Size;Patients;Performance;Persons;Phase;photocuring;photopolymerization;Plant Resins;polymerization shrinkage;polymerization stress;Polymers;Preparation;Production;Property;Psychological reinforcement;Quality of life;reaction rate;Refractive Indices;remineralization;reproductive;Research;Residual state;Resistance;restoration;restorative dentistry;restorative material;Sampling;scale up;Scanning;Selection Criteria;Shapes;Solubility;statistics;Stress;Structural defect;Structure;Surface;System;Testing;Therapeutic;Time;Tooth structure;Tooth Tissue;Topical application;Universities;uptake;Urethane;virtual;Viscosity;Vision;Water

PROJECT_TITLE: High-performance BPA-free dental restoration composites with remineralization capabilities

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-D (10)]


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

ORG_CITY: SAN DIEGO

ORG_NAME: ELECTRONIC BIOSCIENCES, INC.

PHR: Project Narrative Current cholesterol testing methods fail to identify many cardiovascular disease (CVD) patients who need treatment to lower their cholesterol levels to reduce the risk of heart attack and stroke. This is because current cholesterol testing methods do not assay the properties of lipoprotein nanoparticles (concentration and size) that serve as better biomarkers for cardiovascular risk. Our proposed device and methodology measures advanced lipid metrics (concentration, size, zeta potential, and dielectric constant) in a compact, simple, and rapid test with lower cost and higher precision than current gold-standard methods, and will represent the new benchmark in lipid testing for CVD diagnosis, treatment, and lipidomics research.

PI_NAMEs: GERMAN, SEAN  (contact)

PROGRAM_OFFICER_NAME: LUNDBERG, MARTHA

PROJECT_TERMS: Arteries;Atherosclerosis;Benchmarking;Biological;Biological Assay;Biological Markers;Biological Sciences;Blood;blood filtration;blood lipoprotein;Blood specimen;Buffers;Cardiovascular Diagnostic Techniques;Cardiovascular Diseases;cardiovascular disorder risk;cardiovascular health;cardiovascular risk factor;Cause of Death;Cells;Cessation of life;Charge;Chemicals;Cholesterol;Clinic;Clinical;Collaborations;Complex;cost;Deposition;design;Devices;Diagnosis;Diagnostic tests;diagnostic value;Diameter;Drops;Electronics;Evaluation;extracellular vesicles;Fatty Acids;Filtration;Fingers;Goals;Head;Health;Health Care Costs;High Density Lipoproteins;High Prevalence;Hospitalization;Human Resources;hypercholesterolemia;improved;Individual;instrument;Laboratories;Link;lipidomics;Lipids;Lipoprotein (a);Lipoproteins;Logistics;Low-Density Lipoproteins;Measurement;Measures;Methodology;Methods;Microfluidics;Molecular;Monitor;Myocardial Infarction;nanolipoprotein particles;nanoparticle;nanopore;Nature;next generation;Noise;particle;Patient Monitoring;Patient risk;Patients;Performance;Pharmaceutical Preparations;Phase;Phospholipids;physical property;Physicians;Physiologic pulse;Plasma;point of care;point of care testing;professor;Property;Proteins;prototype;rapid test;Reader;Research;Research Personnel;Resolution;response;Risk;Risk Assessment;Risk Factors;Risk Reduction;Role;Saliva;Sampling;scale up;screening;Sensitivity and Specificity;sensor;Serum;Signal Transduction;skills;Small Business Technology Transfer Research;Specificity;Speed;Standardization;Stroke;Surface;System;Systems Integration;Techniques;Technology;Testing;Time;Tissues;tool;Training;Triglycerides;United States;Universities;Utah;Very low density lipoprotein;Vial device;Width;zeta potential

PROJECT_TITLE: Next-Generation Cardiovascular Risk Assessments Via State-Of-The-Art Lipoprotein Characterization

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Cocaine;Drug Abuse (NIDA only);Estrogen;HIV/AIDS;Infectious Diseases;Neurosciences;Stimulant Use and Misuse;Substance Misuse;Women's Health Research

ORG_DEPT: PHARMACOLOGY

ORG_NAME: DREXEL UNIVERSITY

PHR: PROJECT NARRATIVE HIV is associated with menstrual cycle abnormalities and hormonal dysregulation. Estradiol signaling in the hypothalamus regulates drug-related behaviors, suggesting that HIV-induced alterations in the hypothalamic estradiol system may mediate the dysregulation of drug-related behaviors. The proposed project will assess the contribution of the hypothalamic estrogen system to the regulation of drug-related behaviors in the EcoHIV mouse model of progressive HIV infection.

PI_NAMEs: BARKER, JACQUELINE M (contact)

PROGRAM_OFFICER_NAME: MCCLURE-BEGLEY, TRISTAN DAVID

PROJECT_TERMS: Acceleration;Acute;Adult;Affect;Amenorrhea;antagonist;Area;Attenuated;Back;Behavior;Behavioral;behavioral plasticity;behavioral response;Cannulations;Cocaine;cocaine exposure;cocaine related behaviors;comorbidity;Coupled;Data;designer receptors exclusively activated by designer drugs;Disinhibition;Dopamine;Drug Regulations;Drug usage;early onset;Endocrine system;ESR1 gene;Estradiol;Estradiol Receptors;Estrogen Receptors;Estrogens;Estrous Cycle;Estrus;Exhibits;experimental study;Feeds;Female;Genetic;Gonadal Hormones;Health;HIV;HIV Infections;Hormonal;Hormones;Hypothalamic structure;Immediate-Early Genes;Individual;Infection;Knowledge;Label;Lesion;Locomotion;male;Medial;Mediating;Menopause;Menstrual cycle;Menstruation;Microinjections;Modeling;mouse model;Mus;Neurobiology;Neurons;Nucleus Accumbens;Pathway interactions;Periodicity;Persons;Pharmaceutical Preparations;Pre-Clinical Model;Preoptic Areas;Process;Production;receptor expression;Recovery;reduced substance use;Regulation;Risk;Rodent;Saline;Serum;Sex Differences;Signal Transduction;Site;substance use;Substance Use Disorder;System;targeted treatment;Testing;Testosterone;Tracer;treatment strategy;Ventral Tegmental Area;Virus Diseases;Woman

PROJECT_TITLE: HIV and estrogen effects on hypothalamic regulation of cocaine-related behavior

STUDY_SECTION: HCCS

STUDY_SECTION_NAME: HIV Comorbidities and Clinical Studies Study Section[HCCS]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Gene Therapy;Genetics;Immunotherapy;Kidney Disease;Orphan Drug;Rare Diseases

ORG_CITY: MILFORD

ORG_NAME: CELLINFINITY BIO, INC.

ORG_STATE: CT

PHR: Project Narrative CAR-T cell therapy is a revolutionary treatment with curative potential against many cancers; however, multiple challenges exist for current cell therapy, particularly for solid tumors. To overcome these challenges, we apply our cell-based directed evolution technology to create superior autologous CAR-Ts targeting a novel antigen in renal cell carcinoma. Successful completion of the proposal will enable a path towards successful IND approval, leading to initiation of a Phase I clinical trial with our lead CAR-T. 2

PI_NAMEs: PATEL, PREMAL  (contact)

PROGRAM_OFFICER_NAME: DJEMIL, SARRA

PROJECT_TERMS: Address;Adult;Animal Cancer Model;Antibody-drug conjugates;anticancer activity;Antigens;Autologous;Benefits and Risks;Binding;Biological Assay;Blood;Cancer Control;CAR T cell therapy;Cell Therapy;Cells;Characteristics;checkpoint therapy;chimeric antigen receptor T cells;Clinical;clinical candidate;clinical development;Clinical Research;Clustered Regularly Interspaced Short Palindromic Repeats;CRISPR library;CRISPR screen;CTLA4 gene;cytokine;cytokine therapy;Cytoplasmic Tail;cytotoxicity;Development;Directed Molecular Evolution;Disease;Disease Progression;Disease remission;Disseminated Malignant Neoplasm;DNA Sequence;Dose;engineered T cells;Engineering;Epigenetic Process;Evolution;exhaustion;Exhibits;Exons;experience;Failure;first-in-human;Flow Cytometry;Gene Modified;Gene Mutation;Genes;Genetic;Genetic Screening;genetic selection;Goals;Hematologic Neoplasms;Immune;immune-related adverse events;Immunotherapy;improved;In Vitro;in vivo;in vivo evaluation;Individual;Infiltration;Inflammatory;Kidney;Knock-in;Knock-out;Lead;Lentivirus Vector;Libraries;loss of function;Malignant Neoplasms;manufacture;Memory;Messenger RNA;Modeling;Modification;Mus;Mutation;next generation;Normal tissue morphology;novel;Oncogenic;Outcome;Pathology;Pathway interactions;patient derived xenograft model;Patients;Pharmaceutical Preparations;Pharmacodynamics;pharmacokinetics and pharmacodynamics;Phase;Phase I Clinical Trials;Phase I/II Clinical Trial;Phase II Clinical Trials;Phenotype;plasmid DNA;Plasmids;PRDM1 gene;pre-clinical;Pre-Clinical Model;preclinical development;Process;Production;programs;Proliferating;Property;Protocols documentation;Renal Carcinoma;Renal Cell Carcinoma;Risk Assessment;SCID Beige Mouse;Side;Site;Solid Neoplasm;T-Cell Proliferation;T-Lymphocyte;Tail;targeted treatment;Technology;Testing;Therapeutic;Time;Toxic effect;Toxicology;transcriptome sequencing;tumor;Tumor Antigens;Tumor Volume;Validation;whole genome

