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市场调查报告书
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1328018

Claudin 18.2 - 靶向免疫治疗：利益相关者、药物方式、管道和商业机会的行业格局分析

Claudin 18.2 - Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from an Industry Perspective
出版日期: | 出版商: La Merie Publishing | 英文 267 Pages | 订单完成后即时交付

价格

Claudin 18.2是一种跨膜蛋白，选择性表达于胃上皮细胞的癌细胞表面。

裸单克隆抗体佐维妥昔单抗是当前所有后续抗密蛋白 18.2 免疫疗法候选药物的黄金标准和基准，因为它是在受控关键临床试验中评估的唯一候选药物。美国、欧盟、日本和中国的监管机构已于 2023 年 6 月至 7 月接受 zolbetuximab 的许可申请，可能于 2024 年获得批准并上市。

在SPOTLIGHT 或GLOW III 期试验中，zolvetuximab 的临床特征显示，无进展生存期分别为1.94 个月或1.41 个月，总生存期为2.69 个月或2.23 个月，具有统计学意义和临床意义的改善，已获得批准。最常见的不良事件是胃肠道噁心、呕吐和食慾下降。此外，只有 39.1% 的胃癌患者符合佐贝妥昔单抗治疗的条件。纳入标准之一是肿瘤组织中紧密蛋白 18.2 的表达，在至少 75% 的癌细胞中观察到中度至强染色。

本报告评估了针对紧密蛋白 18.2 的新型抗体和细胞疗法候选药物的行业前景。它确定并概述了 48 家在该领域开展研发活动的公司和 68 种候选产品。每个公司简介都提供了有关公司背景/历史、财务状况、相关技术、协作交易和 Claudin 18.2 特定管道概述的信息。

目录

第一章执行摘要

第二章概述与研究方法

第3章密蛋白的发现、结构和功能18.2

  • 发现紧密蛋白 18.2 作为高度谱系特异性的癌症靶点
  • 密蛋白18.2的结构和功能

第 4 章 Claudin-18.2 在癌症中的表达谱

  • Claudin-18.2 在胃癌和胃食管交界处 (GEJ) 癌中的表达
  • Claudin 18.2在胃癌、GEJ癌、胰腺癌等癌症中的表达
  • 癌症中紧密蛋白 18.2 表达概述

第五章 胃癌、食道癌、胰腺癌的发病情况

  • 胃癌
  • 食道癌
  • 胰腺癌

第 6 章 Claudin 18.2 许可协议

第7章Claudine的利益相关者分析18.2

第 8 章 针对紧密蛋白 18.2 的候选免疫疗法的管线分析

  • Claudin 18.2 药物模式和开发阶段
  • 终止 Claudine 18.2 研发计划
  • Zolbetuximab 作为密蛋白 18.2 靶向免疫治疗的基准
  • 靶向紧密蛋白 18.2 的裸单克隆抗体
  • Claudin 18.2 靶向抗体药物偶联物 (ADC)
  • 靶向 Claudin 18.2 的嵌合抗原受体 T 细胞 (CAR-T)
  • Claudin 18.2 靶向双特异性 T 细胞接合抗体
  • Claudin 18.2 靶向双特异性肿瘤免疫 (IO) 抗体

