Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028

List of Tables

“Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028” Report Findings & Highlights:

First Claudin 18.2 Targeting Antibody Commercial Launch By H1 2024
Claudin 18.2 Targeted Drugs In Clinical Trials: > 60 Drugs
Global Claudin 18.2 Current Market Trend & Developments
Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase
Insight On Technical & Clinical Platforms For Developing Claudin 18.2 Therapy
Claudin 18.2 Targeted Therapy Development Approaches: CAR T Cell Therapy, Bispecific Antibodies, Antibody Drug Conjugates

Cancer is marked by the presence of numerous biomarkers, many of which are being used as targets for precision medicine. Among the various promising cancer proteins, Claudin-18 (CLDN18) has become a compelling option with considerable therapeutic promise. Particular attention has been aroused by the emergence of CLDN18.2, a variation of CLDN18. The expression pattern of CLDN18.2 is distinct and it is mostly present in the gastric mucosa. This variant has gained prominence due to its association with certain malignancies. As investigations into the therapeutic potential of CLDN18 continue, its impact on the pharmaceutical domain is poised to be substantial, potentially revolutionizing the way we treat some cancers.

CLDN18, a protein that is largely linked with tight junctions in epithelial cells, has received a lot of interest recently because of its potential as a therapeutic target. One of its key advantages is that it is expressed in a variety of tumors, including pancreatic, gastric and lung cancers. Because of this selective expression, it is an appealing target for precision medicine, enabling the creation of targeted medicines that protect healthy tissues while destroying malignant tissues. Therefore, CLDN18 overexpression in diverse malignancies offers a unique opportunity in the realm of cancer pharmaceuticals.

In addition, the usage of CLDN18.2 as a cancer therapeutic target has also showed promise in terms of lowering drug resistance. Resistance mechanisms are less likely to develop when the exact protein responsible for the cancer is specifically targeted, boosting the effectiveness of treatment. Therefore, loaded with several benefits, the potential of CLDN18 and CLDN18.2 has not clearly not gone unnoticed by the pharmaceutical sector.

Zolbetuximab, a first-in-class investigational monoclonal antibody designed to target the CLDN18, is being developed for the first-line treatment of patients with gastric or gastroesophageal junction cancer that is CLDN18.2-positive HER2-negative. Astellas, the developer of Zolbetuximab, announced in July 2023 that the FDA had approved their biologics license application (BLA) for Zolbetuximab, also granting it a priority review. If approved, Zolbetuximab will become the first CLDN18.2-targetd drug to become available in the US for these patients. In addition, Astellas has also filed applications for Zolbetuximab approval in Japan, Europe and China. The drug is being evaluated in multiple late-phase clinical trials in gastric and gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma.

Apart from antibodies like Zolbetuximab, chimeric antigen receptor T-cell (CAR-T) therapies targeting CLDN18.2 are also under development. These cell-based therapies represent a cutting-edge approach to combating cancers that express CLDN18.2 CAR-T therapy involves the genetic modification of donor or patient-derived T cells to recognize and attack cancer cells, and when applied to CLDN18.2-expressing cancers, the therapy holds great promise. For instance, the Affiliated Hospital of Qingdao University is conducting a clinical trial with 9 participants to assess the safety and tolerability of iPD-1-Claudin18.2-CAR-T therapy, XKDCT086, in recurrent or refractory gastric cancer expressing Claudin18.2. This novel approach not only highlights the adaptability of Claudin18.2 as a therapeutic target but also underscores the evolving nature of precision medicine in the treatment of cancer.

CLDN18.2-targeted therapies have also aided the growth of personalized therapies in cancer treatment. Treatments customized to the patient's CLDN18.2 levels could improve treatment outcomes significantly. In addition, therapies that target CLDN18 or CLDN18.2 can potentially be used in combination with current therapies to boost their efficacy. For instance, pairing CLDN18-targeted therapies with immunotherapies represents a powerful cancer treatment strategy that requires further investigation.

Pharmaceutical companies are heavily spending on CLDN18 research, realizing its market upheaval potential. CLDN18-focussed ventures may be appealing to investors looking for prospects in the pharmaceutical sector. Small pharmaceutical companies working on CLDN18-targeting therapies are also becoming more visible in the pharmaceutical market. KYM Biosciences, for example, announced a global license agreement with global pharma giant AstraZeneca in February 2023 for its CLDN18.2 targeting antibody-drug conjugate CMG901, the first of its kind. AstraZeneca will be responsible for the global research, development, manufacturing and commercialization of CMG901. According to the agreement, AstraZeneca will pay KYM an upfront payment of US$ 63 million upon closing of the transaction, as well as another US$ 1.1 billion on further research and sales-related milestones.

Therefore, CLDN18 and its variant CLDN18.2 are a ray of hope in the pharmaceutical industry, especially cancer therapy. Its prevalence in numerous cancers as well as encouraging outcomes from research investigations and clinical trials have continuously highlighted its importance. CLDN18 has a fascinating potential as a therapeutic target and could potentially alter the way we approach cancer therapy.

