All CRADAs - NIH/CDC/FDA (1985-August 2017)
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Fiscal yearCalendar Year ExecutedCRADA NumberCRADA TypeCRADA TitleStatusExecution DateICCollab Company IDAbstract
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20172016C-008-2017/0MEfficacy of AbbVie Proprietary Therapeutic Antibody in Preclinical Models of HER2+ Breast Cancer Brain MetastasisActive2016-09-23NCIAbbVieThe National Cancer Institute (NCI) will perform a comprehensive characterization of AbbVie Inc.’s (AbbVie) proprietary antibody, for the prevention of metastases in HER2+ cancers in NCI’s preclinical models of HER2+ breast cancer metastasis to the brain. The NCI will conduct mouse studies on the efficacy of AbbVie proprietary antibody alone and potentially, in combination with other therapeutic regimens to determine its ability to prevent brain metastasis.
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20172017C-018-2017/0SIdentification of high titer Epstein Barr Virus (EBV) immune globulin from human plasma and in vitro and in vivo characterization of the EBV immune globulin in collaboration with ADMAActive2017-01-30NIAIDADMA Biologics, Inc.The National Institute of Allergy and Infectious Diseases and ADMA Biologics, Inc. have entered into a Collaborative Research and Development Agreement (CRADA) to identify and generate high titer Epstein-Barr virus (EBV) immune globulin from human plasma that could be potentially developed for treatment of patients at risk for EBV lymphoproliferative disease. Persons who have not previously been infected with EBV and are immune deficient such as those receiving organ or hematopoietic stem cell transplants or those with certain congenital immune deficiencies are at risk for EBV lymphoproliferative disease which can result in fatal lymphomas. High titer EBV human immune globulin, derived from plasma of human donors can be developed further into a therapeutic that might be given to EBV seronegative immune compromised persons to reduce the risk of EBV lymphoproliferative disease.
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20172017C-042-2017/0MEvaluation of Agenus Inc.’s Heat Shock Protein-Peptide Complex-96 Vaccine (HSPPC-96) to Treat GlioblastomaActive2017-01-13NCIAgenus, Inc.Under a Materials-Cooperative Research and Development Agreement (M-CRADA), NCI will evaluate Agenus Inc.’s (Agenus) heat shock protein-peptide complex-96 vaccine (HSPPC-96) through conducting a clinical protocol entitled “ A randomized, double blind phase II trial of Radiation Therapy plus Temozolomide and Pembrolizumab with and without HSPPC-96 in newly diagnosed Glioblastoma (GBM)” (“Study”). The Study is a multi-center study that is being conducted by institutions participating in the Brain Tumor Trials Collaborative (BTTC). The Neuro-Oncology Branch of the NCI will be one of the centers conducting this Study. This research may have implications for the treatment of cancer.
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20172016C-010-2017/0SGene Therapy for the Treatment of AADC DeficiencyActive2016-11-18NCATSAgilis Biotherapeutics LLCAromatic L-amino acid decarboxylase (AADC) is the enzyme responsible for the final step in the synthesis of neurotransmitters dopamine (which is then synthesized into norepinephrine and subsequently epinephrine) and serotonin (which is then synthesized into melatonin). AADC deficiency is a rare genetic disorder arising from mutation of the DDC gene (dopa decarboxylase), and results in severe developmental failures, global muscular hypotonia and dystonia, severe, longlasting seizures known as oculo-gyric crises, frequent hospitalizations (including prolonged stays in intensive care), and the need for life-long care. Symptoms and severity vary depending on the type of underlying genetic mutation which abrogates AADC enzyme function. Patients with severe forms often die before the age of 6-7 years due to severe motor dysfunction, autonomic abnormalities, and secondary complications such as choking, hypoxia, and pneumonia. No treatment options other than palliative care currently exist for AADC patients. Gene therapy with adeno-associated virus (AAV) human AADC has been tested in patients with AADC deficiency, first under a compassionate use protocol to treat 8 subjects (early results published in Science Translational Medicine- Sci Transl Med 4, 134ra61 (2012)) and subsequently in a follow-on Phase I/II study enrolling 10 subjects. Both trials showed promising safety and efficacy results. Treated subjects show dopamine production in the striatum as visualized by FDOPA PET imaging and the accumulation of the dopamine metabolite homo-vanillic acid, whereas untreated patients do not. Treated subjects also exhibit significant gains on motor function scales (e.g. the AIMS and PDMSII) and on cognitive scales (e.g. the CDIIT). Efficacy bservations also include children being able to feed themselves, interact with caregivers, engage in physical therapy, stand and walk, and learn receptive and expressive language skills. Adverse consequences of the disease have been diminished.Agilis Biotherapeutics and TRND will work with the regulatory authorities to advance this muchneeded treatment. The collaboration between Agilis and TRND focuses on defining and filling the gap of preclinical studies needed for regulatory filings such as toxicology and biodistribution analyses and process development and manufacturing. The Agilis/TRND partnership may help bring a life-saving treatment to children with AADC deficiency in the US and around the world.
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20171900C-088-2017/0SEvaluation of Alexion's Eculizumab (Soliris) in patients with inherited CD55 deficiencyPending-IC Execution1900-11-11NIAIDAlexion Pharmaceuticals, Inc.The National Institute of Allergy and Infectious Diseases, a part of the US National Institutes of Health, and Alexion Pharmaceuticals, Inc. have entered a Cooperative research and Development Agreement to test the use of Eculizumab (Soliris) in a COSS-deficient patient population which experience significant protein loss through the gastrointestinal tract along with life-threatening thrombotic events associated with increased complement activation on the surface of host cells. This collaboration will test the use of Soliris, a complement inhibitor authorized for use in atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH), in this new patient population.
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20171900C-038-2017/0MAn investigation of the role of IL-36 in commendal-specific immunity using Amgen, Inc's proprietary IL-3R blocking antibody and two of its IL-36 based murine modelsActive1900-11-11NIAIDAmgen Inc.Under a Materials Cooperative Research and Development Agreement, the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, aims to investigate the role of the cytokine IL-36 in the promotion of cornmensal-specific immunity. This will be accompl ished by determining the i11 vivo requirement for IL-36/R signaling in the accumulation and in the function of cutaneous T cells fo llowing commensal colonization using a variety of Amgen. Inc." s proprietary I L-36 mouse lines.
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20171900C-108-2017/0MRole of OPG-Fc and/or anti-IL-6 Treatment to Prevent Fibrous Dysplasia Initiation and Progression in MicePending-IC Execution1900-11-11NIDCRAmgen Inc.FD is a disease caused by the postzygotic acquisition of the mutation GNAS R201C or R201H by bone marrow stromal cells (BMSCs). These activating mutations lead to excessive production of intracellular cyclic adenosine monophosphate (cAMP), upregulating the expression of RANKL and IL6 via PKA signaling. This increased production of RANKL and IL6 in the bone microenvironment causes increased osteoclastogenesis and resorption, which plays a key role in the establishment and expansion of the FD lesions and is associated to lesional pain. Treatment with denosumab (antibody against RANKL), tocilizumab (antibody against IL6R) and bisphosphonates reduced pain in these patients and at least denosumab caused an apparent radiographic improvement of FD lesions and even possibly lesion regression. Encouraged by the promising results of these studies, some of them based on the compassionate treatment of subject(s), the NIH believes that RANKL and IL-6 blockade has the potential to directly target all the tissue affected by FD, as the NIH hypothesizes that these proteins play an important role not only in FD progression, but also in its initiation. The NIH plans to study the effects of blocking the signaling of RANKL, IL6 or the combination of both in a transgenic mouse model. To block pathways, the NIH will use an antibody against IL6R as well as the chimeric protein OPG-Fc, developed by Amgen. The NIH will study the effect of these drugs at FD initiation, possibly pretreating the animals from developing FD lesions, and during FD progression, by treating animals after inducing the lesions. The NIH is also interested in studying the effects of the withdrawal of these treatments to assess the possibility of lesion regression.
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20172016C-004-2017/0MDevelopment of a therapeutic for leishmaniasis using Amgen, Inc's proprietary Anti-muCSF1R antibodyActive2016-10-17NIAIDAmgen Inc.Under a Materials Cooperative Research and Development Agreement, the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, aims to investigate whether selective depletion of dermal macrophages by prior treatment using Amgen's proprietary blocking antibody against Macrophage colony-stimulating factor I receptor, will induce a healing phenotype in C57BL/6 mice infected with a non-healing strain of Leishmania major. The secondary aim is to test this proprietary antibody as a treatment for active cutaneous leishmaniasis.