第九章公司简介

  • 中国境外主要生物製药公司
    • Astellas Pharma
    • AstraZeneca
    • BioNTech
    • Bristol Myers Squibb
    • Merck
    • Roche
  • 中国以外的其他生物製药公司
    • ABL Bio
    • Abpro
    • CARTEXEL
    • Elevation Oncology
    • Integral Molecular
    • Leap Therapeutics
    • Phanes Therapeutics
    • SOTIO Biotech
    • TORL BioTherapeutics
    • Triumvira Immunologcics
  • 中国生物製药公司在境外开展临床开发
    • Antengene
    • CARsgen Therapeutics
    • I-Mab Biopharma
    • Innovent Biologics
    • Jiangsu Hengrui Pharmaceuticals
    • La Nova Medicines
    • RemeGen
    • SparX Group
    • Transcenta Holding
    • Zai Lab
  • 中国生物製药公司在中国进行临床开发
    • Beijing Mabworks Biotech
    • Biotheus
    • CSPC Pharmaceutical Group
    • Gracell Biotechnologies
    • Jiangsu Aosaikang Pharmaceutical
    • L&L Biopharma
    • Legend Biotech
    • Nanjing Kaedi Biotherapeutics
    • Qilu Pharmaceutical
    • QureBio
    • Shandong Boan Biotechnology
    • Shanghai Junshi Biosciences
    • Shanghai Longyao Biotechnology
    • Sichuan Kelun-Biotech Biopharmaceutical
    • Suzhou Immunofoco Biotechnology
    • Zhejiang Doer Biologics
  • 进行非临床和临床前研发的中国生物製药公司
    • Akeso
    • Dragon Boat Biopharmaceutical
    • Elpiscience Biopharmaceutical
    • Genor Biopharma
    • OriCell Therapeutics
    • Shanghai Genbase Biotechnology

第 10 章 抗紧密蛋白 18.2 候选药物简介

  • 裸单克隆抗体
  • 抗体药物偶联物
  • 嵌合抗原受体T细胞
  • 双特异性 T 细胞接合抗体
  • Claudin 18.2 靶向双特异性免疫肿瘤 (IO) 抗体
  • Claudin 18.2 x 4-1BB 双特异性抗体
  • Claudin 18.2 x CD47/SIRPα 双特异性抗体
  • Claudin 18.2 x PD-L1 双特异性抗体

第十一章 参考资料

Product Code: LMFR0039

This report provides you with a landscape description and analysis of discovery and development of claudin 18.2 (CLDN18.2)-targeted antibody and cell therapy candidates from an industry perspective as of August 2023. CLDN18.2 is transmembrane protein selectively expressed on the cancer cell surface of gastric epithelial cells.

The report brings you up-to-date with information about and analysis of

Claudin 18.2 target identification and validation;

Differential expression profile of claudin 18.2 in health and tumor tissues;

Incidence of cancers with significant expression of claudin 18.2 in major countries;

Scope and economic terms of licensing agreements for anti-CLDN18.2 immunotherapy candidates and discovery technologies;

Stakeholders in the field: major pharma and biotech, ex-China biotech companies; Chinese major pharma and Chinese emerging biopharma companies;

Specific company profiles, especially of Chinese, including financial situation;

Pipeline description and analysis regarding drug modalities, indications, territories (global vs regional), R&D stage;

Preclinical and clinical experience with CLDN18.2 immunotherapy candidates;

Specific profiles of anti-CLDN18.2 immunotherapy candidates.

The naked monoclonal antibody zolbetuximab has become the current gold standard and benchmark for all follow-on anti-CLDN18.2 immunotherapy candidates as zolbetuximab is the only candidate that has been evaluated in controlled pivotal clinical studies. Regulatory agencies in the US, the European Union, Japan and China have accepted license applications for zolbetuximab in June/July 2023 and potential approvals and market launches are expected during the course of 2024.

The clinical profile of zolbetuximab showed statistically significant and clinically relevant improvements in progression free survival by 1.94 or 1.41 months and in overall survival of 2.69 or 2.23 in the SPOTLIGHT or GLOW phase III trials, respectively. Major adverse events were gastrointesintal symptoms nausea, vomiting and decreased appetite. Furthermore, only 39.1% of gastric cancer patients were eligible to treatment with zolbetuximab. One of the inclusion criteria was expression of CLDN18.2 in tumor tissue defined by moderate to strong staining in ≥75% of cancer cells.

This product profile leaves sufficient space for improvements in efficacy, safety and patient eligibility by next generation anti-CLDN18.2 immunotherapy candidates. To generate more effective and safe CLDN18.2-targeted antibody and cell therapy candidates, several drug modalities with potential for enhanced effector function, increased safety and broader patient population have applied:

Naked monoclonal antibodies (mAbs) with enhanced target affinity and increased ADCC, CDC & ADCP;

Antibody-drug conjugates (ADCs) with improved linker & conjugation technology and payloads;

Chimeric antigen receptor (CAR) T-Cells (CAR-T) with improved constructs (signalling domains, armored, modular design);

Anti-CLDN18.2 Bispecific T-Cell Engaging (BiTE or TCE) Antibodies for recruitment of cytotoxic T-cells;

CLDN18.2-Targeted Bispecific Immuno-Oncology (I-O) Antibodies for checkpoint blockade or immune stimulation.