PROJECT_TITLE: Advancing Next Generation CAR-T cells for Renal Cell Carcinoma

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-V (13)]


NIH_SPENDING_CATS: Bioengineering;Cannabinoid Research;Drug Abuse (NIDA only);Substance Misuse

ORG_CITY: Bedford

ORG_NAME: VOX BIOMEDICAL LLC

ORG_STATE: MA

PHR: Project Narrative This proposed research project will develop and demonstrate a method for electrically charging and collecting exhaled breath aerosols on a photolithographically defined 0.1 mm diameter area to greatly improve the sensitivity of trace aerosol detection by tunable laser spectroscopy (TLS). Sensing and identifying trace drug quantities as well as viruses in exhaled breath provides an important and non-invasive means of identifying affected individuals. Due to the limited amount of exhaled drug or virus aerosols it is necessary to concentrate those exhaled aerosols onto very small areas to achieve TLS detection sensitivity in the sub-nanogram range.

PI_NAMEs: LINDEN, KURT J (contact)

PROGRAM_OFFICER_NAME: KOSTOV, YORDAN VALTCHOV

PROJECT_TITLE: Breath aerosol capture by electric field concentration

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-S (12)]


NIH_SPENDING_CATS: Aging;Assistive Technology;Behavioral and Social Science;Bioengineering;Clinical Research;Disability Research;Patient Safety;Rehabilitation

ORG_CITY: PITTSBURGH

ORG_NAME: VEST INC.

PHR: Project Narrative This project will complete the development and commercial launch of a much needed and innovative accessibility system for homes and assisted living environments that will improve the safety and independence of individuals with mobility impairments. The Mobius system can easily be installed and adapted by the end user, caregiver or a handyperson and is comprised of ergonomic, aesthetically pleasing grab bars, handrails and assistive technology attachments that solve a range of mobility problems. Mobius fills a major gap in the market for home modifications and falls prevention technology to allow older adults to remain at home and successfully age in place.

PI_NAMEs: CHOVAN, CHRIS  (contact)

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: 3D Print;Activities of Daily Living;Address;Adult;Affect;Age;aged;Aging;aging in place;Aluminum;American;Architecture;Area;Arthritis;Assisted Living Facilities;Bathing;Biotechnology;Caregivers;Chronic lung disease;Climacteric;Collaborations;commercial launch;commercialization;Companions;consumer demand;Contractor;coping;cost;cost effective;County;Dedications;design;Development;Devices;disability;Disabled Persons;Disease;Environment;ergonomics;Esthetics;Evaluation;evaluation/testing;Fall prevention;falls;Feedback;field study;Focus Groups;foot;Foundations;Funding;Future;Grant;Health;Health Technology;Heart Diseases;Home;Hospitalization;Housing;human old age (65+);improved;Individual;Injections;Injury;injury-related death;innovation;Instruction;Insurance Coverage;Laboratories;Lifting;manufacture;Marketing;Medical;Medical center;mobility aid;Mobility decline;Modeling;Modification;Molds;multiple chronic conditions;New York;novel;older adult;Older Population;Participant;Pennsylvania;Performance;Persons;Phase;physical impairment;Population;Privatization;Process;Production;programs;prototype;Recommendation;Reporting;Research;Resources;Safety;safety testing;Schedule;Secure;Self-Help Devices;Series;Small Business Innovation Research Grant;Specialist;System;Technology;Testing;Time;tool;Training;Universities;Update;usability;volunteer;Walking;Work

PROJECT_TITLE: Mobius Accessibility Mounting System and Assistive Technology Product Line to Support Independence and Safety for Older Adults and Persons with Disabilities

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CCHI-J (10)]


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Genetics;HIV/AIDS;Human Genome;Infectious Diseases;Lung;Microbiome;Nutrition;Pediatric;Pediatric - AIDS;Prevention

ORG_CITY: Aurora

ORG_NAME: UNIVERSITY OF COLORADO DENVER

PHR: Project Narrative Developing Interventions for The Protection of HIV-Exposed Uninfected Infants against Severe Infections HIV-exposed uninfected infants (HEU) have higher risk of infections, hospitalizations, and death than HIV- unexposed infants (HU) during the first 1-2 years of life. By comparing HEU with HU, we will determine the characteristics of the gut bacteria that may contribute to the poor health outcomes of HEU and how they relate to the immune system, blood metabolites, and bacteria in the infant respiratory tract. We will also test 2 dietary interventions that may alter the relative frequency of bacteria in the gut of HEU.

PI_NAMEs: MADHI, SHABIR A;WEINBERG, ADRIANA  (contact)

PROGRAM_OFFICER_NAME: MAJJI, SAI PRASANNA

PROJECT_TERMS: 16S ribosomal RNA sequencing;Affect;Age;Antigen-Presenting Cells;antiretroviral therapy;Bacteria;Biological Assay;Blood;Cells;Cessation of life;Characteristics;Defect;design;Diet;Dietary Intervention;Disease;dysbiosis;Education;Effectiveness;effector T cell;Epigenetic Process;Etiology;Female;Fermentation;forging;Frequencies;gastrointestinal infection;Genes;Genomics;Goals;gut bacteria;gut dysbiosis;gut microbiome;gut microbiota;gut-lung axis;high risk;HIV;HIV Infections;HIV-exposed uninfected infant;Hospitalization;Immune;immune function;Immune response;Immune system;Immune System Diseases;Immunogenomics;Immunologics;improved;In Vitro;in vivo;Incidence;Infant;Infant Development;infant gut microbiome;Infection;infection risk;innovation;Intervention;Life;Lung;male;Measures;Mediating;Mediator;Metabolic;metabolome;metabolomics;Metagenomics;microbial;microbiome;microbiome composition;microbiota;microorganism;Milk;Morbidity - disease rate;multidisciplinary;nasopharyngeal swab;Natural Killer Cells;Neonatal;Outcome Measure;pasteurization;Pathway interactions;Pattern;Persons;Pharmaceutical Preparations;Phenotype;Plasma;Play;poor health outcome;Pregnancy;pregnant;programs;Randomized;Rectum;Regulatory T-Lymphocyte;Reporting;Reproducibility;respiratory microbiome;respiratory microbiota;Respiratory System;Respiratory Tract Infections;Risk;Role;Scientist;Severities;Shotguns;Supplementation;Swab;T-Lymphocyte;Testing;therapy design;transcriptomics

PROJECT_TITLE: Developing Interventions for Protecting HIV-Exposed Uninfected Infants against Severe Infections

STUDY_SECTION: HIVD

STUDY_SECTION_NAME: HIV Immunopathogenesis and Vaccine Development Study Section[HIVD]


NIH_SPENDING_CATS: Bioengineering;Cancer;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Radiation Oncology;Rural Health;Social Determinants of Health

ORG_CITY: NICHOLASVILLE

ORG_NAME: WILD DOG PHYSICS, LLC

ORG_STATE: KY

PHR: Healthcare disparities in the US result in large segments of the population without access to radiation therapy RT. We proposes to design and test a new-generation QA device, that addresses these unmet medical needs. When successful, this important innovation will help to bring accurate, state-of-the-art radiation therapy treatments to patients who might otherwise not receive them.

