Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1383&sort=-title
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-title", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-title", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1384&sort=-title", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1382&sort=-title" }, "data": [ { "type": "Grant", "id": "8786", "attributes": { "award_id": "1R43GM142408-01A1", "title": "A quick and simplified method (QuickRibo-mRNA) for isolation of ribosome protected mRNA fragments for translatome identification", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 22244, "first_name": "MICHAEL", "last_name": "SAKALIAN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-15", "end_date": "2022-12-14", "award_amount": 301818, "principal_investigator": { "id": 24584, "first_name": "Prashant K.", "last_name": "Khade", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1754, "ror": "", "name": "RIBO-THERAPEUTICS LLC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1754, "ror": "", "name": "RIBO-THERAPEUTICS LLC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "The goal of this proposal is to establish and validate a novel method for the isolation of ribosome protected mRNA footprints for translatome identification. Translatome or Ribosome profiling (RP), a deep sequencing technique of ribosome-protected mRNA footprints, is a powerful method that gives a “snapshot” of actively translating mRNA. Revolutionizing the capacity to capture every step of mRNA translation at sub-codon resolution, it potentially allows one to monitor the rate and location of mRNA translation in the cell and annotate the new protein coding sequences of genomes. RP, therefore, affords a vast opportunity to explore and model complex cellular processes in real time. This methodology has been mined extensively in numerous diseases including cancer, immunology and neurology. RP identified several new micro-peptides and protein from COVID mRNA, further expanding its potential as a novel target-identification method. In this context, RP has emerged as a potent method to identify mRNA frameshifting and novel ORFs, and providing valuable insights for understanding functional elements of the genome, disease pathogenesis and evaluation of impact treatment in the case of mRNA therapeutics and cancer therapy in a gene and the tissues specific manner. However, RP applications are stunted and limited to specialized labs because it requires expertise, specialized instruments and time-consuming - taking up to ~5 days on an average. In turn, this affects the cost, quality of the final data and thereby obscuring the mRNA translational landscape. Given the power and potential for widespread use, there is an urgent and unmet need for alternative/improved RP technology similar to RNA purification methods which are less time consuming, free of artifacts and inexpensive. In Phase-I application, we proposed two specific aims to refine the QuickRibo-mRNA method, validate and compare it with current RP methods to establish its efficacy. In aim-1 we will establish and validate the QuickRibo-mRNA methodology in various conditions and cell types in obtaining uniform ribosome protected mRNA fragments with improved percent read mapping to coding sequences. In aim-2 we will compare the efficacy of QuickRibo-mRNA with known ribosome profiling technologies. We believe that phase-I proposal will provide a benchmark for phase II, which can streamline the QuickRibo-mRNA method for performing ribosome profiling with high reproducibility and efficiency. In the end RP will be done proficiently in the simplest way with less time, instrumentation and expertise to identify gene “expression with reading frames and translation efficiency” before making any conclusions entirely based on RNA-gene “expression profile”.", "keywords": [ "2019-nCoV", "Address", "Affect", "Animals", "Back", "Benchmarking", "Biology", "Buffers", "California", "Categories", "Cell Count", "Cell physiology", "Cells", "Code", "Codon Nucleotides", "Complex", "Consumption", "Cycloheximide", "Cytolysis", "Data", "Development", "Diagnostic Reagent Kits", "Disease", "Elements", "Filtration", "Future", "Gel", "Gene Expression", "Genes", "Genetic Translation", "Genome", "Genomics", "Goals", "Impact evaluation", "Intercistronic Region", "Italy", "Length", "Libraries", "Location", "Manufacturer Name", "Maps", "Measurement", "Messenger RNA", "Methodology", "Methods", "MicroRNAs", "Modeling", "Molecular Weight", "Monitor", "Morphologic artifacts", "Neurology", "Nucleotides", "Open Reading Frames", "Pathogenesis", "Peptides", "Periodicity", "Phase", "Phenotype", "Physiological", "Plants", "Positioning Attribute", "Preparation", "Principal Investigator", "Production", "Proteins", "Proteomics", "Puromycin", "RNA", "RNA library", "RNA purification", "Reading Frames", "Reproducibility", "Research Personnel", "Resolution", "Ribonucleases", "Ribosomes", "Sensitivity and Specificity", "Small RNA", "Techniques", "Technology", "Therapeutic", "Time", "Tissue Sample", "Tissues", "Transcript", "Translating", "Translations", "Universities", "Untranslated Regions", "Virus", "Work", "base", "cancer immunotherapy", "cancer therapy", "cell type", "commercialization", "comparative efficacy", "coronavirus disease", "cost", "cost effective", "data quality", "deep sequencing", "efficacy evaluation", "gel electrophoresis", "improved", "in vivo", "insight", "instrument", "instrumentation", "neoantigens", "novel", "novel virus", "nuclease", "professor", "repaired", "ribosome profiling", "therapeutic RNA", "trait", "transcriptome", "transcriptome sequencing", "translatome", "tumor immunology", "web site" ], "approved": true } }, { "type": "Grant", "id": "10393", "attributes": { "award_id": "1R01HS028438-01A1", "title": "A quality and cost analysis of interprofessional team continuity in ICUs", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [ { "id": 22615, "first_name": "Brent", "last_name": "Sandmeyer", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-01", "end_date": "2027-06-30", "award_amount": 386395, "principal_investigator": { "id": 26374, "first_name": "Olga", "last_name": "Yakusheva", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Critical care is the most complex, resource-intensive and costly care setting