Global COVID-19 – Pipeline Analysis 2020

SKU ID :UMI-15666588 | Published Date: 15-May-2020 | No. of pages: 164
1. REPORT INTRODUCTION 1.1 Objective of the Study 12 1.2 Limitation 12 1.3 Stakeholders 12 1.4 Currency used in the Report 12 1.5 Secondary Research 12 1.6 Scope of the COVID-19 – Pipeline Analysis Study 12 2. RESEARCH METHODOLOGY OR ASSUMPTION 14 2.1 Research Methodology for the COVID-19 – Pipeline Analysis 2020 14 2.1.1 Main objective of the COVID-19 – Pipeline Analysis 2020 14 3. EXECUTIVE SUMMARY 16 4. DISEASE OVERVIEW 18 4.1 Introduction 18 4.2 Etiology 19 4.3 Virology 19 4.3.1 Physicochemical Properties 21 4.3.2 Receptor Interactions and Cell Entry 21 4.4 Diversity of Coronaviruses 22 4.5 Epidemiology and clinical features of human coronaviruses 22 4.5.1 Source of Infection 22 4.5.2 Spectrum of Infection 22 4.5.3 Clinical Features 23 4.5.4 Epidemiological Characteristics in Mainland China and other countries 24 4.5.5 Herd Susceptibility 25 4.6 Pathogenesis 25 4.6.1 Virus Entry and Spread 25 4.6.2 Pathological Findings 26 4.6.3 Acute Respiratory Distress Syndrome (ARDS) 26 4.6.4 Cytokine Storm 26 4.6.5 Immune Dysfunction 27 4.7 Signs and Symptoms 29 4.8 Diagnostic testing 31 4.8.1 Nucleic Acid Test 48 4.8.2 Serologic Diagnosis 49 4.8.3 CRISPR/Cas13 System 49 4.8.4 Imaging Technology 49 4.9 Treatment 50 4.9.1 Type I IFNs 50 4.9.2 Convalescent Plasma 53 4.9.3 Protective Monoclonal Antibody 53 4.9.4 Protease 53 4.9.5 Others 54 4.9.6 Vaccines 54 4.9.7 Proposed COVID-19 Triage Algorithm for Low-income Settings Without Established Local Transmission 56 5. PIPELINE THERAPEUTICS AT A GLANCE 57 5.1 General Overview (Clinical Stage Products) 57 5.2 General Overview (Non-Clinical Stage Products 58 6. CLINICAL PRODUCTS UNDER DEVELOPMENT BY TARGET 59 7. COMPARATIVE ANALYSIS 61 7.1 General Overview 61 8. LATE PHASE PRODUCTS (PHASE III) 62 8.1 Comparative Analysis 62 8.2 ASC09+Ritonavir: Ascletis Pharmaceuticals Co., Ltd. 63 8.2.1 Product Description 63 8.2.2 Research and Development 63 8.2.2.1 Clinical Studies 63 8.2.2.1.1 Phase III 63 8.2.3 Product Development Activities 64 8.2.3.1 Collaboration 64 8.3 CD24Fc: OncoImmune 66 8.3.1 Product Description 66 8.3.2 Research and Development 67 8.3.2.1 Clinical Studies 67 8.3.2.1.1 Phase III 67 8.4 Favipiravir: FUJIFILM Toyama Chemical Co., Ltd. 69 8.4.1 Product Description 69 8.4.2 Research and Development 70 8.4.2.1 Clinical Studies 70 8.4.2.1.1 Phase III 70 8.5 Hydroxychloroquine: Sanofi-Aventis 72 8.5.1 Product Description 72 8.5.2 Research and Development 72 8.5.2.1 Clinical Studies 72 8.5.2.1.1 Phase III 72 8.6 Remdesivir: Gilead Sciences 76 8.6.1 Product Description 76 8.6.2 Research and Development 76 8.6.2.1 Pre-clinical Studies 76 8.6.2.2 Clinical Studies 77 8.6.2.2.1 Phase III 77 8.7 Ruxolitinib: Incyte Corporation 79 8.7.1 Product Description 79 8.7.2 Research and Development 79 8.7.2.1 Clinical Studies 79 8.7.2.1.1 Phase III 79 8.7.3 Product Development Activities 80 8.7.3.1 Collaboration Agreement 80 8.8 Tocilizumab: Hoffmann-La Roche 82 8.8.1 Product Description 82 8.8.2 Research and Development 83 8.8.2.1 Clinical Studies 83 8.8.2.1.1 Phase III 83 8.9 Tradipitant: Vanda Pharmaceuticals 85 8.9.1 Product Description 85 8.9.2 Research and Development 86 8.9.2.1 Clinical Studies 86 8.9.2.1.1 Phase III 86 8.9.3 Product Development Activities 86 8.9.3.1 Licensing Agreement 86 8.9.3.2 Patent 86 9. MID PHASE