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20172017C-046-2017/0SAn Open Label Pilot Study of Denosumab Treatment for Fibrous DysplasiaActive2017-03-27NIDCRAmgen Inc.Amgen Inc. (“Amgen”) and the National Institute of Dental and Craniofacial Research (“NIDCR”) have entered into a Cooperative Research and Development Agreement (“CRADA”) under which Amgen will supply its proprietary compound denosumab for an NIDCR sponsored clinical trial. The study will assess if denosumab is effective at decreasing bone turnover in patients with fibrous dysplasia (FD). This is the first clinical study of the RANKL inhibitor denosumab as a potential novel therapy for FD.
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20172017C-059-2017/0SClinical Study(ies) with Formulary Agent(s) Provided by Amgen Inc.Active2017-04-26NCIAmgen Inc.Amgen Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative. Under the CRADA NCI’s DCTD will distribute Amgen Inc.’s anti-cancer agent(s) to investigators to conduct investigator-initiated clnical trials.
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20172017C-066-2017/0MIntracellular Trafficking of Iron in Mammalian CellsActive2017-04-28NIDDKAmgen Inc.
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20172017C-060-2017/0SStudy(ies) with Formulary Agent(s) Provided by AstraZeneca ABActive2017-04-19NCIAstrazenecaAstraZeneca AB and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative. Under the CRADA DCTD will distribute AstraZeneca AB’s anti-cancer agent(s) provided to the NCI Formulary to investigators to conduct investigator-initiated clnical trials.
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20171900C-107-2017/0SUse of AstraZeneca AB’s Anti-Cancer Agent(s)in Combination Clinical TrialsPending-IC Execution1900-11-11NCIAstraZeneca ABAstraZeneca AB and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on clinical studies using anti-cancer agents proprietary to AstraZeneca.
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20172017C-049-2017/0SUse of AstraZeneca AB’s Anti-Cancer Agents in NCI-MATCH (Protocol EAY131) and NCI Pediatric MATCH (Protocol APEC1621) Clinical TrialsActive2017-03-08NCIAstraZeneca ABAstraZeneca AB and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which they will collaborate on the NCI MATCH and NCI Pediatric MATCH trials.
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20172017C-019-2017/0MCXCR2i AZD5069, Anti-CXCR2 antibody 18-74-5, and CSF1Ri AZD7507Active2017-01-06NIDCDAstraZeneca Limited UKNIDCD will use multiple syngenic mouse models of oral cancer to examine mechanisms by which myeloid-derived suppressor cells (MDSCs), an immunosuppressive population, are recruited to the tumor microenvironment via the CXCR2/CXCL1-CXCL2 axis. Therapeutic blockade of MDSC recruitment via a chemokine (C-X-C motif) receptor 2 (CXCR2) inhibition strategy will also be examined as a potential way to revert immunosuppression and increase tumor rejection.
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20172017C-073-2017/0MAurora Kinase B Drives Merkel Cell Carcinoma GrowthActive2017-05-08NCIAstraZeneca Limited UKUsing a mouse xenograft model, the National Cancer Institute (NCI) will study the ability of a study drug, the aurora kinase B inhibitor, AZD2811, an accurin nanoparticle-encapsulated active metabolite of the prodrug barasertib (AZD1152), a selective inhibitor of aurora kinase B (AURKB; Aurora-B), to slow the growth of Merkel Cell Carcinoma (MCC) tumors that are either Merkel cell polyomavirus (MCPyV) positive or negative in an effort to gain an understanding of underlying pathophysiological differences between them that may help guide future treatment paradigms for patients with MCC.
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20172017C-105-2017/0MPreclinical Evaluation of AstraZeneca UK Limited’s Proprietary Small Molecule Inhibitors Vistusertib (Dual Mammalian Target of Rapamycin Complex 1/Mammalian Target of Rapamycin Complex 2 (mTORC1/mTORC2) Inhibitor) and Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) for Efficacy in Lymphoid MalignanciesActive2017-07-31NCIAstraZeneca Limited UKUnder a Materials Cooperative Research and Development Agreement, the National Cancer Institute will conduct a preclinical study of AstraZeneca UK Limited’s proprietary compounds, vistusertib (dual mammalian target of rapamycin complex 1/mammalian target of rapamycin complex 2 (mTORC1/mTORC2) inhibitor) and acalabrutinib (Bruton's tyrosine kinase (BTK) inhibitor), using in vitro and in vivo experiments
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20172016C-023-2017/0MPreclinical Evaluation of AstraZeneca UK Limited’s Proprietary Small Molecule Inhibitors AZD4320 (B-cell lymphoma 2/B-cell lymphoma-extra large (BCL2/BCL-XL) inhibitor), AZD5991 (Myeloid cell leukemia-1 (MCL-1) inhibitor), and AZ5576 (Cyclin-dependent kinase 9 (CDK9) inhibitor), for Efficacy in Lymphoid MalignanciesActive2016-12-06NCIAstraZeneca UK Limited
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20172017C-061-2017/0SA Phase IIb clinical study to evaluate the safety and efficacy of AstraZeneca’s proprietary inhibitors cediranib and olaparib in women with BRCA1/2 mutation-associated ovarian cancer and nonhigh risk serous ovarian cancerActive2017-04-23NCIAstraZeneca UK LimitedThe National Cancer Institute will collaborate with AstraZeneca Pharmaceuticals LP (AstraZeneca) to evaluate AstraZeneca’s proprietary inhibitors cediranib and olaparib for the treatment of ovarian cancer. The Parties will conduct a Phase IIb clinical study to evaluate the safety and efficacy of these inhibitors in women with BRCA1/2 mutation-associated ovarian cancer and non-high risk serous ovarian cancer and perform correlative analyses of immune system and cancer cell markers.
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20172016C-012-2017/0SA Prospective, Non-Interventional Clinical Assessment Study in X-Linked Myotubular Myopathy (XLMTM) Subjects Aged 3 Years and Younger (INCEPTUS)Active2016-12-16NINDSAudentes 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 pre-Phase 1 prospective, non‑interventional clinical assessment study in X-linked Myotubular Myopathy (XLMTM) subjects aged 3 years and younger (INCEPTUS).
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20172017C-043-2017/0SEvaluation of Avidea's synthetic, polymer-based vaccine technology, "Immunotherapeutic Nanoscaffolds" (IMNs) for infectious disease and cancer treatment in animal modelsActive2017-02-23NIAIDAvidea TechnologiesThe National Institute of Allergy and Infectious Diseases (NIAID) and Avidea Technologies (Avidea) have entered into an agreement to investigate and evaluate Avidea’s polymer-based vaccine technology, “Immunotherapeutic Nanoscaffolds” (IMNs) in preclinical animal models for infectious disease prevention and cancer treatment.
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20172016C-006-2017/0SEvaluation of the Clinical Safety, Tolerability, and Efficacy of Anetumab Ravtansine (BAY 94-9343) in Subjects Expressing Lung AdenocarcinomaActive2016-11-10NCIBayer HealthCare Pharmaceuticals, Inc.The National Cancer Institute and Bayer HealthCare Pharmaceuticals Inc. (“Bayer”) have entered into a clinical Cooperative Research and Development Agreement (CRADA) to collaborate on the evaluation of Bayer’s proprietary antimesothelin Antibody-Drug Conjugate, BAY 94-9343, as a cancer therapeutic agent.
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20172017C-095-2017/0MDevelopment and Characterization of anti-BCMA CAR-expressing T-cell Subtypes that may Provide Enhanced Anti-Tumor EfficacyActive2017-07-07NCIbluebird bioUnder a Materials Cooperative Research and Development Agreement (M-CRADA), NCI will utilize its proprietary method of inhibiting T cell differentiation in combination with bluebird bio Inc.’s lentiviral vectors to develop and characterize specific effector and memory T cell subtypes that may provide enhanced anti-tumor efficacy.
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20172017C-033-2017/0SStudies Using Bristol-Myers Squibb's Formulary Agent(s)Active2017-01-10NCIBristol-Myers SquibbBristol-Myers Squibb and NCI have entered into a Cooperative Research and Development Agreement whereby Bristol-Myers Squibb agrees to provide its proprietary agents to the NCI in support of the Cancer Moonshot Initiative, the NCI Formulary, in which NCI and Collaborator will facilitate investigator initiated and sponsored clinical trials.