contributing over $130 billion to national health expenditures annually. Approximately 4 million patients are admitted to intensive care units (ICUs) each year with average mortality rate ranging from 8-19. Recently COVID-19 has highlighted that staffing interprofessional teams in ICUs is quite challenging. One feature of healthcare staffing that has received much attention in settings outside of the ICU is continuity of care – whereby a patient is cared for by a small team of identified professionals over time – has been long recognized as an essential attribute of high- quality, patient-centered care. In primary care, greater continuity of patient care is associated with fewer emergency department visits and hospitalizations, lower healthcare costs, and higher patient satisfaction. Continuity-based acute care staffing models also exist, but are rarely adopted and sustained in practice, particularly in ICUs where continuity-based assignments can be challenging to operationalize. Importantly, although critical care is delivered by interprofessional teams of physicians, nurses, and respiratory therapists, continuity of interprofessional ICU teams has never been conceptualized or measured before. Without this knowledge, it is difficult to know whether hospitals and administrators should prioritize continuity of ICU care, which could be a missed opportunity to improve quality of patient care and outcomes in this critically ill, costly patient population. The overall goal of our study is to examine the effect of continuity of ICU interprofessional teams on patient outcomes and organizational economic outcomes, in order to develop an interprofessional assignment decision-support tool that optimizes the continuity of interprofessional ICU team care. We propose to examine the quality and costs of an interprofessional team continuity staffing approach in ICUs to guide future interventions in 13 ICUs across two different healthcare systems using data from over 2 years. We will examine interprofessional team continuity of shift-level ICU clinician teams (a nurse, a physician, and a respiratory therapist) assigned to each patient during the ICU stay. We define two dimensions of team continuity: intra-professional continuity, measuring each of the clinician’s experience caring for the patient previously during the patient’s stay, and inter-professional continuity, measuring the clinicians’ joint experience working together as a team. We hypothesize that care delivered by shift-level ICU teams with higher intra- and inter-professional continuity will result in improved patient outcomes and reduced costs. Our research team has a strong record of joint publications on attributes of patient care teams including continuity of care with expertise in health economics, critical care nursing and medicine and engineering. Completion of the study will generate the most robust evidence, to date, to inform organizational priorities about continuity-based interprofessional staffing in ICUs, to improve care for critically ill ICU patients.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "11806", "attributes": { "award_id": "5R01HS028438-02", "title": "A quality and cost analysis of interprofessional team continuity in ICUs", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Agency for Healthcare Research and Quality (AHRQ)" ], "program_reference_codes": [], "program_officials": [ { "id": 27666, "first_name": "Geri", "last_name": "Goins", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-01", "end_date": "2027-06-30", "award_amount": 398628, "principal_investigator": { "id": 26374, "first_name": "Olga", "last_name": "Yakusheva", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Critical care is the most complex, resource-intensive and costly care setting contributing over $130 billion to national health expenditures annually. Approximately 4 million patients are admitted to intensive care units (ICUs) each year with average mortality rate ranging from 8-19. Recently COVID-19 has highlighted that staffing interprofessional teams in ICUs is quite challenging. One feature of healthcare staffing that has received much attention in settings outside of the ICU is continuity of care – whereby a patient is cared for by a small team of identified professionals over time – has been long recognized as an essential attribute of high- quality, patient-centered care. In primary care, greater continuity of patient care is associated with fewer emergency department visits and hospitalizations, lower healthcare costs, and higher patient satisfaction. Continuity-based acute care staffing models also exist, but are rarely adopted and sustained in practice, particularly in ICUs where continuity-based assignments can be challenging to operationalize. Importantly, although critical care is delivered by interprofessional teams of physicians, nurses, and respiratory therapists, continuity of interprofessional ICU teams has never been conceptualized or measured before. Without this knowledge, it is difficult to know whether hospitals and administrators should prioritize continuity of ICU care, which could be a missed opportunity to improve quality of patient care and outcomes in this critically ill, costly patient population. The overall goal of our study is to examine the effect of continuity of ICU interprofessional teams on patient outcomes and organizational economic outcomes, in order to develop an interprofessional assignment decision-support tool that optimizes the continuity of interprofessional ICU team care. We propose to examine the quality and costs of an interprofessional team continuity staffing approach in ICUs to guide future interventions in 13 ICUs across two different healthcare systems using data from over 2 years. We will examine interprofessional team continuity of shift-level ICU clinician teams (a nurse, a physician, and a respiratory therapist) assigned to each patient during the ICU stay. We define two dimensions of team continuity: intra-professional continuity, measuring each of the clinician’s experience caring for the patient previously during the patient’s stay, and inter-professional continuity, measuring the clinicians’ joint experience working together as a team. We hypothesize that care delivered by shift-level ICU teams with higher intra- and inter-professional continuity will result in improved patient outcomes and reduced costs. Our research team has a strong record of joint publications on attributes of patient care teams including continuity of care with expertise in health economics, critical care nursing and medicine and engineering. Completion of the study will generate the most robust evidence, to date, to inform organizational priorities about continuity-based interprofessional staffing in ICUs, to improve care for critically ill ICU patients.