1. Claudin 18.2 Therapy - New Epoch For Cancer Treatment

2. Introduction To Claudin 18.2 Therapy

2.1. Understanding Claudin 18.2 Proteins
2.2. Chronicle & Development of Claudin 18.2 Therapy

3. Need For Claudin 18.2 Targeted Therapy

4. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy

4.1. Monoclonal Antibody Therapy
4.2. Bispecific Antibody
4.3. CAR T Cell Therapy
4.4. Antibody Drug Conjugate

5. Claudin 18.2 Therapy In Gastric & Pancreatic Cancer: Clinical Trends & Innovations

5.1. Gastric Cancer
5.2. Pancreatic Cancer

6. Global Claudin 18.2 Current Market Trend & Developments

6.1. Current Market Development Outlook
6.2. Future Market Outlook

7. Claudin 18.2 Therapy Trend Analysis By Region

7.1. US
7.2. China
7.3. Europe
7.4. UK
7.5. Japan
7.6. Australia
7.7. South Korea

8. Global Claudin 18.2 Drugs Clinical Trials Overview

8.1. By Company
8.2. By Country
8.3. By Therapy Class
8.4. By Indication
8.5. By Patient Segment
8.6. By Phase

9. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase

9.1. Research
9.2. Preclinical
9.3. Phase-I
9.4. Phase-I/II
9.5. Phase-II
9.6. Preregistration

10. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

11. Global Claudin 18.2 Therapy Market Dynamics

11.1. Market Drivers
11.2. Market Challenges

12. Competitive Landscape

12.1. Abpro Therapeutics
12.2. Antengene Corporation
12.3. Arovella Therapeutics
12.4. Astellas Pharma
12.5. AstraZeneca
12.6. Beijing Mabworks Biotech
12.7. BioNTech
12.8. Biotheus
12.9. CARsgen
12.10. Dragonboat Biopharmaceutical
12.11. Gracell Biotechnology
12.12. Harbour BioMed
12.13. Innovent Biologics
12.14. Integral Molecular
12.15. Klus Pharma
12.16. L and L Biopharma
12.17. LaNova Medicines Limited
12.18. Leap Therapeutics
12.19. Luye Pharma Group
12.20. Nanjing Bioheng Biotech
12.21. Nanjing KAEDI Biotech
12.22. NBE-Therapeutics
12.23. OriCell Therapeutics
12.24. Qilu Pharmaceutical
12.25. Shanghai Junshi Biosciences
12.26. Sparx Therapeutics
12.27. Tillead Therapeutics
12.28. TORL Biotherapeutics
12.29. Transcenta Holding
12.30. Zai Biopharmaceutical