This report evaluates the industry landscape of claudin18.2-targeted novel antibody and cell therapy candidates. The report is based on the identification and description of 48 companies with research and development activities in the field and 68 distinct product candidates.

For each company, a profile has been elaborated providing information about the company background/history, the financial situation, relevant technology, partnering deals and CLDN18.2-specific pipeline overview.

Specific profiles of 56 anti-CLDN18.2 immunotherapy candidates have been prepared to describe design and construct of the candidate, applied technologies, the preclinical in vitro and in vivo profile and clinical experience, if available. All information is fully referenced, either with 107 scientific references (conference abstracts, Posters, presentations, full paper) or hyperlinks leading to the source of corporate information, such as press releases, corporate presentations, annual reports, SEC disclosures and homepage content.

What will you find in the report?

Profiles of R&D companies active in the field;

Description of Big Pharma's role in the field (in-house R&D, partnering and investing);

Comprehensive description and analysis of established and emerging drug modality technologies;

Competitor and pipeline analysis for each drug modality applied in anti-CLDN18 immunotherapy candidates;

Territories of major competition;

Preclinical and clinical profiles of anti-CLDN18.2 immunotherapy candidates;

Drug modality preferences of major pharma;

Scope and economic terms of collaboration and licensing deals.

Who will benefit from the report?

Venture capital, private equity and investment managers;

Managers of Big Pharma venture capital firms;

Financial analysts;

Business development and licensing (BDL) specialists;

Patent attorneys and specialists;

CEO, COO and managing directors;

Corporate strategy analysts and managers;

Chief Technology & Scientific Officer;

R&D portfolio, technology and strategy managers;

Clinical and preclinical development specialists

Table of Contents

Frequent Abbreviations

1 Executive Summary

2 Overview and Methodology

3 Discovery, Structure and Function of Claudin 18.2

  • 3.1 Discovery of Claudin 18.2 as a highly lineage-specific cancer target
  • 3.2 Structure and Function of Claudin 18.2

4 Expression Profile of Claudin 18.2 in Cancer

  • 4.1 CLDN18.2 expression in gastric and gastro-esophageal junction (GEJ) cancer
  • 4.2 CLDN18.2 expression in gastric, GEJ, pancreatic and other cancers
  • 4.3 Summary of CLDN18.2 Expression in Cancer

5 Incidence of gastric, esophageal and pancreatic cancer

  • 5.1 Gastric cancer
  • 5.2 Esophageal cancer
  • 5.3 Pancreatic cancer

6 CLDN18.2 Licensing Agreements

7 Analysis of Claudin 18.2 Stakeholders

  • 7.1 Major Biopharmaceutical Companies outside of China with CLDN18.2 Programs
  • 7.2 Other Biopharmaceutical Companies outside of China with CLDN18.2 Programs
  • 7.3 Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs outside of China
  • 7.4 Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs inside of China
  • 7.5 Chinese Biopharmaceutical Companies with Non-Clinical & Preclinical R&D of CLDN18.2 Programs