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "12354", "attributes": { "award_id": "1R21AA031377-01", "title": "A Qualitative Analysis of Social and Behavioral Processes Associated with Self-Change in Drinking in an Existing Cohort of Black and White Emerging Adults", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 26558, "first_name": "Bradley Townsend", "last_name": "Kerridge", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-15", "end_date": "2025-08-31", "award_amount": 180500, "principal_investigator": { "id": 28275, "first_name": "JAMES", "last_name": "MACKILLOP", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 28276, "first_name": "JAMES G.", "last_name": "MURPHY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 694, "ror": "https://ror.org/01cq23130", "name": "University of Memphis", "address": "", "city": "", "state": "TN", "zip": "", "country": "United States", "approved": true }, "abstract": "In the United States, emerging adults (EAs, ages 18-29) consume alcohol at higher rates than people in any other age group, and the number and rate of alcohol-related deaths increased approximately 25% during the first two years of the COVID-19 pandemic. Black EAs and EAs who are not graduates of four-year colleges experience greater consequences from alcohol use and have been identified as an understudied, high-priority group by both NIAAA and the US Institute of Medicine. Funded by NIAAA, we have followed a diverse community-based cohort of 601 emerging adults since 2017 (mean age at inception = 22.5; 47% White, 42% Black; 35% without a college degree). Phase one of Project BETA was the first to carefully examine behavioral economic predictors of alcohol use trajectories in the mid-twenties and has generated 34 publications and supported 4 funded secondary grants. We recently completed data collection and have identified subgroups of emerging adults who have (1) reduced their drinking since becoming involved with the study and report consistent low-risk drinking over the past year based on the WHO Classification (N = 281) or (2) increased drinking or been relatively persistent high-risk drinkers throughout the course of study (as defined by the WHO Classification; N = 174). The proposed R21 will leverage these existing subgroups by having 40 participants from each of these subgroups (50% of participants enrolled will be Black) view a summary of their individual drinking trajectories throughout their 3.5-year participation in the parent study to facilitate a discussion of potentially modifiable factors associated with self- change or persistent risky drinking, including behavioral economic variables and experiences of discrimination. In addition to gaining an understanding of how participants successfully changed their drinking, our interviews and qualitative analyses will also gain insights into how to design and disseminate prevention and intervention programs to reduce alcohol risk for diverse community-residing emerging adults. We will obtain feedback on preferred intervention content, modalities, and locations/venues. Our team includes experts in emerging adult alcohol misuse, addiction and recovery, brief interventions, qualitative methods, and cultural adaptation of alcohol treatments for Black Americans and is thus ideally suited to successfully complete these aims and to use the results to develop and refine effective, culturally informed alcohol prevention approaches with high potential for dissemination in community settings in a subsequent R01 application.", "keywords": [ "Address", "Age", "Alcohol abuse", "Alcohol consumption", "Alcohols", "Attention", "Behavioral", "Black American", "Black race", "COVID-19 pandemic", "COVID-19 pandemic effects", "Classification", "Communities", "Coronavirus", "Data", "Data Collection", "Development", "Drug usage", "Economics", "Education", "Enrollment", "Feedback", "Female", "Funding", "Goals", "Grant", "Health", "Home", "Individual", "Informal Social Control", "Institute of Medicine (U.S.)", "Intervention", "Interview", "Knowledge", "Life", "Location", "Longitudinal Studies", "Modality", "Morbidity - disease rate", "National Institute on Alcohol Abuse and Alcoholism", "Outcome", "Parents", "Participant", "Persons", "Pharmaceutical Preparations", "Phase", "Prevalence", "Prevention", "Prevention approach", "Prevention program", "Process", "Public Health", "Publications", "Qualitative Methods", "Qualitative Research", "Recovery", "Reporting", "Research", "Rewards", "Risk", "Risk Factors", "Social support", "Source", "Stress", "Subgroup", "United States", "addiction", "age group", "alcohol abuse therapy", "alcohol consequences", "alcohol misuse", "alcohol prevention", "alcohol risk", "alcohol risk reduction", "alcohol-related death", "behavioral economics", "binge drinking", "brief intervention", "cohort", "college", "community setting", "comorbidity", "design", "drinking", "emerging adult", "emerging adulthood", "evidence base", "experience", "help-seeking behavior", "high risk", "high risk drinking", "high risk population", "insight", "intervention program", "modifiable risk", "mortality", "pandemic disease", "pandemic impact", "pandemic stress", "participant enrollment", "perceived discrimination", "preventive intervention", "protective factors", "racial population", "social", "substance use", "systemic barrier", "trend" ], "approved": true } }, { "type": "Grant", "id": "8797", "attributes": { "award_id": "1R43HL158409-01A1", "title": "A PTP4A3 inhibitor for SARS-CoV-2-mediated acute lung injury", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22454, "first_name": "GUOFEI", "last_name": "Zhou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-20", "end_date": "2022-08-31", "award_amount": 252208, "principal_investigator": { "id": 24599, "first_name": "JOHN