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1 | Fiscal year received | Calendar Year Executed | CRADA Number | CRADA Type | CRADA Title | Status | Execution Date | if month 10-12 | Fiscal Year Executed | IC | Collab Company ID | Abstract | ||||||||||||||||||
2 | 2019 | 0 | C-015-2019-0 | S | Preclinical Evaluation of National Institute of Allergy and Infectious Diseases (NIAID)'s Epstein-Barr Virus(EBV) Vaccine formulated with GlaxoSmithKline Biologicals SA's Adjuvants AS01, AS03, and AS04 in NIAIDE's vivo models of EBV infection | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAID | GlaxoSmithKline Biologicals SA | The National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline Biologicals SA (GSK) have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate NIAID's Epstein-Barr Virus (EBV) vaccines using GSK's proprietary adjuvants for the immune response in animal models of EBV. EBY is the major cause of infectious mononucleosis and is also associated with several other cancers such as Hodgkin's lymphoma, non-Hodgkin lymphoma, Burkitt's lymphoma, gastric cancer, and nasopharyngeal carcinoma. No licensed EBY vaccine is currently available to prevent infection or diseases associated with EBV. | ||||||||||||||||||
3 | 2019 | 2019 | C-016-2019-0 | S | Development of Selective Inhibitors of Mesothelin Sheddase | Active | Jan 21, 2019 | 0 | 2019 | NCI | GaloreTx Pharmaceuticals Private Limited | Under the terms of a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and GaloreTx Pharmaceuticals Private Limited (GTX) will collaborate on the development of selective inhibitors of mesothelin sheddase. Using GTX’s novel minimal pharmacophore-based method for targeting cell surface protein-protein interactions and NCI’s expertise in the treatment of mesothelin-expressing cancers, the Parties will work together to identify inhibitors of mesothelin shedding and determine if such inhibitors can improve the treatment efficacy of mesothelin-expressing tumors. | ||||||||||||||||||
4 | 2019 | 2018 | C-017-2019-0 | M | Preclinical investigation of CTI BioPharma Corp.’s proprietary immunomodulatory compound, pacritinib | Active | Dec 10, 2018 | 12 | 2019 | NCI | CTI BioPharma Corp. | The National Cancer Institute and CTI BioPharma Corp. will collaborate under a Materials Cooperative Research and Development Agreement (M-CRADA) to conduct preclinical studies to evaluate the use of CTI BioPharma Corp.’s proprietary immunomodulatory compound, pacritinib, as a therapeutic for treatment of Kaposi sarcoma-associated herpesvirus (KSHV)-associated and idiopathic multicentric Castleman disease (KSHV-MCD). | ||||||||||||||||||
5 | 2019 | 2019 | C-018-2019-0 | S | Clinical Development of Daiichi Sankyo’s Proprietary DS-8201a, a Human Epidermal Growth Factor Receptor 2 (HER2)-targeted Antibody-drug Conjugate, as an Anti-Cancer Agent | Active | Jan 23, 2019 | 0 | 2019 | NCI | Daiichi Sankyo, Inc. | Daiichi Sankyo and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of DS-8201a, a Human Epidermal Growth Factor Receptor 2 (HER2)-targeted Antibody-drug Conjugate, proprietary to Daiichi Sankyo, as an anti-cancer agent. | ||||||||||||||||||
6 | 2019 | 2019 | C-019-2019-0 | S | Development of a Novel Bioinformatics Platform to Flag Potentially Actionable Genetic and Somatic Mutations in Humans | Active | Mar 12, 2019 | 0 | 2019 | NCI | TransMed Systems, Inc. | The National Cancer Institute and TransMed Systems, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to develop a clinic-ready, web-based tool, using NCI’s Oncogenomics browser with TransMed’s proprietary Precision Medicine Platform, that will aid clinicians in therapeutic decision-making. | ||||||||||||||||||
7 | 2019 | 2019 | C-020-2019-0 | M | Investigation of cancer progression in tumor-associated immune cell populations | Active | Jan 11, 2019 | 0 | 2019 | NIEHS | Merck Sharp & Dohme Corp. | A growing body of evidence supports the idea that endocrine disrupting chemical exposure during development can increase female reproductive cancer risk later in life. There remains a critical need for mechanistic information and biomarkers that will enable identification of susceptible populations and support the development of appropriate diagnostic/prognostic biomarkers and therapeutics. Furthermore, there is widespread interest in the immune system component of the tumor microenvironment and its role in cancer progression. Blocking immunosuppressive mechanisms to stimulate a pro-inflammatory tumor icroenvironment is being investigated as an additional cancer therapy that would support adjuvant chemotherapy. One particular mechanism is PD-1-PD-Ll/2 blockade, which functions to activate T-cells, increase tumor infiltrating lymphocytes (TILs), and promote tumor cell destruction. The overarching goal of this Research Plan is to characterize the tumor-associated immune cell population in endometrial cancer lesions induced by early-life exposure to the potent synthetic estrogen diethylstilbestrol (DES) and determine if treatment with the Collaborator Research Material alters cancer progression. | ||||||||||||||||||
8 | 2019 | 2019 | C-021-2019-0 | M | Evaluation of Amgen Inc.’s Denosumab, in BRCA1/2 Mutation Carriers Scheduled for Risk-reducing Salpingo-oophorectomy, for the Prevention of Ovarian Cancer | Active | Jan 31, 2019 | 0 | 2019 | NCI | Amgen, Inc. | Under the terms of a Clinical Materials-Cooperative Research and Development Agreement (CMCRADA), Amgen, Inc. and the National Cancer Institute (NCI) will conduct a clinical study of Amgen’s proprietary agent, Denosumab, for the prevention of ovarian cancer in women with BRCA1/2 mutations undergoing salpingo-oophorectomy. This clinical study will evaluate the use of denosumab, a RANKL inhibitor, for the prevention of ovarian cancers in BRCA1/2 mutation carriers. | ||||||||||||||||||
9 | 2019 | 2019 | C-022-2019-0 | S | Clinical Development of Forty Seven, Inc.’s Hu5F9-G4, an anti-CD47 Monoclonal Antibody, as an Anti-Cancer | Active | Feb 1, 2019 | 0 | 2019 | NCI | Forty Seven, Inc. | Forty Seven, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of Hu5F9-G4 (5F9), an anti-CD47 antibody proprietary to Forty Seven, Inc., as an anti-cancer agent. | ||||||||||||||||||
10 | 2019 | 2019 | C-023-2019-0 | S | Clinical Development of LMB2, an anti-CD25 Immunotoxin, for Targeting Tumor-Infiltrating T-Regulatory cells (T-regs) and Stimulating Anti-Tumor Responses | Active | Feb 5, 2019 | 0 | 2019 | NCI | Navrogen Inc | Under the terms of a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and Navrogen, Inc. will collaborate on the clinical development of NCI’s anti-CD25 immunotoxin, LMB-2, for the treatment of mesothelioma and lung cancer, as well as the development of a humanized IgG1 anti-CD25 antibody suitable for generating antibody-drug conjugates (ADCs). | ||||||||||||||||||
11 | 2019 | 0 | C-024-2019-0 | S | Evaluation of Elysium Health, Inc’s Proprietary Ingredient, Nicotinamide Riboside Plus Pterostilbene (NRPT), for Preclinical Analysis of Interventions of Alzheimer’s Disease | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIA | Elysium Health, Inc. | Under this Cooperative Research and Development Agreement (CRADA), the National Institute on Aging (NIA) and Elysium Health, Inc. (Elysium) will investigate the effects of Elysium’s proprietary formula, nicotinamide riboside plus pterostilbene (NRPT), for its ability to mitigate certain symptoms in preclinical models of Alzheimer’s disease (AD).q | ||||||||||||||||||
12 | 2019 | 2019 | C-025-2019-0 | S | Evaluation of Viz.ai Software for Development of Non-Contrast CT Large Vessel Occlusion Calculator | Active | Mar 13, 2019 | 0 | 2019 | NINDS | Viz.ai Incorporated | The goal of this Cooperative Research and Development Agreement (CRADA) between Viz.ai, Inc and the National Institute of Neurological Disorders and Stroke (NINDS) is to validate and evaluate Viz.ai’s computer-aided triage software called VIZ LVO. The software uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke. It is a clinical decision support software designed to analyze computed tomography (CT) images of the brain and send a text notification to a neurologist if large vessel occlusion (LVO) is suspected. The U.S. Food and Drug Administration has recently approved the marketing of the clinical decision support software. NINDS and Viz.AI are collaborating to validate the CT-based estimate of core in comparison to NINDS clinical and MRI data. | ||||||||||||||||||
13 | 2019 | 2019 | C-026-2019-0 | M | Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study in Healthy volunteers to Evaluate the Safety and Efficacy of PepTcell Limited's AGS-v Plus, a Universal Mosquito-Borne Disease Vaccine using NIAID's Aedes albopictus and Aedes aegypti Mosquito Challenge Model | Active | Mar 20, 2019 | 0 | 2019 | NIAID | PepTCell Limited | The National Institute of Allergy and Infectious Diseases (NIAID) and PepTcell Limited, trading as SEEK, have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate the safety and efficacy of PepTcell Limited's novel vaccine AGS-v plus, a proteinbased vaccine that stimulates both antibody and THI responses against mosquito saliva during an insect feeding, in a Phase lb clinical trial. This in turn activates macrophages and dendritic cells at the site of the bite, suppressing the typical TH2 responses and blocking infection by the vector borne pathogen. This vaccine looks to have potential to work against multiple vector borne pathogens including but not limited to chikungunya and Zika virlils. Under this collaboration, the Parties will test immunogenicity before and after vacb nation and after stimulation by clean mosquito feeding with Aedes albopictus, primary vector for Chikungunya, and with Aedes aegypti, primary vector for Zika virus. These mosquito ~pecies have been implicated in the transmission of other important viruses such as dengue, lacrosse virus, St. Louis encephalitis virus, equine encephalitis virus, and yellow fever. Mosquitoes will bemonitored post-feeding to assess for an effect on their survival and fecJ ndity. Moreover, the extent of the reactions at the bite site in volunteers will be recorded. In ~ddition, the ability of immune cells and serum to impede infection by Chikungunya and Zika virus coated in mosquito saliva will be tested in ex-vivo assays. | ||||||||||||||||||
14 | 2019 | 0 | C-027-2019-0 | S | The study and development of mRNA-based malaria vaccines using CureVac's proprietary mRNA technology | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAID | CureVac AG | The National Institute of Allergy and Infectious Diseases (NIAID) and CureVac AG (CureVac) have entered into a Cooperative Research and Development Agreement ~CRADA), to design and construct messenger RNA (mRNA) vaccines expressing malaria antigens and to develop candidate vaccines in the fields of Transmission Blocking Vaccine and Placental Malaria Vaccine. | ||||||||||||||||||