PI_NAMEs: MOLLOY, JANELLE ARLENE (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: Abbreviations;Address;Adoption;Advocate;analytical tool;Appalachian Region;Assessment tool;Benchmarking;Canis familiaris;Characteristics;Clinic;Clinical;Collection;commercialization;Computer software;cost;Coupled;Data;Data Analyses;Dependence;design;Devices;Dose;dosimetry;Elderly;Feasibility Studies;Funding;Future;Generations;Geography;health care disparity;human old age (65+);Image;image guided radiation therapy;imaging system;Improve Access;improved;improved outcome;Incidence;Industry Standard;innovation;Intensity-Modulated Radiotherapy;inter-institutional;International;Kentucky;Linear Accelerator Radiotherapy Systems;Longitudinal trends;low and middle-income countries;machine vision;manufacture;Marketing;Measurement;Mechanics;Medical;Medical center;Methods;Modernization;Monitor;non-compliance;nonmetropolitan area;novel;Optics;Patients;Peer Review;peer support;Performance;Persons;Phase;Physics;Population;Positioning Attribute;Process;product development;Protocols documentation;prototype;Qualifying;quality assurance;Quality Control;Radiation;Radiation therapy;Radiosurgery;research clinical testing;Resource-limited setting;Resources;Risk;Rural;rural setting;Safety;Sensitivity and Specificity;Series;Services;smoking-related cancer;software development;Specific qualifier value;System;Techniques;Technology;Testing;Time;Trademark;transmission process;Travel;treatment strategy;underserved area;Universities;Validation;Visible Radiation;Vulnerable Populations;Work

PROJECT_TITLE: Improving allocation of scarce medical physics resources through a novel, comprehensive quality assurance device.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-Z (10)]


NIH_SPENDING_CATS: Biotechnology;Chronic Liver Disease and Cirrhosis;Digestive Diseases;Genetics;HIV/AIDS;Hepatitis;Hepatitis - B;Immunization;Infectious Diseases;Liver Disease;Prevention;Vaccine Related

PHR: Project Narrative People living with HIV (PLWH) are at increased risk of hepatitis B virus (HBV) infection, but do not uniformly develop protective immune responses to traditional HBV vaccines. A potent new vaccine against HBV was shown to be highly effective in PLWH. This project will dissect immune cell characteristics that improve vaccine responses in PLWH and assess the effects of vaccination on the HIV reservoir, the barrier to HIV cure.

PI_NAMEs: COX, ANDREA L (contact);SCULLY, EILEEN PATRICIA

PROGRAM_OFFICER_NAME: RADKE, JOSHUA BRYAN

PROJECT_TERMS: active control;adaptive immune response;Adjuvant;Agonist;AIDS clinical trial group;aluminum sulfate;Antibodies;Antibody Formation;Antibody Response;Antibody titer measurement;arm;B-Lymphocytes;Biological Assay;CD4 Positive T Lymphocytes;Cell Physiology;Cells;Cellular Immunity;Cessation of life;Characteristics;chemokine;Cirrhosis;Clinical Trials;Critical Pathways;cytokine;Data;Development;digital;DNA;Dose;Exclusion;Exposure to;Flow Cytometry;follow-up;Genes;Genetic Transcription;Goals;Hepatitis B;Hepatitis B Infection;Hepatitis B Surface Antigens;Hepatitis B Vaccination;Hepatitis B Vaccines;Hepatitis B Virus;high dimensionality;HIV;HIV Infections;HIV-1;Hour;Immune;Immune response;Immune system;Immunity;Immunologics;Impairment;improved;Innate Immune Response;Laboratories;Maintenance;Malignant neoplasm of liver;Measures;metabolic profile;NK Cell Activation;novel vaccines;Outcome;Participant;Pathway interactions;Persons;Phase;phase III trial;Phenotype;Plasma;Polymerase Chain Reaction;Population;Prevention;Prevention strategy;Protocols documentation;Proviruses;Randomized;Randomized, Controlled Trials;Recording of previous events;Regimen;Research;response;Risk;RNA;Series;Single Nucleotide Polymorphism;single-cell RNA sequencing;Specimen;Surface;T cell response;T-Lymphocyte;Testing;TLR9 gene;transcriptome sequencing;transcriptomics;United States;Vaccinated;Vaccination;vaccination outcome;Vaccine Adjuvant;Vaccine Antigen;Vaccine Design;vaccine response;Vaccines;Virus Diseases

PROJECT_TITLE: Dissecting Hepatitis B Vaccine Adjuvant Effects on Immune Responses and the HIV Reservoir in PLWH


ORG_NAME: QRONO, INC

PHR: PROJECT NARRATIVE A breakdown in intestinal tolerance mediated by a reduced number and function of tolerogenic dendritic cells (tolDCs) precedes the onset of symptomatic disease during Type 1 Diabetes (T1D). This proposal seeks to test whether QR402, a DC-targeted AMPK agonist designed to restore tolDCs in the GI tract, can restore intestinal tolerance and prevent disease onset in proof-of-concept in vitro and in vivo models of T1D. Successful completion of the proposed project will result in the validation and development of a first-in-class, oral, DC- specific nanotherapy, which could provide a much-needed preventative treatment option for T1D-susceptible patients.

PI_NAMEs: CARGILL, CHRISTINA PAIGE (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: 5'-AMP-activated protein kinase;Adoptive Transfer;Adverse effects;Agonist;Animals;Anti-Inflammatory Agents;Antigens;Appearance;Autoantigens;Autoimmune;Autoimmunity;autoreactive T cell;B-Cell Activation;B-Lymphocytes;Blood Glucose;Cells;chronic autoimmune disease;clinical development;clinical translation;Clinical Trials;Clone Cells;Collaborations;Continuous Glucose Monitor;Coupled;Custom;Data;Dendritic Cells;design;Development;diabetes pathogenesis;Diabetic mouse;diabetogenic;differentiation in vitro;Disease;Dose;Down-Regulation;draining lymph node;effector T cell;efficacy evaluation;Enteral;Enzyme-Linked Immunosorbent Assay;Failure;Flow Cytometry;Frequencies;functional loss;Future;Gastrointestinal tract structure;General Population;Germ Cells;Heart Hypertrophy;High Pressure Liquid Chromatography;Histology;Homeostasis;Hyperglycemia;Immune;immune cell infiltrate;Immune mediated destruction;Immune response;Immune Tolerance;Immunologics;immunopathology;Immunotherapy;Impairment;In Vitro;in vivo;in vivo Model;Inbred NOD Mice;Inflammatory;Insulin;insulin dependent diabetes mellitus onset;Insulin-Dependent Diabetes Mellitus;interest;Interleukin-10;intestinal homeostasis;Intestines;Investments;Lactic Acidosis;Life Expectancy;Maintenance;Measures;Mediating;Metabolic;Modeling;Monitor;mouse model;Mus;nanomedicine;nanoparticle;nanotherapy;novel;novel therapeutics;Onset of illness;Oral;Oral Administration;Pancreas;Pathway interactions;Patients;Persons;Pharmaceutical Preparations;pharmacologic;Phase;Phenotype;Population;Positioning Attribute;pre-clinical;preclinical study;Predisposition;prevent;Preventive therapy;Preventive treatment;Privatization;Production;Regulatory T-Lymphocyte;sensor;Series;Serious Adverse Event;Serum;Severity of illness;Small Business Technology Transfer Research;Small intestine mucous membrane;Spleen;standard care;Structure of beta Cell of islet;T cell response;T-Lymphocyte;targeted treatment;Testing;therapeutic target;therapy development;Toxic effect;United States;Validation;Work

PROJECT_TITLE: Restoring Tolerance with an Oral AMPK Agonist Nanomedicine Targeting Intestinal Dendritic Cells as a Preventative Therapy for Type 1 Diabetes

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-D (10)]


ORG_CITY: Somerville

ORG_NAME: SANAHEAL, INC.

PHR: NARRATIVE Hemorrhage during trauma injuries and major surgeries in patients under coagulopathic condition is a serious medical emergency associated with high morbidity and mortality due to the limited efficacy of conventional coagulation-based hemostatic strategies and the absence of an effective solution. During the prior development (Phase I-equivalent), the collaborative team developed and evaluated a proof-of-concept prototype of a hemostatic bioadhesive paste for rapid coagulation-independent control of bleeding. In the proposed project, we will continue the optimization and validation of the hemostatic bioadhesive paste based on pre-clinical GLP testing in compliance with FDA regulatory guidance toward the FDA IDE approval in advance of a pivotal clinical trial for the ultimate regulatory clearance and commercialization.