S.", "last_name": "LAZO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "The Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) is responsible for the current COVID-19 pandemic. SAR-CoV-2, like other coronaviruses, infects human airways and enters cells via its S (Spike) protein, which binds to the human angiotensin-converting enzyme 2 (ACE2) and is primed by the host serine protease TMPRSS2. Both ACE2 and TMPRSS2 have been observed on pulmonary microvascular epithelium and endothelium. A subset of COVID-19 patients develop acute respiratory distress syndrome (ARDS) and subsequently septic shock and multi-organ failure; about half will die. The clinical worsening in the later phases of COVID-19 are thought to result from Spike protein binding to the pulmonary microvascular endothelium and epithelium, which leads to a damaged respiratory tract and ultimately a systemic inflammatory response or cytokine storm. There are currently no FDA-approved drugs/therapeutics that treat the pulmonary damage and ARDS associated with COVID-19. KeViRx is proposing to develop an entirely new therapeutic strategy that prevents or mitigates the initial pulmonary damage and halts the lethal cytokine storm. Our lead compound, KVX-053, is a reversible, selective, allosteric inhibitor of PTP4A3 phosphatase with excellent in vivo pharmacokinetic properties and drug-like properties. Moreover, mice tolerated multiple exposures to KVX-053 In culture KVX-053 was not cytotoxic to human ovarian epithelial cells or fibroblasts at concentrations up to 25 µM. Surprisingly, we found that KVX-053 markedly enhanced the pulmonary microvascular barrier function before and after injury caused by bacterial lipopolysaccharide and vascular endothelial growth factor. PTP4A3 phosphatase is known to be induced in lung cells 12 h after SARS-CoV infection and to control cytokine release. The overall hypothesis of this Phase I SBIR application is that the PTP4A phosphatase family has a sentinel role in the acute lung injury of ARDS and the systemic inflammatory response in COVID-19.The goal of the project is to repurpose KVX-053 for use in individuals with COVID-19 and for future pandemics involving acute lung injury. This Phase I SBIR application has three proof-of-concept Specific Tasks. Specific Task 1 will determine the ability of a novel, potent, allosteric, small molecule PTP4A3 inhibitor, KVX-053, to block SARS-CoV-2 Spike 1 protein-mediated loss of pulmonary endothelial barrier function and cytokine release in vitro. Specific Task 2 will determine the ability of KVX-053 to block SARS-CoV-2 Spike 1 protein-mediated pulmonary alveolar epithelial barrier function and cytokine release in vitro. Specific Task 3 will determine the ability of KVX-053 to inhibit acute lung injruy in mice caused by the SARS-CoV-2 Spike 1 protein.", "keywords": [ "2019-nCoV", "ACE2", "Acute", "Acute Lung Injury", "Adult Respiratory Distress Syndrome", "Binding", "Binding Proteins", "Blood Vessels", "COVID-19", "COVID-19 pandemic", "COVID-19 patient", "Cells", "Clinical", "Coronavirus", "Coronavirus spike protein", "Development", "Drug Kinetics", "Electrical Resistance", "Endothelial Cells", "Endothelium", "Epithelial", "Epithelial Cells", "Exhibits", "Exposure to", "FDA approved", "Family", "Fibroblasts", "Functional disorder", "Funding", "Future", "Goals", "Human", "In Vitro", "Individual", "Infection", "Inflammation", "Inflammatory", "Influenza", "Injury", "Kinetics", "Lead", "Link", "Lipopolysaccharides", "Lung", "Lung Inflammation", "Measures", "Mediating", "Multiple Organ Failure", "Mus", "Outcome", "Ovarian", "PTP4A2 gene", "Pathologic", "Pathway interactions", "Permeability", "Pharmaceutical Preparations", "Pharmacodynamics", "Phase", "Phosphoric Monoester Hydrolases", "Population", "Pre-Clinical Model", "Prevention", "Property", "Proteins", "Recombinants", "Respiratory System", "Role", "SARS coronavirus", "SARS-CoV-2 inhibitor", "SARS-CoV-2 spike protein", "Sentinel", "Septic Shock", "Serine Protease", "Small Business Innovation Research Grant", "Specificity", "TMPRSS2 gene", "Testing", "Therapeutic", "Time", "Vascular Endothelial Growth Factors", "Viral", "Virus", "alveolar epithelium", "analog", "clinical development", "cytokine", "cytokine release syndrome", "in vivo", "inhibitor/antagonist", "innovation", "lung injury", "macrophage", "monocyte", "monolayer", "mouse model", "neutrophil", "novel", "novel therapeutic intervention", "pandemic disease", "preclinical development", "prevent", "real time monitoring", "small molecule", "systemic inflammatory response" ], "approved": true } }, { "type": "Grant", "id": "8798", "attributes": { "award_id": "3R43HL158409-01A1S1", "title": "A PTP4A3 inhibitor for SARS-CoV-2-mediated acute lung injury", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22454, "first_name": "GUOFEI", "last_name": "Zhou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-20", "end_date": "2022-08-31", "award_amount": 55000, "principal_investigator": { "id": 24599, "first_name": "JOHN S.", "last_name": "LAZO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "The Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) is responsible for the current COVID-19 pandemic. SAR-CoV-2, like other coronaviruses, infects human airways and enters cells via its S (Spike) protein, which binds to the human angiotensin-converting enzyme 2 (ACE2) and is primed by the host serine protease TMPRSS2. Both ACE2 and TMPRSS2 have been observed on pulmonary microvascular epithelium and endothelium. A subset of COVID-19 patients develop acute respiratory distress syndrome (ARDS) and subsequently septic shock and multi-organ failure; about half will die. The clinical worsening in the later phases of COVID-19 are thought to result from Spike protein binding to the pulmonary microvascular endothelium and epithelium, which leads to a damaged respiratory tract and ultimately a systemic inflammatory response or cytokine storm. There are currently no FDA-approved drugs/therapeutics that treat the pulmonary damage and ARDS associated with COVID-19. KeViRx is proposing to develop an entirely new therapeutic strategy that prevents or mitigates the initial pulmonary damage and halts the lethal cytokine storm. Our lead compound, KVX-053, is a reversible, selective, allosteric inhibitor of PTP4A3 phosphatase with excellent in vivo pharmacokinetic