15 | 2019 | 2019 | C-028-2019-0 | S | Targeting Bruton’s Tyrosine Kinase In Chronic Lymphocytic Leukemia | Active | Mar 14, 2019 | 0 | 2019 | NHLBI | Nurix, Inc. | Under a Cooperative Research and Development Agreement (CRADA), Nurix, Inc. (Collaborator) and the National Heart, Lung, and Blood Institute (IC) are collaborating to determine whether inducing Bruton’s tyrosine kinase (BTK) degradation provides a novel mechanism to target BCR signaling that will remain effective in chronic lymphocytic leukemia (CLL) tumors and subsets of lymphoma having Cys481 mutations, and whether this degradation has more profound effects on BCR signaling than kinase inhibition. | ||||||||||||||||||
16 | 2019 | 2019 | C-029-2019-0 | M | Evaluation of MAX BioPharma’s proprietary Hedgehog pathway inhibitors, Oxy210 and Oxy186 | Active | Jan 16, 2019 | 0 | 2019 | NCI | MAX BioPharma, Inc. | The National Cancer Institute (NCI) and MAX BioPharma will collaborate under a Materials Cooperative Research and Development Agreement (M-CRADA) on the evaluation of MAX BioPharma’s proprietary Hedgehog (Hh) pathway inhibitors, Oxy210 and Oxy186, in the regulation of TGF-beta and Hedgehog signaling and their anti-tumor activities in mouse models. | ||||||||||||||||||
17 | 2019 | 2019 | C-030-2019-0 | S | An Open-Label, First-in-human, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate, BAY 2287411, in Patients with Solid Tumors Known to Express Mesothelin | Active | Mar 4, 2019 | 0 | 2019 | NCI | Bayer HealthCare Pharmaceuticals, Inc. | The National Cancer Institute and Bayer HealthCare Pharmaceuticals Inc. have entered into a clinical Cooperative Research and Development Agreement (CRADA) to collaborate on the evaluation of Bayer’s proprietary Thorium-227 labeled antibody-chelator conjugate, BAY 2287411, as a cancer therapeutic agent. | ||||||||||||||||||
18 | 2019 | 0 | C-031-2019-0 | S | Clinical Development of Agenus Inc.’s Proprietary AGEN1181, CTLA-4 Inhibitor, as an Anti-Cancer Agent | Withdrawn | 00/00/00 | 0 | 2019 | NCI | Agenus, Inc. | Agenus Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of AGEN1181, CTLA-4 Inhibitor proprietary to Agenus, as an anti-cancer agent. | ||||||||||||||||||
19 | 2019 | 2019 | C-032-2019-0 | S | Therapeutic Applications of HDL-Mimetics in Sickle Cell Disease for Modulating Red Blood Cell Membrane Cholesterol | Active | May 1, 2019 | 0 | 2019 | NHLBI | Hartis-Pharma Sarl | Under a Cooperative Research and Development Agreement (CRADA), Hartis Pharmaceuticals, S.A. (Collaborator) and the National Heart, Lung, and Blood Institute (IC) are collaborating to develop a High Density Lipoprotein (HDL)-mimetic drug therapy for modulating cholesterol content of red blood cells (RBCs). The level of HDL in plasma is inversely related to the incidence of cardiovascular disease. This has been attributed to the ability of HDL to promote the removal of excess cholesterol from cells, such as macrophages in atherosclerotic plaque, but HDL also removes cholesterol from other cells like RBCs. The cholesterol content of RBCs, which has also been shown to be positively related to the incidence of CVD, is in rapid equilibrium with cholesterol on HDL and accounts for the abnormal RBC shapes commonly observed in patients with dyslipidemia. Increased cholesterol on RBCs is known to adversely alter RBC function, such as gas exchange, and also its physical properties, such as deformability and aggregability. Collaborator has shown that treatment of RBCs with HDL and selected HDL peptidomimetics rapidly removes cholesterol and improves RBC rigidity making them more permeable and amenable to gas exchange. The main goal of the CRADA is to investigate the effect of the HDL-mimetic developed by the IC, namely the 5A peptide complexed with sphingomyelin (Fx-5A), and other novel HDL-mimetics on modulating the cholesterol content of RBCs and its functional and physical properties. If successful, results from this CRADA may lead to a clinical trial on the use of HDL-mimetic therapy for the treatment of sickle cell disease and other diseases affected by the cholesterol content of RBCs. | ||||||||||||||||||
20 | 2019 | 2019 | C-033-2019-0 | S | Challenge study evaluation of the protective efficacy of Inovio Pharmaceuticals, Inc.'s proprietary vaccine, ino-4700, IN NIAID's non-human primate model of MERS-CoV | Active | Mar 25, 2019 | 0 | 2019 | NIAID | Inovio Pharmaceuticals, Inc. | The National Institute of Allergy and Infectious Diseases (NIAID) and Inovio Pharmaceuticals,Inc. (lnovio) have entered into a Cooperative Research and Development Agreement (CRADA) to test the protective efficacy oflnovio's proprietary Middle East Respiratory Syndrome coronavirus (MERS-CoV) vaccine, INO-4700, with extended DNA dose ranging, in NIAID's non-human primate and mouse models ofMERS-CoV. MERS-CoV is an emerging respiratory pathogen that causes severe respiratory disease in humans, with a high case fatality rate of ~35%. The World Health Organization has included MERS-CoV on its list of 10 emerging infectious disease priorities needing urgent research and development attention, and it is included in the NIAID pandemic preparedness panel. | ||||||||||||||||||
21 | 2019 | 2019 | C-034-2019-0 | S | Clinical Study of Collaborator’s Proprietary VTS-270 for liver conditions associated with Niemann Pick Type-C (NPC) in Adult patients | Active | Mar 29, 2019 | 0 | 2019 | NICHD | Mallinckrodt Pharmaceuticals | Under this CRADA, NICHD and Mallinckrodt will perform a clinical study of VTS-270 for the treatment of liver conditions associated with Niemann Pick Type-C (NPC) in Adult patients. Mallinckrodt will provide its VTS-270 for use by NICHD. NICHD will perform the clinical research. This work is designed to address an unmet need in the NPC patient population. | ||||||||||||||||||
22 | 2019 | 0 | C-035-2019-0 | S | Non-human primate studies to test the safety and efficacy of lentiviral vectors and genome editing to induced fetal hemoglobin HbF for treating hemoglobinopathies | Pending-IC Execution | 00/00/00 | 0 | 2019 | NHLBI | St. Jude Children's Research Hospital | Investigators at St. Jude are developing gene therapy methods to induce fetal hemoglobin (HbF) expression in human erythroid cells for treating hemoglobinopathies including sickle cell disease (SCD) and beta thalassemia. These methods include: 1) lentiviral vectors encoding shRNA that efficiently reduces mRNA encoding BCLl lA, a repressor of fetal hemoglobin synthesis 2) genome editing approaches that modify the extended human beta globin locus to induce HbF. To evaluate the efficacy and safety of these approaches in vivo, we will perform autologous gene therapy on rhesus macague primates in collaboration with Dr. Tisdale at the NHLBI. Unlike murine or other lower vertebrate strains, rhesus macaque monkeys recapitulate the switch from fetal to adult Hb that occurs at birth. Moreover, these animals survive for more than 5 years post gene therapy, which allows us to test the long term effects of the procedure, including the potential to develop leukemia. Thus, these animals most closely approximate human patients for evaluating the safety and efficacy of our gene therapy approaches. | ||||||||||||||||||
23 | 2019 | 2019 | C-036-2019-0 | M | Testing of Ionis Pharmaceuticals Inc’s Proprietary Antisense Oligonucleotides Targeted to Human and Mouse Lamin A/C for the Treatment of Progeria in Cell Culture and Animal Models | Active | Mar 8, 2019 | 0 | 2019 | NCI | IONIS Pharmaceuticals, Inc. | Under a Materials Cooperative and Research Development Agreement (M-CRADA) the National Cancer Institute (NCI) will test Ionis Pharmaceuticals Inc.’s (Ionis) proprietary antisense oligonucleotides targeted to human and mouse lamin A/C for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) using NCI’s cell culture and animal model systems. | ||||||||||||||||||
24 | 2019 | 2019 | C-037-2019-0 | S | Clinical Evaluation of Bristol Myers Squibb’s (BMS) ProprietaryNivolumab (anti-PD1), Tadalafil and Oral Vancomycin in Patients with Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic | Active | Apr 5, 2019 | 0 | 2019 | NCI | Bristol-Myers Squibb | Under a Cooperative Research and Development Agreement (CRADA), NCI will evaluate BMS’s Nivolumab through conducting a clinical protocol entitled “Phase II Study of Nivolumab (anti-PD1), Tadalafil and Oral Vancomycin in Patients with Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer from Colorectal or Pancreatic Cancers.” The study is being conducted at the NIH Clinical Center. This research may have implications for the treatment of refractory primary hepatocellular carcinoma or liver dominant metastatic cancer from colorectal cancer or pancreatic adenocarcinoma. | ||||||||||||||||||
25 | 2019 | 0 | C-038-2019-0 | S | Biosense Webster Navigation Catheters for Structural Heart Interventional Procedures | Pending-IC Execution | 00/00/00 | 0 | 2019 | NHLBI | Biosense Webster | The National Heart, Lung, and Blood Institute’s Laboratory of Cardiovascular Intervention and Biosense Webster, Inc., a division of Johnson & Johnson, will examine the application of Biosense Webster’s CARTO VIZIGO guiding sheath to perform certain complex heart interventional procedures using porcine models. Advances made under this collaboration may be directly applicable to similar heart procedures in humans for which there is a current lack of suitable commercially available image guidance tools. | ||||||||||||||||||
26 | 2019 | 2019 | C-039-2019-0 | S | Development of Matinas' Encochleation of Amphotericin B (CAMB) for the Treatment of Cryptococcal Meningitis | Active | Apr 2, 2019 | 0 | 2019 | NIAID | Matinas BioPharma Holdings, Inc. | The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institute of Health (NIH), and Matinas BioPharma Nanotechnologies, Inc. (Matinas) of Bedminster New Jersey have entered into a Cooperative Research and Development Agreement (CRADA) to: 1) Conduct preclinical evaluation of the efficacy, pharmacokinetic, and safety profile of cochleated formulations of amphotericin (CAMB) and RNA antisense molecules in animal models of cryptococcal meningitis. The antisense formulations to be used will be directed against immune molecules including the mTOR regulatory protein DDX6 as well as other potential targets such as IL6 with and without corticosteroid therapy. 2) Conduct preclinical studies developing and testing CAMB PET imaging to test for brain delivery of CAMB. 3) Conduct preclinical studies evaluating dose response efficacy of CAMB in animal models of cryptococcal meningitis. | ||||||||||||||||||