PI_NAMEs: YUK, HYUNWOO  (contact)

PROGRAM_OFFICER_NAME: WARREN, RONALD Q

PROJECT_TERMS: Acquired von Willebrand disease;Address;Adhesions;Adhesives;aging population;Anticoagulation;Atrial Fibrillation;Biocompatible Materials;biomaterial compatibility;Blood;Blood coagulation;Blood Coagulation Disorders;Blood Coagulation Factor;Cardiovascular system;Cellulose;Chemicals;Clinical;Clinical Trials;Coagulation Process;commercialization;cost;Cyclic GMP;cytotoxicity;Dependence;design;Development;Devices;Disease;economic cost;Effectiveness;Ensure;Event;Family suidae;FDA approved;Fibrin;Freezing;Future;Gelatin;Healthcare Systems;Hemorrhage;Hemostatic Agents;Hemostatic function;Heparin;high risk;In Vitro;in vivo;in vivo Model;Injury;left ventricular assist device;Light;Liver;manufacturing scale-up;Mechanics;Medical;Medical Device;Medical emergency;meetings;Methods;Mineral Oil;Modeling;Morbidity - disease rate;mortality;novel;Operative Surgical Procedures;Oral;Organ;Outcome;Paste substance;Patients;Performance;Perioperative;Phase;porcine model;pre-clinical;preclinical evaluation;preclinical study;Preclinical Testing;Preparation;primary endpoint;prototype;Radiation;Rattus;Research Design;Residual state;Resistance;response;Risk;seal;Small Business Innovation Research Grant;Solid;Sterility;Sterilization;Surgical Blood Loss;System;Technology;Testing;Thrombin;Time;Tissues;Translating;Trauma;Validation;ventricular assist device;Warfarin;Work;Writing

PROJECT_TITLE: Hemostatic Bioadhesive Paste for Coagulation-Independent Rapid Control of Bleeding

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-W (12)]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: INDIANAPOLIS

ORG_NAME: DEGROME THERAPEUTICS, INC.

ORG_STATE: IN

PHR: Project Narrative The objective of this STTR phase I grant is to identify potent and brain permeable small-molecule degraders of amyloid precursor protein (APP) as novel therapeutics for treatment of Alzheimer’s diseases (AD).

PI_NAMEs: HAO, CHUNHAI CHARLIE (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: 3-Dimensional;abeta accumulation;Abeta synthesis;absorption;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease model;Alzheimer's disease patient;Alzheimer's disease therapeutic;Alzheimer's disease therapy;Amyloid;Amyloid beta-42;Amyloid beta-Protein;Amyloid beta-Protein Precursor;amyloid protein precursor-binding protein 1;Binding;Biological Assay;Biological Availability;Blood - brain barrier anatomy;blood-brain barrier permeabilization;Brain;Cell Membrane Permeability;Chemicals;clinical development;Clinical Trials;Collecting Cell;computational chemistry;Computer Assisted;Computers;Cytoplasm;Dementia;Deposition;design;Development;Disease;Drug Design;drug discovery;Drug Kinetics;Early identification;effective therapy;efficacy evaluation;Endosomes;Enzyme-Linked Immunosorbent Assay;Excretory function;extracellular;Formalin;Freezing;Glues;Goals;Grant;Immunohistochemistry;Impaired cognition;improved;induced pluripotent stem cell;Induced pluripotent stem cell derived neurons;inhibitor;Intraperitoneal Injections;Lead;lead optimization;Learning;Libraries;Lysosomes;Mediating;Metabolic;Metabolism;Modeling;Modification;Molecular;Monoclonal Antibodies;mouse model;Mus;Neurons;novel;novel therapeutics;Organoids;Pathogenesis;Pathway interactions;patient derived induced pluripotent stem cells;Permeability;Pharmaceutical Preparations;pharmacophore;Pharmacotherapy;Phase;Play;Production;Proliferating;Property;protein degradation;protein protein interaction;Proteins;recruit;Reporting;secretase;Senile Plaques;Small Business Innovation Research Grant;Small Business Technology Transfer Research;small molecule;small molecule inhibitor;small molecule libraries;Solubility;Specificity;Structure-Activity Relationship;Testing;Therapeutic;therapeutic evaluation;therapeutic target;Toxic effect;Treatment Efficacy;Western Blotting

PROJECT_TITLE: Development of Small-Molecule Degraders of APP as the first-in-class drugs for Alzheimer's therapy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 AN-P (11)]


FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Behavioral and Social Science;Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Pediatric;Pediatric - AIDS;Rare Diseases;Social Determinants of Health;Tuberculosis

ORG_CITY: BOSTON

ORG_NAME: BOSTON MEDICAL CENTER

PHR: PROJECT NARRATIVE Tuberculosis (TB) is a top-ten killer of children worldwide and is viciously synergistic with the global HIV pandemic. The projects proposed here will use unique databases and novel social network and ethnographic approaches to quantify and describe the relationship between HIV, TB, and children’s social environments. The results will inform child TB case detection strategies and policy to close the pediatric TB detection and treatment gaps in high HIV/TB-burden settings.

PI_NAMEs: CAMPBELL, JEFFREY IAN (contact)

PROGRAM_OFFICER_NAME: CHIOU, CHEN-CHIA CHRISTINE C

PROJECT_TERMS: 5 year old;Adult;Affect;Age;Air;antiretroviral therapy;arm;Automobile Driving;Birth;Boston;Caregivers;Cessation of life;Child;Childhood;co-infection;cohort;Cohort Studies;Communicable Diseases;Complex;Contact Tracing;Data;Databases;Detection;Diagnosis;Disease;early childhood;Educational workshop;Enrollment;Environment;epidemiology study;ethnographic method;Ethnography;Evolution;experience;Face;fluidity;Foundations;Future;Goals;Health;high risk population;HIV;HIV anti-retroviral;HIV Infections;HIV/TB;Household;illicit drug use;Illicit Drugs;improved;Incidence;indexing;Individual;individual patient;Infection;innovation;insight;K-Series Research Career Programs;Life;Liquid substance;Measures;Medical center;member;men;Mentors;Mentorship;Meta-Analysis;Morbidity - disease rate;mortality;National Institute of Allergy and Infectious Disease;National Institute of Child Health and Human Development;novel;pandemic disease;Pathway Analysis;perinatal HIV;Persons;Physicians;Play;Policies;Predisposition;Prevalence;prevent;prospective;Prospective Studies;Prospective, cohort study;Province;Questionnaires;recruit;Reporting;Research;Research Design;Research Personnel;Research Support;Risk;Risk Factors;risk mitigation;Role;Scientist;skills;Smoke;social;Social Environment;social epidemiology;Social Network;South Africa;Structure;Survival Analysis;Testing;therapy adherence;Training;transmission process;Tuberculosis;Uncertainty;Universities

PROJECT_TITLE: The relationship between HIV exposure, contact networks, and TB in children under 5 years old

STUDY_SECTION: AIDS

STUDY_SECTION_NAME: Acquired Immunodeficiency Syndrome Research Study Section[AIDS]


ADMINISTERING_IC: OH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

ORG_CITY: HANOVER

ORG_NAME: CREARE, LLC

ORG_STATE: NH

PHR: PROJECT NARRATIVE  The treatment of infectious patients (such as those with COVID-19 and influenza) with Noninvasive Positive Pressure Ventilation (NPPV) currently poses a risk of spreading the disease through mask leakage. The device developed in this project will enable NPPV treatment with virtually no mask leakage and greatly reduced risk. This will enable widespread use of this effective treatment on infectious patients while protecting health care workers and other patients.

PI_NAMEs: MICKA, DANIEL  (contact)

PROGRAM_OFFICER_NAME: O'NEILL, EDUARDO

PROJECT_TITLE: Refinement of Very Low Leakage Non-Invasive Ventilation Mask for Infectious Patients

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 RCCS-B (11)]


ADMINISTERING_IC: NS

ED_INST_TYPE: UNIVERSITY-WIDE

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;HIV/AIDS;Infectious Diseases;Neurodegenerative;Neurosciences

ORG_CITY: WASHINGTON

ORG_NAME: GEORGETOWN UNIVERSITY

ORG_STATE: DC

PHR: Project Narrative Despite the introduction of combination antiretroviral therapy (cART), the prevalence of HAND today is similar to that of the pre-cART era and affects up to 50% of people living with HIV (PLWH). In this proposal, I will use in vivo and in vitro models, I will use human samples, and I will employ techniques such as immunoassays, proteomics, and calcium imaging to investigate the hypothesis that gp120 induces endoplasmic reticulum stress, leading to increased accumulation of Aβ. This research is important for our understanding of the mechanisms underlying HAND neuropathology and will provide me with the training to help me achieve my goals of being a scientist that specializes in molecular mechanisms of neurodegenerative disorders.