properties and drug-like properties. Moreover, mice tolerated multiple exposures to KVX-053. In culture KVX-053 was not cytotoxic to human ovarian epithelial cells or fibroblasts at concentrations up to 25 µM. Surprisingly, we found that KVX-053 markedly enhanced the pulmonary microvascular barrier function before and after injury caused by bacterial lipopolysaccharide and vascular endothelial growth factor. PTP4A3 phosphatase is known to be induced in lung cells 12 h after SARS-CoV infection and to control cytokine release. The overall hypothesis of this Phase I SBIR application is that the PTP4A phosphatase family has a sentinel role in the acute lung injury of ARDS and the systemic inflammatory response in COVID-19.The overall goal of the project is to repurpose KVX-053 for use against SARS-CoV-2 infection and for future viral pandemics involving acute lung injury. This Phase I SBIR application has three proof- of-concept Specific Tasks. Specific Task 1 will determine the ability of a novel, potent, allosteric, small molecule PTP4A inhibitor, KVX-053, to block SARS-CoV-2 Spike 1 protein-mediated loss of pulmonary endothelial barrier function and cytokine release in vitro. Specific Task 2 will determine the ability of KVX-053 to block SARS-CoV- 2 Spike 1 protein-mediated pulmonary alveolar epithelial barrier function and cytokine release in vitro. Specific Task 3 will determine the ability of KVX-053 to inhibit acute lung injury in mice caused by the SARS-CoV-2 Spike 1 protein.", "keywords": [ "2019-nCoV", "ACE2", "Acute Lung Injury", "Acute Respiratory Distress Syndrome", "Binding", "Binding Proteins", "COVID-19", "COVID-19 pandemic", "COVID-19 patient", "Cells", "Clinical", "Coronavirus", "Drug Kinetics", "Endothelium", "Epithelial", "Epithelial Cells", "Exposure to", "FDA approved", "Family", "Fibroblasts", "Future", "Goals", "Human", "In Vitro", "Individual", "Infection", "Injury", "Lead", "Lipopolysaccharides", "Lung", "Mediating", "Multiple Organ Failure", "Mus", "Ovarian", "PTP4A2 gene", "Pharmaceutical Preparations", "Phase", "Phosphoric Monoester Hydrolases", "Property", "Proteins", "Respiratory System", "Role", "SARS coronavirus", "SARS-CoV-2 infection", "SARS-CoV-2 inhibitor", "Sentinel", "Septic Shock", "Serine Protease", "Small Business Innovation Research Grant", "TMPRSS2 gene", "Therapeutic", "Vascular Endothelial Growth Factors", "Viral", "alveolar epithelium", "cytokine", "cytokine release syndrome", "in vivo", "inhibitor/antagonist", "lung injury", "novel", "novel therapeutic intervention", "pandemic disease", "prevent", "small molecule", "systemic inflammatory response" ], "approved": true } }, { "type": "Grant", "id": "9715", "attributes": { "award_id": "3R43HL158409-01A1S2", "title": "A PTP4A3 inhibitor for SARS-CoV-2-mediated acute lung injury", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22454, "first_name": "GUOFEI", "last_name": "Zhou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-07-15", "end_date": "2022-08-31", "award_amount": 6500, "principal_investigator": { "id": 24599, "first_name": "JOHN S.", "last_name": "LAZO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1758, "ror": "", "name": "KEVIRX INC.", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "The Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) is responsible for the current COVID-19 pandemic. SAR-CoV-2, like other coronaviruses, infects human airways and enters cells via its S (Spike) protein, which binds to the human angiotensin-converting enzyme 2 (ACE2) and is primed by the host serine protease TMPRSS2. Both ACE2 and TMPRSS2 have been observed on pulmonary microvascular epithelium and endothelium. A subset of COVID-19 patients develop acute respiratory distress syndrome (ARDS) and subsequently septic shock and multi-organ failure; about half will die. The clinical worsening in the later phases of COVID-19 are thought to result from Spike protein binding to the pulmonary microvascular endothelium and epithelium, which leads to a damaged respiratory tract and ultimately a systemic inflammatory response or cytokine storm. There are currently no FDA-approved drugs/therapeutics that treat the pulmonary damage and ARDS associated with COVID-19. KeViRx is proposing to develop an entirely new therapeutic strategy that prevents or mitigates the initial pulmonary damage and halts the lethal cytokine storm. Our lead compound, KVX-053, is a reversible, selective, allosteric inhibitor of PTP4A3 phosphatase with excellent in vivo pharmacokinetic properties and drug-like properties. Moreover, mice tolerated multiple exposures to KVX-053 In culture KVX-053 was not cytotoxic to human ovarian epithelial cells or fibroblasts at concentrations up to 25 µM. Surprisingly, we found that KVX-053 markedly enhanced the pulmonary microvascular barrier function before and after injury caused by bacterial lipopolysaccharide and vascular endothelial growth factor. PTP4A3 phosphatase is known to be induced in lung cells 12 h after SARS-CoV infection and to control cytokine release. The overall hypothesis of this Phase I SBIR application is that the PTP4A phosphatase family has a sentinel role in the acute lung injury of ARDS and the systemic inflammatory response in COVID-19.The goal of the project is to repurpose KVX-053 for use in individuals with COVID-19 and for future pandemics involving acute lung injury. This Phase I SBIR application has three proof-of-concept Specific Tasks. Specific Task 1 will determine the ability of a novel, potent, allosteric, small molecule PTP4A3 inhibitor, KVX-053, to block SARS-CoV-2 Spike 1 protein-mediated loss of pulmonary endothelial barrier function and cytokine release in vitro. Specific Task 2 will determine the ability of KVX-053 to block SARS-CoV-2 Spike 1 protein-mediated pulmonary alveolar epithelial barrier function and cytokine release in vitro. Specific Task 3 will determine the ability of KVX-053 to inhibit acute lung injruy in mice caused by the SARS-CoV-2 Spike 1 protein.", "keywords": [ "2019-nCoV", "ACE2", "Acute", "Acute Lung Injury", "Acute Respiratory Distress Syndrome", "Binding", "Binding Proteins", "Blood Vessels", "COVID-19", "COVID-19 pandemic", "COVID-19 patient", "Cells", "Clinical", "Coronavirus", "Coronavirus spike protein", "Development", "Drug Kinetics", "Electrical Resistance", "Endothelial