PRODUCTS (PHASE II) 88 9.1 Comparative Analysis 88 9.2 APN-01: Apeiron Biologics 89 9.2.1 Product Description 89 9.2.2 Research and Development 90 9.2.2.1 Clinical Studies 90 9.2.2.1.1 Phase II 90 9.2.3 Product Development Activities 90 9.2.3.1 Acquisition Agreement 90 9.3 Aviptadil: Relief Therapeutics 92 9.3.1 Product Description 92 9.3.2 Research and Development 92 9.3.2.1 Clinical Studies 92 9.3.2.1.1 Phase II 92 9.3.3 Product Development Activities 92 9.3.3.1 Divestment Agreement 92 9.3.3.2 IND Application 93 9.3.3.3 Acquisition Agreement 93 9.4 BXT-10: Bioxytran 95 9.4.1 Product Description 95 9.4.2 Research and Development 96 9.4.2.1 Pre-clinical Studies 96 9.4.2.2 Clinical Studies 96 9.4.2.2.1 Phase II 96 9.4.3 Product Development Activities 97 9.4.3.1 Licensing 97 9.5 Leronlimab: CytoDyn 98 9.5.1 Product Description 98 9.5.2 Research and Development 98 9.5.2.1 Clinical Studies 98 9.5.2.1.1 Phase II 98 9.5.3 Product Development Activities 99 9.5.3.1 Acquisition Agreement 99 9.6 Lopinavir+Ritonavir: AbbVie 101 9.6.1 Product Description 101 9.6.2 Research and Development 101 9.6.2.1 Clinical Studies 101 9.6.2.1.1 Phase II 101 9.6.3 Product Development Activities 101 9.6.3.1 Collaboration 101 9.7 Plitidepsin: PharmaMar 103 9.7.1 Product Description 103 9.7.2 Research and Development 103 9.7.2.1 Preclinical Studies 103 9.7.2.2 Clinical Studies 104 9.7.2.2.1 Phase II 104 9.8 Sarilumab: Sanofi-Aventis 106 9.8.1 Product Description 106 9.8.2 Research and Development 107 9.8.2.1 Clinical Studies 107 9.8.2.1.1 Phase II/III 107 9.8.3 Product Development Activities 108 9.8.3.1 Collaboration Agreement 108 9.8.3.2 Technology 109 9.9 SNG001: Synairgen Research 111 9.9.1 Product Description 111 9.9.2 Research and Development 111 9.9.2.1 Clinical Studies 111 9.9.2.1.1 Phase II 111 9.9.3 Product Development Activities 112 9.9.3.1 Technology 112 10. EARLY STAGE PRODUCTS (PHASE I and IND) 115 10.1 Comparative Analysis 115 10.2 AmnioBoost: Lattice Biologics 116 10.2.1 Product Description 116 10.2.2 Research and Development 116 10.2.2.1 Clinical Studies 116 10.2.2.1.1 Phase I 116 10.3 Baloxavir marboxil/Favipiravir and Lopinavir/Ritonavir: Shionogi & Co., Ltd. 118 10.3.1 Product Description 118 10.3.2 Research and Development 118 10.3.2.1 Clinical Studies 118 10.3.2.1.1 Phase 0 118 10.4 Gimsilumab: Roivant Sciences 120 10.4.1 Product Description 120 10.4.2 Research and Development 120 10.4.2.1 Clinical Studies 120 10.4.2.1.1 Phase I 120 10.5 REGN3048+REGN3051: Regeneron Pharmaceuticals 122 10.5.1 Product Description 122 10.5.2 Research and Development 122 10.5.2.1 Pre-clinical Studies 122 10.5.2.2 Clinical Studies 122 10.5.2.2.1 Phase I 122 10.5.3 Product Development Activities 123 10.5.3.1 Collaboration Agreement 123 10.5.3.2 Technology 124 10.6 Ifenprodil: Algernon Pharmaceuticals 126 10.6.1 Product Description 126 10.6.2 Research and Development 126 10.6.2.1 Pre-clinical Studies 126 10.6.2.2 Clinical Studies 127 10.6.2.2.1 Planned Phase II 127 10.6.3 Product Development Activities 127 10.6.3.1 Recent Initiatives towards COVID-19 Pandemic 127 10.6.3.2 Manufacturing Agreement 128 10.6.3.3 IND Application 128 10.6.3.4 Contract Agreement 128 10.7 Remestemcel-L: Mesoblast 130 10.7.1 Product Description 130 10.7.2 Research and Development 130 10.7.2.1 Clinical Studies 130 10.7.2.1.1 Phase II/III 130 10.7.3 Product Development Activities 131 10.7.3.1 IND Application 131 10.7.3.2 