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20172017C-071-2017/0SA study of the CD300 family of receptors in collaboration with Bristol Myers Squibb Company, for understanding their involvement in cancer and other inflammatory diseasesActive2017-05-25NIAIDBristol-Myers Squibb CompanyUnder a Cooperative Research and Development Agreement the National Institute of Allergy and Infectious Diseases (NIAID) and Bristol-Myers Squibb Company will study how CD300 receptors are regulating inflammation, cancer and other human diseases. NIAID has shown that CD300 receptors are directly involved in regulating the development of autoimmunity (CD300f), cancer (CD300f), inflammatory bowel disease (CD300f), and sepsis (CD300b). These studies indicate that targeting CD300 receptors is likely to have significant value for modulating immune dysfunctions in a variety of disorders, such as autoimmune diseases and cancer. The goals of this CRADA are to: (I) develop antibodies specific to mouse CD300 receptors, (2) evaluate the efficacy of the generated anti-CD300 antibodies in anti-tumor responses in mice, and (3) determine how CD300 receptors regulate antigen processing and presentation, T cell responses, cytokine production and, consequently, anti-tumor responses. The scope of the CRADA is to develop CD300 biology tools and leverage them in murine models of cancer and/or inflammatory diseases to understand CD300 immunoreceptors' role in pathogenesis of different diseases.
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20171900C-104-2017/0SClinical Development of Calithera Biosciences, Inc.’s Anti-Cancer Agent, CB-839, an Oral Inhibitor of Human GlutaminasePending-IC Execution1900-11-11NCICalithera Biosciences, Inc.Calithera 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 Collaborator’s proprietary oral inhibitor of human glutaminase, CB-839, as an anti-cancer agent.
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20172017C-050-2017/0SPhase 1/2 Study of Celgene Corporation's Proprietary Lenalidomide (CC-5013) in the Treatment of Primary Effusion Lymphoma and KSHV-associated Large Cell LymphomaActive2017-04-04NCICelgene Corp.NCI and Celgene Corporation will work together under a Cooperative Research and Development Agreement to develop Celgene Corporation’s proprietary immunomodulatory compound, lenalidomide, as a therapeutic for Primary Effusion Lymphoma and KSHVassociated large cell lymphoma.
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20172017C-067-2017/0SClinical Development of Celgene Corporation’s MEDI4736, an anti- Programmed Death-Ligand 1 (PD-L1) Monoclonal Antibody, as an Anti-Cancer Agent for Hematological CancersActive2017-05-18NCICelgene Corp.Celgene Corporation 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 Medi4736, an anti-PD-L1 inhibitor within the Immune-Mediated Therapy for Cancer (IMT-C) portfolio, as an anti-cancer agent in combination with other immunomodulatory compounds.
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20172017C-048-2017/0SEffect of Nicotinamide Riboside on Skeletal Muscle Function in Heart FailureActive2017-04-06NHLBIChromaDex, Inc.One component of heart failure progression is the development of mitochondrial bioenergetic dysfunction which effects both the heart and skeletal muscle. These skeletal muscle changes are thought to contribute towards overall fatigue, reduced exercise tolerance and inflammation in heart failure. Interestingly exercise training to improve heart failure patient activity levels, improves skeletal muscle mitochondrial capacity and inflammation. Biochemical and bioenergetic consequences of impaired mitochondrial oxidative phosphorylation leads to decreased NAD+ levels, which exacerbate mitochondrial dysfunction by inactivating the NAD+ dependent sirtuin enzymes. Experimental studies using NAD+ precursors to increase NAD+ production have been shown to normalize NADH/NAD+ ratios and activate Sirtuin enzymes, resulting in enhanced oxidative phosphorylation with beneficial effects in numerous systems including skeletal muscle and the immune system. In this study NHLBI will directly assess the effect of the NAD+ precursor, nicotinamide riboside (NR) on skeletal muscle mitochondrial oxidative phosphorylation in heart failure subjects by: skeletal muscle NMR spectroscopy assessment of the rate of high energy phosphate recovery in response to submaximal exercise; assessment of the effect of NR on functional capacity using cardiopulmonary exercise testing (CPET) to determine VO2max and anaerobic threshold; evaluation of the NR effect on serum metabolomics and inflammation at rest and in response to CPET. These studies would enable a more comprehensive assessment of the role for NR supplementation on skeletal muscle mitochondrial function and immune responses in subjects with systolic heart failure.
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20172017C-055-2017/0SDevelopment of novel D2 dopamine receptor (D2R) antagonists as cancer therapeuticsActive2017-03-30NINDSConverGeneThe Molecular Neuropharmacology Section (MNS) of the National Institute of Neurological Disorders and Stroke (NINDS) and ConverGene have entered into a Collaborative Research and Development Agreement (CRADA) to optimize and develop novel antagonists of D2 dopamine receptors (D2R). These antagonists include, but are not limited to, ConverGene’s lead molecules in the CVG-101 series. It has been shown that D2Rs are over-expressed in several types of human cancer, including ematological and pancreatic cancers, and that D2R inhibition is associated with anti-cancer activity. This work will expand the understanding of D2R pharmacology and signaling as it relates to oncology targets.
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20172017C-083-2017/0SDirect Repair of a Genetic Mutation in a Mouse Model of Glycogen Storage Disease Type Ia, Using CRISPR TechnologyActive2017-06-29NICHDCRISPR Therapeutics AGUnder this CRADA, the Eunice Kennedy Shriver National Institute Child Health and Human Development (NICHD) and CRISPR will test a method for the direct repair of site mutations in a mouse model of Glycogen Storage Disease Type Ia (GSD1a). CRISPR will provide its proprietary technology including gRNA selection and packaging into custom vector designs. NICHD will characterize the mouse model for disease progression and will perform therapy experiments. The Parties will assess direct DNA site repair as a therapeutic approach to GSD1a.
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20172017C-085-2017/0SThe study and development of mRNA vaccines and antibodies for Filoviruses preventive vaccines and therapeutics using Cure Vac's proprietary mRNA technologyActive2017-06-28NIAIDCureVac AGUnder a Cooperative Research and Development Agreement (CRADA), The National Institute of Allergy and Infectious Diseases (NIAID) and CureVac AG (CureVac) propose to design and construct messenger RNA (mRNA) vaccines expressing proteins from and monoclonal antibodies against filoviruses (Ebola and Marburg), and to evaluate their potential as preventative vaccines and therapeutics.
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20172017C-045-2017/0SDevelopment of NICHD’s Combination Copper Plus AAV Gene Therapy for Menkes DiseaseActive2017-03-13NICHDCyprium Therapeutics Inc.Under this CRADA, NICHD and Collaborator will advance an AAV-based ATP7A-targeted gene therapy for Menkes Disease alone and Copper Histidinate Injection for Menkes, each alone or in combination. The work is focused in three areas: regulatory advancement of Copper Histidinate for FDA approval, pre-clinical development of the AAV-based ATP7A-targeted gene therapy, and clinical studies of the AAV-based ATP7A-targeted gene therapy.
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20172017C-056-2017/0STranscatheter modification of the native mitral valveActive2017-04-17NHLBIEdwards Lifesciences LLCTranscatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. For these patients the only options appear to avoid TMVR or in some to cause a focused heart attack and to wait 6 weeks. NHLBI has developed and tested a technique to tear the existing mitral valve leaflet and enable TMVR in patients who have no other options. The procedure is called intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices commercially available, there has been short-term success with implanted transcatheter aortic valve devices in the mitral position for TMVR in patients. The purpose of this study is to perform and carefully study LAMPOON and TMVR in patients who have no good options to treat their mitral valve failure, using heart valve devices designed to implant in the aortic valve position. This CRADA between Edwards Lifesciences and NHLBI DIR will support a 30-subject multicenter, FDA IDE license, clinical trial of LAMPOON during TMVR in patients at risk of left ventricular outflow tract obstruction. The primary endpoint will be technical success at 30 days, and outcomes will be followed up to five years.
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20172017C-069-2017/0SClinical Evaluation of the Combination of Eleven Biotherapeutic’s Vicinium with AstraZeneca AB’s Durvalumab in Patients with High-Grade Non-Muscle-Invasive Bladder CancerActive2017-06-01NCIEleven Biotherapeutics, Inc.Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and Eleven Biotherapeutics (Eleven) will collaborate on the development of Eleven’s proprietary targeted therapeutic Vicinium, in combination with AstraZeneca AB’s (AstraZeneca) immune checkpoint inhibitor Durvalumab for the treatment of non-muscleinvasive bladder cancer.