27 | 2019 | 2019 | C-040-2019-0 | S | Preclinical and Clinical Development of PDS Biotechnology Corporation’s Proprietary Versamune® Platform-Based HPV Immunotherapy | Active | Apr 22, 2019 | 0 | 2019 | NCI | PDS Biotechnology Corporation | Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and PDS Biotechnology Corporation (PDS Bio) will collaborate to evaluate PDS Bio’s proprietary HPV Versamune® immunotherapy platform in preclinical and clinical studies for the treatment of HPV-associated malignancies. The Parties will evaluate PDS Bio’s Versamune® HPV vaccine (also known as PDS0101), and if mutually agreeable, may evaluate Versamune® using NCI’s HPV-containing peptides reflecting HPV agonist epitopes. | ||||||||||||||||||
28 | 2019 | 2019 | C-041-2019-0 | S | Evaluation of Collaborator’s Proprietary Adenine Base Editor (ABE) Gene Editing System in an Animal Model of Glycogen Storage Disease Type Ia (GSD-Ia) | Active | Apr 13, 2019 | 0 | 2019 | NICHD | Beam Therapeutics, Inc. | Under this CRADA, the Eunice Kennedy Shriver National Institute Child Health and Human Development (NICHD) and Beam Therapeutics, Inc. (BEAM) will test a method for the direct repair of site mutations in a mouse model of Glycogen Storage Disease Type Ia (GSD1a). BEAM will provide its proprietary adenine base editor (ABE) technology and humanized G6pc mouse. The Parties will validate the mouse as a GSD1a disease model. NICHD will characterize the mouse model for disease progression. BEAM will prepare its gene editing system for tests using one or more delivery modalities. NICHD will perform gene repair experiments. The Parties will assess the direct DNA site repair by ABE as a therapeutic approach to GSD1a. | ||||||||||||||||||
29 | 2019 | 2019 | C-042-2019-0 | S | Phase 1/2 Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-lymphocyte Antigen 4 (CTLA4) Haploinsufficiency of Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-lymphocyte Antigen 4 (CTLA4) Haploinsufficiency | Active | Apr 25, 2019 | 0 | 2019 | NIAID | Bristol-Myers Squibb Company | The National Institute of Allergy and Infectious Diseases and Bristol-Myers Squibb Company (BMS) have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate in a phase 1/2 clinical study the safety and efficacy of BMS' proprietary drug Abatacept (ORENCIA®) for the treatment of chronic cytopenia in patients with cytotoxic T-lymphocyte antigen 4 (CTLA4) haploinsufficiency. | ||||||||||||||||||
30 | 2019 | 0 | C-043-2019-0 | S | A Phase 1/2, Open -Label, Multicenter, Single-Arm Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients with Severe Sickle Cell Disease | Pending-IC Execution | 00/00/00 | 0 | 2019 | NHLBI | Bioverativ Therapeutics, Inc. | The National Heart, Lung, and Blood Institute and Bioverativ Therapeutics, Inc. have entered into a clinical Cooperative Research and Development Agreement (“CRADA”) to collaborate on the evaluation of Bioverativ’s proprietary zinc finger nuclease technology, BIVV003, in which the BCL11A gene is modified to enable production of disease- modifying levels of fetal hemoglobin, in the treatment of sickle cell disease. | ||||||||||||||||||
31 | 2019 | 2019 | C-044-2019-0 | S | Exosomal Isolation and Identification of Candidate Biomarkers from Cognition Therapeutics’ Elayta™ Clinical Trial Samples | Active | Apr 16, 2019 | 0 | 2019 | NIA | Cognition Therapeutics, Inc. | The National Institute on Aging (“NIA”) and Cognition Therapeutics, Inc. (“CogRx”) will work together under this Cooperative Research and Development Agreement (“CRADA”) to characterize exosomes from human plasma samples collected during ongoing clinical trials from patients treated with CogRx’s proprietary drug, Elayta™ (“CT1812”). The goal of this CRADA is to investigate target engagement biomarkers of CT1812 in Alzheimer’s disease. | ||||||||||||||||||
32 | 2019 | 2019 | C-045-2019-0 | S | Clinical Development of Bayer HealthCare Pharmaceuticals Inc.’s BAY 1895344, an Oral Small-molecule ATR kinase Inhibitor, as an Anti-Cancer Agent | Active | Apr 29, 2019 | 0 | 2019 | NCI | Bayer HealthCare Pharmaceuticals, Inc. | Bayer HealthCare Pharmaceuticals Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of ATRi as an anti-cancer agent. | ||||||||||||||||||
33 | 2019 | 2019 | C-046-2019-0 | M | Use of METAFORA Biosystems’ proprietary receptor binding domain (RBD) ligands to study the cellular location and function of amino acid and glucose transporters in CD4+ and CD8+ T cell biology | Active | May 14, 2019 | 0 | 2019 | NHLBI | METAFORA Biosystems | Complement is engrained in the immunologist’s mind as a quintessential part of innate immunity, vitally required for the detection and removal of invading pathogens. This current understanding of the complement system is rooted in the prevailing perception that complement operates mostly as a serum effector system. Recent work challenges this view: Complement activation is not - as always thought - confined to the extracellular space but can be activated intracellularly where it mediates specific intracellular signaling events connected with the cell’s nutrient and metabolism sensing machinery. Importantly, this serum-independent, but intracellular and autocrine functioning complement system - which Dr. Kemper’s group has coined ‘complosome’ - is an integral and critical part of human CD4+ T helper cell 1 (Th1) induction and contraction and CD8+ cytotoxic T cell activity. In consequence, reduction of complosome activity is connected with recurrent infections, and augmentation of complosome activity contributes to autoimmune disease. Under a Materials Cooperative Research and Development Agreement (M-CRADA), METAFORA Biosystems’ proprietary receptor binding domain (RBD) ligands will be used by Dr. Kemper’s laboratory to better define the exact cellular location and function of key amino acid and glucose transporters during human CD4+ T cell/Th1 induction and contraction. | ||||||||||||||||||
34 | 2019 | 2019 | C-047-2019-0 | S | Use of Agios Pharmaceuticals, Inc.’s Anti-Cancer Agent Ivosidenib, an IDH1m Inhibitor, in NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) Clinical Trial | Active | Apr 25, 2019 | 0 | 2019 | NCI | Agios Pharmaceuticals, Inc. | Agios Pharmaceuticals, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which Agios will provide ivosidenib to support the NCI pediatric MATCH trial. | ||||||||||||||||||
35 | 2019 | 2019 | C-048-2019-0 | S | Development of Allogeneic CAR T cells for the Treatment of Glypican-3 (GPC-3), Glypican-2 (GPC-2), Major Histocompatibility Complex (MHC)/PRAME, and MHC/NY-ESO-1 Expressing Solid Tumors | Active | Apr 24, 2019 | 0 | 2019 | NCI | CRISPR Therapeutics AG | The National Cancer Institute and CRISPR Therapeutics have entered into a Cooperative Research and Development Agreement (CRADA) for the development of allogeneic anti GPC-3, anti GPC-2, anti-MHC/PRAME, and anti-MHC/NY-ESO-1 CAR T cells for the treatment of diseases that may include but are not restricted to hepatocellular carcinoma (HCC) and neuroblastoma. | ||||||||||||||||||
36 | 2019 | 2019 | C-049-2019-0 | S | Development of Gene Therapy for GM1 Gangliosidosis | Active | May 9, 2019 | 0 | 2019 | NHGRI | Axovant Sciences, Inc. | National Human Genome Research Institute (NHGRI), Axovant Sciences, Inc. (Axovant), and the University of Massachusetts (UMass) have entered into a Collaborative Research and Development Agreement (CRADA) to develop a potential gene therapy for GM1 gangliosidosis, an extremely rare lysosomal storage disorder, whose current care is limited to symptomatic medical management. The gene therapy utilizes an AAV9 vector expressing the human galactosidase beta 1 gene (AAV9-GLB1) to restore the enzyme activity that is missing or dysfunctional in the disease. The collaboration will include clinical development at NHGRI of a systemic AAV9-GLB1 gene therapy in patients with GM1 gangliosidosis to support BLA filing and commercialization. | ||||||||||||||||||
37 | 2019 | 2019 | C-050-2019-0 | S | The Development of FKBP52-Targeting Agents for the Treatment of Cancer | Active | May 1, 2019 | 0 | 2019 | NCI | MAIA Biotechnology, Inc. | Under the terms of a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI), University of Texas El-Paso (UTEP) and MAIA Biotechnology, Inc. (MAIA) will collaborate in the development of agents that target FKBP52 for the treatment of cancer. This research could have implications specifically for the treatment of androgen receptor-mediated cancers such as prostate cancer. | ||||||||||||||||||
38 | 2019 | 2019 | C-051-2019-0 | S | Challenge study evaluation of the protective efficacy of Inovio Pharmaceuticals, Inc.'s proprietary vaccine, INO-450, in NIAID's non-human primate model of Lassa fever | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAID | Inovio Pharmaceuticals, Inc. | The National Institute of Allergy and Infectious Diseases (NIAID) and Inovio Pharmaceuticals, Inc. (lnovio) have entered into a Cooperative Research and Development Agreement (CRADA) to test the protective efficacy of Inovio's proprietary Lassa fever vaccine, INO-4500, with extended DNA dose ranging, in NIAID's non-human primate model of Lassa virus (LASV). LASV is an emerging pathogen that may cause severe hemorrhagic fever in humans. LASV is endemic in several countries of West Africa and is responsible for 300,000-500,000 cases of human disease and 5,000 deaths annually. The World Health Organization has included LASV on its list of IO emerging infectious disease priorities needing urgent research and development attention, and it is included in the NIAID pandemic preparedness panel. | ||||||||||||||||||
39 | 2019 | 2019 | C-052-2019-0 | S | The Efficacy of Rejuvenate BiomedTM Proprietary RJx-01 in Improving Longevity, Health and Function, and Resilience in Mice | Active | May 28, 2019 | 0 | 2019 | NIA | Rejuvenate Biomed NV | Under a Cooperative Research and Development Agreement (CRADA), NIA`s Translational Gerontology Branch, Experimental Gerontology Section and Rejuvenate Biomed NV (“Rejuvenate”) will collaborate to evaluate the effects of Rejuvenate’s proprietary formulation, RJx-01, on various characteristics of aging, including overall health, survival, and resilience in aging mouse models. | ||||||||||||||||||
40 | 2019 | 2019 | C-053-2019-0 | M | Studies to Evaluate Aurigene Discovery Technologies Limited’s Proprietary Compounds, AU-BGB14227, AU-CBB-16770, AU-BEI-10458, and acetylene derivative of AU-BEI-10458, in Combination with EGFR inhibitors such as Osimertinib in Lung Cancer | Active | May 2, 2019 | 0 | 2019 | NCI | Aurigene Discovery Technologies Limited | Under a Materials Cooperative Research and Development Agreement (M-CRADA), the National Cancer Institute (NCI) will evaluate Aurigene Discovery Technologies Limited's proprietary compounds, AUBGB-14227, AU-CBB-16770, AU-BEI-10458 and acetylene derivative of AU-BEI-10458, in combination with EGFR inhibitors, such as osimertinib, in studies of lung cancer. This research may have implications for the treatment of cancer. | ||||||||||||||||||