Partnership 131 10.7.3.3 Licensing Agreement 131 10.8 TJM2: I-Mab Biopharma 133 10.8.1 Product Description 133 10.8.2 Research and Development 133 10.8.2.1 Clinical Studies 133 10.8.2.1.1 Phase I 133 10.8.3 Product Development Activities 133 10.8.3.1 IND Application 133 11. PRE-CLINICAL AND DISCOVERY STAGE PRODUCTS 135 11.1 Comparative Analysis 135 12. THERAPEUTIC ASSESSMENT (CLINICAL PRODUCTS) 137 12.1 Assessment by Stage and Product Type 137 12.2 Assessment by Stage and Product Type 138 12.3 Assessment by Route of Administration 139 12.4 Assessment by Stage and Route of Administration 140 12.5 Assessment by Molecule Type 141 12.6 Assessment by Stage and Molecule Type 142 13. EXECUTIVE SUMMARY 143 14. VACCINES UNDER DEVELOPMENT BY COMPANIES 145 14.1 Clinical Stage Vaccines 145 14.2 Ad5-nCoV: CanSino Biologics Inc. 146 14.2.1 Product Description 146 14.2.2 Research and Development 146 14.2.2.1 Pre-clinical Studies 146 14.2.2.2 Clinical Studies 146 14.2.2.2.1 Phase I 146 14.2.3 Product Development Activities 146 14.2.3.1 Technology 146 14.3 mRNA-1273: Moderna Inc. 148 14.3.1 Product Description 148 14.3.2 Research and Development 148 14.3.2.1 Clinical Studies 148 14.3.2.1.1 Phase I 148 14.3.3 Product Development Activities 149 14.3.3.1 Funding 149 14.4 INO-4800: Inovio Pharmaceuticals 151 14.4.1 Product Description 151 14.4.2 Research and Development 151 14.4.2.1 Pre-clinical Studies 151 14.4.2.2 Clinical Studies 151 14.4.2.2.1 Phase I 151 14.4.3 Product Development Activities 152 14.4.3.1 Collaboration 152 14.4.3.2 Funding 152 14.5 Non-Clinical Stage Vaccines 154 15. VACCINES UNDER DEVELOPMENT BY UNIVERSITIES 157
Figure 1: β-coronavirus Particle and Genome 20 Figure 2: Key Events in the Early Stage of SARS-CoV-2 Outbreak 24 Figure 3: Postulated Pathogenesis of SARS-CoV-2 Infection 28 Figure 4: Proposed COVID-19 Triage Algorithm for Low-income Settings Without Established Local Transmission 56 Figure 5: Total Number of Products in COVID-19 61 Figure 6: Late Stage Products (Phase III) 62 Figure 7: CD24Fc: Mechanism of Action 66 Figure 8: Avigan: Mechanism of Action 69 Figure 9: Inhibitory Action of Tocilizumab in IL-6 Signaling 82 Figure 10: Tradipitant: NK-1R Antagonist 85 Figure 11: Mid Stage Products (Phase II) 88 Figure 12: APN01: Mode of Action 89 Figure 13: BXT-10: Structure 95 Figure 14: Gal-3 Inhibitor: Mechanism Of Action 95 Figure 15: Plitidepsin: Mechanism of Action 103 Figure 16: Kevzara: Mechanism of Action 106 Figure 17: Early Stage Products (Phase I and IND) 115 Figure 18: Pre-clinical and Discovery Stage Products 135 Figure 19: Assessment by Stage and Product Type 137 Figure 20: Assessment by Stage and Product Type 138 Figure 21: Assessment by Route of Administration 139 Figure 22: Assessment by Stage and Route of Administration 140 Figure 23: Assessment by Molecule Type 141 Figure 24: Assessment by Stage and Molecule Type 142 Figure 25: Clinical Stage Vaccines 145 Figure 26: Non-Clinical Stage Vaccines 154 Table 1: Summary of Chemotherapeutic Drugs under Clinical Trial for COVID-19 30 Table 2: SARS-CoV-2 Tests Commercially Available or in Development for the Diagnosis of COVID-19 31 Table 3: Summary of Chemotherapeutic Drugs under Clinical Trial for COVID-19 52 Table 4: Clinical Products under Development by Target 59 Table 5: Total Number of Products in COVID-19 61 Table 6: Late Stage Products (Phase III) 62 Table 7: Clinical Trial Description: