As our understanding of cancer has progressed, newer therapies, such as various targeted therapies and immunotherapy, have become an important part of today's cancer treatment regimens. This report focuses on pharmacological therapies–in particular, the pipelines of emerging drugs—for treatment of solid tumors, discussing:
• The various types of solid tumors that are the focus of the most pharmacological effort, including information about the specific disease, its incidence and epidemiology, current treatment options, and R&D challenges.
• Pipelines of emerging targeted therapies for treatment of solid tumors, organized by pathway or category.
• Business and strategic considerations relating to pharmacological therapy for solid tumors, including discussions of the current and projected markets, and market trends.
• Major challenges and hurdles for companies developing solid tumor therapies.
• Interviews with experts in the field of solid tumors, which were conducted exclusively for this report.

Cancer is not a single disease, but includes many different diseases that are all characterized by the uncontrolled growth and spread of abnormal cells. Within the broad categories of cancer (such as breast or lung cancer), there are many different types. And, even within one type of cancer, the molecular changes that caused the cancer vary with different tumors.
Therapies for Solid Tumors: Pipelines, Markets, and Business Considerations discusses selected major solid tumors that represent the greatest effort by companies developing new therapies for solid tumors. This report begins with an initial focus on pharmacological treatment options currently used for the major solid tumors. While chemotherapy drugs have been used for several decades, more recently, targeted small-molecule drugs and biological therapies including monoclonal antibodies have been introduced. This early chapter discusses all of these therapies.
The major focus of Therapies for Solid Tumors: Pipelines, Markets, and Business Considerations is on pipelines of emerging drugs for treatment of solid tumors. Over 80 therapies that have reached Phase III development are profiled in the body of this report. However, these novel late-stage therapies only represent the "tip of the iceberg" of new therapies being developed for treatment of solid tumors. Information regarding emerging therapies in Phase II or earlier stages of development, plus certain additional Phase III candidates, is presented in tables. More than 530 companies developing more than 1,330 new therapies for solid tumors are included in this report.
Biopharmaceutical companies are exploiting hundreds of potential targets or therapeutic approaches for development of new cancer therapies. The more than 1,330 potential new therapies discussed in this Insight Pharma Report work by a wide range of mechanisms. Many of these emerging cancer therapies have multiple mechanisms of action, and are therefore included in multiple tables within this report.
Therapies for Solid Tumors: Pipelines, Markets, and Business Considerations discusses business strategies relating to development of pharmacological therapies for solid tumors. This includes an analysis of the current market and the potential markets for emerging therapies. Also discussed are major challenges and other tactical considerations for companies working in this space. This Insight Pharma Report concludes with expert interviews with some of these companies.

About the Author

Lucy J. Sannes, PhD, MBA, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.

Table Of Contents


Executive Summary

Chapter 1

Introduction
Scope of the Report

Chapter 2

Review of Selected Major Solid Tumors Targeted by Pharmaceutical Companies
2.1. Brain Cancer
2.2. Breast Cancer
2.3. Cervical Cancer
2.4. Colorectal Cancer
2.5. Head and Neck Cancer
2.6. Lung CancerNon-Small-Cell Lung Cancer
Small-Cell Lung Cancer
2.7. Melanoma
2.8. Ovarian Cancer
2.9. Pancreatic Cancer
2.10. Prostate Cancer
2.11. Renal Cancer