PI_NAMEs: AGBEY, CHRISTY  (contact)

PROGRAM_OFFICER_NAME: MATTHEWS, MARGUERITE

PROJECT_TERMS: abeta accumulation;Abeta synthesis;Affect;aged;Alzheimer's Disease;Amyloid;Amyloid beta-42;Amyloid beta-Protein;Amyloid beta-Protein Precursor;amyloid pathology;antiretroviral therapy;Axonal Transport;behavioral impairment;Binding;Biological Assay;Biological Markers;blood-brain barrier crossing;Brain;Calcium;Cells;Central Nervous System;Central Nervous System Infections;Cerebrospinal Fluid;Data;Disease;Endoplasmic Reticulum;endoplasmic reticulum stress;env Gene Products;Enzyme-Linked Immunosorbent Assay;Exhibits;experimental study;Exposure to;Glycoproteins;Goals;Heat shock proteins;Hippocampus;HIV;HIV Envelope Protein gp120;HIV Infections;HIV-associated neurocognitive disorder;Homeostasis;Human;Image;Immune;Immunoassay;Immunohistochemistry;Impaired cognition;In Vitro;in vitro Model;in vivo;Incidence;Infection;Link;Mass Spectrum Analysis;Measures;Methods;Microtubules;misfolded protein;Molecular;mortality;motor impairment;National Institute of Neurological Disorders and Stroke;Nerve Degeneration;Neurodegenerative Disorders;neuroinflammation;neuron loss;neuronal survival;Neurons;neuropathology;neurotoxic;neurotoxicity;Pathogenesis;Pathologic;Patients;Peptides;Persons;pharmacologic;Prevalence;prevent;Productivity;Proteins;Proteolysis;Proteomics;Rattus;Research;Research Personnel;Role;Sampling;Scientist;Senile Plaques;Synapses;Techniques;Testing;Tissues;Training;Transgenic Mice;Travel;United States National Institutes of Health;Universities;Viral Proteins;Virus Diseases;Virus Replication;Virus Shedding;Western Blotting

PROJECT_TITLE: Dysregulated AB in HAND: The Role of GP120 Induced Endoplasmic Reticulum Stress

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17A-G (20)]


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Nanotechnology;Orphan Drug;Prevention;Rare Diseases;Vaccine Related

ORG_CITY: BUFFALO

ORG_NAME: POP BIOTECHNOLOGIES, INC

ORG_STATE: NY

PHR: PROJECT NARRATIVE (RELEVANCE) Hematogenously disseminated candidiasis in humans has become the third leading cause of hospital-acquired blood stream infections and despite antifungal therapy at least 40~50% of affected individuals will die of this disease. As there is no approved antifungal vaccine for use in humans and significant therapeutic challenges remain, our approach is disease prevention through active vaccination. Our ultimate goal is to develop the first “universal” liposome-displayed double-peptide vaccine that protects against all medically significant Candida species, as well as address the fundamental question concerning vaccine induced immunity in high-risk neutropenia populations.

PI_NAMEs: XIN, HONG  (contact)

PROGRAM_OFFICER_NAME: LIU, BAOYING

PROJECT_TERMS: Active Immunization;Address;Adjuvant;Affect;anti-fungal agents;Antibodies;Antibody Response;Antibody titer measurement;Antibody-mediated protection;Antifungal Therapy;antigen-specific T cells;Antigens;Biotechnology;Blood;Candida;Candida albicans;Candida auris;Candidiasis;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;Cell surface;clinical application;clinically relevant;Cobalt;COVID-19 vaccine;cytokine;Data;Disease;disorder prevention;Disseminated candidiasis;Dose;Drug resistance;Epitopes;Freeze Drying;Fructosediphosphate Aldolase;Fungal Vaccines;fungus;Glycopeptides;Goals;Healthcare;Hematogenous;High Pressure Liquid Chromatography;high risk;Homocysteine S-methyltransferase;Hospitalization;Hospitals;Human;Immune;Immune response;Immunity;Immunization;Immunize;Immunocompetent;Immunocompromised Host;immunogenic;Immunoglobulin G;Immunologic Memory;in vivo;Inbred BALB C Mice;Individual;Infection;innovation;Intervention;Intramuscular;Licensing;Life;Liposomes;Measures;Mediating;Medical;Modeling;Modernization;Morbidity - disease rate;mortality;mosaic;mouse model;Multi-Drug Resistance;Mus;nanoparticle;Neutropenia;next generation;novel;Organ;Organ Transplantation;particle;Passive Immunization;pathogenic fungus;Patients;Peptide Vaccines;Peptides;pharmacologic;Phase II Clinical Trials;phase III trial;Phospholipids;Pilot Projects;Play;Population;Populations at Risk;Porphyrins;primary endpoint;protective efficacy;prototype;Proxy;Public Health;Resistance;Resistant candida;response;Role;Sepsis;Serum;side effect;Solid;Splenocyte;Stream;synthetic peptide;System;T cell response;TCF Transcription Factor;technology platform;Therapeutic;Toxic effect;universal vaccine;Vaccination;vaccination strategy;Vaccine Adjuvant;vaccine candidate;vaccine evaluation;vaccine-induced immunity;Vaccines;Work

PROJECT_TITLE: Liposome-displayed peptide vaccine against disseminated candidiasis by clinically-relevant Candida species


ORG_CITY: SEATTLE

ORG_NAME: FRED HUTCHINSON CANCER CENTER

ORG_STATE: WA

PHR: PROJECT NARRATIVE Understanding the host factors that regulate HIV transmission is important for designing ways to prevent new infections. We have identified a host factor that inhibits replication of the types of HIV strains that are not readily transmitted and thus may hold clues to how to prevent infection. We propose to study this host gene in mucosal cells that are the target for HIV transmission to determine the importance of this gene in the transmission bottleneck.

PI_NAMEs: OVERBAUGH, JULIE M. (contact)

PROGRAM_OFFICER_NAME: MCDONALD, DAVID JOSEPH

PROJECT_TERMS: Ablation;Address;Binding;Biological;Biology;Biology of HIV Transmission;Blood;CCR5 gene;CD4 Positive T Lymphocytes;Cells;Chronic;CXCR4 gene;design;experimental study;Genes;Genetic;glycosylation;Guide RNA;high risk;HIV;HIV envelope protein;HIV Infections;HIV Receptors;HIV risk;Human;indexing;Individual;Infection;Infection prevention;Integration Host Factors;Knock-out;knockout gene;Life Cycle Stages;Measures;Membrane Fusion;Modeling;Modification;Mucous Membrane;Mutate;Phenotype;Polysaccharides;Predisposition;prevent;Process;receptor;receptor expression;Risk;Role;screening;sexual HIV transmission;Site;T-Lymphocyte;Testing;Time;transmission process;UDP-galactose transporter;Variant;Viral;Virus;Virus Diseases;Virus Replication;Work

PROJECT_TITLE: Characterization of a new CXCR4-specific restriction factor

STUDY_SECTION: HVCD

STUDY_SECTION_NAME: HIV Molecular Virology, Cell Biology, and Drug Development Study Section[HVCD]


NIH_SPENDING_CATS: Genetics;HIV/AIDS;Infectious Diseases

ORG_CITY: BALTIMORE

ORG_DEPT: CHEMISTRY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE COUNTY

PHR: Projective Narrative During HIV-1 virus assembly, two copies of the genomic RNA are selectively packaged by a small number of viral Gag polyproteins. Understanding the molecular determinants of this complex that functions as a nucleant for further virus assembly, as well as the understanding of its interactions with host cell factors will extend not only our current understanding about the late phase of infection of HIV-1, but also lead to the development of novel strategies for the treatment of AIDS and potentially even improved gene delivery vectors with greater packaging efficiencies.

PI_NAMEs: HOLLMANN, NELE MERRET (contact)

PROJECT_TERMS: 5' Untranslated Regions;Acquired Immunodeficiency Syndrome;Adopted;Advisory Committees;Affinity;Area;Binding;Binding Sites;Biophysics;Capsid;career;Cell membrane;Cells;Complex;crosslink;Cryoelectron Microscopy;Cytoplasm;Data;Data Collection;delivery vehicle;Development;dimer;drug development;Elements;Engineering;experimental study;Feasibility Studies;Fluorescence;Future;gag Gene Products;Gene Delivery;Genetic study;Genome;genomic RNA;Genomics;Goals;Guide RNA;HIV Genome;HIV Infections;HIV-1;Immunoprecipitation;improved;insight;Integration Host Factors;intermolecular interaction;Isotopes;Label;Mediating;member;Mentors;Mentorship;Michigan;Molecular;nanomolar;NMR Spectroscopy;novel;novel strategies;Nucleocapsid;Nucleocapsid Proteins;Nucleotide Mapping;Nucleotides;Phase;Physical condensation;Phytic Acid;programs;Proteins;Protocols documentation;recruit;Research;Resolution;Ribonucleoproteins;RNA;Sampling;Shapes;Signal Transduction;Site;skills;stoichiometry;structural biology;structural determinants;Structure;Techniques;Testing;three dimensional structure;Titrations;trafficking;treatment strategy;Universities;Utah;Viral;Viral Genome;viral RNA;Virion;Virus;Virus Assembly;Virus Replication;Visualization;Work

PROJECT_TITLE: Ribonucleoprotein complexes involved in the late phase of HIV-1 replication


NIH_SPENDING_CATS: Biomedical Imaging;Mental Health

ORG_CITY: NEW YORK

ORG_NAME: IN VIVO ANALYTICS, INC.

