Global Claudin 18.2-Targeted Immunotherapy Landscape Analysis Report 2023: Potential Approvals and Market Launches Expected During the Course of 2024

DUBLIN, Sept. 20, 2023 /PRNewswire/ -- The "Claudin 18.2-Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from An Industry Perspective" report has been added to  ResearchAndMarkets.com's offering. 

This comprehensive report offers valuable insights into the world of claudin 18.2 (CLDN18.2)-targeted antibody and cell therapy candidates, as of August 2023. CLDN18.2, a transmembrane protein found exclusively on the surface of cancer cells in gastric epithelial tissues, takes center stage in this analysis from an industry perspective.

You'll delve into the industry landscape surrounding innovative claudin18.2-targeted antibody and cell therapy candidates. The report shines a light on 48 companies actively engaged in research and development within this field, highlighting 68 unique product candidates.

Each company is meticulously profiled, providing essential details about their history, financial status, technological advancements, partnership agreements, and a comprehensive overview of their CLDN18.2-specific pipeline.

Moreover, you'll find detailed profiles of 56 anti-CLDN18.2 immunotherapy candidates. These profiles offer insights into candidate design and construction, applied technologies, preclinical in vitro and in vivo performance, and, where available, clinical experience.

Rest assured, all information is rigorously sourced, with 107 scientific references, including conference abstracts, posters, presentations, full papers, and hyperlinks to corporate sources such as press releases, presentations, annual reports, SEC disclosures, and website content. Explore the world of CLDN18.2-targeted therapies with confidence through this comprehensive industry analysis.

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 gastrointestinal 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 at least 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;
• 2-Targeted Bispecific Immuno-Oncology (I-O) Antibodies for checkpoint blockade or immune stimulation.

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.

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

Key Topics Covered:

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 / SIRP? 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 / SIRP? 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

For more information about this report visit https://www.researchandmarkets.com/r/u3lpvl

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