41 | 2019 | 2019 | C-054-2019-0 | S | Clinical Development of Cleave Biosciences, Inc.’s CB-5339, p97/VCP Inhibitor, as an Anti-Cancer Agent | Active | May 23, 2019 | 0 | 2019 | NCI | Cleave Biosciences, Inc. | Cleave Biosciences, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of CB-5339, a small molecule p97 inhibitor, proprietary to Cleave Biosciences, Inc., as an anti-cancer agent. | ||||||||||||||||||
42 | 2019 | 0 | C-055-2019-0 | S | Challenge study evaluation of the proprietary chimpanzee adenoviral vectored vaccines against Nipah virus and Lassa virus in NIAID's non-human primate models of Nipah virus and Lassa virus, and in NIAID's guinea pig model of Lassa virus | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAID | Jenner Institute, Oxford University | The National Institute of Allergy and Infectious Diseases (NIAID) and Jenner Institute, OxfordUniversity (Oxford) have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate the protective efficacy of Oxford's chimpanzee adenoviral vectored vaccines against Nipah virus and Lassa virus in NIAID's non-human primate models ofNipah virus and Lassa virus, and in NIAi D's guinea pig model of Lassa virus. The World Health Organization has listed Nipah virus and Lassa virus as requiring accelerated research and development due to the lack of efficacious drugs and vaccines and their high potential for an epidemic. Development of corresponding vaccines will be a milestone achievement in public health. | ||||||||||||||||||
43 | 2019 | 0 | C-056-2019-0 | S | Identification of Novel Therapeutics for Alagille Syndrome (ALGS) | Pending-IC Execution | 00/00/00 | 0 | 2019 | NCATS | Alagille Syndrome Alliance | The Alagille Syndrome Alliance (ALGSA) patient foundation and biopharmaceutical company Retrophin, Inc. are proposing a collaboration with the National Center for Advancing Translational Sciences (NCATS), Therapeutics for Rare and Neglected Diseases (TRND) Biology Laboratory for the development of potentially novel therapeutics for patients suffering from Alagille Syndrome (ALGS). The scope of this collaborative project is potential validation of an identified drug repurposing target, and assay development, high-throughput screening (HTS) and hit validation to identify chemical matter on novel mechanisms. The plan outlines assay development in relevant cell types of hepatic lineage, HTS, and hit validation to identify compounds that potentially can be advanced into hit-to-lead. Retrophin is interested in the continued development of any hit compounds identified through this collaboration, with the goalof delivering a new, novel therapeutic options to patients suffering from Alagille Syndrome. | ||||||||||||||||||
44 | 2019 | 2019 | C-057-2019-0 | S | IND Enabling of 177Lu-DOTA-EB-PSMA Radionuclide Treatment for Metastatic Prostate Cancer | Active | Jun 11, 2019 | 0 | 2019 | NIBIB | Sinotau Pharmaceutical Group | Under a Cooperative Research and Development Agreement (CRADA), Sinotau Pharmaceutical Group (Sinotau) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) are collaborating to enable the Investigational New Drug (IND Enabling) of EB-PSMA as clinical diagnostic and therapeutic radionuclide labeled agents. EB-PSMA is invented recently by NIH researchers and licensed to Sinotau Pharmaceutical Group (Sinotau) as the candidate for global development and commercialization to treat patients with prostate specific membrane antigen(PSMA) expressing metastases. Preliminary results in mouse xenograft models and an investigator sponsored clinical study show that, the incorporation of an Evans Blue (EB)-motif into the PSMA ligand, when radiolabeled with 177Lu or 90Y, endows the traditional PSMA ligands new features of longer in vivo retention and higher lesion accumulation to deliver enhanced radiation exposure to the prostate cancer metastases. These findings warrant formal clinical studies, and the collaboration between the inventors’ institution and Sinotau will combine our strengths to enable the IND filing. The scope of this CRADA consists of a systematic pharmacology and toxicity study under the regulations of good laboratory practice (GLP), along with CMC (chemistry, GMP manufacturing and control). A Phase 1 clinical protocol will also be included in the IND filingdossier with at least one (1) clinical site identified. Sinotau is to use its long-time experience and workforce in organizing and in promoting the research practicing systems to meet the standards of the GLP (or GLP-like) pharmacology and toxicology tests along with GMP (or GMP-like) manufacturing of drug substance. The NIBIB and its inventers/scientists will provide expertise and capability in radiochemistry optimization and in pre-clinical disease models, while obtaining experience in advancing a pre-clinical candidate into clinic towards commercialization that can benefit more patients in need. In addition to providing their scientific and operational input, the collaborator Sinotau will also provide due payments to cover the occurred expenses in contracted staffing, materials and contracted services. | ||||||||||||||||||
45 | 2019 | 0 | C-058-2019-0 | S | Evaluation of the therapeutic benefit of Verastem’s proprietary drug (duvelisib) in patients with chronic lymphocytic leukemia (CLL) progressing on Bruton tyrosine kinase inhibitor, ibrutinib | Pending-IC Execution | 00/00/00 | 0 | 2019 | NHLBI | Verastem, Inc. | Under a Cooperative Research and Development Agreement (CRADA), Verastem, Inc. (Collaborator) and the National Heart, Lung, and Blood Institute (IC) are collaborating to determine whether Collaborator’s proprietary drug (duvelisib) can restore disease control in chronic lymphocytic leukemia (CLL) patients progressing on Bruton tyrosine kinase inhibitor (BTKi) therapy. | ||||||||||||||||||
46 | 2019 | 0 | C-059-2019-0 | S | Evaluation of CD47 Inhibitors for Potential Use in the Treatment of Cancer | Pending-SCR Scheduled | 00/00/00 | 0 | 2019 | NCI | Morphiex Biotherapeutics | The National Cancer Institute and Morphiex Biotherapeutics, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on the evaluation of a CD47-specific phosphorodiamidate morpholino oligomer (PMO) and to develop CD47 PMO analogs, as potential cancer therapeutic agents. | ||||||||||||||||||
47 | 2019 | 2019 | C-060-2019-0 | M | Improving AA V Transduction by Expressing Albumin Fusion Payloads | Active | May 16, 2019 | 0 | 2019 | NIDCR | Albumedix Ltd | IC investigators have shown that AAV transduction is a complex process and can be altered by interaction with specific cellular proteins. Additionally, serum proteins are reported to alter AA Vtransduction. Under this collaboration, IC investigators will study the effect different forms of recombinant albumin supplied by the collaborator on AA V transduction using in vitro model systems. If successful, the IC investigators may test the optimal formulation on AA V transduction in vivo using different animal models. | ||||||||||||||||||
48 | 2019 | 2019 | C-061-2019-0 | M | Evaluation of Ionis Pharmaceuticals’ proprietary Antisense Oligonucleotides Targeted to Human and Mouse SMYD3 for the Treatment of Cancer | Active | May 30, 2019 | 0 | 2019 | NCI | IONIS Pharmaceuticals, Inc. | Under a Materials Cooperative and Research Development Agreement (M-CRADA), the National Cancer Institute (NCI) will use Ionis Pharmaceuticals Inc.’s (Ionis) proprietary antisense oligonucleotides targeted to human and mouse SET and MYND domain containing 3 (SMYD3) to investigate the roles of SMYD3 in head and neck squamous cell carcinoma (HNSCC). This research may have implications in the treatment of cancer. | ||||||||||||||||||
49 | 2019 | 0 | C-062-2019-0 | S | Characterization and application of Halozyme's ENHANZE® drug delivery technology with YRC, NIAID, NIH's anti-HIV broadly neutralizing monoclonal antibodies | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAID | Halozyme, Inc. | Isolation and development of broadly neutrali zing antibodies to HIV are providing promising new options for both preventative and therapeutic interventions for this disease. Broadly neutralizing antibodies to HIV have been discovered and continue to be modified to yield progressively better neutralizing capacity. However, improved methods of delivery are needed to optimize their use. A Cooperative Research and Development Agreement (CRADA) between Halozyme, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID) will test Halozyme's recombinant human hyaluronidase PH20 (rHuPH20) co-injected with NIAID's HIV monoclonal antibodies in clinical trials using subcutaneous administration. By combining NIAID's antibodies and Halozyme's rHuPH20, this collaboration aims to optimize their subcutaneous administration. | ||||||||||||||||||
50 | 2019 | 0 | C-063-2019-0 | M | Role of myostatin in impaired whole-body glucose homeostasis observed with mice lacking β-arrestin-1 in adipocytes | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIDDK | Acceleron Pharma | Recent studies have revealed that β-arrestin family proteins (barr1 and barr2) regulate many important physiological functions; however, the role of barr1 and barr2 in adipocyte function remains unexplored. Using targeted interventions to evaluate signaling mechanisms in an adipose tissue-specific mutant mouse model, researchers at the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health hope to better understand the role of barr1 in regulating adipocyte function and insulin resistance. These studies may show that targeting β-arrestin family proteins in adipocytes may be a novel way to ameliorate insulin resistance and treat Type 2 Diabetes. | ||||||||||||||||||
51 | 2019 | 0 | C-064-2019-0 | M | Evaluation of Merck's potential inhibitors of BAM complex by NIH/NIDDK by using an in vitro outer membrane protein assembly assay | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIDDK | Merck Sharp & Dohme Corp | Chemical compounds isolated by scientists at Merck Sharpe and Dohme, Corp. will be tested for their ability to inhibit the activity of a bacterial protein complex called the barrel assembly machinery (Bam) complex. Because the Bam complex is essential for the survival of Gram-negative bacteria (a group that includes many multi-drug resistant “superbugs”), compounds that inhibit its activity may represent a novel class of antibiotics. Dr. Bernstein and his colleagues at NIDDK/NIH will use an in vitro assay that they developed a few years ago to determine if the compounds inhibit the ability of the purified Bam complex to catalyze the assembly of outer membrane proteins. Each compound will be titrated to obtain a quantitative assessment of its potency. If any of the compounds exhibit significant inhibitory activity, additional studies with modified versions of the Bam complex will be performed to identify the subunit that it targets. Biophysical assays will be performed to obtain direct evidence that compounds of interest bind to specific subunits of the Bam complex. | ||||||||||||||||||