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20172016C-013-2017/0SClinical Study(ies) with Formulary Agent(s) Provided by Eli Lilly and CompanyActive2016-12-18NCIEli Lilly and CompanyEli Lilly and Company and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative. Under the CRADA DCTD will distribute Eli Lilly’s anti-cancer agent(s) provided to the NCI Formulary to investigators to conduct investigator-initiated clnical trials.
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20172017C-072-2017/0SEvaluation of a Potential Role for Stromal Cell Platelet Derived Growth Factor Receptor Alpha (PDGFRa) in Sarcoma and Epithelial Tumor Growth and MetastasisActive2017-05-18NCIEli Lilly and CompanyUnder a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and Eli Lilly and Company (Lilly) will collaborate on a research study to determine the potential role for stromal cell platelet derived growth factor receptor alpha (PDGFRa) in sarcoma and epithelia tumor growth and metastasis.
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20172017C-076-2017/0SUse of Eli Lilly and Company’s Anti-Cancer Agent LY 3023414 in NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) Clinical TrialActive2017-06-06NCIEli Lilly and CompanyEli Lilly and Company and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute the investigational agent, LY 3023414 in support of the NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) clinical trial.
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20171900C-091-2017/0SPreclinical evaluation of National Institute on Drug Abuse’s modafinil analogs as potential treatments of substance use disordersActive1900-11-11NIDAEncepHeal Therapeutics, IncThe National Institute on Drug Abuse (NIDA) and EncepHeal Therapeutics, Inc. will conduct a research study under a Collaborative Research and Development Agreement (CRADA) to characterize NIDA’s modafnil analogs as potential treatment for substance use disorders.
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20172017C-051-2017/0SAnalysis of the Effects of EpicentRx, Inc’s Proprietary Epigenetic Agent RRx-001 on Immune Responses in Cancer PatientsActive2017-03-21NCIEpicentRx, Inc.Under a Cooperative Research and Development Agreement, the National Cancer Institute (NCI) and EpicentRx, Inc. (EpicentRx) will collaborate on a research project to evaluate cancer patients’ immune responses to treatment with EpicentRx’s proprietary epigenetic agent RRx-001. NCI will analyze patient samples from two separate combined-treatment clinical trials to evaluate: (a) effectiveness of RRx-001 in increasing the overall survival of patients with un-resectable or metastatic lung cancers, epithelial ovarian cancer, and some neuroendocrine cancers; and (b) the safety and dose limiting toxicity of RRx-001 on refractory solid tumors or lymphomas. This research could have potential future clinical implications for the treatment of cancer.
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20172016C-003-2017/0SClinical Development of Epizyme Inc.’s Pinometostat, a Histone Methyltransferase Inhibitor, as an Anti-Cancer AgentActive2016-10-28NCIEpizyme Inc.Epizyme 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 Pinometostat, a Histone Methyltransferase Inhibitor, as an anti-cancer agent.
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20172017C-037-2017/0SClinical Study(ies) with Formulary Agent(s) Provided by Genentech, Inc.Active2017-02-03NCIGenentech. Inc. (Roche)Genentech, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative, NCI Formulary. Under the CRADA DCTD will distribute Genentech, Inc.’s anti-cancer agent(s) provided to the NCI Formulary to investigators to conduct investigator-initiated clinical trials.
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20172017C-044-2017/0SUse of Genentech Inc.’s Anti-Cancer Agent vemurafenib in NCI Pediatric Molecular Analysis for Therapy Choice (MATCH) Clinical TrialActive2017-04-10NCIGenentech. Inc. (Roche)Genentech Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute the vemurafneib in support of the Pediatric MATCH trial.
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20172017C-068-2017/0SUse of Genentech Inc.’s Anti-Cancer Agent Obinutuzumab in a Clinical TrialActive2017-05-08NCIGenentech. Inc. (Roche)Genentech Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute Genentech’s Obinutuzumab in support of a Protocol.
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20172017C-030-2017/0SPreclinical evaluation of monoclonal antibodies directed against HERV-K envelope protein in cellular and animal models for HERV-K associated Amyotrophic Lateral Sclerosis (ALS)Active2017-01-30NINDSGeneuro SAUnder a Cooperative Research and Development Agreement (CRADA), the National Institute of Neurological Disorders and Stroke and GeNeuro SA will work together to test and evaluate several monoclonal antibodies against HERV-K envelope protein (Env) provided by Geneuro, SA. The antibodies will be evaluated for their properties to neutralize Amyotrophic Lateral Sclerosis (ALS) -related biological and pathological effects induced by HERV-K envelope expression in various model systems.
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20172016C-032-2017/0MThe Molecular Analyses of Medullary Thyroid Carcinoma (MTC) Tissues Obtained from Patients with Locally Advanced or Metastatic MTC Participating in a Phase III Prospective, Randomized, Placebo Controlled, Clinical Trial of VandetnanibActive2016-12-21NCIGenzyme Corporation (Sanofi)Under the terms of a Materials Cooperative Research and Development Agreement (M-CRADA), the National Cancer Institute (NCI) will perform a comprehensive molecular characterization of medullary thyroid carcinoma (MTC) tissues obtained from patients with advanced MTC participating in a clinical trial of vandetanib compared to placebo.
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20172016C-020-2017/0MInvestigating the effects of kinase inhibitor C377 on morphology, hsp90/hsp70-based chaperone machinery and HERG stability in iPSC-derived human cardiac myocytesActive2016-11-15NCIGilead Sciences, Inc.
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20172017C-031-2017/0SPhase 1 Dose Escalating, Double-Blind, Randomized Comparator Controlled Trial of the Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines against Plasmodium falciparum at Full and Fractional Dosing in Adults in MaliActive2017-01-05NIAIDGlaxoSmithKline Biologicals, S.A.The National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologicals S.A. have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate in a Phase 1 dose escalating, double-blind, randomized comparator controlled clinical trial, the safety and immunogenicity of Pfs25M-EPA/AS01B and Pfs230D1M-EPA/AS01B Vaccines, transmission blocking Vaccines against Plasmodium falciparum.
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20172016C-026-2017/0MDetermination of the Structure of a Respiratory Syncytial Virus (RSV) Nucleoprotein (N-protein) to Greater Elucidate Vaccine DevelopmentActive2016-12-09NCIGlaxoSmithKline LLC
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20172017C-096-2017/0SClinical Development of GlaxoSmithKline LLC’s GSK525762, an Oral Bromodomain and Extra-terminal (BET) Motif Inhibitor, as an Anti-Cancer AgentActive2017-07-31NCIGlaxoSmithKline LLCGlaxoSmithKline, LLC (GSK) 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 GSK525762, an Oral Bromodomain and Extra-terminal (BET) Motif Inhibitor, proprietary to GSK, as an anti-cancer agent.
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20172017C-054-2017/0SA Clinical Trial Using Horizon Pharma Ireland Limited’s Agent, ACTIMMUME®Active2017-04-19NCIHorizon Pharma Ireland LimitedHorizon Pharma Ireland Limited and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute Horizon’s investigational agent, ACTIMMUME®, in support of a Protocol.
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20172017C-047-2017/0SEvaluation of Incyte Europe S.à.r.l.’s Proprietary Anti-OX40 Agonist Antibody (INCAGN1949), Anti-GITR Agonist Antibody (INCAGN0187), Anti-PD1 Antibody (INCSHR01210), and IDO Inhibitor Molecule (INCB024360Active2017-03-09NCIIncyte Europe SaruInstitute and Incyte Europe S.à.r.l. (Incyte) will collaborate to evaluate the potential therapeutic benefit of Incyte’s anti-OX40 agonist antibody (INCAGN1949), anti-GITR agonist antibody (INCAGN0187), anti-PD1 antibody (INCSHR01210), and IDO inhibitor molecule (INCB024360). These agents will be evaluated as single agents and in combination therapies in preclinical and clinical studies. INCAGN1949 and INCAGN0187 will only be evaluated for the treatment of cancer. INCSHR01210 and INCB024360 will be evaluated for the treatment of cancer and inflammation.