PHR: InVivo Analytics seeks funding for developing a modular imaging platform for bioluminescence imaging of small animal models addressing challenges in imaging performance and sensitivity, multi-view imaging, anatomical co-registration, user accessibility, and automated image data analysis.

PI_NAMEs: KLOSE, ALEXANDER D. (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: 3-Dimensional;Address;Adoption;Affect;Anatomy;Anesthesia procedures;Animal Model;Animals;anti-cancer research;Area;base;Biological;Biological Process;bioluminescence imaging;Characteristics;Collimator;Communicable Diseases;Communities;Complex;Computer software;cost;cost effective;Coupled;Data;Data Analyses;design;detector;Development;Diffuse;Disease;Drug Kinetics;Elements;Ensure;Face;Fostering;Funding;Gases;Head;human disease;human model;Image;Image Analysis;imaging capabilities;imaging modality;imaging platform;imaging system;improved;in vivo;in vivo imaging;Individual;innovation;lens;Light;Location;Longitudinal Studies;Maps;Methods;Modality;Molds;Noise;novel;nuclear imaging;Optics;Organ;Performance;Phase;photon-counting detector;Photons;pre-clinical;preclinical imaging;Probability;quantitative imaging;quantum;Reproducibility;Research;Signal Transduction;Source;Standardization;stem cells;success;Surface;System;Tissues;tomography;tool;Training;Transcend;Visualization

PROJECT_TITLE: A modular bioluminescence imaging platform using a novel multi-aperture method


NIH_SPENDING_CATS: Bioengineering

ORG_CITY: ITHACA

ORG_NAME: MITEGEN, LLC

PHR: Project narrative Cryopreservation of oocytes, sperm, and embryos can play a key role in propagation of animals used in biomedical research and in preserving the genetics of the thousands to hundreds of thousands of strains of each species that have been developed. Advances in understanding ice formation during both cooling and warming and its developmental consequences combined with new technology for automated ultra-rapid convective cryocooling and ultra-rapid convective warming promise to increase cryopreservation success rates, expand the range of species and strains that can be successfully cryopreserved, and facilitate their biobanking. These advances may also impact human assisted reproduction, preservation of endangered species, and biobanking of other small biological samples.

PI_NAMEs: APKER, BENJAMIN ARTHUR (contact)

PROGRAM_OFFICER_NAME: BARNES, CHARLES ASHLEY

PROJECT_TERMS: absorption;Animal Experimentation;Animals;aqueous;assisted reproduction;base;biobank;Biological;Biomedical Research;Cattle;Chemicals;Cloning;cost effective;Cryopreservation;Crystallography;Dehydration;Development;Diagnostic;Disasters;Domestic Animals;Drops;Drosophila genus;Electromagnetic Energy;Embryo;embryo cryopreservation;Enzymes;Excision;experimental study;Family suidae;flexibility;Generations;Genetic;Genetic Drift;Genetic Variation;Hand;Human;Ice;Image;improved;Laboratories;Lipids;Liquid substance;Measurement;Medicine;Methods;millimeter;millisecond;nanoparticle;new technology;Nitrogen;oocyte cryopreservation;Oocytes;optical imaging;Osmotic Shocks;Outcome;Penetration;Phase;Phase Transition;Play;Preparation;preservation;prevent;primary outcome;protein aggregation;Protocols documentation;prototype;Recovery;Reporting;Reproducibility;Robot;Robotics;Sampling;Speed;sperm cell;success;Technology;Time;Toxic effect;transcriptome;transcriptome sequencing;Work;X ray diffraction analysis;Zebrafish

PROJECT_TITLE: Improving cryopreservation outcomes of small biological samples through ultra-fast convective cooling and warming

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-G (15)]


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Biotechnology;Brain Disorders;Cardiovascular;Gene Therapy;Genetics;Heart Disease;Intellectual and Developmental Disabilities (IDD);Mucopolysaccharidoses (MPS);Neurosciences;Orphan Drug;Pediatric;Prevention;Rare Diseases;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Non-Human;Transplantation

ORG_CITY: Eagan

ORG_NAME: RECOMBINETICS, INC.

ORG_STATE: MN

PHR: Project Narrative This project aims to address the pressing need for effective therapies for MPS IVA (Morquio Syndrome), a rare lysosomal disorder characterized by severe skeletal abnormalities and growth impairment due to GALNS enzyme deficiency. Currently, existing treatments such as enzyme replacement therapy (ERT) are ineffective against the severe skeletal manifestations of the disease. The research proposes to create a large animal model of MPS IVA using genetically engineered swine, allowing for the study of disease biology and the development of potential gene therapies, such as in vivo AAV and ex vivo lentiviral gene transfer.

PI_NAMEs: CAMPBELL, JARRYD MATTHEW (contact);MCIVOR, R. SCOTT

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Acetylgalactosamine;Address;adeno-associated viral vector;Advanced Development;Affect;Aftercare;Age Months;Allogenic;Animal Model;Animals;Autologous;autosome;Biodistribution;Biological Assay;Biology;Birth;Blood;bone;Bypass;Cardiac;Cartilage;Cell Nucleus;Cells;cellular transduction;Cervical spinal cord structure;Chondroitin Sulfate C;Clinical Treatment;Clinical Trials;Clustered Regularly Interspaced Short Palindromic Repeats;comparative;comparative effectiveness;Comparative Study;Defect;Dependovirus;design;Development;digital;Disease;disease model;Dose;Echocardiography;effective therapy;effectiveness evaluation;Engraftment;enzyme activity;enzyme deficiency;enzyme replacement therapy;Enzymes;Euthanasia;Exhibits;Extracellular Matrix;Family suidae;fetal;Fibroblasts;Future;GALNS gene;gene therapy;Gene Transfer;Generations;Genetic Engineering;Genotype;Glycosaminoglycans;Goals;Growth;Harvest;Heart;Heart Diseases;Heart Valve Diseases;Hematopoietic Stem Cell Transplantation;Hematopoietic stem cells;Histologic;Human;human disease;Impairment;improved;in vivo;Individual;ineffective therapies;Inherited;insight;intravenous administration;Keratan Sulfate;Knock-in;Knock-out;Laboratories;lentivirally transduced;Lentivirus Vector;Lysosomal Storage Diseases;Metabolic;Metabolic Diseases;Methods;Minnesota;Modality;Modeling;Morbidity - disease rate;mortality;mouse model;Mucopolysaccharidoses;Mucopolysaccharidosis I;Mucopolysaccharidosis II;Mucopolysaccharidosis IV;Mucopolysaccharidosis IV A;Mus;Mutation;Nervous System Disorder;Neurologic Symptoms;novel;novel strategies;novel therapeutics;Obstruction;offspring;Oocytes;Outcomes Research;Pathology;Pathway interactions;Patients;Peripheral;Phase;phase 1 study;phase 2 study;porcine model;Positioning Attribute;preclinical efficacy;preclinical study;Preparation;prevent;Prevention;Procedures;Production;Rattus;relative effectiveness;repaired;Reporting;Research;Research Personnel;Risk;Rodent;Safety;scale up;skeletal;skeletal abnormality;skeletal disorder;skeletal dysplasia;Small Business Innovation Research Grant;Somatic Cell;somatic cell nuclear transfer;Source;spinal cord compression;Sulfatases;Tail;Testing;Therapeutic;therapeutic gene;Tissues;tool;Trachea;treatment strategy;Universities;vector;Work;X-Ray Computed Tomography

PROJECT_TITLE: Gene Therapy for MPS IV A in a Novel Porcine Model of the Disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IVBH-V (11)]


NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Heart Disease;Hematology;Wound Healing and Care

ORG_CITY: PEMBROKE PINES

ORG_NAME: CIRCULATECH LLC

ORG_STATE: FL

PHR: Narrative Surgical drains, common to cardiac surgeries, often fail to adequately retain chest tube patency in post-surgical care leading to complications from incomplete drainage of retained blood. CirculaTech will advance methods and technologies in preventing surgical drain blockages, namely to enhance the understanding of saline irrigation in averting clogs in surgical drains and to develop an in vivo porcine model mimicking post-cardiac surgery blood drainage. Development of this technology will prevent post-surgical cardiac complications caused by retained blood resulting from occluded chest drains.

