GLOBAL CANCER IMMUNOTHERAPY MARKET ANALYSIS TO 2022

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GLOBAL CANCER IMMUNOTHERAPY MARKET ANALYSIS TO 2022: Antibody Drug Conjugates (ADCs), Bispecific Monoclonal Antibodies, Cancer Vaccines, Cytokines, Interferons, Chimeric Antigen Receptor (CAR) T-Cell Therapy, PD-1/PD-L1 inhibitors, Dendritic Cells, Checkpoint Inhibitors, Adopted Cell Therapy (ACT) & IDO Inhibitors

Published October 2017      Download sample here

Contact deirdre@kellysci.com for more information

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GLOBAL CANCER IMMUNOTHERAPY MARKET ANALYSIS TO 2022:

Antibody Drug Conjugates (ADCs), Bispecific Monoclonal Antibodies, Cancer Vaccines, Cytokines, Interferons, Chimeric Antigen Receptor (CAR) T-Cell Therapy, PD-1/PD-L1 inhibitors, Dendritic Cells, Checkpoint Inhibitors, Adopted Cell Therapy (ACT) & IDO Inhibitors

Published October 2017       Sample of report here

 

Within the cancer therapeutics space, which today is worth over $100 billion globally, immunotherapeutic drugs have gained worldwide acceptance. This is because they are targeted therapeutics that have high specificity for cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $54 billion in 2016 alone and are forecast to surpass $100 billion in 2022. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 340 pages.

 

  • An overview of cancer immunotherapy that includes: monoclonal antibodies, ADC’s, cancer vaccines and non-specific cancer immunotherapies and CAR T therapies.
  • Focus on current trends in cancer immunotherapies that include: anti-PD-1 and anti-PDL1 drugs, Dendritic cell vaccines, T-cell therapies and cancer
  • Insight into the challenges faced by drug developers, particularly about the success failure ratios in developing cancer immunotherapy drugs.
  • Descriptions of more than 23 cancer immunotherapeutics approved and used as targeted drugs
  • Insight into the various immunotherapeutics available for specific cancer
  • Description and data for the prevalence of cancer types that are addressed by cancer immunotherapeutics.
  • Overall global cancer therapeutics market, leading market players and the best selling cancer
  • Detailed account of the market for cancer immunotherapeutics by geography, indication, company and individual
  • Profiles, marketed products and products in the pipeline of 79 companies that are located globally
  • Summary table to identify the category of immunotherapy drug offered by the 79
  • Specific chapter on the CAR-T industry detailing manufacturing, regulations and pricing

 

 

1.1   Executive Summary

 

Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market. The rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early detection techniques, higher patient awareness and a growing aging population. Furthermore, the FDA’s pro-science attitude will accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $100 billion by 2022. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.

 

Prior to the launching of Yervoy, the five-year survival rate for patients with early stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%. Yervoy has been reported to have a survival rate of 25% when tested alone. When tested as part of a combination therapy treatment with Bristol’s nivolumab, the two-year survival rates rose to 88% for patients with late-stage cancer. Increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated. Other key therapeutic players in this market include Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), Ibrance (palbociclib) the newly approved Bavencio (avelumab) and Imfinzi (durvalumab) and of course the first CAR-T therapy Kymriah (tisagenlecleucel). The second CAR-T therapy, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval in October 2017.

 

Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy space, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given a fast-track approval on December 22, 2014. The majority of immune-oncology agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1/PDL1 mechanisms.  A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting. Of course, Novartis gained the first CAR-T FDA approval for Kymriah (tisagenlecleucel ,CTL019), in August 2017, for children and young adults with B-cell ALL. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval. This is a major boost for the global and US immunotherapy, and gene therapy markets.

 

 

What Are CAR-T Therapies? How Will They Impact the Market?

 

CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered T cells have numerous advantages including:

  • Intracellular domain can be modified to increase efficacy and durability of CAR-T
  • CAR-T are still subject to the same regulatory and tolerogenic constraints of natural T cells, including checkpoints, Treg, MDSC
  • CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration
  • Can be modified to express suicide genes that limit CAR-T population if toxicity occurs

 

To date, the main challenges associated with CAR T therapy include manufacturing, regulations, pricing and toxicity in patients. Currently there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome. In July 2017, an FDA advisory panel determined that the benefits of CAR T outperform the risks.  Kymriah (tisagenlecleucel) by Novartis is indicated to treat children and young adults with acute leukemia and performed well in the ELIANA trial. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval and became the first CAR-T cell therapy on the US market. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval.

 

 

The CAR-T industry is addressing unmet needs in specific relapsed cancers, and trials have indicated that some patients show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Novartis, Juno Therapeutics, Kite Pharma and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From 2017, Kelly Scientific forecasts that CAR T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.

 

1.2    Key Questions Answered in this Report

 

 