List of Figures

Figure 2-1: Function of Claudin 18.2 Protein
Figure 2-2: Functional Classification of the Claudin Family Proteins
Figure 2-3: Dichotomous Role of Claudin 18.2 Protein in Cancer
Figure 2-4: Claudin 18 Isoforms
Figure 3-1: Global - Gastric Cancer Incidences & Deaths (Million), 2020
Figure 4-1: Therapeutic Approach for Claudin 18.2 protein
Figure 4-2: mAb - Mode of Action
Figure 4-3: Claudin 18.2 - Novel Monoclonal Antibodies in Clinical Research
Figure 4-4: Advantage of Bispecific Antibodies
Figure 4-5: PT886 - Phanes Therapeutics Development Vista
Figure 4-6: Q-1802 Phase I/II Study - Initiation & Completion Year
Figure 4-7: QLS31905 Phase I/II Study - Initiation & Completion Year
Figure 4-8: ASP2138 - Astellas Pharma
Figure 4-9: CARsgen Pharmaceuticals Collaboration - Fudan & Peking University for CT041 & CT048
Figure 4-10: Immunofoco - Pipeline for Claudin 18.2 Therapy
Figure 4-11: NCT06084286 Phase I Study - Initiation & Completion Year
Figure 4-12: SKB315 - Clinical Trial & Collaboration Overview
Figure 4-13: RC118 Phase I/I Study - Initiation & Completion Year
Figure 4-14: Claudin 18.2 -ADCs Candidates
Figure 5-1: Upregulation of Claudin 18.2 in Gastric Cancer
Figure 5-2: HEC-016 Phase I Study - Initiation & Completion Year
Figure 5-3: Structure & Mode of Action for TJ-CD4B
Figure 5-4: Osemitamab Phase I/II Study - Initiation & Completion Year
Figure 5-5: LY011 Phase I/II Study - Initiation & Completion Year
Figure 5-6: SOT102 Phase I Study - Initiation & Completion Year
Figure 5-7: KD-496 Phase I Study - Initiation & Completion Year
Figure 5-8: SPX-101 Phase I Study - Initiation & Completion Year
Figure 5-9: Zolbetuximab Phase II Study - Initiation & Completion Year
Figure 6-1: Companies involved in Clinical Trial for Claudin 18.2 Therapy
Figure 6-2: Global - Claudin 18.2 Target Therapy Market (US Million), 2024 - 2028
Figure 6-3: Aspects Determining the Future of Claudin 18.2 Therapy
Figure 7-1: TAC101-CLAUDIN 18.2 Phase I Study - Initiation & Completion Year
Figure 7-2: Triumvira Immunologics - Pipeline for Claudin 18.2 Therapies
Figure 7-3: TORL-2-307 Phase I Study - Initiation & Completion Year
Figure 7-4: Aspects Influencing the Claudin 18.2 Therapy in US
Figure 7-5: China - Major Candidates in Clinical Trial
Figure 7-6: LM302 Phase II Study - Initiation & Completion Year
Figure 7-7: Strategic Collaboration Between LaNova & Turning Point
Figure 7-8: TQB2103 Phase I Study - Initiation & Completion Year
Figure 7-9: CARsgen Therapeutics Pipeline for Claudin 18.2
Figure 7-10: CT041 Phase II Study - Initiation & Completion Year
Figure 7-11: NCT06084286 Phase I Study - Initiation & Completion Year
Figure 7-12: SOT102 Phase I/II Study - Initiation & Completion Year
Figure 7-13: AZD0901 Phase II Study - Initiation & Completion Year
Figure 7-14: AZD0901 Phase II Study - Initiation & Completion Year
Figure 7-15: CMG901 - Partnership Between AstraZeneca & KYM Bioscience
Figure 7-16: Zolbetuximab - Reasons for Approval of Biologics License Application & Priority Designations
Figure 7-17: SPOTLIGHT Phase III Study - Initiation & Completion Year
Figure 7-18: GLOW Phase III Study - Initiation & Completion Year
Figure 7-19: ASP2138 Phase I Study - Initiation & Completion Year
Figure 7-20: Collaboration of SparX Group & Arovella Therapeutics for Claudin 18.2 iNKT cell therapy
Figure 7-21: ATG-022 Phase I Study - Initiation & Completion Year
Figure 8-1: Global - Claudin 18.2 Drugs Clinical Trials by Company (Numbers), 2023 till 2028
Figure 8-2: Global - Claudin 18.2 Drugs Clinical Trials by Country (Numbers), 2023 till 2028
Figure 8-3: Global - Claudin 18.2 Drugs Clinical Trials by Therapy Class (Numbers), 2023 till 2028
Figure 8-4: Global - Claudin 18.2 Drugs Clinical Trials by Indication (Numbers), 2023 till 2028
Figure 8-5: Global - Claudin 18.2 Drugs Clinical Trials by Patient Segment(Numbers), 2023 till 2028(Numbers), 2023 till 2028
Figure 8-6: Global - Claudin 18.2 Drugs Clinical Trials by Phase (Numbers), 2023 till 2028
Figure 10-1: CARsgen Pharmaceuticals - CycloCAR platform
Figure 10-2: LaNova - LX-ADC™ Platform
Figure 10-3: Phanes Therapeutics - PACbody
Figure 10-4: Phanes Therapeutics - SPECpair
Figure 11 1: Market Drivers for Claudin 18.2 Therapy
Figure 11 2: Market Challenges for Claudin 18.2 Therapy

List of Tables

Table 2-1: Subfamilies of Claudin involved in Different Types of Cancer Formation
Table 4-1: Monoclonal Antibody Approaches Targeting Claudin 18.2 Protein
Table 4-2: Bispecific Antibody Approaches Targeting Claudin 18.2 Protein
Table 4-3: CAR-T Therapy Approaches Targeting Claudin 18.2 Protein
Table 4-4: Antibody Drug Conjugate Approaches Targeting Claudin 18.2 Protein
Table 5-1: Gastric Cancer - Ongoing Clinical Trials For Claudin 18.2 Therapy
Table 7-2: US - Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-1: China - Ongoing Clinical Trials for Claudin 18.2 Therapy
Table 7-3: EU - Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-5: UK- Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-4: Japan - Ongoing Clinical Trial for Claudin 18.2
Table 7-6: Australia - Ongoing Clinical Trial for Claudin 18.2
Table 7-7: South Korea - Ongoing Clinical Trial for Claudin 18.2

Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028

Description

Table of Contents

List of Tables

Table of Contents

1. Claudin 18.2 Therapy - New Epoch For Cancer Treatment

2. Introduction To Claudin 18.2 Therapy

3. Need For Claudin 18.2 Targeted Therapy

4. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy

5. Claudin 18.2 Therapy In Gastric & Pancreatic Cancer: Clinical Trends & Innovations

6. Global Claudin 18.2 Current Market Trend & Developments

7. Claudin 18.2 Therapy Trend Analysis By Region

8. Global Claudin 18.2 Drugs Clinical Trials Overview

9. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase

10. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

11. Global Claudin 18.2 Therapy Market Dynamics

12. Competitive Landscape

List of Figures

List of Tables