Cells", "Endothelium", "Epithelial", "Epithelial Cells", "Exhibits", "Exposure to", "FDA approved", "Family", "Fibroblasts", "Functional disorder", "Funding", "Future", "Goals", "Human", "In Vitro", "Individual", "Infection", "Inflammation", "Inflammatory", "Influenza", "Injury", "Kinetics", "Lead", "Link", "Lipopolysaccharides", "Lung", "Measures", "Mediating", "Multiple Organ Failure", "Mus", "Outcome", "Ovarian", "PTP4A2 gene", "Pathologic", "Pathway interactions", "Permeability", "Pharmaceutical Preparations", "Pharmacodynamics", "Phase", "Phosphoric Monoester Hydrolases", "Population", "Pre-Clinical Model", "Prevention", "Property", "Proteins", "Pulmonary Inflammation", "Recombinants", "Respiratory System", "Role", "SARS coronavirus", "SARS-CoV-2 inhibitor", "SARS-CoV-2 spike protein", "Sentinel", "Septic Shock", "Serine Protease", "Small Business Innovation Research Grant", "Specificity", "TMPRSS2 gene", "Testing", "Therapeutic", "Time", "Vascular Endothelial Growth Factors", "Viral", "Virus", "alveolar epithelium", "analog", "clinical development", "cytokine", "cytokine release syndrome", "in vivo", "inhibitor", "innovation", "lung injury", "macrophage", "monocyte", "monolayer", "mouse model", "neutrophil", "novel", "novel therapeutic intervention", "pandemic disease", "preclinical development", "prevent", "real time monitoring", "small molecule", "systemic inflammatory response" ], "approved": true } }, { "type": "Grant", "id": "10862", "attributes": { "award_id": "3R01HD105863-02S1", "title": "A prospective study of male factors, fertility, and pregnancy outcomes", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 23846, "first_name": "Esther", "last_name": "Eisenberg", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-10-01", "end_date": "2023-09-30", "award_amount": 177509, "principal_investigator": { "id": 26955, "first_name": "MICHAEL L", "last_name": "EISENBERG", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 21020, "first_name": "LAUREN A", "last_name": "WISE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 860, "ror": "", "name": "BOSTON UNIVERSITY MEDICAL CAMPUS", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "The proposed supplement will be based on data from Pregnancy Study Online (PRESTO), an ongoing NIH- funded prospective cohort study that enrolls women trying to conceive and follows them from preconception through 6 months after delivery (R01HD086742). Eligible female participants are aged 21-45 years, residents of North America, trying to conceive, and not using contraception or fertility treatment at enrollment. After enrollment, female participants invite their male partners to complete a baseline questionnaire. During 6/2013- 7/2022, PRESTO has enrolled more than 16,750 female participants and nearly 4,000 of their male partners. All questionnaires are completed online and data collection continued during the COVID-19 pandemic. In April 2020, we added new questions for both partners on COVID-19 infection and stressors related to the pandemic, including changes in lifestyle, behaviors and health care, and in January 2021, we added questions for both partners on SARS-CoV-2 vaccination (ever vaccinated, type of vaccine, and date of each shot). In November 2021, we added questions about booster shots. We also obtained female-reported data on male SARS-CoV-2 vaccination and COVID-19 infection data in the event that the male partner did not enroll. Since the study’s inception, participants have reported detailed baseline data about socio-demographics, lifestyle, anthropometrics, and medical history. On each bimonthly questionnaire (administered for up to 12 months), female participants report additional data about their pregnancy status and any changes in their exposures or covariates. We will use the above prospectively-collected data to examine the extent to which SARS-CoV-2 vaccination and COVID-19 infection in both partners are associated with spontaneous abortion (SAB), including early SAB (<8 weeks of gestation). We will consider various windows of possible effects of vaccination and infection, examine the number of vaccine doses (including boosters), and identify differences by other possible effect modifiers (e.g., age). We will control for several confounders, including COVID-19-related stressors, and also present results separately by early and late SAB (<8 vs. ≥8 weeks of gestation). Finally, we will examine the effects of joint exposures in both members of a couple (e.g., both partners vaccinated, female partner vaccinated, male partner vaccinated, vs. neither partner vaccinated). Among at least 1,600 U.S. participants who reported a study-related conception after 12/14/2020, we will estimate the hazard ratio and 95% confidence interval using Cox proportional hazards regression models. Our interdisciplinary research team has published extensively on vaccine-related effects and reproductive outcomes, many of which are based on PRESTO data, and we have the expertise necessary to study these research questions. Given our ongoing prospective data collection throughout the pandemic, our successful recruitment of a large and diverse population of couples, and our prospective collection of pregnancy data, PRESTO is uniquely-positioned to analyze data on vaccination and SAB and provide essential information to the scientific community and the public on vaccine safety.", "keywords": [ "Address", "Affect", "Age", "American", "Behavior", "Biotechnology", "COVID-19", "COVID-19 impact", "COVID-19 pandemic", "COVID-19 vaccination", "Canada", "Clinic Visits", "Clinical Trials", "Collection", "Communities", "Conceptions", "Confidence Intervals", "Contraceptive methods", "Couples", "Data", "Data Collection", "Data Reporting", "Diagnosis", "Diet", "Dose", "Eligibility Determination", "Enrollment", "Event", "Female", "Fertility", "Financial cost", "Funding", "Geography", "Goals", "Health", "Health Personnel", "Healthcare", "Home", "Hospitals", "Incidence", "Individual", "Infection", "Infrastructure", "Interdisciplinary Study", "Investigation", "Joints", "Life Style", "Measures", "Medical", "Medical History", "Modeling", "North America", "Online Systems", "Outcome", "Participant", "Population", "Population Heterogeneity", "Positioning Attribute", "Pregnancy", "Pregnancy Outcome", "Pregnancy Tests", "Pregnancy loss", "Process", "Prospective