PUBLISHER: La Merie Publishing | PRODUCT CODE: 1328018
PUBLISHER: La Merie Publishing | PRODUCT CODE: 1328018
Claudin 18.2 - Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from an Industry Perspective
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