PI_NAMEs: PISTINER, JAKE  (contact);TSCHABRUNN, CORY MICHAEL

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TERMS: Acceleration;Address;adverse outcome;Air;air filter;Animal Model;Animal Testing;Animals;Arteries;Atrial Fibrillation;Benchmarking;Blood;Blood Circulation;Blood coagulation;Blood flow;Breeding;Cardiac;Cardiac Surgery procedures;Cardiac Tamponade;Caring;Catheters;Chest;Chest Tubes;clinical practice;Coagulation Process;commercialization;Coronary Artery Bypass;Data;design;Device Designs;Devices;Drainage procedure;Economic Burden;Effectiveness;Exhibits;Failure;Family suidae;Female;Freezing;Geometry;Hemostatic function;Hospital Costs;Hospitals;Hour;human study;improved;In Vitro;in vivo;in vivo Model;Infusion procedures;innovation;interest;Irrigation;Label;large scale production;Legal patent;Link;Location;Maintenance;male;Manuals;manufacture;Measures;Mediastinal;Mediastinum;Medical Device;Methods;Milk;Modeling;Nurses;Operative Surgical Procedures;Outcome;Patients;Performance;Phase;Physiological;Pleural effusion disorder;porcine model;Postoperative Period;Preparation;prevent;Procedures;prototype;Pump;Recovery;Reporting;Research Personnel;response;Saline;standard of care;Sternotomy;success;Surgical wound;Syndrome;Technology;technology development;Testing;Thrombophilia;Time;Translating;Tube;United States National Institutes of Health;Veins;Visual;Work;wound

PROJECT_TITLE: Proactive Dual-Irrigation Cardiac Chest Tube to Maintain Postoperative Patency


NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Heart Disease;Hypertension;Networking and Information Technology R&D (NITRD);Patient Safety

ORG_CITY: LOWELL

ORG_NAME: DYNOCARDIA, INC.

PHR: Project Narrative ViTrack® is a cuff-less, wrist-wearable device, and first of it is kind computer vision technology for accurate and continuous measurements of BP and other advanced heart parameters. We will complete the required verification and validation for ViTrack to enable FDA 510(k) submission. ViTrack will immediately benefit 35 million critically ill patients annually in US hospitals.

PI_NAMEs: THANIKACHALAM, MOHAN  (contact)

PROJECT_TERMS: Acute Renal Failure with Renal Papillary Necrosis;Address;Admission activity;Agreement;American;Animals;Area;arm;Arterial Lines;Biological Sciences;Blood Pressure;blood pressure control;Blood Pressure Monitors;Calibration;Chronic Disease;Chronic Kidney Failure;Clinical;Clinical Research;Computer Vision Systems;Cost Savings;Credentialing;Critical Care;Critical Illness;design;design verification;Development;Devices;Diastolic blood pressure;Disease Management;Effectiveness;Ensure;Feedback;Funding;Goals;Grant;Head;Health Care Costs;Healthcare;healthcare community;Heart;Heart Abnormalities;Heart failure;Heart Rate;heart rhythm;Height;hemodynamics;Home;Hospitals;Hour;Hydrostatic Pressure;Hypertension;Hypotension;improved;improved outcome;innovation;Interview;large scale production;Lead;manufacturing process;Marketing;Measurement;Measures;meetings;Methods;Monitor;Morphologic artifacts;Motion;Movement;Myocardial Infarction;myocardial injury;new technology;Operating Rooms;Operative Surgical Procedures;Outpatients;Output;Patient Monitoring;Patients;Patients' Rooms;Penetration;Periodicals;phase 2 study;Physicians;Positioning Attribute;pressure;Process;Production;programs;remote patient monitoring;research clinical testing;respiratory;Risk;risk mitigation;Sales;Savings;Secure;sensor;sensor technology;Series;Skin;skin color;Sleep Apnea Syndromes;Small Business Innovation Research Grant;standard measure;Stroke;Technology;Testing;Time;usability;Validation;verification and validation;wearable device;Work;Wrist

PROJECT_TITLE: Design verification and validation of ViTrack - an accurate, continuous, non-invasive blood pressure monitor

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (19)]


ORG_CITY: COLUMBIA

ORG_NAME: DOTY SCIENTIFIC, INC.

ORG_STATE: SC

PHR: Low-loss Bi-directional THz Couplers to Enable Affordable MAS-DNP-NMR Narrative Thousands of researchers regularly use Nuclear Magnetic Resonance (NMR) techniques for structure and function determination in biological macromolecules. The advances developed under this project, combined with several other advances under separate projects, will allow NMR laboratories to improve their sensitivity on solids by orders of magnitude, on a budget they will be able to afford. This will equip biomedical researchers with superb new tools for the structure-function studies of membrane proteins and cellular membrane systems.

PI_NAMEs: DOTY, FRANCIS DAVID (contact)

PROJECT_TERMS: 3D Print;Alzheimer's Disease;Amyloid Fibrils;Binding;Biological;Biomedical Research;Budgets;Cellular Membrane;cold temperature;Communication;cost;Crowding;design;Development;enhancing factor;Extremely High Frequency Radio Waves;Frequencies;Future;Gold;HIV;improved;in silico;Laboratories;macromolecule;Magic;Malignant Neoplasms;manufacture;Measures;Membrane Proteins;Methods;microwave electromagnetic radiation;novel;Nuclear;Nuclear Magnetic Resonance;Pharmaceutical Preparations;Phase;Physiologic pulse;Plastics;Play;Price;Proline;Proteins;prototype;Publishing;Research Personnel;Resolution;Role;Sampling;Shapes;simulation;Small Business Innovation Research Grant;Solid;solid state;solid state nuclear magnetic resonance;Source;Spectrum Analysis;structural biology;Structure;System;Techniques;Technology;Testing;Time;tool;waveguide

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Behavioral and Social Science;Childhood Obesity;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Nutrition;Obesity;Pediatric;Prevention

ORG_CITY: PROVIDENCE

ORG_NAME: MIRIAM HOSPITAL

ORG_STATE: RI

PHR: PROJECT NARRATIVE Weight bias internalization (WBI) has been associated with a number of negative physical and mental health consequences for adolescents with obesity, including negative weight-related outcomes. This study will develop, adapt, and pilot test a combined treatment for WBI and behavioral weight control for adolescents, designed to improve WBI and mechanisms of weight stigma induced weight gain including biological markers of stress and inflammation, and dysregulated eating behaviors. Addressing WBI as a particularly salient and impactful psychosocial stressor could improve behavioral weight control outcomes and improve physical and psychological stress for adolescents with obesity.

PI_NAMEs: DARLING, KATHERINE ELIZABETH (contact)

PROGRAM_OFFICER_NAME: OSGANIAN, VOULA

PROJECT_TERMS: Address;Adolescent;adolescent health;adolescent health outcomes;Adolescent obesity;Award;Behavior Control;behavior test;Behavior Therapy;Behavioral Weight Control;Biological Markers;Body Weight decreased;C-reactive protein;Calories;Clinical;Clinical Trials;Combined Modality Therapy;Consumption;critical developmental period;Dedications;design;Development;Diabetes Mellitus;Eating Behavior;emotional eating;Environment;evidence base;feasibility testing;Focus Groups;Goals;Hospitals;Hydrocortisone;improved;Inflammation;Interleukin-6;Intervention;K-Series Research Career Programs;Knowledge;loss of control over eating;Maps;Mental Health;Mentored Patient-Oriented Research Career Development Award;Mentors;Mentorship;Modeling;novel;Obesity;Outcome;Phase;physical conditioning;Physiological;pilot test;pilot trial;Prevalence;Psychological Stress;psychosocial stressors;Research;Research Personnel;Research Project Grants;research study;response;Self Direction;skills;social stigma;Stress;stressor;Testing;Training;Training Programs;Universities;Weight;Weight Gain;Weight maintenance regimen;Youth

PROJECT_TITLE: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes

STUDY_SECTION: DDK

STUDY_SECTION_NAME: Digestive Diseases and Nutrition C Study Section[DDK-C]


ORG_CITY: STREAMWOOD

ORG_NAME: DENOVX, LLC

PHR: Project Narrative: Relevance to Public Health Research Structural biology facilitates an understanding of biological function. Technological advances in structure determination methods like cryoelectron microscopy (cryoEM or cryo-EM) assist researchers in determining the structure of biological molecules and larger assemblies that are relevant to human health. Improvements in cryoEM workflows will enhance the structure-based understanding of disease genesis, progression, and therapy and will have far reaching benefits to Public Health.