Studies", "Prospective cohort study", "Public Health", "Publications", "Publishing", "Questionnaires", "Registries", "Reporting", "Research", "Risk", "Risk Factors", "SARS-CoV-2 infection", "SARS-CoV-2 infection history", "Series", "Spontaneous abortion", "Testing", "Time", "United States", "United States National Institutes of Health", "Vaccinated", "Vaccination", "Vaccines", "Woman", "aged", "booster vaccine", "cohort", "coronavirus disease", "follow-up", "hazard", "infertility treatment", "male", "member", "pandemic disease", "post SARS-CoV-2 infection", "pregnant", "prospective", "psychologic", "recruit", "reproductive", "reproductive outcome", "research study", "secondary analysis", "sociodemographics", "socioeconomics", "stressor", "subfertility", "trying to conceive", "vaccine safety" ], "approved": true } }, { "type": "Grant", "id": "7110", "attributes": { "award_id": "3UH3OD023275-05S1", "title": "A prospective study of critical environmental exposures in formative early life that impact lifelong health in rural US children: the New Hampshire Birth Cohort Study", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 10604, "first_name": "SUSAN ALISON", "last_name": "Laessig", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2016-09-21", "end_date": "2021-08-31", "award_amount": 321906, "principal_investigator": { "id": 22909, "first_name": "MARGARET Rita", "last_name": "KARAGAS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 386, "ror": "https://ror.org/049s0rh22", "name": "Dartmouth College", "address": "", "city": "", "state": "NH", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 386, "ror": "https://ror.org/049s0rh22", "name": "Dartmouth College", "address": "", "city": "", "state": "NH", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary/Abstract: Major gaps exist in our knowledge of the health impacts of widespread and dramatically expanding exposures among children in the US. Children from rural regions are particularly understudied, but may experience higher exposures to contaminants by drinking unregulated water; from household air pollution from wood stoves; and consequent to their rural and changing landscape (e.g., from climate change). As part of this ECHO Pediatric Cohorts application, we propose to take advantage of the NIEHS/EPA supported New Hampshire Birth Cohort Study (NHBCS): a rural, ongoing pregnancy cohort that has accrued over 1,500 maternal-infant dyads. By the beginning of the UH3 phase of this application, the anticipated cohort size will be 2,000, and as part of this ECHO Pediatric Cohorts application, accrual will be extended to 3,000 maternal-infant pairs. Clinical outcomes are being ascertained from interval interviews, questionnaires, medical records, in-person assessments and laboratory tests. The study has archived environmental (tap water and indoor air) and biological samples during pregnancy (maternal blood, urine and hair), as well as biological samples acquired at birth (infant cord blood, placenta and meconium) and during childhood (urine, blood, buccal cells, breast milk, toenails and stool). The ability to utilize these samples for a wide range of downstream analyses has been demonstrated. For the current application, emerging hypotheses of concern will be addressed by: (1) leveragingthe extant NHBCS to perform targeted and unsupervised metabolomic analyses of 1,000 cord blood samples and 250 paired maternal gestational blood samples, and assess associations with exposures, early growth, and the infant microbiome; (2) expandingdata acquisition, sample collection and participant accrual to more precisely characterize exposures and timing of early life exposures by obtaining urinary metal metabolomic measurements, and exposome monitoring data from the first trimester of pregnancy, along with spatial analysis of naturally shed teeth for prenatal metal concentrations; and (3) extending follow-up to identify childhood exposures to contaminants (through biomarkers and personal monitors); the home environment (e.g., physical activity and sleep patterns, food environment, green, blue and white space, and media usage); and medical exposures (e.g., prescription and non-prescription medications and surgical interventions) that relate to fetal and childhood growth, obesity at age 3 years, respiratory infection and asthma by age 5 years, and pulmonary function data at age 7.5 years. Novel statistical approaches will be used to determine the role of the intestinal and salivary microbiome as mediators of these effects. The collective expertise, methodologies, data, samples and preliminary results from this study will contribute to the planning of the broader ECHO Pediatric Cohorts initiative in order to advance our understanding of the environmental factors early in life that drive childhood and lifelong health.", "keywords": [ "3 year old", "5 year old", "Address", "Affect", "Age", "Air", "Air Pollutants", "Air Pollution", "Archives", "Area", "Asthma", "Award", "Behavior", "Behavioral", "Biological", "Biological Markers", "Birth", "Blood", "Blood specimen", "COVID-19", "COVID-19 pandemic", "Cells", "Cessation of life", "Chemicals", "Child", "Child Development", "Child Health", "Childhood", "Clinical", "Cohort Studies", "Colorado", "Community Health", "Country", "Data", "Diagnosis", "Diet", "Disinfectants", "Disinfection", "Economics", "Enrollment", "Ensure", "Environmental Exposure", "Environmental Risk Factor", "Ethnic Origin", "Ethnic group", "Exposure to", "Family", "Feces", "First Pregnancy Trimester", "Food", "Food Packaging", "Future", "Geographic Locations", "Gestational Age", "Growth", "Hair", "Hand", "Health", "Home environment", "Household Air Pollution", "Human Milk", "Infant", "Intervention", "Interview", "Intestines", "Knowledge", "Laboratories", "Life", "Life Style", "Location", "Measurement", "Measures", "Meconium", "Mediator of activation protein", "Medical", "Medical Records", "Metals", "Methodology", "Methods", "Mission", "Monitor", "National Institute of Environmental Health Sciences", "Natural experiment", "New Hampshire", "Obesity", "Operative Surgical Procedures", "Outcome", "Parents", "Participant", "Pediatric cohort", "Perception", "Persons", "Pharmaceutical Preparations", "Phase", "Physical activity", "Placenta", "Play", "Poison", "Policies", "Population", "Pregnancy", "Prospective