  • What is the global market for cancer immunotherapeutics by product class such as MAbs, vaccines and non-specific immunotherapies, through 2022?
  • What is the global market for cancer immunotherapeutics by geography, through 2022?
  • What is the global market for cancer immunotherapeutics by indication, through 2022?
  • What is the global market for MAbs by type such as naked MAbs and ADCs, through 2022?
  • What are the market values for Herceptin, Avastin, Erbitux, Yervoy, Mabthera, Adectris, and Keytruda?
  • What is the global market for cancer vaccines?
  • What is the global market for cytokines in cancer immunotherapy?
  • The projected market values for Nivolumab, Tecentriq, DCVax-L, Imfinzi?
  • What immunotherapies were approved between 1986 and 2017?
  • What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
  • What are naked MAbs and how many of them have been approved by the FDA?
  • What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
  • What are the common cytotoxic “wareheads” used in ADCs?
  • What are the important clinical assets in ADCs?
  • How many bispecific MAbs are in late-stage development?
  • What are the common side effects of MAbs in cancer immunotherapy?
  • What are cancer vaccines and how many of them have been licensed to be marketed?
  • How many cytokines have been approved for being used in cancer immunotherapy?
  • What are the major checkpoint inhibitors in clinical development?
  • What is the current status of anti-PD-1 drugs, dentritic cell therapies, T-cell therapies and cancer vaccines?
  • What are the most valuable R&D projects in cancer immunotherapy and what would be their approximate sales revenues in 2022?
  • Number of melanoma drugs approved between 1998 and 2017?
  • Number of lung cancer drugs approved between 1998 and 2017?
  • Number of brain cancer drugs approved between 1998 and 2017?
  • What is CAR T Therapy?
  • What are the main challenges associated with CAR T therapy?
  • What is the status of CAR T therapeutic approval?
  • What are the current regulations for immunotherapies in USA, Europe & Japan?
  • What are the main manufacturing steps and challenges in CAR T therapy?

 

 

The report is supported by over 180 tables & figures over 370 pages. This report is presented as follows:

The global market for cancer immunotherapy by the following sub-categories are presented:

  • By Segment (Monoclonal Antibodies, Cancer Vaccines, Non-Specific Therapies, Checkpoint Inhibitors)
  • By Product Segment (Antibody Drug Conjugates (ADCs), Bispecific Monoclonal Antibodies, Cytokines, Interferons, Chimeric Antigen Receptor (CAR) T-Cell Therapy, PD-1/PD-L1 inhibitors, Dendritic Cells, Adopted Cell Therapy (ACT) & IDO Inhibitors)
  • By Company (e.g Amgen, Merck, Eli Lilly, GlaxoSmithKline, Janssen, Genentech, Roche, Bristol Myers Squibb)

 

 

A comprehensive account of company product portfolios are provided for 79 Cancer Immunotherapy pharma and biotech companies including:

  • Amgen Inc.
  • Biogen Idec Inc.x
  • Bristol-Myers Squibb Co.
  • Cellectis
  • Cellerant Therapeutics Inc.
  • Celldex Therapeutics
  • Eli Lilly and Co.
  • EMD Serono Inc.
  • Genentech Inc.
  • Genmab AS
  • GlaxoSmithKline
  • ImmunoGen Inc.
  • Immunomedics Inc.
  • Janssen Biotech Inc.
  • Juno Therapeutics Inc.
  • Merck & Co., Inc.
  • Oxford BioTherapeutics Ltd.
  • Progenics Pharmaceuticals Inc.
  • Roche Holdings Inc.
  • Seattle Genetics Inc.
  • Sorrento Therapeutics Inc.
  • Kite Pharma
  • Novartis

Fore more information, please email deirdre@kellysci.com

Table of Contents

1.0       Executive Summary                                                                                                    21

1.1       Objectives of Report                                                                                                     22

1.2       Key Questions Answered in this Report                                                                         22

1.3       Data Sources and Methodology                                                                                     23

2.0       Cancer Immunotherapy: An Overview                                                                       24

2.1       Human Immune System                                                                                                24

2.1.1    Components of Human Immune System                                                                        25

2.2       Types of Cancer Immunotherapy                                                                                   26

2.3       Monoclonal Antibodies (Mabs) to Treat Cancer                                                             27

2.3.1    Most Frequently Targeted Antigens by MAbs                                                                27

2.4       Types of Monoclonal Antibodies (MAbs)                                                                      29

2.4.1    Naked MAbs                                                                                                                29

2.4.2    Conjugated Monoclonal Antibodies                                                                               30

2.4.2.1 Components of an Antibody Drug Conjugate (ADC)                                                      30

2.4.2.2 Mechanism of Action of Antibody Drug Conjugate (ADC)                                             31

2.4.2.3 The Cytotoxic Wareheads used in ADCs                                                                        31

2.4.2.4 Successful Cytotoxin Wareheads                                                                                   32

2.4.2.5 Developmental Timeline of ADCs                                                                                 33

2.4.2.6 Target Antigens for ADCs in Preclinical and Clinical Development                                   34

2.4.2.7 Important Clinical Assets in ADCs                                                                                34

2.4.3    Bispecific Monoclonal Antibodies                                                                                 36

2.4.3.1 Technology Platforms for the Production of Bispecific MAbs                                         37

2.4.4    Safety and Side Effects of MAbs in Cancer Immunotherapy                                            37

2.5       Cancer Vaccines                                                                                                           38

2.5.1    Cancer Vaccines in Development                                                                                  39

2.6       Non-Specific Cancer Immunotherapies and Adjuvants                                                    42

2.6.1    Cytokines                                                                                                                    42

2.6.2    Interferon (IFN)                                                                                                            42

2.7       New Frontiers in Cancer Immunotherapy Research                                                        43

2.7.1    Drugs for Targeting Immune Checkpoints                                                                      43

2.7.1.1 Cytotoxic T-Lymphocyte-Associated Protein-4 (CTLA-4)                                              43

2.7.1.2 Programmed Death 1 (PD-1) and Programmed Death Ligand 1 (PD-L1)                          43

2.7.1.3 Major Checkpoint Inhibitors in Clinical Development                                                    43

2.7.2    Chimeric Antigen Receptor (CAR) T Cell Therapy                                                         44

2.7.3    Tumor-Infiltrating Lymphocytes (TILs) and Interleukin-2 (IL-2)                                     44

2.8       Cancer Immunotherapy: Timeline of Progress                                                                44

3.0       Current Status of Cancer Immunotherapy: An Overview                                          48

3.1       Programmed Death (PD-1) Inhibitors                                                                             48