PI_NAMEs: BOND, ANDREW H. (contact)

PROGRAM_OFFICER_NAME: FLICKER, PAULA F

PROJECT_TERMS: Acceleration;Adsorption;Adverse effects;Affect;Air;aqueous;Area;Behavior;Benchmarking;Biological;Biological Process;Biological Sciences;Carbon;Charge;Chemicals;Citric Acid Cycle;Collaborations;commercial application;Complex;copolymer;Cryoelectron Microscopy;Crystallization;Data;data quality;Deposition;design;Development;Diameter;Disease;Drug Design;Electron Microscopy Facility;Engineering;Ensure;Enzymes;Escherichia coli;Ferritin;Film;Funding;Goals;graphene;Health;Human;Hydrogen Bonding;hydrophilicity;Hydrophobic Surfaces;Hydrophobicity;Hydroxyl Radical;improved;innovation;interfacial;Legal patent;Marketing;Membrane Proteins;Metals;meter;Methods;Microscopy;Modification;Molecular Conformation;Nobel Prize;Outcome;Oxides;particle;Pharmacologic Substance;Phase;Plasma;Polyethylene Glycols;Polypropylenes;Preparation;Property;Proteins;prototype;Public Health;public health research;quinol fumarate reductase;Randomized;Reproducibility;Research Personnel;Resolution;Ribosomes;Sampling;Science;skills;Specimen;structural biology;Structure;Surface;technological innovation;Technology;Texture;Thermodynamics;Thick;Thinness;Time;Water;Wettability

PROJECT_TITLE: Improving Cryo-EM Specimen Quality Using Surface Science


ORG_CITY: DENVER

ORG_NAME: UNIVERSITY OF DENVER (COLORADO SEMINARY)

PHR: Project Narrative. Human Immunodeficiency Virus Type-1 (HIV-1) remains as a global health burden despite effective treatments. However, poorly understood aspects of the viral infection cycle remain, such as assembly and cell- to-cell virus spread. We propose to utilize advanced single-molecule imaging approaches to understand the process of HIV-1 assembly and cell-to-cell virus spread to inform future therapies targeting these processes.

PI_NAMEs: VAN ENGELENBURG, SCHUYLER  (contact)

PROJECT_TERMS: 3-Dimensional;Actins;Address;Adhesions;Adhesives;CD4 Antigens;Cell membrane;Cell surface;Cells;Chimera organism;Complex;Cytoplasmic Tail;Cytoskeleton;Data;density;Detection;Development;Diffusion;effective therapy;Electron Microscopy;Endosomes;Equilibrium;Event;Future;global health;Glycoproteins;Hand;HIV-1;Human;imaging approach;Immune;Infection;innovation;Integration Host Factors;Integrins;Investigation;Laboratories;Lateral;Lysosomes;Measures;Mediating;Membrane Fusion;Membrane Glycoproteins;Methodology;Modeling;molecular scale;monomer;nanoscale;novel strategies;particle;Pathway interactions;Peptides;Play;Population;Process;Property;Proteomics;Rationalization;Recycling;Regulation;Role;single molecule;Site;spatiotemporal;stem;Structure;superresolution imaging;Surface;Synapses;T-Lymphocyte;targeted treatment;Testing;Therapeutic;Therapeutic Intervention;Time;tool;trafficking;transmission process;ultra high resolution;Viral;Viral Antigens;viral transmission;Virion;virological synapse;Virus;Virus Assembly;Virus Diseases

PROJECT_TITLE: Identifying determinants of HIV-1 responsible for the nanoscale distribution and dynamics of virus assembly


ORG_CITY: Boston

ORG_NAME: QUANTUM SIMULATION TECHNOLOGIES, INC.

PHR: Project Narrative Computational free energy calculations, such as Free Energy Perturbation (FEP) have demonstrably improved the efficiency and cost of drug discovery—improving the speed and cost of late-stage discovery by as much as a third—leading to broad adoption of the FEP approach by the majority of pharma companies in their hit-to- lead efforts. Despite this, there is much room for improvement of FEP, owing to its reliance on simplistic molecular mechanics (MM) force fields, which are quite limited in terms of the classes of drug targets for which this kind of force field is reliable. We have addressed these limitations with a uniquely performant quantum mechanics/molecular mechanics force field representation, which we have integrated into a validated FEP platform, and which, with the work described here, we plan to significantly improve via extensive algorithmic changes and extension of the methods to GPU platforms.

PI_NAMEs: PEARLMAN, DAVID A (contact)

PROGRAM_OFFICER_NAME: NGUYEN, HAN

PROJECT_TERMS: Acceleration;Address;Adoption;Algorithms;Benchmarking;beta-Cyclodextrins;Binding;Biology;Chemistry;Code;Complex;computational chemistry;computational platform;computerized tools;Computing Methodologies;cost;Democracy;Drug Costs;drug discovery;Drug Targeting;Equation;Evaluation;Free Energy;Frequencies;Grant;Hybrids;Hydrogen;improved;Inferior;interest;Lead;lead candidate;Ligand Binding;Ligands;Marketing;mechanical energy;mechanical force;Methods;Modeling;Modernization;Modification;molecular dynamics;molecular mechanics;Motion;next generation;novel;Nucleic Acids;parallel computer;Pharmacologic Substance;Phase;Preparation;programs;Proteins;Publications;Quantum Mechanics;receptor;Reliability of Results;Research;Running;Sampling;Scheme;Series;Speed;success;System;tautomer;Testing;Time;tool;Triage;Validation;vibration;virtual screening;Visualization;Water;Work

PROJECT_TITLE: Next generation free energy perturbation (FEP) calculations--enabled by a novel integration of quantum mechanics (QM) with molecular dynamics allowing a large QM region and no sampling compromises

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Digestive Diseases;Immunotherapy;Machine Learning and Artificial Intelligence;Microbiome;Prevention

ORG_CITY: TUSCALOOSA

ORG_NAME: EVIMERO, LLC

ORG_STATE: AL

PHR: Project Narrative Evimero NCATS P1 OPE Project Microbiomes – the vast ecosystems of bacteria, viruses, and other microorganisms that line our intestines, our skin, and in fact everywhere our bodies encounter the outside world – are turning out to be crucial players in maintaining our health. Microbiomes get imbalanced, or “dysbiotic,” when they are exposed to poor diet, too many antibiotics, or from other diseases – and that can contribute to a wide variety of diseases, including some of our most challenging, long-term chronic disorders like inflammatory bowel disease, some cancers, and even Parkinson's or Alzheimer's diseases relevant to hundreds of thousands of people. The technology we’re working on here will systematically eliminate, or neutralize, biologically active proteins and other molecules that connect the imbalanced microbiome to human disease; we expect this to revolutionize discovery of new drugs that can heal broken microbiomes and prevent or treat diseases for which we have no current treatment strategy.

PI_NAMEs: GOEPP, JULIUS G (contact)

PROGRAM_OFFICER_NAME: PITTENGER, STEVEN THEODORE

PROJECT_TERMS: adult stem cell;Affect;Alzheimer's Disease;analytical method;Animal Model;Antibiotics;Antibodies;antibody and antigen binding;Antigens;Artificial Intelligence;Bacteria;Binding;Biological Assay;Biological Markers;Birds;Cardiometabolic Disease;Characteristics;Chronic;Chronic Disease;Colon;Colonic inflammation;companion diagnostics;correctional system;cost;Coupled;Critical Pathways;cross reactivity;cytokine;Diagnosis;Disease;disease phenotype;disorder risk;drug discovery;Drug Modulation;dysbiosis;Ecosystem;egg;Enzyme-Linked Immunosorbent Assay;Epithelium;Equilibrium;Event;Exposure to;Family;Feasibility Studies;fecal microbiome;Formulation;frontier;Genomics;Glean;Goals;Grant;gut inflammation;gut microbiome;healing;Health;Health Promotion;Homeostasis;Human;human disease;human model;human stem cell-derived;human tissue;IgY;Immunize;Immunotherapeutic agent;Impaired health;In Vitro;in vitro Model;in vitro testing;Individual;Inflammation;Inflammatory;Inflammatory Bowel Diseases;inhibitor;innovation;Intercept;interest;Intestinal Cancer;Intestines;Laboratories;Legal patent;Machine Learning;Malignant Neoplasms;Maps;Mediating;Mediator;metabolomics;Metagenomics;metaproteomics;microbial;Microbial Taxonomy;microbiome;microbiome analysis;microbiome composition;microbiome therapeutics;microorganism;Modeling;Molecular;Monoclonal Antibodies;monolayer;multiple omics;National Center for Advancing Translational Sciences;Neurodegenerative Disorders;novel therapeutics;Oral;Organoids;Parkinson Disease;Pathology;Pathway interactions;Performance;Persons;Pharmaceutical Preparations;Phase;phase 2 study;Phenotype;Physiological;polyclonal antibody;Positioning Attribute;prevent;Preventive;Process;Production;protective pathway;Proteins;rational design;Resolution;Set protein;Signal Transduction;Signaling Molecule;Skin;Small Business Innovation Research Grant;Surveys;Systems Biology;Taxonomy;Techniques;Technology;Testing;Therapeutic;therapeutic target;Tight Junctions;Tissues;Transducers;treatment strategy;Unhealthy Diet;Virus;Western Blotting;Work

PROJECT_TITLE: Targeted Immunotherapeutics In Dysbiotic Microbiomes - A Feasibility and Proof-of-Concept Study

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]