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

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Global Claudin 18.2 Targeted Therapy Market Opportunity and Clinical Trials Insight 2028 Report Findings and 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 and Developments
Global Claudin 18.2 Drugs Clinical Trials By Company, Indication and Phase
Insight On Technical and 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.

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Claudin 18.2 Therapy – New Epoch For Cancer Treatment

Introduction To Claudin 18.2 Therapy

2.1 Understanding Claudin 18.2 Proteins

2.2 Chronicle and Development of Claudin 18.2 Therapy

Need For Claudin 18.2 Targeted Therapy

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

Claudin 18.2 Therapy In Gastric and Pancreatic Cancer: Clinical Trends and Innovations

5.1 Gastric Cancer

5.2 Pancreatic Cancer

Global Claudin 18.2 Current Market Trend and Developments

6.1 Current Market Development Outlook

6.2 Future Market Outlook

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

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

Global Claudin 18.2 Drugs Clinical Trials By Company, Indication and Phase

9.1 Research

9.2 Preclinical

9.3 Phase-I

9.4 Phase-I/II

9.5 Phase-II

9.6 Preregistration

Technical and Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

Global Claudin 18.2 Therapy Market Dynamics

11.1 Market Drivers

11.2 Market Challenges

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

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 and 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 and Completion Year

Figure 4-7: QLS31905 Phase I/II Study – Initiation and Completion Year

Figure 4-8: ASP2138 – Astellas Pharma

Figure 4-9: CARsgen Pharmaceuticals Collaboration – Fudan and Peking University for

CT041 and CT048

Figure 4-10: Immunofoco – Pipeline for Claudin 18.2 Therapy

Figure 4-11: NCT06084286 Phase I Study – Initiation and Completion Year

Figure 4-12: SKB315 - Clinical Trial and Collaboration Overview

Figure 4-13: RC118 Phase I/I Study – Initiation and 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 and Completion Year

Figure 5-3: Structure and Mode of Action for TJ-CD4B

Figure 5-4: Osemitamab Phase I/II Study – Initiation and Completion Year

Figure 5-5: LY011 Phase I/II Study – Initiation and Completion Year

Figure 5-6: SOT102 Phase I Study – Initiation and Completion Year

Figure 5-7: KD-496 Phase I Study – Initiation and Completion Year

Figure 5-8: SPX-101 Phase I Study – Initiation and Completion Year

Figure 5-9: Zolbetuximab Phase II Study – Initiation and 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 and Completion Year

Figure 7-2: Triumvira Immunologics – Pipeline for Claudin 18.2 Therapies

Figure 7-3: TORL-2-307 Phase I Study – Initiation and 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 and Completion Year

Figure 7-7: Strategic Collaboration Between LaNova and Turning Point

Figure 7-8: TQB2103 Phase I Study – Initiation and Completion Year

Figure 7-9: CARsgen Therapeutics Pipeline for Claudin 18.2

Figure 7-10: CT041 Phase II Study – Initiation and Completion Year

Figure 7-11: NCT06084286 Phase I Study – Initiation and Completion Year

Figure 7-12: SOT102 Phase I/II Study – Initiation and Completion Year

Figure 7-13: AZD0901 Phase II Study – Initiation and Completion Year

Figure 7-14: AZD0901 Phase II Study – Initiation and Completion Year

Figure 7-15: CMG901 - Partnership Between AstraZeneca and KYM Bioscience

Figure 7-16: Zolbetuximab - Reasons for Approval of Biologics License Application and

Priority Designations

Figure 7-17: SPOTLIGHT Phase III Study – Initiation and Completion Year

Figure 7-18: GLOW Phase III Study – Initiation and Completion Year

Figure 7-19: ASP2138 Phase I Study – Initiation and Completion Year

Figure 7-20: Collaboration of SparX Group and Arovella Therapeutics for Claudin 18.2

iNKT cell therapy

Figure 7-21: ATG-022 Phase I Study – Initiation and 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

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-ADCandtrade; 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

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

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