3.1.1    Important Events and Advantages for Nivolumab in Melanoma Indication                       49

3.1.2    Important Events and Advantages for Nivolumab in Non-Small Cell Lung Cancer           50

3.1.3    Important Events and Advantages for Nivolumab in Renal Cell Cancer                           50

3.1.4    Nivolumab Studies for Melanoma                                                                                 50

3.1.5    Nivolumab Studies for Non-Small Cell Lung Cancer (NSCLC)                                       51

3.1.6    Nivolumab Studies for Renal Cell Cancer (RCC)                                                            51

3.2       MK-3475 (Pembrolizumab)                                                                                          51

3.2.1    Important Events and Advantages for MK-3475 in Melanoma                                         51

3.2.2    Important Events and Advantages for MK-3475 in NSCLC                                            52

3.2.3    Important Events for MK-3475 in RCC                                                                         52

3.3       RG7446 from Roche                                                                                                     52

3.3.1    Important Events for RG7446 in Melanoma                                                                   53

3.3.2    Important Events and Advantages for RG7446 in NSCLC                                               53

3.3.3    Important Event for RG7446 in RCC                                                                             54

3.3.4    RG7446 Studies in NSCLC                                                                                           54

3.3.5    RG7446 Studies in RCC                                                                                               54

3.3.6    RG7446 Study in RCC                                                                                                 55

3.4       Pidilizumab from CureTech                                                                                          56

3.5       An Overview of Anti-PD-1 Clinical Development                                                          56

3.5.1    Other Checkpoint Inhibitors in Development                                                                  58

3.6       Studies with Yervoy (Ipilimumab)                                                                                 58

3.7       Studies with Tremelimumab                                                                                          60

3.8       KAHR-102                                                                                                                  60

3.9       TIM3 Antibody                                                                                                            60

3.10     BMS-989016                                                                                                               60

3.11     ImmuTune IMP701 and ImmuFact IMP321                                                                   61

3.12     Dendritic Cell Therapies                                                                                               61

3.12.1  Provenge (Sipuleucel-T)                                                                                               62

3.12.2  AGS-003 from Argos Therapeutics                                                                                62

3.12.3  DCP-001 from DCPrime                                                                                               63

3.12.4  DC-Vax from Northwest Biotherapeutics                                                                       63

3.13     Chimeric Antigen Receptor T-Cells (CAR-T) Therapies                                                 63

3.13.1  CLT109                                                                                                                       63

3.13.2  Chimeric Antigen Receptors (CAR) Program by Juno                                                     64

3.13.3  Chimeric Antigen Receptor (CAR) T-Cell Program by Bluebird Bio                               64

3.13.4  UCART19 from Cellectis                                                                                             64

3.13.5  Chimeric Immune Receptor (CIR) T-Cells from Abramson Cancer Center                       65

3.13.6  CD19 eACT CAR-T Therapy from Kite Pharma                                                            65

3.13.7  Autologous CAR-T Program for Breast Cancer from Adaptimmune                                65

3.14     Cancer Vaccines                                                                                                           65

3.14.1  HyperAcute                                                                                                                 65

3.14.2  MAGE-A3 Antigen-Specific Cancer Immunotherapeutic                                                67

3.14.3  ADXS-HPV                                                                                                                 67

3.14.4  IDO Inhibitors                                                                                                              68

3.14.5  Indoximod and NLG-919 (INCY)                                                                                  68

3.14.6  INCB24360 (INCY)                                                                                                     68

3.14.7  deCellVax (BMSN)                                                                                                      68

3.15     Miscellaneous Immunotherapies                                                                                    69

3.15.1  Contego (Lion Biotechnologies)                                                                                    69

3.15.2  TG4010 (Transgene)                                                                                                     69

3.16     Most Valuable R&D Projects in Cancer Immunotherapy                                                 69

3.16.1  Nivolumab (Opdivo)                                                                                                     70

3.16.2  MK-3475                                                                                                                     70

3.16.3  RG7446                                                                                                                       70

3.16.4  Palbociclib                                                                                                                   71

3.16.5  DCVax-L                                                                                                                     71

3.16.6  MEDI4736                                                                                                                   71

4.0       Challenges in Cancer Medicine Research: An Overview                                            64

4.1       Years of Failures and Emerging Successes in Melanoma Medicine Research                   64

4.1.1    Future Outlook for Melanoma Drugs                                                                             73

4.2       A New Era for Lung Cancer Medicines                                                                          74

4.2.1    Progresses Made in Lung Cancer Medicine Research                                                     74

4.2.2    Successes and Failures in Lung Cancer Medicine Development                                       75

4.2.3    Future Outlook for Lung Cancer Medicines                                                                    75

4.3       Ray of Hope for Brain Cancer Patients                                                                           76

4.3.1    Progress made for Brain Cancer Treatment in Recent Years                                            76

4.3.2    Successes and Failures in Brain Cancer Drug Development                                            76

5.0       Cancer Immunotherapeutic Products: An Overview                                                  78

5.1       I-Labelled Tositumomab (Bexxar)                                                                                 78

5.2       Y-Labelled Ibritumomab (Zevalin)                                                                                78

5.3       Alemtuzumab (Campath)                                                                                              79

5.4       Adotrastuzumab Emtansine (Kadcyla)                                                                           79

5.5       Bacillus Calmette-Guerin (BCG)                                                                                   80

