human papillomavirus protein e7 (e7)-pipeline review, h2 2017

human papillomavirus protein e7 (e7)-pipeline review, h2 2017


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Executive Summary

Human Papillomavirus Protein E7 (E7)-Pipeline Review, H2 2017

Summary

Human Papillomavirus Protein E7 (E7) pipeline Target constitutes close to 38 molecules. Out of which approximately 27 molecules are developed by companies and remaining by the universities/institutes. The latest report Human Papillomavirus Protein E7 (E7)-Pipeline Review, H2 2017, outlays comprehensive information on the Human Papillomavirus Protein E7 (E7) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type.

Human Papillomavirus Protein E7 (E7)-Human Papilloma Virus (HPV) E7 protein belongs to a group of proteins called oncoproteins. It plays a role in viral genome replication by driving entry of quiescent cells into the cell cycle. E7 protein has both transforming and trans-activating activities. It induces the disassembly of the E2F1 transcription factor from RB1, with subsequent transcriptional activation of E2F1-regulated S-phase genes. Ii interferes with host histone deacetylation mediated by HDAC1 and HDAC2, leading to transcription activation. It plays an important role in the inhibition of both antiviral and antiproliferative functions of host inteferon alpha. The molecules developed by companies in Phase III, Phase II, Phase I, Preclinical, Discovery and Unknown stages are 2, 7, 3, 13, 1 and 1 respectively. Similarly, the universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 3, 1, 6 and 1 molecules, respectively. Report covers products from therapy areas Oncology, Women's Health and Infectious Disease which include indications Human Papillomavirus (HPV) Associated Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Head And Neck Cancer Squamous Cell Carcinoma, Head And Neck Cancer, Anal Cancer, Oropharyngeal Cancer, Hepatocellular Carcinoma, Human Papillomavirus Infections, Lung Cancer, Metastatic Transitional (Urothelial) Tract Cancer, Non-Small Cell Lung Carcinoma, Rectal Cancer and Recurrent Head And Neck Cancer Squamous Cell Carcinoma.

Furthermore, this report also reviews key players involved in Human Papillomavirus Protein E7 (E7) targeted therapeutics development with respective active and dormant or discontinued projects. Driven by data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Scope

-The report provides a snapshot of the global therapeutic landscape for Human Papillomavirus Protein E7 (E7)

-The report reviews Human Papillomavirus Protein E7 (E7) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

-The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

-The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

-The report reviews key players involved in Human Papillomavirus Protein E7 (E7) targeted therapeutics and enlists all their major and minor projects

-The report assesses Human Papillomavirus Protein E7 (E7) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

-The report summarizes all the dormant and discontinued pipeline projects

-The report reviews latest news and deals related to Human Papillomavirus Protein E7 (E7) targeted therapeutics

Reasons to buy

-Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

-Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

-Identify and understand the targeted therapy areas and indications for Human Papillomavirus Protein E7 (E7)

-Identify the use of drugs for target identification and drug repurposing

-Identify potential new clients or partners in the target demographic

-Develop strategic initiatives by understanding the focus areas of leading companies

-Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics

-Devise corrective measures for pipeline projects by understanding Human Papillomavirus Protein E7 (E7) development landscape

-Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope



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Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Human Papillomavirus Protein E7 (E7)-Overview 9

Human Papillomavirus Protein E7 (E7)-Therapeutics Development 10

Products under Development by Stage of Development 10

Products under Development by Therapy Area 11

Products under Development by Indication 12

Products under Development by Companies 13

Products under Development by Universities/Institutes 19

Human Papillomavirus Protein E7 (E7)-Therapeutics Assessment 21

Assessment by Mechanism of Action 21

Assessment by Route of Administration 22

Assessment by Molecule Type 24

Human Papillomavirus Protein E7 (E7)-Companies Involved in Therapeutics Development 26