Chapter 3

Current Pharmacological Treatment Options for Solid Tumors
3.1. Brain Cancer
3.2. Breast CancerChemotherapy
Hormone Therapy
Targeted Therapy: HER2-Positive Cancers
3.3. Cervical Cancer
3.4. Colorectal CancerChemotherapy
Targeted Therapy: EGF Receptor
Targeted Therapy: VEGF Receptor
3.5. Head and Neck Cancer
3.6. Lung CancerNon-Small-Cell Lung Cancer
Chemotherapy
Kinase Inhibitors
Angiogenesis Inhibitor
Photodynamic Therapy
Small-Cell Lung Cancer
3.7. Melanoma
3.8. Ovarian Cancer
3.9. Pancreatic CancerChemotherapy
Kinase Inhibitors
3.10. Prostate CancerLuteinizing Hormone-Releasing Hormone (LHRH) Agonists
Luteinizing Hormone-Releasing Hormone (LHRH) Antagonists
Antiandrogens
Androgen Synthesis Inhibitor
Chemotherapy
Immunotherapy
3.11. Renal CancerImmunotherapy
Kinase Inhibitors
Vascular Endothelial Growth Factor (VEGF) Inhibitor
3.12. Other Cancers

Chapter 4

Selected Emerging Targeted Therapies That Block Cell Growth, Cell Cycle and Replication, DNA Repair, Cell Proliferation, Tumor Invasion, and Metastasis
4.1. Selected Inhibitors of the EGF Receptor Tyrosine Kinase FamilyBoehringer Ingelheim’s Afatinib
CIMAB’s, YM Biosciences’, and Others’ Nimotuzumab
Eli Lilly’s and Bristol-Myers Squibb’s Necitumumab
Kadmon’s KD019
Pfizer’s Dacomitinib
Roche/Genentech’s PERJETA (Pertuzumab) - Approved June 2012
Roche/Genentech’s Trastuzumab Emtansine
4.2. Selected Inhibitors of the Ras-Raf-MEK-ERK PathwayGlaxoSmithKline’s Dabrafenib
GlaxoSmithKline’s Trametinib
4.3. Selected Inhibitors of c-MetArQule’s, Daiichi Sankyo’s, and Kyowa Hakko Kirin’s Tivantinib
Exelixis’ Cabozantinib
Roche/Genentech’s Onartuzumab
4.4. Selected Inhibitors of Insulin-like Growth Factor (IGF) and Insulin-like Growth Factor Type 1 Receptor (IGF1R)Amgen’s and Takeda Pharmaceutical’s Ganitumab
Astellas Pharma’s Linsitinib
4.5. Selected TGF-?2 InhibitorsAntisense Pharma’s Trabedersen
4.6. Selected Kit and PDGFR InhibitorsAB Science’s Masitinib
4.7. Selected PARP (Poly [ADP-Ribose] Polymerase) InhibitorsSanofi’s Iniparib
4.8. Selected Inhibitors of the PI3K-Akt-mTOR PathwayMerck’s and ARIAD Pharmaceuticals’ Ridaforolimus
4.9. Other Emerging Therapies with Antiproliferative EffectsPolaris Group’s ADI-PEG 20
Roche/Genentech’s Erivedge - Approved January 2012

Chapter 5

Selected Emerging Therapies That Induce Apoptosis
Onconova Therapeutics’ Estybon (Rigosertib)

Chapter 6

Selected Emerging Angiogenesis Inhibitors and Vascular-Targeting Agents
6.1. Selected Angiogenesis Inhibitors That Target VEGFR, PDGFR, and/or FGFRAbbott’s Linifanib
Advenchen Laboratories’, LSK BioPartners’, and Jiangsu Hengrui Medicine’s Apatinib
Amgen’s and Takeda Pharmaceutical’s Motesanib (AMG 706)
Astellas Pharma’s, AVEO Oncology’s, and Kyowa Hakko Kirin’s Tivozanib
Bayer HealthCare’s Regorafenib
Boehringer Ingelheim’s Nintedanib
Bristol-Myers Squibb’s Brivanib
Eisai’s Lenvatinib
Eli Lilly’s Ramucirumab
Novartis’ Dovitinib
Pfizer’s Inlyta (Axitinib; Approved January 2012)
Sanofi’s and Regeneron’s Zaltrap (Aflibercept)
Taiho Pharmaceutical’s Orantinib
6.2. Selected Angiogenesis Inhibitors That Target TIE Receptor and/or Its LigandsAmgen’s and Takeda Pharmaceutical’s AMG 386
6.3. Selected Integrin InhibitorsMerck Serono’s Cilengitide
6.4. Selected Other Angiogenesis InhibitorsActive Biotech’s and Ipsen’s Tasquinimod
Medigen Biotechnology’s PI-88
6.5. Selected Vascular Targeting/Disrupting AgentsMolMed’s NGR-hTNF
Sanofi’s Ombrabulin