52 | 2019 | 0 | C-065-2019-0 | S | Anti-Fibrotic Activity of Novel Hybrid CB1 Receptor Antagonist/AMP Kinase Activator Compounds in Bleomycin-Induced Lung Fibrosis in Mice | Pending-IC Execution | 00/00/00 | 0 | 2019 | NIAAA | Inversago Pharma Inc. | This CRADA plan aims to explore the therapeutic potential of novel, dual target compounds in mouse models of obesity-related liver fibrosis and idiopathic pulmonary fibrosis (IPF), diseases that currently lack efficacious treatment. In complex diseases including fibrotic disorders, simultaneous targeting of multiple cellular pathways is thought to improve therapeutic efficacy. There is evidence that increased activity of the endocannabinoid (EC)/CB1 receptor (CB1R) system and decreased activity of the enzyme AMP kinase (AMPK) are pathogenic factors in various fibrotic disorders. The IC has developed novel, CB1R inverse agonists/AMPK activator compounds that are devoid of CNS side effects due to their limited brain penetrance. The IC proposes to test the antifibrotic efficacy of the two lead compounds compared to the therapeutic efficacy of a single-target CB1R inverse agonist in a mouse model of obesity-related steatohepatitis/liver fibrosis and a bleomycin-induced model of IPF. These studies build upon the hypothesis that simultaneous targeting of CB1R and AMPK will result in improved anti-fibrotic efficacy compared to engaging only one of these targets. The proposed study will also explore a novel, intratracheal inhalational drug delivery system in the IPF model as a way to improve target cell engagement while reducing the exposure of off-target tissues. In case of favorable outcomes, the Collaborator is committed to further develop the successful compound for clinical testing by developing an effective oral formulation and conducting IND-enabling ADMET studies. | ||||||||||||||||||
53 | 2019 | 2019 | C-066-2019-0 | M | Preclinical Evaluation of Kymera Therapeutics, Inc.’s Proprietary Small Molecule Interleukin-1 Receptor-associated Kinase 4 (IRAK4) Degraders for Efficacy in Lymphoid Malignancies | Active | Jun 6, 2019 | 0 | 2019 | NCI | Kymera Therapeutics, Inc. | Under a Materials Cooperative Research and Development Agreement, the National Cancer Institute will conduct a preclinical study of Kymera Therapeutics, Inc.’s proprietary small molecule interleukin-1 receptor-associated kinase 4 (IRAK4) degraders, using in vitro and in vivo experiments. | ||||||||||||||||||
54 | 2019 | 0 | C-067-2019-0 | S | Use of Loxo Oncology’s Anti-Cancer Agent LOXO-292, a RET inhibitor, in NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) Clinical Trial | Pending-SCR Scheduled | 00/00/00 | 0 | 2019 | NCI | Loxo Oncology, Inc. | Loxo Oncology, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which Loxo Oncology, Inc. will provide LOXO-292 to support the NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) Clinical Trial. | ||||||||||||||||||
55 | 2018 | 2017 | C-033-2018-0 | M | Identification of small molecules for reversion of cellular aging defects | Non-Active | Dec 25, 2017 | 12 | 2018 | NCI | Astellas Japan | Under this Materials Cooperative Research and Development Agreement (M-CRADA), the National Cancer Institute will screen the Astellas Pharma Inc. compound library to identify small molecules that revert the aging defects in Hutchinson-Gilford Progeria Syndrome (HGPS). | ||||||||||||||||||
56 | 2018 | 2018 | C-034-2018-0 | S | A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients (ASPIRO) | Active | Feb 17, 2018 | 0 | 2018 | NINDS | Audentes Therapeutics, Inc. | The National Institute of Neurological Disorders and Stroke (NINDS), an institute of the National Institutes of Health (NIH) part of the U.S. Department of Health and Human Services is collaborating with Audentes Therapeutics, Inc. as one site in a multi-site clinical trial, entitled “A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients (ASPIRO)”. | ||||||||||||||||||
57 | 2018 | 2018 | C-035-2018-0 | M | Preclinical Studies of the Effects of Targeting the RANK/RANKL Signaling Pathway, using Amgen’s proprietary mu-RANK-Fc recombinant fusion protein, on the development of ovarian cancer. | Active | Jan 28, 2018 | 0 | 2018 | NCI | Amgen, Inc. | Under the terms of a Materials Cooperative Research and Development Agreement (MCRADA), Amgen, Inc. and the National Cancer Institute (NCI) will conduct a preclinical study of the effects of pharmacological inhibition of the RANK/RANKL signaling pathway on the development of ovarian cancer, with Amgen, Inc.’s proprietary agent, mu-RANK-Fc recombinant fusion protein, in NCI’s genetically engineered mouse models of ovarian cancer. | ||||||||||||||||||
58 | 2018 | 2018 | C-036-2018-0 | S | Development and Validation of P2Y14 antagonists to treat inflammation | Active | Mar 5, 2018 | 0 | 2018 | NIDDK | Kantum Diagnostics, Inc. | The Breton laboratory at MGH/Partners has discovered that activation of the P2Y14 receptor, present in renal collecting duct intercalated cells (ICs), induces the recruitment of pro-inflammatory immune cells into the kidney 1. Kantum has signed a licensing agreement with Partners Healthcare on the use of P2Y14 antagonists to treat renal inflammation. Following a trauma (e.g. cardiac surgery, sepsis, myocardial infarction), the molecule UDP-glucose (UDP-G) is released from injured cells into systemic circulation where it is then filtered and concentrated in the kidneys. Urinary UDP-G, a P2Y14 receptor agonist, binds the receptor on the luminal surface of ICs to up-regulate the production and secretion of chemokines that attract pro-inflammatory immune cells, primarily neutrophils and monocytes 1. This infiltration of immune cells into the kidneys creates an intense inflammation reaction that causes renal injury 2-4. The P2Y14 receptor is expressed in several tissues and cells, including human neutrophils and lung, and UDP-G promotes P2Y14 receptor-mediated neutrophil motility 5-7. In addition, P2Y14 receptor antagonists reduce lung inflammation 6,8. Therefore, while the current agreement is directly related to renal inflammation, there is potential for extending the use of P2Y14 antagonists for the treatment of inflammation in other conditions, including sepsis and lung inflammation. | ||||||||||||||||||
59 | 2018 | 2018 | C-037-2018-0 | S | Cooperative Research and Development Agreement for the Development of T cell Therapy Using Neoantigen Reactive T Cell Receptors Retrovirally Transduced into Autologous Peripheral Blood Lymphocytes | Active | Mar 9, 2018 | 0 | 2018 | NCI | Kite Pharma | Under this Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and Kite Pharma Inc. will generate proof-of-concept data for personalized neo-antigen T cell receptor (neoAgTCR)-engineered autologous T-cell therapy using retroviral insertion of genes encoding neoAg-specific TCRs, and using autologous engineered T cells. A streamlined, high-throughput process for neoAgTCR isolation from various sources, including peripheral blood, will be developed jointly. The safety and efficacy of adoptive cell therapy (ACT) thatuses KRAS mutation targeting TCRs in patients with KRAS mutant tumors also will be evaluated. | ||||||||||||||||||
60 | 2018 | 2018 | C-038-2018-0 | S | Evaluation of Intrexon Corporation’s Proprietary Cytokine Expressing Adenovectors and Proprietary Vaccines | Active | Feb 28, 2018 | 0 | 2018 | NCI | Intrexon Corporation | Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and Intrexon Corporation (Intrexon) will collaborate to evaluate Intrexon’s proprietary cytokine-expressing adenovectors and Intrexon’s proprietary vaccines, as single agents and in combination therapies, in preclinical and clinical studies for the treatment of cancer. | ||||||||||||||||||
61 | 2018 | 2018 | C-039-2018-0 | S | Gene Editing in Sickle Cell Disease | Active | Jun 8, 2018 | 0 | 2018 | NHLBI | MaxCyte | Mutations in specific genes have now been identified for many inherited hematological diseases. Although allogeneic stem cell transplant is potential curative, there are significant associated risks and many patients do not have appropriate donors. Ex vivo gene therapy using viral vector transduced CD34+ hematopoietic stem cells (HSCs) provides clinical benefit for some diseases. However, vector-related genotoxicity, protein expression and function associated with this integrating vector gene therapy indicates alternate approaches be evaluated. Recent advances in targeted gene editing tools appear promising in achieving genetic manipulations at specific genomic sites. MaxCyte, Inc., and the National Heart, Lung, and Blood Institute have entered into a Cooperative Research and Development Agreement (CRADA). The objective of the CRADA is to undertake collaborative pre-clinical development of gene-corrected autologous CD34+ HSC as potential treatment for sickle cell disease (SCD); wherein the mutation in β-globin (HBB) gene locus is reverted back to wild type sequence, thereby restoring endogenous protein expression and red blood cell function. | ||||||||||||||||||
62 | 2018 | 2018 | C-040-2018-0 | S | Clinical and Non-Clinical Studies with Chimeric Monoclonal Antibody to the Disialoganglioside (GD2-Antigen) Ch14.18 (Dinutuximab) | Active | Mar 9, 2018 | 0 | 2018 | NCI | United Therapeutics Corporation | The National Cancer Institute (NCI) and United Therapeutics Corporation (UTC) will Continue to collaborate under a Cooperative Research and Development Agreement on clinical and non-clinical studies using Chimeric Monoclonal Antibody (Ch14.18) to the Disialoganglioside (GD2-Antigen) also known as dinutuximab. The NCI and UTC will also continue to conduct late-stage clinical trials of Ch14.18 as a treatment in children with high-risk neuroblastoma and in patients with recurrent neuroblastoma, osteosarcoma or other tumors. | ||||||||||||||||||
63 | 2018 | 2018 | C-041-2018-0 | S | The Clinical Evaluation of Peloton Therapeutics’ Hypoxia Inducible Factor – 2 Alpha (HIF-2α) Inhibitor PT2977 in von Hippel-Lindau (VHL) Disease | Active | Mar 15, 2018 | 0 | 2018 | NCI | Peloton Therapeutics, Inc. | Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and Peloton Therapeutics, Inc. (Peloton), will collaborate on the development of Peloton’s proprietary, small molecule hypoxia inducible factor – 2 alpha factor (HIF-2α) inhibitor PT2977 for the treatment of von Hippel-Lindau (VHL) disease. | ||||||||||||||||||