5.6       Bevacizumab (Avastin)                                                                                                 80

5.7       Brentuximab Vedotin (Adcetris)                                                                                    80

5.8       Cetuximab (Erbitux)                                                                                                     81

5.9       Cervarix                                                                                                                       81

5.10     Denileukin Diftitox (Ontak)                                                                                          82

5.11     Gardasil                                                                                                                       82

5.12     Gemtuzumab (Mylotarg)                                                                                               82

5.13     Hepatitis B Vaccine                                                                                                      82

5.14     Interferon Alfa (IFN-alfa)                                                                                             82

5.15     Interleukin-2 (IL-2)                                                                                                      83

5.16     Ipilimumab (Yervoy)                                                                                                    83

5.17     Ofatumumab (Arzerra)                                                                                                 83

5.18     Panitumumab (Vectibix)                                                                                               83

5.19     Pembrolizumab (Keytruda)                                                                                           83

5.20     Rituximab (Mabthera)                                                                                                  84

5.21     Sargramostim (Leukine)                                                                                                84

5.22     Sipuleucel-T (Provenge)                                                                                               84

5.23     Trastuzumab (Herceptin)                                                                                              84

6.0       Available Immunotherapies for Cancer by Disease Type: An Overview                     86

6.1       Melanoma Skin Cancer and Immunotherapy                                                                  87

6.1.1    Ipilimumab (Yervoy) for Advanced Melanoma                                                              87

6.1.2    PD-1 Inhibitors (Keytruda and Opdivo) for Advanced Melanoma                                    87

6.1.3    Cytokines for Advanced Melanoma                                                                               87

6.1.4    Interferon Alfa as Adjuvant Therapy for Melanoma                                                        87

6.1.5    Bacille Calmette-Guerin (BCG) Vaccine for Melanoma                                                  88

6.1.6    Imiquimod (zyclara) Cream for Melanoma                                                                     88

6.2       Breast Cancer and Immunotherapy                                                                                88

6.2.1    Promising Therapeutic Vaccine Product Candidates for Breast Cancer                             88

6.2.2    Promising Checkpoint Inhibiting Product Candidates for Breast Cancer                           89

6.2.3    Promising Adoptive T Cell Therapy Product Candidates for Breast Cancer                      89

6.2.4    Promising Antibody Product Candidates for Breast Cancer                                             89

6.3       Immunotherapy for Prostate Cancer                                                                               89

6.3.1    Therapeutic Vaccines for Prostate Cancer                                                                      90

6.3.2    Checkpoint Inhibitors for Prostate Cancer                                                                      91

6.3.3    Adoptive Cell Therapy for Prostate Cancer                                                                    92

6.4       Immunotherapy for Lung Cancer                                                                                   92

6.4.1    Monoclonal Antibodies for Lung Cancer                                                                        92

6.4.1.1 Promising MAb Product Candidates for Lung Cancer                                                     92

6.4.1.2 Checkpoint Inhibitors for Lung Cancer                                                                          93

6.4.1.3 Therapeutic Vaccines for Lung Cancer                                                                          95

6.4.1.4 Promising Adoptive T Cell Transfer Product Candidates for Lung Cancer                        95

6.5       Immunotherapy for Colorectal Cancer                                                                           96

6.5.1    Promising Monoclonal Antibody Product Candidates for Colorectal Cancer                     96

6.5.2    Trials Using Checkpoint Inhibitors and Immune Modulators for Colorectal Cancer          97

6.5.3    Clinical Trials for Vaccines Indicated for Colorectal Cancer                                           97

6.5.4    Adoptive Cell Therapy for Colorectal Cancer                                                                 98

6.5.5    Oncolytic Virus Therapy for Colorectal Cancer                                                              98

6.5.6    Adjuvant Immunotherapy for Colorectal Cancer                                                             98

6.5.7    Cytokines for Colorectal Cancer                                                                                    98

6.6       Immunotherapies in Development for Lymphoma                                                          99

6.6.1    Therapeutic Vaccines in Development for Lymphoma                                                    99

6.6.2    Checkpoint Inhibitors for Lymphoma                                                                            99

6.6.3    Adoptive T Cell Transfer for Lymphoma                                                                       99

6.6.4    Monoclonal Antibodies for Lymphoma                                                                          100

6.7       Immunotherapy for Kidney Cancer                                                                                100

6.7.1    Checkpoint Inhibitors for Kidney Cancer                                                                       100

6.7.2    Vaccines for Kidney Cancer                                                                                          100

6.7.3    Adoptive Cell Therapy for Kidney Cancer                                                                     101

6.8       Dominance of MAbs and Vaccines in Cancer Clinical Research                                      101

6.9       Oncology Biologics Losing Patent Protection                                                                 101

7.0       Cancer Incidence and Mortality: An Overview                                                          103

7.1       Global Economic Burden of Cancer                                                                               103

7.2       Global Burden of Cancer                                                                                              104

7.3       Top Five Most Frequent Cancers, Globally                                                                    104

7.3.1    Global Prevalence of Colorectal, Breast and Lung Cancers                                             105

7.3.2    Percentage of Top Three Cancers Diagnosed Globally                                                    105

7.3.2.1 Mortality due to Lung, Liver and Stomach Cancers                                                        106

7.3.2.2 Percentage of Death due to Lung, Liver and Stomach Cancers                                         107

7.4       Cancer Deaths in Women                                                                                              107

7.5       Prevalence and Mortality for Cancer Types Addressed by Immunotherapy                       108

7.5.1    Breast Cancer                                                                                                               108