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20172017C-027-2017/0SDevelopment and Evaluation of Intrexon Corporation’s Proprietary Non-viral Sleeping Beauty Vectors for Genetic Modification of Peripheral Blood Lymphocytes with Genes Encoding Mutated Tumor Neoantigen-specific T Cell Receptors (also referred to as Mutation Reactive T Cell Receptors) that Have Been Identified Using NCI Proprietary MethodsActive2017-01-09NCIIntrexon Corporation
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20171900C-099-2017/0SEvaluation of Ionis Pharmaceutical’s Proprietary Androgen Receptor Inhibitor, IONIS-ARRX, for Prostate Cancer for Safety and Efficacy in Prostate Cancer PatientsPending-IC Execution1900-11-11NCIIONIS Pharmaceuticals, Inc.The National Cancer Institute (NCI) will evaluate Ionis Pharmaceutical’s proprietary generation 2.5 antisense oligonucleotide (ASO) inhibitor, IONIS-ARRX (ISIS 560131), for the treatment of prostate cancer. Specifically, the NCI will determine the dosing schedule, safety and efficacy of ARRX in the neoadjuvant setting for prostate cancer.
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20172017C-057-2017/0MEvaluation of the untranslated region of the SMN2 gene with antisense oligonucleotidesActive2017-04-10NINDSIONIS Pharmaceuticals, Inc.Under a Materials Cooperative Research and Development Agreement (MCRADA), the National Institute of Neurological Disorders and Stroke of the National Institutes of Health will conduct research to evaluate Ionis Pharmaceuticals Inc.’s proprietary antisense technology designed to target the 3’-UTR of SMN2 to increase SMN2 mRNA levels by blocking its degradation.
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20172017C-086-2017/0MEvaluation of Ionis Pharmaceutical Inc’s Proprietary Antisense Oligonucleotides Targeted to Mouse CD47 Antigen in NCI’s Mouse Cells and Mouse Models of Angiogenesis, Ischemia, or TumorigenesisActive2017-06-06NCIIONIS Pharmaceuticals, Inc.Under a Materials Cooperative and Research Development Agreement (M-CRADA), the National Cancer Institute (NCI)will perform a pre-clinical study to evaluate the effects of Ionis Pharmaceutical Inc’s (Ionis) proprietary antisense oligonucleotides targeted to mouse cluster of differentiation 47 (CD47) in NCI’s mouse cells and mouse models of angiogenesis, ischemia or tumorigenesis.
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20172017C-028-2017/0SStudy(ies) with Formulary Agent(s) Provided by Kyowa Kirin Pharmaceutical Development, Inc.Active2017-01-12NCIKyowa Hakko Kirin Pharma, Inc.Collaborator and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative. Under the CRADA DCTD will distribute Collaborator’s anti-cancer agent(s) including Mogamulizumab provided to the NCI Formulary to investigators to conduct investigator-initiated clinical Studies.
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20172017C-077-2017/0SPreclinical assessment of the neurochemical effects on N-[4-trifluromethyl)benzyl]4-methoxybutyramide (GET73) in ratsActive2017-06-26NIDALaboratorio Farmaceutico CT SrlThe National Institute on Drug Abuse (NIDA) and CT Sanremo Laboratorio Farmaceutico will conduct a research study under a Collaborative Research and Development agreement (CRADA) to characterize the neurochemical changes that occur in the brain of rodents after administration of different doses of N-[(4-trifluoromethyl)benzyl]4-methoxybutyramide (GET73) alone, or in the presence of different doses of alcohol.
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20172016C-022-2017/0SAdoptive Immunotherapy for Thymic Stromal Lymphopoietin Receptor (TSLPR)-Positive Hematologic Malignancy with Chimeric Antigen Receptor (CAR)-Modified Lymphocytes that Includes a Safety TagActive2016-12-21NCILentigen Corporation (Miltenyi)Under the terms of a Cooperative Research and Development Agreement (CRADA), the National Cancer Institue (NCI) and Lentigen Technology, Inc. (LTI) will collaborate in a research study to develop LTI’s proprietary lentiviral-based chimeric antigen receptors (CARs) targeting TSLPR (thymic stromal lymphopoietin receptor) for the treatment of hematologic malignancies. Collaborative studies implementing new approaches to automated lymphocyte purification, transduction, and expansion in culture featuring the CliniMACS® Prodigy (Miltenyi Biotec) will be carried out, as will studies of the impact of including specific safety factors into the CAR lentiviral expression vector.
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20172017C-058-2017/0SDevelopment of a Clinic-Ready Memory T Cell Population Endowed with Stem Cell-Like Properties (TSCM) that can be Transduced with Lentiviral Vector (LV) for Chimeric Antigen (CAR) T-Cell-Based TherapyActive2017-04-19NCILentigen Technology, Inc. (Miltenyi)The National Cancer Institute and Lentigen Technology, Inc. have entered into a Cooperative Research and Development Agreement to develop a clinic-ready memory T cell population endowed with stem cell-like properties (TSCM) for CD19/CD20 chimeric antigen (CAR) T-cellbased therapy. To achieve this, the Parties will use NCI’s proprietary methods to generate the TSCM, and Lentigen Technology’s (LTI) proprietary lentiviral vectors and proprietary CliniMACS Prodigy system to transduce and expand TSCM populations.
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20172017C-062-2017/0SClinical Evaluation of Lixte Biotechnology Holdings, Inc.’s Proprietary Compound LB-100, a Protein Phosphatase 2A InhibitorActive2017-04-15NCILixte Biotechnology Holding, Inc.Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and Lixte Biotechnology Holdings, Inc. (Lixte) will collaborate to evaluate Lixte’s LB- 100, a protein phosphatase 2A inhibitor, in clinical studies for the treatment of glioblastoma.
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20172017C-079-2017/0STreatment of Methylmalonic Acidemia by GeneRide™Active2017-06-26NHGRILogicBio Therapeutics, Inc.ABSTRACT OF THE RESEARCH PLAN:National Human Genome Research Institute (NHGRI) and LogicBio Therapeutics, Inc., have entered into a Cooperative Research and Development Agreement (CRADA) to conduct a pre-clinical study to evaluate and develop gene therapy for a rare hereditary metabolic disorder, Methylmalonic Acidemia (MMA). 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 using the GeneRide™ technology that may be able to effectively address some of the devastating effects of such metabolic diseases.
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20172017C-041-2017/0SStudy(ies) with Formulary Agent(s) Provided by Loxo Oncology Inc.Active2017-02-07NCILoxo Oncology, Inc.Loxo Oncology, Inc. and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) to support the Cancer Moonshot initiative. Under the CRADA DCTD will distribute LOXO-101, a small molecule therapeutic, provided to the NCI Formulary to investigators to conduct investigator-initiated clinical trials.
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20172017C-097-2017/0SPhase 1, Open-Label, Dose Escalation Study of Macrogenics Inc.’s Proprietary Monoclonal Antibody, MGA271, in Pediatric Patients with B7-H3-Expressing Relapsed or Refractory Solid TumorsActive2017-08-21NCIMacroGenics, Inc.Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and MacroGenics, Inc. will collaborate to perform a Phase I clinical study of Macrogenics Inc.’s proprietary monoclonal antibody, MGA271, in pediatric patients with B7-H3-expressing relapsed or refractory solid tumors and will conduct various correlative studies relevant to the clinical study.
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20172017C-084-2017/0SPreclinical Investigation of PD-1+ PBL Selection Using NCI Proprietary PBL Selection and Purification Methods and MedImmune Proprietary PD-1 Selection and Purification Methods, Using Medimmune Proprietary anti-PD-1 AntibodiesActive2017-06-20NCIMedImmune LLC (AstraZeneca)The principal goal of this Cooperative Research and Development Agreement (CRADA) is to develop and optimize peripheral blood lymphocyte (PBL) purification methods to isolate and enrich for a population of PD-1 positive PBLs that would be tumor reactive. These cells are to be isolated by using NCI proprietary selection and purification methods and MedImmune’s proprietary anti- PD-1 antibodies, MEDI0680 and MEDI3097
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20172017C-090-2017/0SClinical Evaluation of the Combination of AstraZeneca AB’s Durvalumab with Eleven Biotherapeutic’s Vicinium in Patients with High-Grade Non-Muscle-Invasive Bladder CancerActive2017-07-10NCIMedImmune, Inc. (AstraZeneca)Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and AstraZeneca AB (AstraZeneca) will collaborate on the development of AstraZeneca’s immune checkpoint inhibitor Durvalumab in combination with Eleven Biotherapeutics’ (Eleven) proprietary targeted therapeutic Vicinium for the treatment of non-muscle-invasive bladder cancer.
