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癌治療のための併用抗体療法概要

Combination Antibody Therapy for Cancer Treatment Overview

発行 Insight Pharma Reports 商品コード 351309
出版日 ページ情報 英文 116 Pages
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癌治療のための併用抗体療法概要 Combination Antibody Therapy for Cancer Treatment Overview
出版日: 2016年01月31日 ページ情報: 英文 116 Pages
概要

組換え抗体は過去20年にわたり、医薬品業界における輝く宝石でした。現在、併用抗体療法は血液悪性腫瘍や固形腫瘍を治療するための最も基本的戦略のひとつとなっています。

当レポートでは、癌治療のための抗体薬剤の臨床的有効性と市場動向、併用抗体治療の見通し、標的抗体療法と免疫抗体療法、化学療法と免疫抗体療法の併用、融合抗体療法などの概要とともに、市場における動向、専門家の見解などをまとめています。

エグゼクティブサマリー

背景

当レポートで網羅されるトピック

併用抗体療法の見通し

第1章 イントロダクション

第2章 標的抗体療法

  • 利用可能な癌ゲノム
  • エピゲノム
  • 抗体と併用した化学療法
  • 標的抗体の併用
  • 標的抗体療法と市場
  • 臨床における標的抗体療法
  • サマリー

第3章 免疫抗体療法

  • 発展と現在の製品
  • 化学療法と免疫抗体療法の併用
  • 免疫抗体の併用
  • 市場における免疫抗体治療法
  • 臨床における免疫抗体療法
  • サマリー

第4章 融合抗体療法

  • 抗体薬剤結合体
  • 抗体生物学的構造
  • 免疫サイトカイン
  • 他の薬剤との併用における融合抗体
  • サマリー

第5章 複合標的および多官能抗体療法

  • 二重特異性および二重標的抗体の臨床研究動向
  • 組換えポリクローナル抗体
  • 併用療法
  • 製造における課題
  • 法規制分野:課題
  • サマリー

第6章 特許期限とバイオシミラーの登場

  • イントロダクション
  • 同市場におけるバイオシミラー抗体
  • 特許期限が近づく標的製品
  • バイオベターの見通し
  • 修飾抗体の明るい未来
  • サマリー

第7章 取引と市場

  • 合併・買収
  • 全合併の起源
  • サマリー

第8章 戦略的課題

  • 基礎研究と臨床研究との調整
  • 腫瘍学への新たなアプローチ:診断と治療
  • 機会と落とし穴
  • サマリー

第9章 当分野の専門家へのインタビュー

第10章 抗体技術の発展に関する業界関係者アンケート

  • 参考情報
  • Cambridge Healthtech Instituteについて

図表

目次

Recombinant antibodies have been the shining jewels in the firmament of the pharma industry for almost the last two decades. They have returned billions of dollars in sales, and if their performance has not been the unalloyed triumph that was foreseen at their inception, they have, at least in some instances, produced impressive gains in patient response. Today they are one of the most fundamental strategies for treating patients with hematological malignancies and solid tumors. This report explores the next level of therapy, combining antibodies with additional agents.

The report consists of eight chapters that address different aspects of the issue of combined antibody therapy - past, present, and future, topics include:

  • A brief review of the clinical efficacy and market status of currently approved antibody-based drugs for cancer therapy
  • Outlook for combination antibody therapeutics
  • Targeted Antibody Therapeutics & Immuno-Antibody Therapeutics
  • Development and Current Products
  • Combination of Chemotherapy and Immuno-antibody therapeutics
  • Combinations of immune-antibodies
  • Immuno- antibody therapeutics in the marketplace
  • Fusion Antibody Therapeutics
  • Multitargeted and Polyfunctional Antibody Therapeutics
  • Patent Expiration and the Rise of Biosimilars
  • Biosimilar antibodies in the market
  • Deals and the Marketplace
  • Interviews with Leading Experts:
    • Interview with Esper Boel, SVP, head of discovery; Ivan Horak, CSO; and Mads Laustsen, CMO at Symphogen
    • Interview with Eric S. Langer, Managing Partner, BioPlan Associates, Inc.
    • Interview with Dr. Laurent Ducry, Group Leader Bioconjugates R&D, Lonza, Valais, Switzerland
    • Interview with Dr. Cheng Liu, CEO, Eureka Therapeutics
    • Interview with Steve King, President, Peregrine Pharma
  • Survey with data from Industry Representatives Concerning Developments in Antibody Technology

Table of Contents

Executive Summary

Background

Topics covered in this report

  • Chapter 1
  • Chapter 2
  • Chapter 3
  • Chapter 4
  • Chapter 5
  • Chapter 6
  • Chapter 7
  • Chapter 8

Outlook for combination antibody therapeutics

CHAPTER - 1

  • Introduction, Scope and Objectives
  • A brief review of the clinical efficacy and market status of currently approved antibody-based drugs for cancer therapy
  • Bevacizumab
  • Necitumumab
  • Dinutuximab.
  • Nivolumab.
  • Blinatumomab
  • Pembrolizumab
  • Ramucirumab
  • Obinutuzumab
  • Ado-trastuzumab emtansine
  • Ipilimumab: Immune checkpoint inhibitors
  • Pertuzumab.
  • Opportunities and challenges for future development
  • 1.2.1. A need for targets.
  • Safety concerns.
  • Objectives and outlook for combination antibody therapy
  • 1.3.1. Overcoming resistance to anti-cancer agents.
  • 1.3.2. Uncertainties in combined antibody therapy.
  • 1.4. Summary