8 Pipeline Analysis of CLDN18.2-Targeted Immunotherapy Candidates

  • 8.1 CLDN18.2 Drug Modalities and Development Stage
  • 8.2 Discontinued CLDN18.2 R&D Programs
  • 8.3 Zolbetuximab as Benchmark for CLDN18.2-Targeted Immunotherapies
  • 8.4 CLDN18.2-Targeted Naked Monoclonal Antibodies
    • 8.4.1 Clinical Experience with Anti-CLDN18.2 Naked Monoclonal Antibodies
  • 8.5 CLDN18.2 Targeted Antibody-Drug Conjugates (ADCs)
    • 8.5.1 Clinical Experience with Anti-CLDN18.2 Antibody-Drug Conjugates
  • 8.6 CLDN18.2 Targeted Chimeric Antigen Receptor T-cells (CAR-T)
    • 8.6.1 Clinical Experience with Anti-CLDN18.2 CAR T-Cells
  • 8.7 CLDN18.2 Targeted Bispecific T-Cell Engaging Antibodies
  • 8.8 CLDN18.2 Targeted Bispecific Immuno-Oncology (I-O) Antibodies
    • 8.8.1 CLDN18.2 x 4-1BB Bispecific Antibodies
    • 8.8.2 CLDN18.2 x CD47 / SIRPα Bispecific Antibodies
    • 8.8.3 CLDN18.2 x PD-L1 Bispecific Antibodies
    • 8.8.4 CLDN18.2 x CD8 Bispecific Antibodies

9 Company Profiles

  • 9.1 Major Biopharmaceutical Companies outside of China
    • 9.1.1 Astellas Pharma
    • 9.1.2 AstraZeneca
    • 9.1.3 BioNTech
    • 9.1.4 Bristol Myers Squibb
    • 9.1.5 Merck
    • 9.1.6 Roche
  • 9.2 Other Biopharmaceutical Companies outside of China
    • 9.2.1 ABL Bio
    • 9.2.2 Abpro
    • 9.2.3 CARTEXEL
    • 9.2.4 Elevation Oncology
    • 9.2.5 Integral Molecular
    • 9.2.6 Leap Therapeutics
    • 9.2.7 Phanes Therapeutics
    • 9.2.8 SOTIO Biotech
    • 9.2.9 TORL BioTherapeutics
    • 9.2.10 Triumvira Immunologcics
  • 9.3 Chinese Biopharmaceutical Companies with Clinical Development outside of China
    • 9.3.1 Antengene
    • 9.3.2 CARsgen Therapeutics
    • 9.3.3 I-Mab Biopharma
    • 9.3.4 Innovent Biologics
    • 9.3.5 Jiangsu Hengrui Pharmaceuticals
    • 9.3.6 La Nova Medicines
    • 9.3.7 RemeGen
    • 9.3.8 SparX Group
    • 9.3.9 Transcenta Holding
    • 9.3.10 Zai Lab
  • 9.4 Chinese Biopharmaceutical Companies with Clinical Development inside China
    • 9.4.1 Beijing Mabworks Biotech
    • 9.4.2 Biotheus
    • 9.4.3 CSPC Pharmaceutical Group
    • 9.4.4 Gracell Biotechnologies
    • 9.4.5 Jiangsu Aosaikang Pharmaceutical
    • 9.4.6 L&L Biopharma
    • 9.4.7 Legend Biotech
    • 9.4.8 Nanjing Kaedi Biotherapeutics
    • 9.4.9 Qilu Pharmaceutical
    • 9.4.10 QureBio
    • 9.4.11 Shandong Boan Biotechnology
    • 9.4.12 Shanghai Junshi Biosciences
    • 9.4.13 Shanghai Longyao Biotechnology
    • 9.4.14 Sichuan Kelun-Biotech Biopharmaceutical
    • 9.4.15 Suzhou Immunofoco Biotechnology
    • 9.4.16 Zhejiang Doer Biologics
  • 9.5 Chinese Biopharmaceutical Companies with Non-Clinical and Preclinical R&D
    • 9.5.1 Akeso
    • 9.5.2 Dragon Boat Biopharmaceutical
    • 9.5.3 Elpiscience Biopharmaceutical
    • 9.5.4 Genor Biopharma
    • 9.5.5 OriCell Therapeutics
    • 9.5.6 Shanghai Genbase Biotechnology