7.5.1.1 Worldwide Incidence of Breast Cancer and Mortality Rate by Geography                        109

7.5.1.2 Female Breast Cancer Incidence in the U.S                                                                    109

7.5.1.3 Five Year Breast Cancer Survival Rates by Stage at Diagnosis and Age in the U.S           110

7.5.1.4 Breast Cancer Incidence in Canada                                                                                111

7.5.1.5 Breast Cancer Incidence and Mortality in Latin America                                                 111

7.5.1.6 Breast Cancer Incidence and Mortality in Europe                                                           112

7.5.1.7 Breast Cancer Incidence in Asia/Pacific                                                                         113

7.5.1.8 Breast Cancer Incidence by Country                                                                              114

7.5.2    Gastric Cancer (Stomach Cancer)                                                                                  118

7.5.2.1 Incidence of Gastric Cancer in Top 15 Countries                                                            118

7.5.3    Colorectal Cancer                                                                                                         119

7.5.3.1 Global Incidence of Colorectal Cancer                                                                           119

7.5.3.2 Worldwide Variations in the Incidence of Colorectal Cancer                                           120

7.5.3.3 Risk Factors for Colorectal Cancer                                                                                121

7.5.3.4 Colorectal Cancer Screening in the U.S                                                                          122

7.5.3.5 Colorectal Cancer Incidence Rates in the U.S. by State                                                   122

7.5.3.6 Colorectal Cancer Mortality Rates (per 100,000) in the U.S. by States                             123

7.5.4    Lung Cancer                                                                                                                124

7.5.4.1 Non-Small Cell Lung Cancer (NSCLC)                                                                         125

7.5.4.2 Global NSCLC Incidence                                                                                             126

7.5.4.3 Lung Cancer in Americas by Gender                                                                             126

7.5.4.4 Tobacco Use and Lung Cancer                                                                                      127

7.5.4.5 Current Therapeutic Options for Lung Cancer                                                                128

7.5.5    Glioblastoma                                                                                                                130

7.5.5.1 Global Incidence of Glioblastoma                                                                                  130

7.5.6    Kidney Cancer                                                                                                             131

7.5.6.1 Global Incidence of Kidney Cancer                                                                               132

7.5.7    Blood Cancer                                                                                                               133

7.5.7.1 Leukemia                                                                                                                     133

7.5.7.2 Blood Cancer in the U.S                                                                                                134

7.5.8    Cervical Cancer                                                                                                            136

7.5.8.1 Global Incidence of Cervical Cancer                                                                              136

7.5.9    Prostate Cancer                                                                                                            137

7.5.9.1 Global Incidence of Prostate Cancer                                                                              137

7.5.9.2 Prostate Cancer Incidence and Mortality by Geography                                                  138

7.5.9.3 Prostrate Cancer in the U. S                                                                                           139

7.5.10  Melanoma                                                                                                                    140

7.5.10.1 Skin Cancer in the U. S                                                                                                141

8.0       Market Analysis                                                                                                         142

8.1       Global Oncology Market                                                                                               142

8.2       Top Ten Companies in Oncology Drug Sales                                                                 143

8.3       Top Five Oncology Drugs                                                                                             144

8.4       Global Oncology Therapeutics Market by Cancer Type                                                  145

9.0       Market for Cancer Immunotherapy                                                                           147

9.1       Key Drivers                                                                                                                 147

9.2       Global Market for Cancer Immunotherapeutics                                                              147

9.3       Global Market for Cancer Immunotherapy by Product Class                                           149

9.4       Global Market for Immunotherapy Drugs by Cancer Type                                              150

9.5       Global Market for Monoclonal Antibodies for Cancer by Type                                       151

9.5.1    Best Selling MAbs                                                                                                        152

9.5.1.1 Market Forecast for Herceptin                                                                                       152

9.5.1.2 Market Value and Forecast for Avastin                                                                          153

9.5.1.3 Global Market for Erbitux                                                                                             154

9.5.1.4 Global Market for Yervoy                                                                                             155

9.5.1.5 Global Market for Mabthera                                                                                          156

9.5.2    Global Market for Antibody Drug Conjugates (ADCs)                                                    157

9.5.2.1 Global Market for Adcetris                                                                                           157

9.5.2.2 Global Market for Keytruda                                                                                          158

9.6       Global Market for Cancer Vaccines                                                                               159

9.6.1    Global Market for Cancer Vaccines by Type                                                                  160

9.7       Global Market for Non-Specific Cancer Immunotherapeutics                                          162

9.8       Market Values for Selected Forthcoming Cancer Immunotherapeutics                             163

9.8.1    Market Value for Nivolumab (Opdivo)                                                                          163

9.8.2    Market Value for RG7446                                                                                             163

9.8.3    Market Value for DCVax-L                                                                                          163

9.8.4    Market Value for MEDI4736                                                                                        164

9.8.5    High Cost of MAbs                                                                                                      164

10.0     Company Profiles                                                                                                       165

10.1     Ablynx NV                                                                                                                  165

10.2     Activartis Biotech GmbH                                                                                              166

10.2.1  GBM Vax Study                                                                                                           166

10.3     Advaxis Inc                                                                                                                  166

10.3.1  Advaxis’ Technology                                                                                                   167

10.3.2  Advaxis’ Product Pipeline                                                                                             167

10.3.2.1 ADXS-HPV                                                                                                                162

10.3.2.2 ADXS-PSA                                                                                                                 167

10.3.2.3 ADXS-cHER2                                                                                                            167

10.4     Aduro BioTech Inc                                                                                                       168

10.4.1  Aduro’s Technology                                                                                                     168

10.4.1.1            CRS-207                                                                                                          169