Chapter 7

Selected Emerging Therapies That Target Hormone Regulation
7.1. Selected Emerging Therapies with Anti-Androgen ActivityAstellas Pharma’s and Medivation’s Enzalutamide
Millennium: The Takeda Oncology Company’s Orteronel
7.2. Selected Other Emerging Therapies Targeting Regulation of HormonesNovartis’ Pasireotide

Chapter 8

Selected Emerging Immune-Based Therapies for Solid Tumors
8.1. Selected Active Immunotherapies and Vaccines in Development for CancerAdvantagene’s ProstAtak
Agennix’ Talactoferrin
Amgen’s Talimogene Laherparepvec
Apeiron’s APN311 (ch14.18/CHO) and APN301 (hu14.18-IL2)
Bavarian Nordic’s PROSTVAC
Biothera’s Imprime PGG
Cancer Advances’ Polyclonal Antibody Stimulator (PAS)
Celldex Therapeutics’ Rindopepimut
CEL-SCI’s Multikine
Eisai’s Farletuzumab
Endo Pharmaceutical’s and Bioniche Life Sciences’ Urocidin
Galena Biopharma’s NeuVax
GlaxoSmithKline’s GSK1572932A and GSK 2132231A
GSK1572932A
GSK 2132231A
immatics biotechnologies’ IMA901
Merck Serono’s and Oncothyreon’s Stimuvax
NewLink Genetics’ HyperAcute-Pancreas (algenpantucel-L)
NovaRx’ Lucanix
Polynoma’s POL-103A
Prima BioMed’s CVac
RECOMBIO’s Racotumomab (1E10)
Transgene’s TG4010
United Therapeutics’ ch14.18
Vaccinogen’s OncoVAX
Vical’s and AnGes’ Allovectin-7
Wilex’ RENCAREX
8.2. Selected Immunoconjugates in DevelopmentActive Biotech’s ANYARA

Chapter 9

Selected Novel Cytotoxic Drugs in Development
9.1. BioNumerik Pharmaceuticals’ Karenitecin
9.2. Celgene’s and Dainippon Sumitomo Pharmaceuticals’ Amrubicin
9.3. Cyclacel Pharmaceutical’s Sapacitabine
9.4. Eleison Pharmaceuticals’ Glufosfamide
9.5. Endocyte’s Vintafolide (EC145)
9.6. Janssen Products’, PharmaMar’s, and Taiho’s Yondelis
9.7. Spectrum Pharmaceuticals’ and Allergan’s EOquin (Apaziquone)
9.8. Taiho Pharmaceutical’s TAS-102
9.9. Threshold Pharmaceuticals’ TH-302
9.10. ZIOPHARM Oncology’s Zymafos (Palifosfamide)

Chapter 10

Selected Other Emerging Therapies for Solid Tumors
10.1. Bayer’s and Algeta’s Alpharadin (Radium-223 Dichloride)
10.2. BioNumerik Pharmaceuticals’ Tavocept
10.3. OncoGenex Technologies’ and Teva Pharmaceutical Industries’ Custirsen Sodium
10.4. Oncolytics Biotech’s REOLYSIN
10.5. Steba Biotech’s Tookad

Chapter 11

Business Considerations
11.1. Current Sales of Drugs for Treatment of Solid Tumors
11.2. Personalized Medicine in the Field of Solid Tumors
11.3. Selected Challenges and Hurdles Being Faced by Companies in the Field of Solid Tumors