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20172017C-070-2017/0SUsing Positron Emission Topography (PET) to Identify in vivo foci of viral SIV infection using 18F labeled Merck Proprietary gp120 binding ligandsActive2017-05-16NCIMerck & CompanyMerck Sharp & Dohme Corp. (Merck) and the National Cancer Institute (NCI) have entered into this Cooperative Research and Development Agreement (CRADA) with the goal to evaluate the feasibility of using Positron Emission Topography (PET) to identify in vivo foci of viral infection in SIV infected macaques using 18F labeled Merck proprietary gp120 binding ligands.
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20172017C-074-2017/0SEvaluation of Merck, Sharpe & Dohme Corp.’s Proprietary ML-3475 (Pembrolizumab), an Anti-PD-1 Antibody, in Combination with Capecitabine and Oxaliplatin for Treatment of Advanced Biliary Tract CarcinomaActive2017-05-18NCIMerck & Company, Inc.Under a Cooperative Research and Development Agreement (CRADA), NCI will evaluate Merck’s MK-3475 (Pembrolizumab) through conducting a clinical protocol entitled “A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody against PD-1, in Combination with Capecitabine and Oxaliplatin (CAPOX) in Subjects with Advanced Biliary Tract Carcinoma (BTC).” The study is being conducted at the NIH Clinical Center. This research may have implications for the treatment of advanced BTC.
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20172017C-035-2017/0SUsing Merck’s proprietary drug, Vorinostat, to assess HDACi for Disease Improvement in Crohn’s DiseaseActive2017-02-06NIAIDMerck Sharp & Dohme CorpThe present study has been designed in order to assess whether short-term (12 weeks) treatment with oral Vorinostat can induce disease improvement in Crohn’s Disease (CD) patients. Subjects with moderate–to-severe active CD not controlled by ongoing treatment with conventional therapies such as 5-aminosalycylates, steroids, or immunosuppressants will be evaluated endoscopically before, and after the treatment period to determine whether Vorinostat is able to induce healing of mucosal lesions. A successful outcome of this study may allow for the rational consideration of selected Histone deacetylase inhibitors (HDACi) for the treatment of chronic inflammation.
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20172017C-039-2017/0MEvaluation of Merck Sharp & Dohme Corp.’s Proprietary MK-3475 (Pembrolizumab), an Anti-PD-1 Antibody, to Treat GlioblastomaActive2017-01-13NCIMerck Sharp & Dohme Corp.Under a Materials-Cooperative Research and Development Agreement (M-CRADA), NCI will evaluate Merck’s MK-3475 (Pembrolizumab) through conducting a clinical protocol entitled “A randomized, double blind phase II trial of Radiation Therapy plus Temozolomide and Pembrolizumab with and without HSPPC-96 in newly diagnosed Glioblastoma (GBM)” (“Study”). HSPPC-96 means Agenus Inc.’s heat shock protein-peptide complex-96 vaccine (HSPPC-96). The Study is a multi-center study that is being conducted by institutions participating in the Brain Tumor Trials Collaborative (BTTC). The Neuro-Oncology Branch of the NCI will be one of the centers conducting this Study. This research may have implications for the treatment of cancer.
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20172017C-100-2017/0SA Phase II Study of Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)Active2017-08-28NHLBIMerck Sharp & Dohme Corp.The National Heart, Lung and Blood Institute (NHLBI), a part of the National Institutes of Health, and Merck Sharp & Dome Corporation have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on a phase II clinical study of Merck’ proprietary agent, Pembrolizumab, in combination with fludarabine and Pharmacyclics’ proprietary agent, ibrutinib, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common type of leukemia in the United States and it predominantly affects the elderly population. CLL patients with high-risk genetic lesions or relapsed or refractory disease show limited response to current therapies, and are in need of effective novel therapies. Results from this study are likely to facilitate the development of treatment regimen that can improve the outcome of high-risk and relapsed/refractory CLL.
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20172017C-014-2017/0SPembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid LeukemiaActive2017-01-03NHLBIMerck Sharpe & Dohme CorpThe National Heart Lung and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and Merck Sharpe & Dohme, Corp will perform collaborative research under a Cooperative Research and Development Agreement (CRADA) to conduct a pilot study to determine the feasibility of a novel combination of Pembrolizumab and Decitabine in relapsed/refractory adult acute myeloid leukemia (AML) patients. While both Pembrolizumab and Decitabine are FDA approved agents, this study will explore giving these drugs in combination for this population of patients. There is no current standard of care for adult relapsed or refractory AML other than offering referral to an appropriate clinical trial. Results from this study could improve treatments for refractory or relapsed AML patients.
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20171900C-109-2017/0SDevelopment of a novel HDAC6-PI3KB/NPs for the treatment of rare cancers with significant unmet medical needPending-SCR Scheduled1900-11-11NCATSNanoLead, Inc.NCATS in collaboration with NanoLead Inc, will develop a specific and selective HDAC6-PI3Kδ dual inhibitor-encapsulated in novel, biodegradable, tetra block polymeric nanoparticles. Recent studies have shown that by disrupting multiple compensatory cyto-protective pathways, Phosphatidylinositol 3-kinases (PI3K) inhibitors in combination with histone deacetylase (HDAC) inhibitors might have potential therapeutic value. HDAC-based therapies will probably be designed based on inhibiting a specific isoform of HDAC (such as HDAC6) and in combination with therapies that target other proteins, such as PI3K, for synergistic effects. The primary objective of this Research Plan is encapsulation of NCATS developed HDAC6-PI3Kδ dual inhibitors into NanoLead’s proprietary novel PLA-PEG-PPG-PEG tetra-block NP system to assist delivery of this anti-cancer agent to malignant cells in vitro and in vivo.
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20172017C-103-2017/0SIdentification of small molecule therapeutics for NGLY1 DeficiencyActive2017-08-23NCATSNGLY1 FoundationNGLY1 Deficiency is a rare and debilitating monogenic disease characterized by developmental delays, seizures, an inability to produce tears, and for which there are currently no approved therapeutic options. Although the gene believed to be responsible for the disease has been identified, it remains unclear how the loss of NGLY1 activity leads to the symptoms observed in patients with the disease. The National Center for Advancing Translational Sciences (NCATS), Therapeutics for Rare and Neglected Diseases (TRND) Biology Laboratory, along with patient foundation, NGLY1.org, and biopharmaceutical company Retrophin, Inc. are collaborating on a research plan to develop different assays for small molecule high-throughput screening in both an effort to better understand the biology of the disease, as well as identify potential small molecules to be developed as a therapeutic for patients suffering from NGLY1 Deficiency.
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20172017C-052-2017/0SIn vivo cardiac diffusion tensor MRI. Experimental validation and assessment of myocardial structure‐function relationships in the normal and post-infarct remodelled heartActive2017-04-19NHLBINHLI, Imperial College of London, UKThe proposed research will optimise and validate in vivo cardiac diffusion tensor magnetic resonance imaging (DT-MRI), which is a non-invasive method for quantitative measurement of the arrangement of heart muscle cells. We will optimise our current in vivo DT-MRI sequence, perform measurements at different phases of the cardiac cycle and address the critical issue of the extent to which myocardial strain affects these measurements. We will assess the influence of strain on the DT-MRI measurements. We will validate our DT-MRI measurements of helix and sheetlet angles against histology in both normal and infarcted hearts. Finally, we will examine the longitudinal development of the relationship between in vivo DT-MRI measures, regional strain, global LV systolic function and parameters of regional and global LV remodelling in an experimental model of myocardial infarction. This research will deliver an optimised sequence validated in both normal and pathologic myocardium for clinical use, preclinical data to underpin interpretation of clinical DT-MRI, and provide important new mechanistic data on post-MI LV remodelling.
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20172017C-024-2017/0SIdentification of and characterization of T cell tuning molecules that modify the immune response to cancer cellsActive2017-05-21NICHDNonpareil Biotechnologies LLC
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20172016C-001-2017/0SA Phase 2a Study of NovaDigm Therapeutics' NDV-3A Vaccine in patients with STAT3-mutated Hyper-IgE SyndromeActive2016-11-21NIAIDNovaDigm Therapeutics, Inc.The National Institute of Allergy and Infectious Diseases and NovaDigm Therapeutics have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on a Phase 2a clinical study to evaluate the safety, tolerability, and immunogenicity of NDV-3A, NovaDigm Therapeutics’s proprietary vaccine against Candida and Staphylococcus aureus in patients with STAT3-mutated hyper IgE syndrome (HIES).