Studies", "Psychosocial Stress", "Questionnaires", "Race", "Research", "Respiratory Signs and Symptoms", "Respiratory Tract Infections", "Restaurants", "Role", "Rural", "Salivary", "Sampling", "Schools", "Science", "Shapes", "Shock", "Silicones", "Site", "Sleep", "Socioeconomic Status", "Stress", "Structure of nail of toe", "Surface", "Testing", "Time", "Tooth structure", "Travel", "Umbilical Cord Blood", "Universities", "Urine", "Viral", "Water", "Wheezing", "Wood stove", "Work", "behavior change", "climate change", "cohort", "coronavirus disease", "design", "drinking", "early life exposure", "ethnic diversity", "experience", "fetal", "follow-up", "food environment", "food insecurity", "healthy lifestyle", "high risk", "interest", "metabolomics", "microbiome", "novel", "obesity in children", "obesity risk", "pandemic disease", "personal care products", "postnatal", "prenatal", "prevent", "programs", "psychosocial", "pulmonary function", "racial and ethnic", "respiratory", "rur" ], "approved": true } }, { "type": "Grant", "id": "8547", "attributes": { "award_id": "2R44TR003747-02A1", "title": "A proprietary single-cell analytics platform for accelerating biologics manufacturing", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 24316, "first_name": "KRISHNA B", "last_name": "BALAKRISHNAN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-07-30", "end_date": "2023-06-30", "award_amount": 855264, "principal_investigator": { "id": 24317, "first_name": "Ayca", "last_name": "YALCIN OZKUMUR", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 662, "ror": "", "name": "ONECYTE BIOTECHNOLOGIES, INC.", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 662, "ror": "", "name": "ONECYTE BIOTECHNOLOGIES, INC.", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: OneCyte Biotechnologies, Inc. is a spin-out from the Massachusetts Institute of Technology (MIT) advancing next-generation single-cell technologies to impact drug development and bio-manufacturing. OneCyte is a pioneer of single-cell proteomics and is developing a platform technology that cuts many months off biologic (e.g. therapeutic monoclonal antibodies (MAbs) or vaccines) drug development. A key challenge in biopharma are slow bio-manufacturing timelines. The world is currently experiencing the impact of slow development timelines on human health and the economy in the extreme example of the COVID-19 pandemic and its burden of rapidly developing and manufacturing billions of doses of novel vaccines and MAbs. This is highlighting the need for accelerated drug development and manufacturing. OneCyte’s single-cell platform technology provides insight into cell biology at an unprecedented scale; potentially enabling new classes of therapeutics, and enhancing basic scientific understandings. The impact of this technology will be reducing time and cost of pharmaceutical development, as well as improving efficacy and safety. This can enable developing new drugs for currently untreatable and rare diseases, which are presently not feasible to develop or manufacture. Beyond this initial application, OneCyte’s technology could become a readily implemented research tool, enhancing the basic understanding of biology, or facilitating engineering of cell function for cell therapy applications. OneCyte is seeking funding to expand the innovative single-cell analytical capabilities and screen for additional critical product quality attributes (PQAs) important for drug safety and efficacy, as well as transition the single-cell technology platform to a commercial process by the end of SBIR Phase II. In Aim 1. OneCyte will develop and implement innovative single-cell assays for additional PQAs, focusing on screening for undesired deviations in drug manufacturability, which lead to reduced drug circulating half-life and reduced production yield. In Aim 2. OneCyte will automate and scale-up single-cell data analytics towards improved predictivity for drug manufacturability, as well as automate the pipeline for commercial data analytics with the necessary minimum user input. In Aim 3. OneCyte will develop a manufacturing ready thermoplastic microfluidic chip, replacing an elastomeric material. Validation of the new plastic chips for use in the single-cell process will be performed by testing cell performance compared to elastomeric chips.", "keywords": [ "Address", "Autoimmune Diseases", "Biological", "Biological Assay", "Biological Response Modifier Therapy", "Biology", "Biomanufacturing", "Bioreactors", "Biotechnology", "COVID-19 pandemic", "Cell Culture Techniques", "Cell Line", "Cell Survival", "Cell Therapy", "Cell physiology", "Cell secretion", "Cells", "Cellular Assay", "Cellular biology", "Chemistry", "Chinese Hamster Ovary Cell", "Clinical Research", "Consumption", "Data Analytics", "Data Storage and Retrieval", "Detection", "Development", "Devices", "Disease", "Dose", "Dyes", "Elastomers", "Engineering", "Funding", "Goals", "Growth", "Half-Life", "Health", "Hour", "Human", "Industry", "Institutes", "Lead", "Lectin", "Machine Learning", "Massachusetts", "Measurement", "Medicine", "Microfluidic Microchips", "Monoclonal Antibodies", "Nanoarray Analytical Device", "Patients", "Pattern", "Performance", "Pharmaceutical Preparations", "Pharmacologic Substance", "Phase", "Process", "Production", "Productivity", "Proteomics", "Rare Diseases", "Readiness", "Research", "Risk", "Safety", "Small Business Innovation Research Grant", "Sterility", "Surface", "Technology", "Testing", "Therapeutic", "Therapeutic Monoclonal Antibodies", "Time", "TimeLine", "Translating", "Vaccines", "Validation", "Variant", "Work", "base", "cancer therapy", "clinical development", "cloud platform", "computerized data processing", "cost", "data infrastructure", "design", "drug development", "drug efficacy", "elastomeric", "experience", "flexibility", "glycosylation", "immunogenicity", "improved", "innovation", "insight", "large datasets", "manufacturability", "medication safety", "nanolitre", "next generation", "novel therapeutics", "novel vaccines", "operation", "phase 1 study", "predictive modeling", "prototype", "scale up", "screening", "single cell technology", "small molecule", "tool", "vaccine-induced antibodies" ], "approved": true } } ], "meta": { "pagination": { "page": 1383, "pages": 1424, "count": 14236 } } }