Abion Inc 26

Advaxis Inc 26

Bioleaders Corp 27

BioNTech AG 27

Cancer Research Technology Ltd 28

Etubics Corp 28

Formune SL 29

Genexine Inc 29

Hookipa Biotech AG 30

iBio Inc 30

Immunovaccine Inc 31

Inovio Pharmaceuticals Inc 31

MedImmune LLC 32

Selecta Biosciences Inc 32

Transgene SA 33

VLPbio 33

Human Papillomavirus Protein E7 (E7)-Drug Profiles 34

ABN-301-Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

Antibodies to Inhibit E7 for HPV Associated Cancer-Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

Aptamer to Target HPV E7 Protein for Cervical Cancer-Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

axalimogene filolisbac-Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

axalimogene filolisbac second generation-Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

BLSILSB-710c-Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

BVAC-C-Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

CerviVax-Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

CUE-101-Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

CUE-201-Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

DNA Vaccine to Target E7 for HPV Associated Cancers-Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

DNA Vaccine to Target E7 for HPV Associated Cervical Intraepithelial Neoplasia-Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

DPXE-7-Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

EDA-HPVE7-Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Enzymes to Inhibit HPV E6 and E7 for Cervical Intraepithelial Neoplasia-Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

Enzymes to Inhibit HPV E7 for Human Papillomavirus Related Cervical Cancer-Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

ETBX-041-Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

Gene Therapy for Human Papilloma Virus Associated Cervical Intraepithelial Neoplasia-Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Gene Therapy to Inhibit E6 and E7 for HPV Associated Cervical Cancer-Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

GLBL-101c-Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

GX-188E-Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

HB-201-Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

human papillomavirus [Serotype 16] vaccine-Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

human papillomavirus [serotypes 16] vaccine-Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

human papillomavirus vaccine-Drug Profile 79

Product Description 79

Mechanism Of Action 79

R&D Progress 79

INO-3106-Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

MEDI-0457-Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

PVX-01-Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

Recombinant Vector Vaccine to Target Human Papillomavirus Protein E7 for HPV Associated Cervical Cancer-Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

SEL-701-Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

TA-CIN-Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

TG-4001-Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

Tricurin-Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

TTFC-E7SH-Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

Vaccine to Target HPV E7 Protein for Cervical Cancer-Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

Vaccine to Target IL-2 and E7 Protein for Cervical Cancer and Oropharyngeal Cancer-Drug Profile 95

Product Description 95

Mechanism Of Action 95

R&D Progress 95

VGX-3100-Drug Profile 96

Product Description 96

Mechanism Of Action 96

R&D Progress 96

Vvax-001-Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

Human Papillomavirus Protein E7 (E7)-Dormant Products 101

Human Papillomavirus Protein E7 (E7)-Discontinued Products 103

Human Papillomavirus Protein E7 (E7)-Product Development Milestones 104

Featured News & Press Releases 104

Jul 13, 2017: Advaxis Lead Immunotherapy Candidate Continues to Build Recognition Among Industry Leaders 104

Jun 26, 2017: Advaxis Axalimogene Filolisbac Data Selected for Poster Presentation at ESGO 2017 104

Jun 19, 2017: Genexine Receives Approval to Initiate Phase Ib/II Trial of GX-188E, HPV Therapeutic DNA Vaccine, in Combination With KEYTRUDA, for the Treatment of HPV-Induced Cervical Cancer 105

Jun 08, 2017: Inovio Begins Phase 3 Clinical Trial of VGX-3100 for the Treatment of HPV-Related Cervical Pre-Cancer 106

May 18, 2017: Advaxis to Host Investor & Analyst Day on June 12 107

May 10, 2017: Inovio Provides Update on MedImmune Launch of Combination Trial for HPV-associated Head & Neck Cancer 107

Apr 24, 2017: Inovio Initiates Phase 2 Efficacy Trial with VGX-3100 For HPV-Related Vulvar Pre-Cancers 108

Apr 18, 2017: Immunovaccine Announces Dosing of First Patient in Investigator-Sponsored Phase 1b/2 Clinical Trial Evaluating Immuno-Oncology Candidate Targeting Incurable HPV-Related Cancers 108

Mar 27, 2017: Advaxis Provides Phase 1 Data of Higher Dose Axalimogene Filolisbac 109