10.4.1.2            AUD-623                                                                                                         169

10.4.1.3            ADU-741                                                                                                         169

10.4.1.4            ADU-S100                                                                                                       169

10.5     Agenus Inc                                                                                                                   170

10.5.1  QS-21 Stimulon                                                                                                            170

10.6     AlphaVax Inc                                                                                                               171

10.6.1  Alpha Vax’s Technology                                                                                              171

10.7     A. Menarini Industrie Farmaceutiche Riunite Srl                                                            171

10.7.1  MEN1112                                                                                                                    172

10.8     Amgen Inc                                                                                                                   172

10.8.1  Vectibix (panitumumab)                                                                                               172

10.8.2  Blinatumomab (Blincyto)                                                                                              173

10.8.3  Rilotumumab                                                                                                               173

10.9     Antigen Express Inc                                                                                                     173

10.9.1  Li-Key Hybrid Vaccines (AE37)                                                                                   173

10.10   Argos Therapeutics Inc                                                                                                 174

10.10.1 AGS-003                                                                                                                     174

10.11   Bavarian Nordic A/S                                                                                                     175

10.11.1 Prostvac                                                                                                                       175

10.11.2 CV-301                                                                                                                        175

10.11.3 MVA-BN PRP                                                                                                              176

10.11.4 MVA-BN HER2                                                                                                           176

10.11.4.1 MVA-BN Brachyury                                                                                                 176

10.12   Bellicum Pharmaceuticals Inc                                                                                       176

10.12.1 BPX-501                                                                                                                      176

10.12.2 BPX-201                                                                                                                      177

10.12.3 BPX-401                                                                                                                      177

10.12.4 BPX-601                                                                                                                      177

10.12.5 BPX-701                                                                                                                      177

10.13   Biogen Idec Inc                                                                                                            178

10.13.1 Rituxan (Rituximab)                                                                                                     178

10.13.2 Gazyva (Obinutuzumab)                                                                                               178

10.14   Biovest International Inc                                                                                               179

10.14.1 BiovaxID                                                                                                                     179

10.15   Bristol-Myers Squibb Company                                                                                    179

10.15.1 Erbitux (cetuximab)                                                                                                      180

10.15.2 OPDIVO (nivolumab)                                                                                                  180

10.15.3 Yervoy (ipilimumab)                                                                                                    180

10.16   Cellectis                                                                                                                       180

10.17   Cellerant Therapeutics Inc                                                                                            181

10.17.1 CLT-008                                                                                                                      182

10.17.2 CLT-009                                                                                                                      182

10.18   Celldex Therapeutics                                                                                                    182

10.18.1 Rindopepimut                                                                                                              182

10.18.2 Glembatumumab vedotin (CDX-011)                                                                            183

10.18.3 Varlilumab (CDX-1127)                                                                                               183

10.18.4 CDX-1401                                                                                                                   183

10.18.5 CDX-301                                                                                                                     183

10.19   CEL-SCI Corp.                                                                                                             183

10.19.1 Multikine                                                                                                                     184

10.20   CureTech Ltd.                                                                                                              184

10.20.1 Pidilizumab (CT-011)                                                                                                   184

10.21   Delta-Vir GmbH                                                                                                          185

10.21.1 Treatment                                                                                                                    185

10.22   Dendreon Corp.                                                                                                            185

10.22.1 Provenge (Sipuleucel-T)                                                                                               185

10.23   DenDrit Biotech USA                                                                                                   186

10.23.1 MelCancerVac                                                                                                             186

10.24   DNAtrix Inc                                                                                                                 186

10.24.1 DNX-2401                                                                                                                   186

10.25   Eli Lilly and Co.                                                                                                           187

10.25.1 Erbitux (Cetuximab)                                                                                                     187

10.26   EMD Serono Inc                                                                                                          187

10.27   Etubics Corp.                                                                                                               188

10.28  Galena Biopharma Inc                                                                                                  189

10.29   Genentech Inc                                                                                                              189

10.29.1 Avastin (bevacizumab) for Metastatic Colorectal Cancer                                                190

10.29.1.1          Avastin and Interferon Alfa for Metastatic Kidney Cancer                                  190

10.29.1.2          Avastin for Metastatic NLCLC                                                                          190

10.29.2 Gazyva (obinutuzumab) for Chronic Lymphocytic Leukemia                                          190

10.29.3 Herceptin (trastuzumab) for Breast Cancer                                                                     190

10.29.3.1          Herceptin and Chemotherapy for Gastric Cancer                                                190

10.29.4 Kadcyla (ado-trastuzumab emtansine)                                                                            191

10.29.5 Perjeta (pertuzumab)                                                                                                     191

10.29.6 Rituxan (rituximab)                                                                                                      191

10.29.7 Genentech’s Cancer Immunotherapy Pipeline Products                                                   192

10.30   Genmab AS                                                                                                                 193

10.30.1 Ofatumumab                                                                                                                193

10.31   GlaxoSmithKline                                                                                                          194

10.31.1 Arzerra (Ofatumumab)                                                                                                 194

10.31.2 Cervarix                                                                                                                       194

10.32   Gliknik Inc                                                                                                                   194

10.33   GlobeImmune Inc                                                                                                         195

10.34   Heat Biologics Inc                                                                                                        196

10.35   Immatics Biotechnologies GmbH                                                                                  196

10.36   ImmunoCellular Therapeutics Ltd.                                                                                197

10.37   Immunocore Ltd.                                                                                                          198

10.37.1 Product Pipeline                                                                                                           198

10.38   ImmunoFrontier Inc                                                                                                      198

