Claudin 18.2 - Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from an Industry Perspective
Claudin(클라우딘) 18.2는 위 상피세포의 암세포 표면에 선택적으로 발현하는 막관통 단백질입니다.
네이키드 모노클로널 항체 졸베툭시맙은 컨트롤된 피보탈 임상시험에서 평가된 유일한 후보이므로 항클라우딘 18.2 면역치료 후보의 모든 후속품의 현재 골드 스탠다드 및 벤치마크가 되고 있습니다. 미국, 유럽연합, 일본, 중국의 규제기관은 2023년 6월-7월 졸베툭시맙 라이선스 신청을 수리하고 있으며, 2024년중 승인되어 출시될 가능성이 있습니다.
졸베툭시맙의 임상 프로파일은 SPOTLIGHT 또는 GLOW 제III상 시험에서 각각 무악화 생존 기간이 1.94개월 또는 1.41개월, 전생존 기간이 2.69개월 또는 2.23개월로, 통계학적으로 의미가 있고 임상적으로 유의미한 개선이 인정되었습니다. 주요 AE(ADVERSE EVENTS)는 위장 증상인 오심, 구토, 식욕 저하였습니다. 또한 졸베툭시맙에 의한 치료 대상이 된 위암 환자는 39.1%에 불과했습니다. 포함 기준의 하나는 종양 조직에서 클라우딘 18.2의 발현이며, 암 세포의 75% 이상에서 중등도에서 강도의 염색이 인정되는 것을 조건으로 했습니다.
클라우딘 18.2 표적 신규 항체 및 세포치료 후보 업계의 상황을 평가하고 있습니다. 이 분야에서 연구개발 활동을 시행하는 48사 및 68개 제품 후보의 식별과 개요를 정리하여 전해드립니다. 각 기업 개요에서는 기업의 배경/역사, 재무 상황, 관련 기술, 제휴 거래, 클라우딘 18.2 고유 파이프라인 개요에 관한 정보를 제공하고 있습니다.
목차
제1장 주요 요약
제2장 개요와 조사 방법
제3장 클라우딘 18.2의 발견, 구조 및 기능
- 계통 특이성 높은 암표적으로서 클라우딘 18.2의 발견
- 클라우딘 18.2의 구조와 기능
제4장 암에서 클라우딘 18.2의 발현 개요
- 위암 및 위식도 접합부(GEJ) 암에서 클라우딘 18.2의 발현
- 위암, GEJ암, 췌장암 및 기타 암에서 클라우딘 18.2의 발현
- 암에서 클라우딘 18.2 발현의 개요
제5장 위암, 식도암, 췌장암의 발생률
제6장 클라우딘 18.2의 라이선싱 계약
제7장 클라우딘 18.2의 이해관계자 분석
제8장 클라우딘 18.2를 표적으로 하는 면역치료 후보 파이프라인 분석
- 클라우딘 18.2 의약품 모달리티와 개발 단계
- 폐지된 클라우딘 18.2 연구개발 프로그램
- 클라우딘 18.2 표적 면역치료 벤치마크로서의 졸베툭시맙
- 클라우딘 18.2를 표적으로 한 네이키드 모노클로널 항체
- 클라우딘 18.2 표적 항체약물접합체(ADC)
- 클라우딘 18.2 표적화 키메라 항원 수용체 T세포(CAR-T)
- 클라우딘 18.2 표적화 이중특이성 T세포 관여 항체
- 클라우딘 18.2 표적화 이중특이성 종양 면역(IO) 항체
제9장 기업 개요
- 중국 국외 대형 바이오의약품 기업
- Astellas Pharma
- AstraZeneca
- BioNTech
- Bristol Myers Squibb
- Merck
- Roche
- 중국 국외 기타 바이오의약품 기업
- ABL Bio
- Abpro
- CARTEXEL
- Elevation Oncology
- Integral Molecular
- Leap Therapeutics
- Phanes Therapeutics
- SOTIO Biotech
- TORL BioTherapeutics
- Triumvira Immunologcics
- 중국 국외에서 임상 개발을 시행하는 중국의 바이오의약품 기업
- Antengene
- CARsgen Therapeutics
- I-Mab Biopharma
- Innovent Biologics
- Jiangsu Hengrui Pharmaceuticals
- La Nova Medicines
- RemeGen
- SparX Group
- Transcenta Holding
- Zai Lab
- 중국내에서 임상 개발을 시행하는 중국의 바이오의약품 기업
- 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
- 비임상 및 전임상 연구개발을 시행하는 중국의 바이오의약품 기업
- Akeso
- Dragon Boat Biopharmaceutical
- Elpiscience Biopharmaceutical
- Genor Biopharma
- OriCell Therapeutics
- Shanghai Genbase Biotechnology
제10장 항클라우딘 18.2 약제 후보 개요
- 네이키드 모노클로널 항체
- 항체약물접합체
- 키메라 항원 수용체 T세포
- 이중특이성 T세포 관여 항체
- 클라우딘 18.2 표적화 이중특이성 종양 면역(IO) 항체
- 클라우딘 18.2 x 4-1 BB 이중특이성항체
- 클라우딘 18.2 x CD47/SIRPα 이중특이성항체
- 클라우딘 18.2 x PD-L1 이중특이성항체
제11장 참고 자료
KSA
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