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20171900C-102-2017/0SNovel mechanisms of D2 dopamine receptor inhibition by select imipridone compoundsPending-IC Execution1900-11-11NINDSOncoceutics, Inc.The Molecular Neuropharmacology Section (MNS) of the National Institute of Neurological Disorders and Stroke (NINDS) and Oncoceutics Inc. have entered into a Collaborative Research and Development Agreement (CRADA) to investigate the molecular interactions and pharmacology of a novel series of imipridone D2R antagonists. These include lead imipridone molecules ONC201, ONC206 and ONC213. ONC201 is the founding member of this imipridone class and has activity in preclinical and clinical models of advanced cancers. Preliminary studies have shown that ONC201 targets the dopamine D2R in a unique way and shows early efficacy in treating different types of cancer. These studies seek to understand the molecular interactions and pharmacology of these compounds at the D2R and to define a putative secondary binding site on the receptor.
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20172017C-065-2017/0SGenetic engineering of ex vivo expanded natural killer (NK) cells to express death receptor 5 (DR5) specific tumor necrosis factor (TNF) related apoptosis inducing ligand (TRAIL) to augment cell-mediated killing of DR5 expressing tumors including multiple myeloma, acute myeloid leukemia, and renal cell carcinoma following adoptive NK cell immunotherapyActive2017-05-11NHLBIOnkImmune LimitedThe National Heart, Lung and Blood Institute (NHLBI), a part of the National Institutes of Health, and Onkimmune, Limited, Dublin 2, Ireland have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on a research project to assess the use of genetically engineered ex-vivo expanded natural killer (NK) cells, expressing death receptor 5 (DR5)-specific tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL) in augmenting cell-mediated killing of DR5 expressing tumors including multiple myeloma (MM), acute myeloid leukemia (AML), and renal cell carcinoma (RCC) following adoptive NK cell immunotherapy. Results from the study could facilitate the development of treatments that help to improve the outcome of these malignancies.
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20172016C-007-2017/0SThe Clinical Evaluation of Peloton Therapeutics’ Hypoxia Inducible Factor-2 alpha (HIF-2α) Inhibitor PT2385 in von Hippel-Lindau (VHL) DiseaseActive2016-11-01NCIPeloton 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 PT2385 for the treatment of von Hippel-Lindau (VHL) disease.
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20172016C-002-2017/0SThe Use of Anti-PD-L1 (Avelumab), OX40 Agonist Antibody, and 4-1BB (Agonist) Monoclonal Antibody in Monotherapy and in Combination ImmunotherapiesActive2016-11-07NCIPfizer Global Research and DevelopmentUnder a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and Pfizer Inc (Pfizer) will collaborate to evaluate anti-PD-L1 antibody (Avelumab), OX40 agonist antibody, and 4-1BB (agonist) monoclonal antibody in monotherapy and in combination immunotherapies
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20172016C-021-2017/0SNovel therapeutic protein for multiple sclerosis disease causes antigen-specific elimination of autoimmune T cells and inflammatory cells (This research is under the Pfizer CTI CRADA)Active2016-12-22NIAIDPfizer, IncPfizer Centers for Therapeutic Innovation (Pfizer CTI) and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health, have entered into a Cooperative Research and Development Agreement to develop novel therapeutics against relapsing/remitting and/or progressive Multiple Sclerosis (MS). MS is a demyelinating disease for which there is no cure and significant unmet medical need. Current medications have significant side effects and do not ameliorate disease in all patients. Nearly all biological therapeutics are approved only for relapsing/remitting MS and not for progressive disease, which afflicts at least 30% of all MS patients. Under this agreement, the NIH, through NIAID, and Pfizer CTI will collaborate to develop novel protein therapeutics to target relapsing/remitting and/or progressive MS preferably with less side effects that currently available treatments.
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20172017C-089-2017/0SIdentification of novel drug discovery targets for underdiagnosed diseasesActive2017-07-03NHGRIPfizer, IncNational Human Genome Research Institute (NHGRI) and Pfizer Inc. have entered into a Cooperative Research and Development Agreement, or CRADA to conduct a research study to identify and evaluate potential drug discovery targets and pathways for diseases that are currently underdiagnosed or difficult to treat. This study has the potential to accelerate identification of new drug targets through the use of human genetic data.
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20172017C-094-2017/0SA Phase II Study of Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLLActive2017-08-28NHLBIPharmacyclics, Inc. (Abbvie)The National Heart, Lung and Blood Institute (NHLBI), a part of the National Institutes of Health, and Pharmacyclics LLC, An AbbVie Company, Inc of Sunnyvale, California have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on a phase II clinical study of Pharmacyclics’ proprietary agent, ibrutinib in combination with fludarabine and Merck Sharp & Dohme Corporation’s proprietary agent, pembrolizumab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common type of leukemia in the United States and it predominantly affects the elderly population. CLL patients with high-risk genetic lesions or relapsed or refractory disease show limited response to current therapies, and are in need of effective novel therapies. Results from this study are likely to facilitate the development of treatment regimen that can improve the outcome of high-risk and relapsed/refractory CLL.
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20172016C-009-2017/0SDelivery of Pixium’s Proprietary Vision Restoration Device to Porcine Retina Using NEI’s Sub-Retinal Transplantation ToolsActive2016-11-09NEIPixium VisionUnder a Cooperative Research and Development Agreement, Pixium will provide the implantable electrode arrays that are part of its proprietary Bionic Vision Restoration System (“PRIMATM”). The National Eye Institute will conduct experiments to surgically deliver these PRIMATM implants to the retina of experimental animals utilizing NEI’s sub-retinal transplantation (“SRT”) tool.
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20172017C-053-2017/0SDiscovery and development of small molecule TRH agonistsActive2017-04-14NIDDKPrimetime Life Sciences, LLCThyrotropin-releasing hormone (TRH) plays an important role in the regulation of thyrotropin (thyroid-stimulating hormone, TSH) and prolactin synthesis and secretion in the pituitary gland and as a neurotransmitter/ neuromodulator within the central and peripheral nervous systems. TRH is located in axons terminating on hypothalamic neurons as well as in other regions of the brain. TRH is involved in modulating energy homeostasis within the CNS. TRH and its analogs have been studied for treatment of treatment of a variety of CNS disorders, such as fatigue (including cancer related fatigue), spinocerebellar ataxia, epilepsy, schizophrenia, Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), Parkinson’s disease (PD) and depression. TRH action is mediated by the two TRH receptor isotypes, subtypes 1 and 2 (TRH-R1 and TRHR2). They are GPCRs that signal primarily via the Gq/11 pathway, which activates phospholipase C and leads to generation of inositol 1,4,5-triphosphate, which is rapidly degraded to inositolmonophosphate (IP1), and 1,2-diacylglycerol. TRH-R2, but not TRH-R1, was found tosignal constitutively in several cell systems.
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20172017C-016-2017/0SIdentification and generation of novel human monoclonal antibodies and bispecific antibodies for cancer therapyActive2017-01-19NCIQLB Biotherapeutics, Inc.
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20172017C-080-2017/0SPreclinical Evaluation of an Epstein Barr Virus (EBV) Vaccine Containing EBV Envelope Protein Antigens in Collaborations with Sanofi US Services Inc.Active2017-07-14NIAIDSanofi US Services Inc.The National Institute of Allergy and Infectious Diseases and Sanofi US Services Inc. have entered into a Collaborative Research and Development Agreement (CRADA) to generate an Epstein-Barr virus (EBV) vaccine containing envelope protein antigens and evaluate this vaccine for the immune response in animal models of EBV. EBV, also known as human herpesvirus 4, is amember of the herpes virus family and is one of the most common oncogenic viruses in humans. More than 95% of all adults are infected with this virus and it is the major cause of infectious mononucleosis (glandular fever). It is also associated with several other cancers such as Hodgkin's lymphoma, non· Hodgkin lymphoma, Burkitt's lymphoma, gastric cancer, nasopharyngeal carcinoma, and has also been linked to conditions associated with human immunodeficiency virus, such as hairy leukoplakia and central nervous system lymphoma. While the need for a vaccine is clear, no licensed EBV vaccine is currently available.