CHAPTER - 2

  • Targeted Antibody Therapeutics
  • 2.1. The unstable cancer genome.
  • 2.2. The epigenome.
  • 2.3. Chemotherapy treatment combined with antibodies
  • 2.4. Combinations of targeted antibodies
  • 2.5. Targeted antibody therapeutics and the marketplace
  • 2.6. Targeted antibody therapeutics in the clinic
  • 2.7. Summary

CHAPTER - 3

  • Immuno-Antibody Therapeutics
  • Development and Current Products
  • Combination of Chemotherapy and Immuno-antibody therapeutics
  • Combinations of immune-antibodies
  • Immuno- antibody therapeutics in the marketplace
  • 3.5. Immuno- antibody therapeutics in the clinic
  • Summary

CHAPTER - 4

  • Fusion Antibody Therapeutics
  • 4.1. Antibody Drug Conjugates (ADCs)
  • Antibody Biologic Constructs (ABCs)
  • Immunocytokines
  • Fusion antibodies in combination with other drugs
  • Summary

CHAPTER - 5

  • Multitargeted and Polyfunctional Antibody Therapeutics
  • 5.1. Status and clinical studies of Bispecific and bi-targeted antibodies
  • 5.2. Recombinant polyclonal antibodies
  • 5.3. Combination therapy
  • 5.4. Challenges in manufacturing
  • 5.5. Regulatory areas: Challenges
  • 5.5. Summary

CHAPTER - 6

  • Patent Expiration and the Rise of Biosimilars
  • 6.1. Introduction
  • Biosimilar antibodies in the market
  • Target products nearing patent expiration
  • Prospects for biobetters
  • A bright future for modified antibodies
  • Summary

CHAPTER - 7

  • Deals and the Marketplace
  • 7.1. Mergers and acquisitions
  • 7.3. The Mother of all Mergers
  • 7.4. Summary

CHAPTER - 8

  • Strategic Issues
  • 8.1. Balancing basic and clinical research
    • 8.1.1. A troubled time for the life sciences
    • 8.1.2. Shoddy and questionable research
    • 8.1.3. A resolution to the funding crisis?
    • 8.1.4. Promising areas of discovery in cancer combination therapies
      • 8.1.4.1. CTLA-4.
      • 8.1.4.2. CD-38.
      • 8.1.4.3. Rectal cancer therapies
  • New approaches to oncology: Diagnostics versus therapeutics
  • 8.2.1. The frustrating search for effective disease biomarkers
  • 8.2.2. A mix of approaches to cancer biomarker discovery.
  • 8.2.3. Three approaches to immunodiagnostic cancer markers
    • 8.2.3.1. The first is the traditional approach of characterization of a single cancer-related marker and its validation as an immunodiagnostic test.
    • 8.2.3.2. The second approach has evolved as sophisticated instrumentation for multiplexing has become more widely available.
    • 8.2.3.3. Yet a third approach is a more indirect one - identifying tumor-specific antibodies in the serum of affected individuals.
  • 8.2.4. Current cancer markers in use
  • 8.3. Opportunities and pitfalls
    • 8.3.1. NCI-MATCH trials
    • 8.3.2. A wide range of treatments offers better odds of survival.
  • Summary

CHAPTER - 9

  • Interviews with Experts in the Field
  • 9.1. Interview with Esper Boel, SVP, head of discovery; Ivan Horak, CSO; and Mads Laustsen, CMO at Symphogen
  • 9.2. Interview with Eric S. Langer, Managing Partner, BioPlan Associates, Inc.
  • 9.3. Interview with Dr. Laurent Ducry, Group Leader Bioconjugates R&D, Lonza, Valais, Switzerland
  • 9.4. Interview with Dr. Cheng Liu, CEO, Eureka Therapeutics
  • 9.5. Interview with Steve King, President, Peregrine Pharma

CHAPTER - 10

  • Questionnaire put to Industry Representatives Concerning Developments in Antibody Technology
  • References
  • About Cambridge Healthtech Institute

FIGURES

  • Figure 1.1.7.1 Ramucirumab (CyramzaTM)
  • Figure 1.1.8.1. Timeline for development of ipilimumab
  • Figure 1.1.11.1. Binding sites on human epidermal growth factor receptor 2 (HER2) for FDA-approved HER2-directed therapies
  • Figure 2.1. Mechanisms that drive drug resistance in cancer cells
  • Figure 2.2.1. Depiction of the Primary Mechanisms that Enable Cancer Cells to Become Drug Resistant
  • Figure 3.1.1. Flash Gordon Comic Strip from the 1950s
  • Figure 3.1. The Il-2 pathway
  • Figure 3.2.1. MAPK Pathway and Mechanism of Vemurafenib
  • Figure 3.3.1. Domain Architecture and Affinity Purification of a scFv:CD40L Fusion Proteins
  • Figure 5.1.1. Alternative possibilities for bispecific Antibodies
  • Figure 8.1.1 Autocrine and Paracrine Loops in SCLC
  • Figure 8.2.1.1. Biomarker discovery over the last 30 years
  • Figure 8.4.1. Rate of new drug approvals

TABLES

  • Table 1.1. FDA-Approved Epigenetic Therapies
  • Table 3.1.1. Currently Approved Non-mAb Anticancer Immunotherapeutics
  • Table 4.1.1. Seattle Genetics ADCs in clinical trials
  • Table 5.2.1. Examples of Oligoclonal and polyclonal antibody therapeutics in development
  • Table 6.1.1 Estimated Patent Expiry Dates
  • Table 7.1. Merger and Acquisition Trends
  • Table 8.1. National R&D by Funder
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