64 | 2018 | 2018 | C-042-2018-0 | M | Brain Tumor Trials Collaborative (BTTC) Study 09-01: Clinical Evaluation of Bayer HealthCare Pharmaceuticals Inc.’s Proprietary Small Molecule Sorafenib | Active | Feb 27, 2018 | 0 | 2018 | NCI | Bayer HealthCare Pharmaceuticals, Inc. | Under this Materials-Cooperative Research and Development Agreement (M-CRADA), Bayer HealthCare Pharmaceuticals Inc.’s drug Sorafenib will be evaluated by the National Cancer Institute through conducting a clinical protocol entitled “A Phase I-II Trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas” (Bayer Study Number: IIR-US-2008-178). | ||||||||||||||||||
65 | 2018 | 2018 | C-043-2018-0 | S | Development of Integrative Standardized Workflows Utilizing Cryo Fluorescence Light Microscopy and Electron Microscopy (cryo-CLEM) Methods for Imaging Cells and Molecules at Near-Native Conditions Using Zeiss’ cryo-CLEM Hardware and Software for its Airyscan LSM 710 Confocal Laser Scanning Microscope | Active | Apr 24, 2018 | 0 | 2018 | NCI | Carl Zeiss Microscopy GmbH | The National Cancer Institute (NCI) and Carl Zeiss Microscopy LLC have entered into a Cooperative Research and Development Agreement (CRADA) to develop workflows and standard operating procedures (SOPs) using Zeiss proprietary software and hardware for cryogenic correlative light and electron microscopy (cryo-CLEM) in order to correlatively image biological specimens, such as HIV virus particles, by cryo-fluorescence light microscopy (LM), followed by 3D electron microscopy (EM) at cryogenic or room temperatures with alignment of the resulting images. The CRADA work will be performed at the Center for Molecular Microscopy (CMM), an organization developed through a collaboration between the NCI’s Center for Cancer Research (CCR) and the Frederick National Laboratory for Cancer Research (FNLCR). | ||||||||||||||||||
66 | 2018 | 2018 | C-044-2018-0 | S | Clinical Development of EMD Serono Research & Development Institute, Inc.’s M3814, an inhibitor of DNA-dependent Protein Kinase Catalytic Subunit (DNA-PKcs), as an Anti-Cancer Agent | Active | Apr 2, 2018 | 0 | 2018 | NCI | EMD Serono Research & Development Institute, Inc. | EMD Serono Research & Development Institute, Inc., a U.S. affiliate of Merck KGaA, Darmstadt, Germany, and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of M3814, an inhibitor of DNA-dependent Protein Kinase Catalytic Subunit (DNA-PKcs), as an Anti-Cancer Agent. | ||||||||||||||||||
67 | 2018 | 2018 | C-045-2018-0 | S | Evaluation of Celgene Corporation’s Marizomib, a Proteasome Inhibitor, for the Treatment of Ependymoma | Active | Apr 16, 2018 | 0 | 2018 | NCI | Celgene Corp. | Under a Cooperative Research and Development Agreement (CRADA), NCI will evaluate Collaborator’s proprietary proteasome inhibitor, Marizomib, through conducting a clinical protocol entitled “Phase II Clinical Trial of Marizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma.” This study is being conducted at the NIH Clinical Center. This research may have implications for the treatment of ependymomas. | ||||||||||||||||||
68 | 2018 | 2018 | C-046-2018-0 | S | Eltrombopag for patients with Fanconi anemia | Active | May 24, 2018 | 0 | 2018 | NHLBI | Novartis Pharmaceutical Corporation | The National Heart Lung and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and Novartis will perform collaborative research under a Cooperative Research and Development Agreement. NHLBI will conduct a clinical study to evaluate the safety and efficacy of Novartis’s eltrombopag in patients diagnosed with a bone marrow failure due to Fanconi anemia (FA). FA is a rare genetic disease that often presents as a bone marrow failure syndrome (BMFS) but also can affect any other organ. Therapy using male hormones (androgens) may temporarily improve the blood production in FA patients but is associated with substantial side effects that often leads to termination of the therapy. Hematopoietic stem cell (HSC) transplantation outcomes have significantly improved over the past two decades, donor availability, graft failure, and FA-specific transplant toxicities are still significant hurdles towards a curative treatment for all FA-associated BMFS. Moreover, attempts at genetic correction of FA are not yet ready for patient care. Recent clinical studies by NHLBI had shown that the thrombopoietin (TPO) mimetic eltrombopag is effective in restoring tri-lineage hematopoiesis in patients with treatment refractory acquired severe aplastic anemia (SAA). Of interest for patients with FA is the observation that eltrombopag also improves the repair of double strand DNA breaks, a mechanism that is impaired in patients with FA. Additionally, NHLBI’s pre-clinical studies indicate that eltrombopag evades INF-γ blockade of signal transduction from the TPO receptor (c-MPL) resulting in improved survival and proliferation of HSCs. Based on these clinical and pre-clinical studies, we designed a clinical trial investigating the potential positive effect of eltrombopag for morbidity and mortality in FA patients. The goal of the collaboration is to develop a more effective treatment for FA associated BMFS and thus to improve the long-term outcome for patients with FA. | ||||||||||||||||||
69 | 2018 | 2018 | C-047-2018-0 | S | Development of T Cell Receptors (TCRs) for Recombinant TCR-based Gene Therapy of Cancer | Active | Apr 10, 2018 | 0 | 2018 | NCI | Lentigen Corporation | The National Cancer Institute and Lentigen Technology, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to discover anddevelopT-cell receptors(TCRs) targeting tumor antigen PRAME for recombinant TCR-based gene therapy of cancer. PRAME is differentially expressed in a variety of pediatric cancers,including neuroblastoma, Ewing’ssarcoma and rhabdomyosarcoma, and is also highly expressed in melanoma, ovarian and small cell lung cancers, making it an attractive pan cancer target. | ||||||||||||||||||
70 | 2018 | 2018 | C-048-2018-0 | S | Use of Kymab Ltd's proprietary Kymouse humanized mouse model to evaluate NIAID's proprietary influenza hemagglutinin stem immunogens | Active | Apr 30, 2018 | 0 | 2018 | NIAID | Kymab Ltd | In an effort to develop influenza vaccines that may prevent pandemics or improve protection against epidemics, the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (VRC, NIAID) has developed recombinant protein vaccines that express the relatively conserved region of influenza surface protein hemagglutinin (HA) known as the stem. Antibodies that bind to the HA stem have greater breadth to bind multiple different influenza virus strains, but because the HA head is immunodominant, stem-directed antibodies are much less abundant than strain-specific HA head antibodies after influenza infection or immunization in humans. Recently, stem-directed broadly-neutralizing antibodies (bnAbs) have been identified in human sera. Work performed by VRC scientists using HA strain-specific B cell probes to perform single cell sorting on human peripheral blood mononuclear cells (PBMCs) and then carry out RT-PCR and sequence paired heavy and light chain variable regions from HA-specific B cells has revealed the presence of memory B cells expressing such stem-directed B cell receptors. Several multi-donor classes of B cell variable heavy and light chain alleles have been identified that are associated with production of these stem-directed antibody responses. These variable heavy chain (Vh) genes are not found in standard animal models of influenza (mice, ferrets, non-human primates). In research conducted by NIAID and Kymab Ltd under a Cooperative Research and Development Agreement (CRADA), scientists will immunize the Kymouse (as performed at Kymab Ltd, Cambridge, UK), which expresses an antibody repertoire generated from human antibody heavy and light chain variable gene segments, to assess the potency and breadth of immunogenicity induced by influenza immunogens, including inactivated vaccines and VRC-produced hemagglutinin stem-only immunogens. | ||||||||||||||||||
71 | 2018 | 2018 | C-049-2018-0 | S | Preclinical Development of Gene Therapy for Niemann-Pick Disease Type C | Active | Apr 23, 2018 | 0 | 2018 | NHGRI | StrideBio, Inc. | National Human Genome Research Institute (NHGRI) and StrideBio (Collaborator) have entered into a Cooperative Research and Development Agreement (CRADA) to conduct a pre-clinical study to evaluate potential gene therapy to treat Niemann-Pick Disease, Type C, a potentiallydevastating rare disease with frequent pediatric onset. | ||||||||||||||||||
72 | 2018 | 2016 | C-050-2018-0 | S | Development of cGMP grade virus-like particles (VLPs) containing premembrane/membrane and envelope (prME) proteins as antigenic components for a vaccine to prevent Zika viral infection | Non-Active | Jul 27, 2016 | 0 | 2018 | CDC | PaxVax, Inc. | The Centers for Disease Control and Prevention and PaxVax, Inc., have entered into a Cooperative Research and Development Agreement to evaluate the feasibility of combining the CDC cell-based Zika virus-like particle (VLP) vaccine platform with the PaxVax biologics manufacturing, regulatory, and clinical trial expertise for the development of a Zika VLP vaccine. | ||||||||||||||||||
73 | 2018 | 2018 | C-051-2018-0 | S | Assess Merck’s proprietary drug Pembrolizumab for Safety in HIV-infected Patients | Active | May 10, 2018 | 0 | 2018 | CC | Merck Sharpe & Dohme Corp | This Cooperative Research and Development Agreement between the National Institutes of Health Clinical Center and Merck Sharp & Dohme Corp is to assess, under an approved protocol, the safety and immunologic effects of Merck's proprietary drug, Pembrolizumab, a humanized monoclonal antibody that binds with high affinity to the T-cell receptor PD-1, in subjects with HIV-1 infection. | ||||||||||||||||||