Mar 23, 2017: EMA Certification Paves the Way for the MAA Submission for Axalimogene Filolisbac in Metastatic Cervical Cancer 110

Mar 22, 2017: Cue Biopharma Announces Selection of Lead Candidate Cue-101 Targeting Human Papillomavirus-Associated Cancers 110

Mar 15, 2017: Advaxis Presents Oral Late-breaking Data on Phase 2 GOG-0265 Study of Axalimogene Filolisbac at SGOs Annual Meeting on Womens Cancer 110

Mar 06, 2017: Dr Igor Matushansky Appointed Global Head, Research and Development of Hookipa Biotech 112

Feb 06, 2017: Advaxis Announces First Patient Dosed in Global Phase 3 AIM2CERV Trial for High-risk, Locally Advanced Cervical Cancer 112

Jan 30, 2017: GOG-0265 Study in Metastatic Cervical Cancer Selected for Late-Breaking Data Presentation at the Society of Gynecologic Oncologys Annual Meeting on Womens Cancer 113

Appendix 115

Methodology 115

Coverage 115

Secondary Research 115

Primary Research 115

Expert Panel Validation 115

Contact Us 115

Disclaimer 116

List of Figures

Number of Products under Development by Stage of Development, H2 2017 10

Number of Products under Development by Therapy Areas, H2 2017 11

Number of Products under Development by Top 10 Indications, H2 2017 12

Number of Products by Stage and Mechanism of Actions, H2 2017 21

Number of Products by Routes of Administration, H2 2017 22

Number of Products by Stage and Routes of Administration, H2 2017 22

Number of Products by Top 10 Molecule Types, H2 2017 24

Number of Products by Stage and Top 10 Molecule Types, H2 2017 24

List of Tables

Number of Products under Development by Stage of Development, H2 2017 10

Number of Products under Development by Therapy Areas, H2 2017 11

Number of Products under Development by Indication, H2 2017 12

Number of Products under Development by Companies, H2 2017 13

Number of Products under Development by Companies, H2 2017 (Contd..1) 14

Products under Development by Companies, H2 2017 15

Products under Development by Companies, H2 2017 (Contd..1), H2 2017 16

Products under Development by Companies, H2 2017 (Contd..2), H2 2017 17

Products under Development by Companies, H2 2017 (Contd..3), H2 2017 18

Number of Products under Investigation by Universities/Institutes, H2 2017 19

Products under Investigation by Universities/Institutes, H2 2017 20

Number of Products by Stage and Mechanism of Actions, H2 2017 21

Number of Products by Stage and Route of Administration, H2 2017 23

Number of Products by Stage and Molecule Type, H2 2017 25

Pipeline by Abion Inc, H2 2017 26

Pipeline by Advaxis Inc, H2 2017 26

Pipeline by Bioleaders Corp, H2 2017 27

Pipeline by BioNTech AG, H2 2017 27

Pipeline by Cancer Research Technology Ltd, H2 2017 28

Pipeline by Etubics Corp, H2 2017 28

Pipeline by Formune SL, H2 2017 29

Pipeline by Genexine Inc, H2 2017 29

Pipeline by Hookipa Biotech AG, H2 2017 30

Pipeline by iBio Inc, H2 2017 30

Pipeline by Immunovaccine Inc, H2 2017 31

Pipeline by Inovio Pharmaceuticals Inc, H2 2017 31

Pipeline by MedImmune LLC, H2 2017 32

Pipeline by Selecta Biosciences Inc, H2 2017 32

Pipeline by Transgene SA, H2 2017 33

Pipeline by VLPbio, H2 2017 33

Dormant Products, H2 2017 101

Dormant Products, H2 2017 (Contd..1), H2 2017 102

Discontinued Products, H2 2017 103

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Advaxis Inc

Bioleaders Corp

BioNTech AG

Cancer Research Technology Ltd

Etubics Corp

Formune SL

Genexine Inc

Hookipa Biotech AG

iBio Inc

Immunovaccine Inc

Inovio Pharmaceuticals Inc

MedImmune LLC

Selecta Biosciences Inc

Transgene SA

VLPbio

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