Chapter 12

Expert Interviews
12.1. Thomas CK Chan, PhDChief Scientific Officer
ArQule
12.2. Habib Fakhrai, PhD Chief Scientific Officer
NovaRx
12.3. Michael G. Hanna, Jr., PhDFounder and Chairman
Vaccinogen
12.4. Spiro RombotisPresident and Chief Executive Officer
Cyclacel Pharmaceuticals
12.5. Vijay B. SamantPresident and CEO
Vical
References
Company Index



TABLES

Table 2.1. Incidence and Mortality of Selected Solid Tumors in the United States, 2011
Table 2.2. Five-Year Relative Survival Rates by Stage of Diagnosis (1999-2006) For Selected Major Cancers Targeted by Pharmaceutical Companies
Table 3.1. Selected Chemotherapy Drugs FDA-Approved for Treatment of Cancer (Most Are Available as Generic Drugs)
Table 3.2. Selected Drugs Approved By the FDA for Treatment of Brain Cancer
Table 3.3. Selected Drugs Approved By the FDA for Treatment of Breast Cancer
Table 3.4. Selected Drugs Approved By the FDA for Treatment of Cervical Cancer
Table 3.5. Selected Drugs Approved By the FDA for Treatment of Colorectal Cancer
Table 3.6. Selected Drugs Approved By the FDA for Treatment of Head and Neck Cancer
Table 3.7. Selected Drugs Approved By the FDA for Treatment of Non-Small-Cell Lung Cancer
Table 3.8. Selected Drugs Approved By the FDA for Treatment of Small-Cell Lung Cancer
Table 3.9. Selected Drugs Approved By the FDA for Treatment of Melanoma
Table 3.10. Selected Drugs Approved By the FDA for Treatment of Ovarian Cancer
Table 3.11. Selected Drugs Approved By the FDA for Treatment of Pancreatic Cancer
Table 3.12. Selected Drugs Approved By the FDA for Treatment of Prostate Cancer
Table 3.13. Selected Drugs Approved By the FDA for Treatment of Renal Cancer
Table 3.14. Selected Drugs Approved By the FDA for Treatment of Other Solid Tumors
Table 4.1. Selected Inhibitors of EGF Receptor Tyrosine Kinase Family
Table 4.2. Selected Inhibitors of the Ras-Raf-MEK-ERK Pathway
Table 4.3. Selected Inhibitors of c-Met
Table 4.4. Selected Inhibitors of Insulin-Like Growth Factor (IGF) and Insulin-Like Growth Factor Type 1 Receptor (IGF1R)
Table 4.5. Selected TGF-?2 Inhibitors
Table 4.6. Selected c-Kit Inhibitors
Table 4.7. Selected PARP (Poly [ADP-Ribose] Polymerase) Inhibitors
Table 4.8. Selected Inhibitors of the PI3K-Akt-mTOR Pathway
Table 4.9. Selected Other Emerging Therapies with Antiproliferative Effects
Table 5.1. Selected Emerging Therapies That Induce Apoptosis
Table 6.1. Selected Growth Factor Receptors and Their Ligands Involved in Angiogenesis
Table 6.2. Selected Angiogenesis Inhibitors That Target VEGFR, PDGFR, or FGFR
Table 6.3. Selected Angiogenesis Inhibitors That Target TIE Receptor and/or Its Ligands
Table 6.4. Selected Integrin Inhibitors
Table 6.5. Selected Other Angiogenesis Inhibitors
Table 6.6. Selected Vascular-Targeting/Disrupting Agents
Table 7.1. Selected Emerging Therapies with Anti-Androgen Activity
Table 7.2. Selected Other Emerging Therapies Targeting Regulation of Hormones
Table 8.1. Selected Emerging Immunotherapies, Immunomodulators, and Vaccines for Treatment of Cancer
Table 8.2. Selected Emerging Immunoconjugates for Treatment of Cancer
Table 9.1. Selected Emerging Cytotoxic Drugs in Development for Treatment of Cancer
Table 10.1. Selected Other Emerging Therapies for Solid Tumors
Table 11.1. Sales of Selected Drugs Used to Treat Solid Tumors

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