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20172017C-093-2017/0SDevelopment of Analytical Methods to Monitor PhotoImmunoTherapy (“PIT”) using Shimadzu Corporation’s Proprietary LIGHTVISION® TechnologyActive2017-08-01NCIShimadzu CorporationThe National Cancer Institute and Shimadzu Corporation will collaborate on the research and development of analytical methods to monitor and evaluate the efficacy of the use of antibodyfluorophore conjugates to induce cell death, known as PhotoImmunoTherapy (“PIT”) using Shimadzu’s proprietary LIGHTVISION® technology.
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20172017C-098-2017/0SClinical Evaluation of MedImmune, LLC’s Proprietary Antibody against Cytotoxic Lymphocyte Antigen 4 (CTLA-4), Tremelimumab, and Monoclonal Antibody against Program Cell Death Ligand 1 (PD-L1), Durvalumab, in Combination with Sillajen Biotherapeutics, Inc.’s Proprietary Pexastimogene Devacirepvec (Pexa-Vec) Oncolytic Virus in Refractory Colorectal CancerActive2017-08-16NCISillaJen Biotherapeutics, Inc.Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and SillaJen, Inc. will collaborate to conduct a Phase I/II clinical trial using Pexa-Vec in��combination with Tremelimumab and Durvalumab in patients with Refractory Colorectal Cancer.
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20172017C-075-2017/0SDevelopment of cytokine analogue-protamine fusion proteins targeting CCR10 and CCR3 on B cells and plasma cells for systemic delivery of siRNA for therapeutic applications; specifically, Waldenström’s macroglobulinemiaActive2017-05-25NIAsiRNAx, Inc.The National Institute on Aging (NIA) and siRNAx, Inc. have entered a Collaborative Research and Development Agreement (CRADA) to develop cytokine analogue-protamine fusion proteins targeting CCR10 and CCR3 on B cells and plasma cells for systemic delivery of siRNA for therapeutic applications; specifically, Waldenström’s macroglobulinemia
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20172017C-040-2017/0SDose-Finding and Preclinical in vitro Safety Investigation for Adeno-associated Virus Type 2 (AAV2)-hCHM in Primary Retinal Pigment Epithelial Cells Differentiated from Choroideremia (CHM) Patient Induced Pluripotent Stem CellsActive2017-02-06NEISpark Therapeutics, Inc.Under a Cooperative Research and Development Agreement, National Eye Institute (NEI) will have access to Spark’s CHM patient-specific induced pluripotent stem cell (iPSC) lines and adenoassociated viral gene expression vectors for choroideremia gene therapy, and perform in vitro testing to examine the toxicity and effects of those viral vectors on retinal pigment epithelium (RPE) cells. NEI will utilize its iPSC technology and RPE cell technology for preparing CHMspecific, iPSC-derived RPE cells for such tests. The parties will work together to assess the preclinical efficacy and safety of Spark’s choroideremia gene therapy vectors.
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20171900C-087-2017/0SLong-term follow of NOMID patients on treatment with SOBI's IL-1 Inhibitor Anakinra for over 10 years, and for Patients who started on Anakinra under 2 years of age for over 3 yearsPending-IC Execution1900-11-11NIAIDSwedish Orphan Biovitrum AB publThe National Institute of Allergy and Infectious Diseases and Swedish Orphan Biovitrum AB (publ} (SOBI) have entered into a Cooperative Research and Development Agreement (CRADA) to conduct a phase VI long-tenn follow up retrospective clinical study on patients treated with SOBl's proprietary IL- I inhibitor anakinra (Kineret ®)to: 1) evaluate the long term efficacy and prevention of progression of inflammatory organ damage in NO MID (Neonatal Onset Multisystem Inflammatory Disease} patients, 2) assess atherosclerosis risk and metabolic changes in the returning patients, and 3) administer anakinra to patients on a compassionate use basis.
95
20171900C-078-2017/0SDevelopment of Probiotics for Human Propionate Oxidation DisordersPending-IC Execution1900-11-11NHGRISynlogic Inc.National Human Genome Research Institute (NHGRI) and Synlogic, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to conduct a pre-clinical study to evaluate engineered probiotics to improve symptoms of propionate oxidation disorders, including propionic acidemia, methylmalonic acidemias (MMAs), and hereditary cobalamin metabolic disorders – rare hereditary metabolic diseases. Current treatments for these inborn erros of metabolism include elective liver and/or combined liver-kidney transplantation, which can eliminate disease symptoms but have many practical limitations. This CRADA study will be useful to further evaluate and confirm the effectiveness of these engineered probiotics to mitigate some of the devastating side effects of these disorders.
96
20172017C-082-2017/0SPreclinical and Clinical Evaluation of Syntrix Biosystems, Inc.’s SX-682, an Inhibitor of CXCR1/2Active2017-06-14NCISyntrix Biosystems, Inc.Under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute and Syntrix Biosystems, Inc. (Syntrix) will collaborate to evaluate Syntrix’s SX-682, a novel, clinical-stage, allosteric inhibitor of CXCR1/2, in preclinical and clinical studies for the treatment of cancer.
97
20172017C-092-2017/0SA Multicenter Study of Tarveda Therapeutics, Inc.’s Proprietary Agent PEN-866 in Subjects with Advanced Solid MalignanciesActive2017-07-19NCITarveda Therapeutics, Inc.The National Cancer Institute and Tarveda Therapeutics, Inc. have entered into a Cooperative Research and Development Agreement (CRADA) to collaborate on a Phase 1/2a clinical study of Tarveda Therapeutics, Inc.’s proprietary agent PEN-866, a drug conjugate containing the SN38 payload linked to an HSP90 inhibitor, for the treatment of patients with advanced solid malignancies and to conduct various correlative studies relevant to the clinical study.
98
20171900C-106-2017/0STo Study the Roles of Sigma-1 Receptor in TEVA’s Compound Pridopidine Against Neurodegenerative DiseasesPending-IC Execution1900-11-11NIDATeva Pharmaceutical Industries Ltd.The National Institute on Drug Abuse (NIDA) and TEVA Pharmaceutical Industries Ltd., will collaborate under a Cooperative Research and Development Agreement (CRADA) to conduct a study on the roles of Sigma-1 Receptor using TEVA’s proprietary compound pridopidine as a treatment against neurodegenerative diseases.
99
20172017C-063-2017/0SA Clinical Trial Utilizing TGR-1202, a Phosphoinositide 3-kinase (PI3K) Delta Inhibitor Proprietary to TG Therapeutics Inc.Active2017-04-26NCITG TherapeuticsTG Therapeutics and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (“CRADA”) under which DCTD will distribute TG Therapeutics’ investigational agent, TGR-1202in support of a Protocol.
100
20172017C-034-2017/0SA Phase IV, Open label Study of the Effects of Apremilast on Vascular Inflammation and Cardiometabolic function in PsoriasisActive2017-04-05NHLBIThe University of PennsylvaniaPsoriasis is a chronic, immune-mediated, inflammatory skin condition characterized by exacerbations and remissions. It is estimated to affect approximately 3% of the US population. Over seven million Americans have been diagnosed with psoriasis and about one million have moderate to severe disease requiring systemic treatments. Despite the broad array of therapeutic options, about 30% of patients with severe psoriasis affecting ≥10% body surface area are not receiving treatment to control their disease. It is now increasingly recognized that psoriasis, like rheumatoid arthritis and systemic lupus erythematosus, is a systemic inflammatory disorder and not only a disorder confined to the skin. An emerging evidence base identifies psoriasis - severe psoriasis in particular - as an independent risk factor for hypertension, diabetes mellitus, obesity, dyslipidemia, myocardial infarction, stroke, and cardiovascular mortality. Psoriasis is associated with defects in high-density lipoprotein (HDL) function, insulin resistance, and increased aortic vascular inflammation, as measured by [l8F]fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT). These changes found in FDG-PET/CT would be the equivalent to a decade of aging in an individual without psoriasis. Patients with moderate to severe psoriasis have an increased risk of myocardial infarction, stroke, and cardiovascular death independent of traditional risk factors. Interestingly, observational data suggests that the use of immunomodulatory therapy with this at-risk population can lower the risk of major cardiovascular events. The purpose of this CRADA is to explore the effects of selective systemic immunomodulation with apremilast on vascular and systemic inflammation as measured by positron emission tomography with [18F]-fluorodeoxyglucose integrated with computed tomography (FDG-PET/CT) imaging and on cardiometabolic biomarkers in patients with moderate to severe psoriasis, as compared to the effects of placebo. It is expected that research will assess vascular inflammation with multi-volumetric product, tissue-to-background ratio and total atherosclerotic burden using FDG-PET/CT.
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