10.39   ImmunoGen Inc                                                                                                           199

10.39.1 IMGN853                                                                                                                    199

10.39.2 IMGN529                                                                                                                    199

10.39.3 IMGN289                                                                                                                    199

10.39.4 IMGN779                                                                                                                    199

10.40   Immunomedics Inc                                                                                                       200

10.41   Immunotope Inc                                                                                                           200

10.41.1 IMT-1012 Immunotherapeutic Vaccine                                                                          201

10.42   Immunovaccine Inc                                                                                                      201

10.43   Inovio Pharmaceuticals Inc                                                                                           202

10.44   Janssen Biotech Inc                                                                                                      202

10.44.1 Doxil                                                                                                                           202

10.44.2 Procrit                                                                                                                          203

10.44.3 Zytiga                                                                                                                          203

10.44.4 Imbruvicia                                                                                                                   203

10.45   Juno Therapeutics Inc                                                                                                   203

10.46   Kite Pharma Inc                                                                                                           204

10.46.1 Kite Pharma’s Technology                                                                                            204

10.46.1.1          eACT (engineered Autologous Cell Therapy)                                                     204

10.46.1.2          DC-Ad GM-CAIX                                                                                            204

10.47   MabVax Therapeutics Holdings Inc                                                                               205

10.48   MedImmune LLC                                                                                                         206

10.49   Merck & Co., Inc                                                                                                         207

10.49.1 Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine             207

10.49.2 Keytruda (Pembrolizumab)                                                                                           207

10.50   Merrimack Pharmaceuticals Inc                                                                                     208

10.51   Morphotek Inc                                                                                                             208

10.51.1 Farletuzumab (MORAb-003)                                                                                        209

10.51.2 Amatuximab (MORAb-009)                                                                                         209

10.51.3 Ontuxizumab (MORAb-004)                                                                                        209

10.51.4 MORAb-066                                                                                                                209

10.52   NewLink Genetics Corp.                                                                                               209

10.53   Northwest Biotherapeutics Inc                                                                                       210

10.54   NovaRx Corp.                                                                                                              211

10.55   OncoPep Inc                                                                                                                211

10.55.1 PVX-410                                                                                                                     211

10.56   Oncothyreon Inc                                                                                                           212

10.57   OSE Pharma SA                                                                                                           212

10.58   Oxford BioTherapeutics Ltd.                                                                                         213

10.58.1 Technologies                                                                                                                213

10.58.1.1 OGAP – Cancer Targeting                                                                                          213

10.58.1.2 Antibody Development                                                                                              213

10.58.1.3 Antibody “arming”                                                                                                    214

10.58.2 Lead Programs                                                                                                            214

10.58.2.1  OX001/MEN1112                                                                                                    214

10.58.2.2  OX002                                                                                                                     214

10.58.2.3  OX003                                                                                                                     214

10.58.2.4  OX004                                                                                                                     214

10.59   Pique Therapeutics                                                                                                       215

10.60   Polynoma LLC                                                                                                             215

10.60.1 MAVIS Trial                                                                                                                215

10.61   Prima BioMed Ltd.                                                                                                       216

10.62   Progenics Pharmaceuticals Inc                                                                                      216

10.62.1 PSMA Targeted Imaging Compound (1404)                                                                  217

10.62.2 PSMA ADC Therapeutic                                                                                              217

10.62.3 Small Molecule Therapeutic (1095)                                                                               217

10.62.4 Azedra                                                                                                                         217

10.63   Regen Biopharma Inc                                                                                                   218

10.63.1 HemaXellerate                                                                                                             218

10.63.2 dCellVax                                                                                                                     218

10.63.3 Diffron C                                                                                                                     218

10.64   Roche Holdings Inc                                                                                                      219

10.64.1 Avastin (Bevacizumab)                                                                                                 219

10.64.2 Gazyva/Gazyvaro (Obinutuzumab; GA101)                                                                   219

10.64.3 Herceptin (Trastuzumab)                                                                                              219

10.64.4 Kadcyla (Trastuzumabum emtansinum)                                                                         219

10.64.5 Mabthera (Rituximab)                                                                                                  219

10.64.6 Perjeta (Pertuzumab)                                                                                                    220

10.65   Seattle Genetics Inc                                                                                                      221

10.65.1 Adcetris (Brentuximab vedotin)                                                                                     222

10.65.2 Seattle Genetics’ Collaborarator Pipeline                                                                       222

10.66   Sorrento Therapeutics Inc                                                                                             223

10.66.1 Sorrento’s Antibody Technologies                                                                                 224

10.66.1.1  G-MAB                                                                                                                    224

10.66.1.2  Antibody Drug Conjugates (ADCs)                                                                            224

10.67   Spectrum Pharmaceuticals Inc                                                                                       224

10.67.1 Zevalin                                                                                                                        224

10.68   Synthon Pharmaceuticals Inc                                                                                         225

10.69   TapImmune Inc                                                                                                            225

10.70   ThioLogics Ltd.                                                                                                            226

10.71   Transgene SA                                                                                                               227

10.72   TVAX Biomedical Inc                                                                                                  228

10.72.1 TVI-Brain-1                                                                                                                 228

10.72.2 TVI-Kidney-1                                                                                                              228

10.73   Vaccinogen Inc                                                                                                            228

10.74   Viventia Biotechnologies Inc                                                                                        229

10.75   Wilex AG                                                                                                                     229

10.76   Ziopharm Oncology Inc                                                                                                230

11.0   Cancer Immunotherapy Market Participants by Product Segment                               231

12.0     CAR T Therapy                                                                                                          233