74 | 2018 | 2017 | C-052-2018-0 | S | Clinical-scale cell engineering process for ex vivo gene correction in autologous CD34+ hematopoietic stem cells for treatment of hereditary diseases using MaxCyte, Inc.'s proprietary electroporation system | Active | Jun 5, 2017 | 0 | 2018 | NIAID | MaxCyte | Many hereditary diseases are caused by mutations in key genes that lead to disruption of certain biological functions that results in disease. Correcting for these mutations in the relevant genes therefore provides a means for clinically managing disease and potentially developing 'cures'. Maxcyte, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID) have entered into a Cooperative Research and development Agreement (CRADA). The objective of the CRADA is to develop a clinical-scale, regulatory and cGMP compliant, ex vivo cell engineering process to safely and precisely correct mutations in functionally relevant genes in patient derived CD34+ hematopoietic stem cells (HSC) and to evaluate the gene-corrected HSC as cell therapy product for treatment of hereditary diseases. The hypothesis will be tested using Chronic Granulomatous Disease (CGD) as a model of hereditary disease. CGD is a group of hereditary diseases in which phagocytes do not produce reactive oxygen compounds (most importantly, the superoxide radical) used to kill certain pathogens. CGD affects about 1 in 200,000 people in the United States, with about 20 new cases diagnosed each year. Management of CGD involves early diagnosis, patient education and antibiotics for prophylaxis and treatment of infections. The morbidity of recurrent infections and inflammation is a major issue, with rates of infection around 0.3 per year. There are multiple known gene mutations that have been validated to correlate with lack of oxidase function leading to disease status. Replacing these defective genes therefore provides a means for clinically managing disease and potentially developing 'cures'. This has been validated clinically, as HSC transplantation from a matched donor is curative, but HSC transplantation has significant associated risks (graft rejection, graft-versus-host disease, potential need for long-term immunosuppression, chemo-therapy related toxicities, safety concerns with mobilization and harvest of HSC from normal healthy volunteer matched donor) and is limited by availability of matched donors. | ||||||||||||||||||
75 | 2018 | 2018 | C-053-2018-0 | M | Conjugation of Apolipoprotein Mimetic Peptides to Albumin | Non-Active | May 8, 2018 | 0 | 2018 | NHLBI | Albumedix Ltd | Among the key features that make albumin-like antibodies effective therapeutic agents is their long half-life, which has been determined to be the result of their binding to neonatal-Fc receptors and endosomal recycling. In contrast, small synthetic peptides have limited utility as therapeutic agents, as they usually have limited potency and efficacy, and their small size and lack of significant secondary structure make them labile to proteases, and subsequent rapid renal clearance. NHLBI and Collaborator propose to investigate a putative strategy for making small synthetic peptides a viable alternative to albumin-like antibodies, by covalently or non-covalently attaching these peptides to modified albumin species, which may increase their effectiveness as therapeutic agents. | ||||||||||||||||||
76 | 2018 | 2018 | C-054-2018-0 | S | Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents | Active | Aug 23, 2018 | 0 | 2018 | NIDDK | Gilead Sciences, Inc. | The goal of the study is to describe the natural history of viral eradication following treatment with direct acting antiviral agents, and to identify predictors of adverse outcomes after sustained viral eradication and regression of fibrosis/cirrhosis. | ||||||||||||||||||
77 | 2018 | 2018 | C-055-2018-0 | S | Development of an Allogeneic iPSC-derived RPE Cell Therapy for Macular Degeneration | Active | May 18, 2018 | 0 | 2018 | NEI | Healios K.K. | The primary goal of this Cooperative Research and Development Agreements (CRADA) is to test the Collaborator’s proprietary Allogeneic Good Manufacturing Practice (GMP)- induced pluripotent stem cell (iPSC), Master Cell Bank in combination with NEI’s retinal pigment epithelium (RPE) differentiation protocols to determine if the RPE produced can form the basis to treat progressive retinal degenerative disease in patients with age-related macular degeneration. | ||||||||||||||||||
78 | 2018 | 2018 | C-056-2018-0 | S | Pre-clinical Development of Azonafide-based Antibody Drug Conjugates | Active | May 2, 2018 | 0 | 2018 | NCI | Oncolinx, Inc. | Oncolinx and the National Cancer Institute have entered into a Cooperative Research and Development Agreement to develop antibody drug conjugates based on NCI’s proprietary azonafide toxins and Oncolinx's expertise in antibody drug conjugates. | ||||||||||||||||||
79 | 2018 | 2018 | C-057-2018-0 | S | The use of Sanofi US Services Inc's Proprietary Protein Expression and Purification ("PEPP") System, Modular Immune In vitro Construct ("MIMIC") Platform, for the Evaluation and Development of NIAID's Proprietary HIV Vaccine Candidates | Active | May 21, 2018 | 0 | 2018 | NIAID | Sanofi US Services Inc. | The National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID, NIH), has developed experimental protein vaccines against HIV, influenza, and other diseases. Sanofi has created an automated protein expression and purification system (PEPP) and a fully autologous human cell-based MIMIC (Modular IMmune In vitro Construct) platform which enables the evaluation of innate and adaptive immunity in vitro, including naYve and recall responses. NIAID and Sanofi have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate NIAID vaccine candidates for HIV with Sanofi's PEPP and MIMIC platform systems. | ||||||||||||||||||
80 | 2018 | 2018 | C-058-2018-0 | M | Assessment of Brain Metabolic Changes after Exposure to Investigational Compounds | Active | May 1, 2018 | 0 | 2018 | NIDA | AstraZeneca Limited UK | The Biobehavioral Imaging and Molecular Neuropsychopharmacology (BIMN) Unit of the National Institute on Drug Abuse will conduct a research study under a Materials Cooperative Research and Development Agreement including studies in experimental animals to assess brain metabolic changes after exposure to investigational compounds. | ||||||||||||||||||
81 | 2018 | 2018 | C-059-2018-0 | S | The use of Kymab Ltd's Proprietary platform technology for Immunizations to elicit fusion peptide-directed HIV-1 Tier-2 neutralizing antibodies | Active | May 31, 2018 | 0 | 2018 | NIAID | Kymab Ltd | A central goal of HIV-1-vaccine development is to elicit antibodies capable of neutra1izing diverse tier-2 strains of HIV-1 through vaccination. The envelope (Env) glycoprotein of HIV-1 is the only viral component exposed on the viral surface, and thus the only viral target of neutralizing antibodies. The IC (Kwong laboratory) recently identified a naturally occurring antibody, VRC34 (Kong et al. Science 2016), which targeted the N-terminal 8 residues of the fusion peptide, an essential component of the HIV-I entry machinery. When conjugated to various carrier proteins, including keyhole limpet hemocyanin (KLH), the N-terminal residues of the fusion peptide can elicit antibodies capable of neutralizing select tier-2 isolates from diverse HIV-I clades. An optimized immunization schedule in wild type mice elicited murine serum responses capable of neutralizing an estimated 30% of tier-2 HIV-I strains from clades A, B and C. This research conducted by the National Institute of Allergy and Infectious Diseases (NIAID) and Kymab Limited under a Cooperative Research and Development Agreement (CRADA) will use the optimized immunization schedule in the Kymouse (as performed at Kymab Ltd, Cambridge, UK) to see if similar antibodies can be elicited with human germline genes. | ||||||||||||||||||
82 | 2018 | 0 | C-060-2018-0 | S | KSS Testing No Real CRADA record | Withdrawn | 00/00/00 | 0 | 2018 | OTT | ||||||||||||||||||||
83 | 2018 | 2018 | C-061-2018-0 | S | A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis (Gilead reference number GS-US-432-4097) | Active | Jul 20, 2018 | 0 | 2018 | NEI | Gilead Sciences, Inc. | The National Eye Institute (NEI) and Gilead Sciences, Inc., (Gilead) are collaborating under a Cooperative Research and Development Agreement to evaluate the efficacy and safety of Gilead’s investigational drug, Filgotinib, for the treatment of non-infectious uveitis. NEI is one of many clinical sites participating in the multicenter, Phase 2 study. | ||||||||||||||||||
84 | 2018 | 0 | C-062-2018-0 | S | S48168 (ARM 210) for the Treatment of Ryanodine Receptor type 1 Related Myopathies (RYR1-RM) | Withdrawn | 00/00/00 | 0 | 2018 | NINR | ARMGO Pharma, Inc. | The National Institute of Nursing Research (NINR), part of the National Institutes of Health (NIH) and ARMGO Pharma, Inc. (Collaborator), have entered into a Cooperative Research and Development Agreement (CRADA) to study the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of S48168 (also known as ARM210) in an exploratory Phase Ib trial. | ||||||||||||||||||
85 | 2018 | 2018 | C-063-2018-0 | S | Clinical Development of GlycoMimetics, Inc.’s GMI-1271, an E-selectin Antagonist, as an Anti-Cancer Agent | Active | May 24, 2018 | 0 | 2018 | NCI | GlycoMimetics, Inc. | GlycoMimetics, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the non-clinical and clinical development of uprolesan (GMI-1271), a proprietary small-molecule designed by GlycoMimetics to selectively block E-selectin (an adhesion molecule on cells in the bone marrow) as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance, as an anti-cancer agent. As part of the CRADA, GlycoMimetics will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled, clinical trial testing the addition of uprolesan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated acute myelogenous leukemia (AML) who are suitable for intensive chemotherapy. This Phase 3 trial will be led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, and the primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study. Under the terms of the CRADA, the NCI may also fund additional research, including clinical trials involving pediatric patients with AML as well as preclinical experiments and clinical trials evaluating alternative chemotherapy combinations. | ||||||||||||||||||
86 | 2018 | 2015 | C-064-2018-0 | M | Live Attenuated Influenza Vaccine (LAIV) Candidate Viruses Utilizing Chimeric Hemagglutinin (HA) Constructs | Non-Active | Apr 23, 2015 | 0 | 2018 | CDC | Icahn School of Medicine at Mount Sinai | The Centers for Disease Control and Prevention (CDC) and the Icahn School of Medicine at Mount Sinai (Mt. Sinai) wish to collaborate to develop a “universal” influenza vaccine candidate. CDC has established a GLP-compliant laboratory facility for the production of live attenuated influenza vaccine (LAIV) virus candidates based on the cold-adapted attenuated donor viruses. Mt. Sinai will provide reverse genetics plasmids required to rescue a LAIV composed of the LAIV backbone gene segments (PB2, PB1, PA, NP, M, NS) with the surface protein coding gene segments designed to encode a chimeric hemagglutinin protein and a contemporary N1 neuraminidase in order to analyze its potential in “universal” influenza vaccine strategies. | ||||||||||||||||||
