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癌症分子標靶治療學

市場調查報告書

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1328018

Claudin 18.2 - 靶向免疫治療：利益相關者、藥物方式、管道和商業機會的行業格局分析

Claudin 18.2 - Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from an Industry Perspective

出版日期: 2023年08月08日 | 出版商:

La Merie Publishing | 英文 267 Pages | 訂單完成後即時交付

價格

簡介目錄圖表

Claudin 18.2是一種跨膜蛋白，選擇性表達於胃上皮細胞的癌細胞表面。

裸單克隆抗體佐維妥昔單抗是當前所有後續抗密蛋白 18.2 免疫療法候選藥物的黃金標準和基準，因為它是在受控關鍵臨床試驗中評估的唯一候選藥物。美國、歐盟、日本和中國的監管機構已於 2023 年 6 月至 7 月接受 zolbetuximab 的許可申請，可能於 2024 年獲得批准並上市。

在SPOTLIGHT 或GLOW III 期試驗中，zolvetuximab 的臨床特徵顯示，無進展生存期分別為1.94 個月或1.41 個月，總生存期為2.69 個月或2.23 個月，具有統計學意義和臨床意義的改善，已獲得批准。最常見的不良事件是胃腸道噁心、嘔吐和食慾下降。此外，只有 39.1% 的胃癌患者符合佐貝妥昔單抗治療的條件。納入標準之一是腫瘤組織中緊密蛋白 18.2 的表達，在至少 75% 的癌細胞中觀察到中度至強染色。

本報告評估了針對緊密蛋白 18.2 的新型抗體和細胞療法候選藥物的行業前景。它確定並概述了 48 家在該領域開展研發活動的公司和 68 種候選產品。每個公司簡介都提供了有關公司背景/歷史、財務狀況、相關技術、協作交易和 Claudin 18.2 特定管道概述的信息。

Claudin 18.2 藥物模式和開發階段
終止 Claudine 18.2 研發計劃
Zolbetuximab 作為密蛋白 18.2 靶向免疫治療的基準
靶向緊密蛋白 18.2 的裸單克隆抗體
Claudin 18.2 靶向抗體藥物偶聯物 (ADC)
靶向 Claudin 18.2 的嵌合抗原受體 T 細胞 (CAR-T)
Claudin 18.2 靶向雙特異性 T 細胞接合抗體
Claudin 18.2 靶向雙特異性腫瘤免疫 (IO) 抗體

第九章公司簡介

中國境外主要生物製藥公司
- Astellas Pharma
- AstraZeneca
- BioNTech
- Bristol Myers Squibb
- Merck
- Roche
中國以外的其他生物製藥公司
- ABL Bio
- Abpro
- CARTEXEL
- Elevation Oncology
- Integral Molecular
- Leap Therapeutics
- Phanes Therapeutics
- SOTIO Biotech
- TORL BioTherapeutics
- Triumvira Immunologcics
中國生物製藥公司在境外開展臨床開發
- Antengene
- CARsgen Therapeutics
- I-Mab Biopharma
- Innovent Biologics
- Jiangsu Hengrui Pharmaceuticals
- La Nova Medicines
- RemeGen
- SparX Group
- Transcenta Holding
- Zai Lab
中國生物製藥公司在中國進行臨床開發
- 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
進行非臨床和臨床前研發的中國生物製藥公司
- Akeso
- Dragon Boat Biopharmaceutical
- Elpiscience Biopharmaceutical
- Genor Biopharma
- OriCell Therapeutics
- Shanghai Genbase Biotechnology

第 10 章抗緊密蛋白 18.2 候選藥物簡介

裸單克隆抗體
抗體藥物偶聯物
嵌合抗原受體T細胞
雙特異性 T 細胞接合抗體
Claudin 18.2 靶向雙特異性免疫腫瘤 (IO) 抗體
Claudin 18.2 x 4-1BB 雙特異性抗體
Claudin 18.2 x CD47/SIRPα 雙特異性抗體
Claudin 18.2 x PD-L1 雙特異性抗體

第十一章參考資料

簡介目錄圖表

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

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

簡介目錄圖表

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