12.1     Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy                 233

12.1.1  Clinical Status of CD19 CAR-T Cells To Date                                                               234

12.1.2  Clinical and Regulatory Challenges for Development of CAR T Cells                              234

12.1.3  Key Regulatory Challenges Associated with CAR-T Development                                  235

12.1.4  Summary of Select CAR-T Products by Juno, Novartis and Kite                                      235

12.1.5  Clinical Benefit Versus Toxicity in CD19-Directed ALL Clinical Trials                           236

12.1.6  How to Manage Toxicity of CAR-T Therapy                                                                  236

13.0     Regulations Pertaining to Immunotherapy Regulation in the USA                             238     

13.1     Center for Biologics Evaluation and Research (CBER)                                                   238

13.1.1  Compliance and Surveillance                                                                                        238

13.1.2  Extra Resources on Immunotherapeutics from the FDA                                                  239

13.1.3  Cellular, Tissue and Gene Therapies Advisory Committee                                              240

13.1.4  Consumer Affairs Branch (CBER) Contact in FDA                                                        242

13.1.5  FDA Regulations Pertaining to Immunotherapies                                                            242

13.1.6  Case Study Ovarian Cancer Immunotherapy Regulations                                                243

13.1.6.1            Efficacy                                                                                                           243

13.1.6.2            Adverse Effects                                                                                                246

13.1.7  Trial Design Considerations for Immunotherapy                                                           246

13.1.8  Development of Immune-Related Response Criteria (irRC) & Clinical Endpoints Specific to Immunotherapies                                                                                                                         246

14.0     Regulations for Immunotherapy in Japan                                                                   249

14.1     PMDA and Immunotherapy                                                                                          251

12.1.1  Increasing the Efficiency in Immunotherapy Regulatory Review                                     253

12.1.2  Forerunner Review Assignment System                                                                         254

12.1.3  Revised Guidelines for Clinical Evaluation of Anti‐Malignant Tumor Agents                   255

12.1.4  Key Contacts Within the PMDA for Immunotherapeutics                                               256

15.0     European Regulation and Immunotherapeutics                                                          263

15.1     Introduction                                                                                                                  263

15.2     Challenges for Immunotherapy in EMEA                                                                       263

15.2.1  EMA Status on Potency Testing                                                                                    264

15.2.1.1            In Vivo Potency Testing                                                                                    264

15.2.1.2            In Vitro Potency Testing                                                                                   264

15.2.1.3            Viable Cell Count                                                                                             265

15.2.1.4            Autologous Cell Based Products                                                                        265

15.2.1.5            Reference Preparation                                                                                       265

15.2.1.6            Adjuvant Containing Immunotherapy Products                                                  265

15.2.2  EMA Status on Identifying hyper, Hypo or non-Responders                                            266

15.3     Challenges Relating to Biomarkers in Immunotherapy                                                    266

15.4     Challenges Relating to Chimeric Antigen Receptor T Cells in Immunotherapy                 267

15.5     Estimating Optimal Cut-Off Parameters                                                                         268

15.6     EU-Approved Immunotherapies in Melanoma                                                                268

15.7     Key Contacts Within EMA for Immunotherapeutics                                                       271

16.0     Manufacturing of Immunotherapies                                                                           272

16.1     Introduction                                                                                                                  272

16.2     Generation of CAR-Modified T Cells                                                                             272

16.2.1  What Co-Stimulation and Activity Domain is Optimal to Use?                                        275

16.2.2  Optimizing Cell Culture Media                                                                                      276

16.2.3  Manufacturing Lentiviral Vectors                                                                                  276

16.2.4  Detection of Integrated CAR-Expressing Vectors                                                           277

16.2.5  Donor Lymphocyte Infusion Procedure                                                                          277

16.2.6  Ex Vivo Costimulation & Expansion of Donor T Cells                                                    277

16.2.7  Infusion to the Patient                                                                                                   277

16.3     Manufacturing Devices and Instruments Required for Immunotherapy Production            278

16.3.1  Leukapheresis                                                                                                              278

16.3.2  Cell Counters and Analyzer                                                                                           279

16.3.3  Cell Seeding, Growth and Propagation                                                                           281

16.4     Good Manufacturing Procedure (GMP) for Immunotherapy                                            281

16.5     Case Study Production of Lentivirus Induced Dendritic Cells under GMP Conditions       282

16.6     Quality Control                                                                                                             283

16.7     Regulatory Affairs                                                                                                        284

16.8     Key Challenges in Manufacturing                                                                                  285

16.8.1  Electroporation of T-cells                                                                                              285

16.8.2  Allogenic CAR T cells                                                                                                  286

16.8.3  Relapse Rates are Critical                                                                                              288

16.8.4  Antigen Negative Relapse                                                                                             289

16.8.5  Incorporating Suicide Genes                                                                                          289

16.8.16 Automation in Cell Therapy Manufacturing                                                                    290

16.8.17 Autologous Cell Therapy Manufacture Scale Up                                                            292

17.0     Supply Chain & Logistics                                                                                           293

17.1     Introduction                                                                                                                  293

17.2     Case Study: Juno Therapeutics                                                                                      293

18.0     Pricing & Cost Analysis                                                                                              296

18.1     Introduction                                                                                                                  296

18.2     CAR T Therapy Market Evaluation                                                                               298

19.0     Current Deals Within the CAR T Market                                                                   301

20.0     CAR T Therapy Company Case Studies                                                                     303

20.1     Juno Therapeutics                                                                                                         303

20.2     Kite Pharma                                                                                                                 311

20.3     Cellectis                                                                                                                       315

 

 

 

 

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