10 Anti-CLDN18.2 Drug Candidate Profiles

  • 10.1 Naked Monoclonal Antibodies
    • 10.1.1 AB011
    • 10.1.2 ASKB589
    • 10.1.3 BA1105
    • 10.1.4 BC008
    • 10.1.5 BNT141
    • 10.1.6 DR30303
    • 10.1.7 GB7004
    • 10.1.8 IBI360
    • 10.1.9 JS012
    • 10.1.10 LM-102
    • 10.1.11 MIL93
    • 10.1.12 NBL-015; FL-301
    • 10.1.13 Osemitamab; TST001
    • 10.1.14 SPX-101
    • 10.1.15 TORL-2-307-MAB
    • 10.1.16 ZL-1211
    • 10.1.17 Zolbetuximab
  • 10.2 Antibody-Drug Conjugates
    • 10.2.1 ATG-022
    • 10.2.2 BA1301
    • 10.2.3 CMG901
    • 10.2.4 IBI343
    • 10.2.5 JS107
    • 10.2.6 LM-302; BMS-986476; TPX-4589
    • 10.2.7 RC118
    • 10.2.8 SHR-A1904
    • 10.2.9 SKB315
    • 10.2.10 SOT102
    • 10.2.11 SYSA1801; EO-3021
    • 10.2.12 TORL-2-307-ADC
  • 10.3 Chimeric Antigen Receptor T-Cells
    • 10.3.1 BNT212
    • 10.3.2 CT041
    • 10.3.3 CT048
    • 10.3.4 GC506
    • 10.3.5 IBI345
    • 10.3.6 IMC002
    • 10.3.7 KD-496
    • 10.3.8 LB1908
    • 10.3.9 LY011
    • 10.3.10 PM3023
    • 10.3.11 TAC01-CLDN18.2
  • 10.4 Bispecific T-Cell Engaging Antibodies
    • 10.4.1 ABP-150
    • 10.4.2 ASP2138
    • 10.4.3 GB264
    • 10.4.4 Gresonitamab; AMG 910
    • 10.4.5 HBM7022; AZD5863
    • 10.4.6 IBI389
    • 10.4.7 QLS31905
    • 10.4.8 WB67
  • 10.5 CLDN18.2 Targeted Bispecific Immuno-Oncology (I-O) Antibodies
    • 10.5.1 CLDN18.2 x 4-1BB Bispecific Antibodies

