클라우딘(Claudin) 18.2 : 표적 면역치료 - 업계 관점으로부터의 이해관계자, 약제 모달리티, 파이프라인, 비즈니스 기회 분석

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