ASC09+Ritonavir 63 Table 8: General Description: ASC09+Ritonavir 64 Table 9: Clinical Trial Description: CD24Fc 68 Table 10: General Description: CD24Fc 68 Table 11: Clinical Trial Description: Favipiravir 70 Table 12: General Description: Favipiravir 70 Table 13: Clinical Trial Description: Hydroxychloroquine 74 Table 14: General Description: Hydroxychloroquine 74 Table 15: Clinical Trial Description: Remdesivir 77 Table 16: General Description: Remdesivir 78 Table 17: Clinical Trial Description: Ruxolitinib 80 Table 18: General Description: Ruxolitinib 80 Table 19: Clinical Trial Description: Tocilizumab 83 Table 20: General Description: Tocilizumab 83 Table 21: Clinical Trial Description: Tradipitant 86 Table 22: General Description: Tradipitant 86 Table 23: Mid Stage Products (Phase II) 88 Table 24: Clinical Trial Description: APN-01 90 Table 25: General Description: APN-01 91 Table 26: Clinical Trial Description: Aviptadil 92 Table 27: General Description: Aviptadil 93 Table 28: Clinical Trial Description: BXT-10 96 Table 29: General Description: BXT-10 97 Table 30: Clinical Trial Description: Leronlimab 99 Table 31: General Description: Leronlimab 99 Table 32: Clinical Trial Description: Lopinavir+Ritonavir 101 Table 33: General Description: Lopinavir+Ritonavir 102 Table 34: Clinical Trial Description: Plitidepsin 104 Table 35: General Description: Plitidepsin 104 Table 36: Clinical Trial Description: Sarilumab 108 Table 37: General Description: Sarilumab 109 Table 38: Clinical Trial Description: SNG001 112 Table 39: General Description: SNG001 113 Table 40: Early Stage Products (Phase I and IND) 115 Table 41: Clinical Trial Description: AmnioBoost 117 Table 42: General Description: AmnioBoost 117 Table 43: Clinical Trial Description: Baloxavir Marboxil, Favipiravir, and Lopinavir-Ritonavir 118 Table 44: General Description: Baloxavir Marboxil, Favipiravir, and Lopinavir-Ritonavir 118 Table 45: Clinical Trial Description: Gimsilumab 121 Table 46: General Description: Gimsilumab 121 Table 47: Clinical Trial Description: REGN3048+REGN3051 123 Table 48: General Description: REGN3048+REGN3051 124 Table 49: Clinical Trial Description: Ifenprodil 127 Table 50: General Description: Ifenprodil 128 Table 51: Clinical Trial Description: Remestemcel-L 131 Table 52: General Description: Remestemcel-L 132 Table 53: General Description: TJM2 134 Table 54: Pre-clinical and Discovery Stage Products 135 Table 55: Assessment by Stage and Product Type 137 Table 56: Assessment by Stage and Product Type 138 Table 57: Assessment by Route of Administration 139 Table 58: Assessment by Stage and Route of Administration 140 Table 59: Assessment by Molecule Type 141 Table 60: Assessment by Stage and Molecule Type 142 Table 61: Clinical Stage Vaccines 145 Table 62: Clinical Trial Description: Ad5-nCoV 146 Table 63: General Description: Ad5-nCoV 147 Table 64: Clinical Trial Description: mRNA-1273 149 Table 65: General Description: mRNA-1273 149 Table 66: Clinical Trial Description: INO-4800 151 Table 67: General Description: INO-4800 152 Table 68: Non-clinical Stage Vaccines 154 Table 69: Vaccines Under Development By Universities 157
Ascletis Pharma Inc., OncoImmune, FUJIFILM Toyama Chemical Co., Ltd., Sanofi, Gilead Sciences, Incyte Corporation, Hoffmann La Roche, Vanda Pharmaceuticals, Apeiron Biologics, Relief Therapeutics Holdings
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