10.5.1.1 FL-302; NBL-016

10.5.1.2 Givastomig

10.5.1.3 PM1032

    • 10.5.2 CLDN18.2 x CD47 / SIRPα Bispecific Antibodies

10.5.2.1 BC007

10.5.2.2 ES028

10.5.2.3 PT886

    • 10.5.3 CLDN18.2 x PD-L1 Bispecific Antibodies

10.5.3.1 Q-1802

10.5.3.2 TST006

11 References

ADDENDUM

Tables in the Text

Figures & Tables

Tables in the Text

  • Table 1 CLDN18.2 Tissue Expression in Cancer - Summary of Study Results
  • Table 2 Rights and Economic Terms of Licensing Agreements for CLDN18.2-Targeted Drug Candidates
  • Table 3 Overview of Major Biopharmaceutical Companies outside of China with CLDN18.2 Programs
  • Table 4 Overview of Other Biopharmaceutical Companies outside of China with CLDN18.2 Programs
  • Table 5 Overview of Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs outside of China
  • Table 6 Overview of Chinese Biopharmaceutical Companies with Clinical Development of CLDN18.2 Programs inside of China
  • Table 7 Overview of Chinese Biopharmaceutical Companies with Non-Clinical & Preclinical R&D of CLDN18.2 Programs
  • Table 8 Overview of Drug Modalities and R&D Stage of CLDN18.2-Targeted Immunotherapeutics in Active Development
  • Table 9 Discontinud CLDN18.2-Targeted Immunotherapeutics
  • Table 10 Naked Monoclonal Antibodies and their Fc Function
  • Table 11 Composition of Anti-CLDN18.2 Antibody-Drug Conjugates (ADCs)
  • Table 12 Autologous Anti-CLDN18.2 Chimeric Antigen Receptor T-cells
  • Table 13 CLDN18.2-Targeted Bispecific T-Cell Engaging Antibodies via CD3
  • Table 14 CLDN18.2-Targeted Immuno-Oncology (I-O) Bispecific Antibodies
  • Table 15 Astellas Pharma's Pipeline of Claudin 18.2-Targeted Drug Candidates
  • Table 16 AstraZeneca's CLDN18.2-Targeted Immunotherapy Franchise
  • Table 17 Claudin 18.2 Immunotherapy Franchise of BioNTech
  • Table 18 Integral Molecular's Pipeline of CLDN18.2-Targeted Antibodies
  • Table 19 Integral Molecular's Pipeline of CLDN18.2-Targeted Antibodies
  • Table 20 TORL Biotherapeutics' Pipeline of CLDN18.2-Targeted Antibodies
  • Table 21 Pipeline of CARsgen Therapeutics' Claudin 18.2 Franchise
  • Table 22 CLDN18.2-Targeted Immunotherapy Franchise of Innovent Biologics
  • Table 23 CLDN18.2-Targeted Immunotherapy Pipeline of Transcenta Holding
  • Table 24 CLDN18.2-Targeted Immunotherapy Pipeline of Biotheus
  • Table 25 CLDN18.2-Targeted Antibodies from CSPC Pharmaceutical Group
  • Table 26 CLDN18.2-Targeted Immunotherapy Pipeline of Nanjing Kaedi Biotherapeutics
  • Table 27 CLDN18.2-Targeted Immunotherapy Pipeline of Junshi Biosciences
  • Table 28 Zhejiang Biologics Pipeline of CLDN18.2-Targeted Antibodies
  • Table 29 CLDN18.2-Targeted Antibody Franchise of Dragon Boat Biopharmaceutical
  • Table 30 OriCell Therapeutic's Pipeline of CLDN18.2-Targeted Bispecific Antibodies
  • Table 31 CLDN18.2-Targeted Immunotherapy Pipeline of Shanghai Genbase Biotechnology
  • Table 32 Clinical Development Program of Zolbetuximab in First-Line GC/GEJ Cancer

Related Companies

Companies mentioned in the report

  • ABL Bio
  • AB Therapeutics
  • Abpro
  • Akeso
  • Antengene
  • Amgen
  • Astellas Pharma
  • AstraZeneca
  • Beijing Immunoah Pharma Tech Co.
  • Beijing Mabworks Biotech
  • BioNTech
  • Biotheus
  • Bristol Myers Squibb
  • CARsgen Therapeutics
  • CARTEXEL
  • CSPC Pharmaceutical Group
  • Dragon Boat Biopharmaceutical Co
  • Elevation Oncology
  • Elpiscience Biopharmaceuticals
  • Flame Biosciences
  • Genor Biopharma
  • Gracell Biotechnologies
  • Harbour BioMed
  • I-Mab Biopharma
  • Innovent Biologics
  • Integral Molecular
  • Jiangsu Aosaikang Pharmaceutical
  • Jiangsu Hengrui Pharmaceuticals
  • Keymed Biosciences
  • KPC Pharmaceutical
  • L&L Biopharma
  • LaNova Medicines Zhejiang
  • Leap Therapeutics
  • Legend Biotech
  • Luzsana Biotechnology
  • Merck
  • Nanjing Kaedi Biotherapeutics
  • NBE Therapeutics
  • Novarock Biotherapeutics
  • OriCell Therapeutics
  • Phanes Therapeutics
  • Qilu Pharmaceuticals
  • QureBio
  • RemeGen
  • Roche
  • Shandong Boan Biotechnology
  • Shanghai Genbase Biotechnology
  • Shanghai Junshi Biosciences
  • Shanghai Longyao Biotechnology
  • Shanghai Novarock Biopharmaceutical Co.
  • Sichuan Kelun-Biotech Biopharmaceutical
  • SOTIO Biotech
  • SparX Group
  • Suzhou Immunofoco Biotechnology
  • Synaffix
  • TORL Biotherapeutics
  • Transcenta Holding
  • Turning Point Therapeutics
  • Xencor
  • Zai Lab
  • Zhejiang Doer Biologics
  • Triumvira Immunologics
  • Zhejiang Doer Biologics