87 | 2018 | 2016 | C-065-2018-0 | S | Development of a safe and effective inactivated and recombinant live attenuated vaccine candidates against Zika virus | Active | Dec 20, 2016 | 12 | 2018 | CDC | Takeda Vaccines | The Centers for Disease Control and Prevention (CDC) and Takeda Vaccines have entered into a Cooperative Research and Development Agreement (CRADA) to primarily develop a safe and effective inactivated vaccine candidate against Zika virus, and secondarily create a recombinant live-attenuated vaccine candidate against Zika virus. | ||||||||||||||||||
88 | 2018 | 2018 | C-066-2018-0 | S | Manipulating ghrelin signaling via GOAT inhibition in alcohol use disorder | Active | Jun 12, 2018 | 0 | 2018 | NIAAA | GLWL Research, Inc. | Ghrelin is a 28-amino acid stomach-derived peptide which has been implicated in a myriad ofmetabolic, cognitive and behavioral physiological and pathological processes. In its acylatedform (acyl-ghrelin), this hormone is implicated in regulating appetite, meal initiation, food intake and food reward. Ghrelin activity is dependent on the enzyme ghrelin-0-acyltransferase (GOAT) which is capable of the acylation of ghrelin. Growing research in rodents and humans suggest that ghrelin may play a role in the mechanisms that regulate alcohol-seeking behaviors. Therefore, pharmacological manipulations of the ghrelin system may represent innovative approaches towards the development of new treatments for alcohol use disorder. The goal of this CRADA is to conduct an initial proof-of-concept double-blind placebo-controlled human laboratory study to test the effects of GOAT inhibition in individuals with alcohol use disorder. | ||||||||||||||||||
89 | 2018 | 2018 | C-067-2018-0 | S | Use of Kymab Ltd's proprietary Kymouse humanized mouse model to evaluate NIAID's proprietary RSV F (DS-Cavl) stabilized in the prefusion conformation | Active | Jul 4, 2018 | 0 | 2018 | NIAID | Kymab Ltd | |||||||||||||||||||
90 | 2018 | 2018 | C-068-2018-0 | S | Imaging biomarkers in a 3D-printed skin carcinoma Platform for drug discovery | Active | Aug 16, 2018 | 0 | 2018 | NCATS | The Rockefeller University | More than 90% of the drugs that enter clinical evaluation fail to reach approval because of lack of efficacy or unexpected toxicity. This failure rate in is large part due to the use of overly simplistic in vitro cell-based assays and animal models with limited predictive value. As knowledge of cellular processes in humans and research technologies have improved, it has become more apparent that the complexity of the cellular pathways, disease relevant cellular backgrounds, cell-cell interactions, and cellular- microenvironment interactions in the tissues are critical for the understanding of drug efficacy and toxicity in humans, and are considerations that need to be integrated into the future drug discovery in vitro cell-based assays. If accurate tissue constructs could be made inexpensively, drug development and discovery could be much easier since they could be more standardized, less costly, and more ethical than the animal models that they would reduce or replace. A challenge to the development of tissue constructs is the lack of an effective noninvasive assay that is capable to monitor cellular anatomy and physiology. Developing such a diagnostic technology would offer an advantage similar to that of machine vision in assembly line production. Quality control in development of tissue constructs to mimic biology is currently achieved through invasive histology, so automated 3D analysis based on noninvasive confocal imaging could not only improve drug efficacy testing but also improve the ability to construct anatomically and physiologically realistic tissue constructs. The Scope of this CRADA is to develop a non-destructive, high throughput cytometry assay platform for drug discovery using trimodal confocal images of novel, 3D printed skin carcinoma construct. | ||||||||||||||||||
91 | 2018 | 2018 | C-069-2018-0 | M | Study of oxytocin receptors in human fat cells | Active | Jun 20, 2018 | 0 | 2018 | NIDDK | GlaxoSmithKline LLC | The IC Investigator will use the highly selective Oxytocin (OT) receptor antagonist retosiban for a very limited in vitro study. In previous work this Investigator found that oxytocin can stimulate glucose uptake in a human skeletal muscle cell line. In this follow-on research, the Investigator intends to use retosiban to confirm that this effect is mediated by OT receptors | ||||||||||||||||||
92 | 2018 | 2018 | C-070-2018-0 | M | Clinical Evaluation of Novartis Pharmaceuticals Corporation’s Proprietary Small Molecule Everolimus in Combination with Bayer HealthCare Pharmaceuticals, Inc.’s Proprietary Small Molecule Sorafenib for the Treatment of Gliomas | Active | Jun 27, 2018 | 0 | 2018 | NCI | Novartis Pharmaceutical Corporation | Under this Materials-Cooperative Research and Development Agreement, Novartis Pharmaceuticals Corporation’s Everolimus will be evaluated through conducting a clinical protocol entitled “A Phase I-II Trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas”. | ||||||||||||||||||
93 | 2018 | 2018 | C-071-2018-0 | S | A study to evaluate the efficacy of Incyte's proprietary tyrosine kinase inhibitor, ruxolitinib, in reducing eosinophilia in patients with myeloid and/or steroid-refractory hypereosinophilic syndrome | Active | Jul 12, 2018 | 0 | 2018 | NIAID | Incyte Corporation | Under a Cooperative Research and Development Agreement (CRADA) the National Institute of Allergy and Infectious Diseases (NIAID) and Incyte Corporation will study the efficacy of the tyrosine kinase inhibitor, ruxolitinib, in reducing eosinophilia in patients with myeloid and/or steroid-refractory hypereosinophilic syndrome. Ruxolitinib is a tyrosine kinase inhibitor that selectively inhibits Janus associated kinases (JAK) 1 and 2. JAK2 V617F mutation or the PCMJJAK2 translocation have been described in a small subset of patients with HES. NIAID has previously identified JAK l or 2 mutations in 7 subjects on a natural history protocol. Recent findings suggest that ruxolitinib might be effective in a subset of patients with myeloid and/or lymphocytic variant HES. The goal of this CRADA is to determine the efficacy of tyrosine kinase inhibition in reducing eosinophilia in patients with myeloid and/or steroid-refractory hypereosinophilic syndrome. The scope of this CRADA, is the clinical trial conducted by Dr. Klion and members of Dr. Klion' s team, and is strictly limited to the investigation of hypereosinophilic syndromes using Incyte's proprietary drug, ruxolitinib. | ||||||||||||||||||
94 | 2018 | 2018 | C-072-2018-0 | S | Assay Development and High Throughput Screening to Identify Inhibitors of Chorismate Mutase | Active | Jun 26, 2018 | 0 | 2018 | NCATS | Primetime Life Sciences, LLC | This project seeks to develop a quantitative high throughput screening (qHTS) assay for the identification of small molecule inhibitors of chorismate mutase (CM). CM is an important enzyme found in plants and microorganisms required for the biosynthesis of the aromatic amino acids phenylalanine and tyrosine. Mammals cannot carry out the de novo biosynthesis of aromatic amino acids and must rely on dietary sources. Thus, a potent and selective drug-like inhibitor of CM would be a valuable antimicrobial agent, particularly for antimicrobial resistant infections. | ||||||||||||||||||
95 | 2018 | 2018 | C-073-2018-0 | M | Preclinical Evaluation of Corvus Pharmaceuticals, Inc.’s Proprietary Interleukin-2-inducible T-cell Kinase (ITK) and Janus Kinase 3 (JAK3) Inhibitors for the Treatment of Tcell Malignancies | Active | Jun 18, 2018 | 0 | 2018 | NCI | Corvus Pharmaceuticals, Inc. | Under a Materials Cooperative Research and Development Agreement, the National Cancer Institute (NCI) will conduct a preclinical evaluation of Corvus Pharmaceuticals, Inc.’s proprietary interleukin-2-inducible T-cell kinase (ITK) and Janus kinase 3 (JAK3) inhibitors for the treatment of T-cell malignancies. | ||||||||||||||||||
96 | 2018 | 2018 | C-074-2018-0 | S | Messenger RNA (mRNA) Therapies for Methylmalonic Acidemias | Active | Jul 3, 2018 | 0 | 2018 | NHGRI | Translate Bio, Inc. | National Human Genome Research Institute (NHGRI) and Translate Bio, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to conduct a study to evaluate Translate Bio’s messenger RNA (mRNA) nanoparticles to treat a rare hereditary metabolic disorder. Current treatments can eliminate many symptoms of this disease, but still have many practical limitations. This CRADA study has the potential to lead to therapy that may be able to effectively address some of the devastating effects of the disease. | ||||||||||||||||||
97 | 2018 | 2018 | C-075-2018-0 | S | Clinical Development of N-acetyl-D-mannosamine (ManNAc) to Treat GNE Myopathy | Active | Jul 17, 2018 | 0 | 2018 | NHGRI | Leadiant Biosciences, Inc | The National Human Genome Research Institute (NHGRI), the National Institute of Neurological Disorders and Stroke (NINDS), the National Insitute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), each an Institute of the National Institutes of Health, and Leadiant (Collaborator) have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate a potential drug treatment, specifically N-acetyl-Dmannosamine (ManNAc), in patients with a rare genetic disease, GNE myopathy. The work will include a clinical study (NN109) and related reseach projects in support of the study. | ||||||||||||||||||
98 | 2018 | 2018 | C-076-2018-0 | M | Development of ARV-771 and ARV-825 for Cancer Therapy | Active | Jun 25, 2018 | 0 | 2018 | NCI | Arvinas, Inc. | Under a Materials Cooperative Research and Development Agreement (M-CRADA), the National Cancer Institute will conduct preclinical studies of Arvinas, Inc.’s proprietary BET protein degraders ARV-771 and ARV-825, using in vitro and in vivo experiments. | ||||||||||||||||||
99 | 2018 | 2018 | C-077-2018-0 | M | Evaluation of Nicotinamide Riboside Chloride (NR) as an AMPKDependent Activator of Sirtuin 1 (Sirt1) Activity | Active | Jun 28, 2018 | 0 | 2018 | NHLBI | ChromaDex, Inc. | IC will use nicotinic riboside chloride (NR) supplied by Collaborator to investigate in mouse models whether or not this nutritional supplement improves mitochondrial health through a 5' adenosine monophosphate-activated protein kinase (AMPK)-dependent mechanism of stimulating sirtuin 1 (Sirt1) activity. If it is determined that there is AMPK-dependence, IC will attempt to elucidate the mechanism of this activation. | ||||||||||||||||||
100 | 2018 | 2018 | C-078-2018-0 | S | Clinical Development of Venetoclax, an Inhibitor of Bcl-2, as an Anti-Cancer Agent | Active | Aug 9, 2018 | 0 | 2018 | NCI | Genentech, Inc. | Genentech Inc., AbbVie Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute certain of Genentech’s and AbbVie’s investigational products in support of Protocols as agreed between the parties. |