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癌症分子標靶治療學

市場調查報告書

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1394201

Claudin 18.2 標靶治療全球市場：市場機會與臨床試驗考量（2028）

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

出版日期: 2023年12月12日 | 出版商:

KuicK Research | 英文 220 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

本報告分析結果及摘要

首款 Claudin 18.2 標靶抗體將於 2024 年上半年上市
Claudin 18.2標靶藥物進入臨床試驗：超過60種藥物
當前全球Claudin 18.2標靶藥物的市場趨勢及動向
Claudin 18.2標靶藥物臨床試驗資訊：依公司、適應症、階段
Claudin 18.2 深入了解治療開發的技術與臨床平台
Claudin 18.2 標靶治療開發方法：CAR T 細胞療法、雙特異性抗體和抗體藥物偶聯物

癌症的生物標記有很多，其中許多被用作精準醫學的標靶。在各種有前景的癌蛋白中，Claudin 18 (CLDN18) 已成為非常有前景的治療選擇。 CLDN18的變異體CLDN18.2的出現引起了特別關注。 CLDN18.2具有獨特的表達模式並且主要存在於胃黏膜中。這種變異因其與某些惡性腫瘤的相關性而引起人們的關注。隨著 CLDN18 治療潛力研究的進展，其對製藥領域的影響將會擴大，有可能徹底改變多種癌症的治療。

CLDN18是一種與上皮細胞緊密連接密切相關的蛋白質，最近因其作為治療標靶的潛力而備受關注。 CLDN18的主要優點之一是它在多種腫瘤中表達，包括胰腺癌、胃癌和肺癌。這種選擇性表達使其成為精準醫學的有吸引力的靶標，從而能夠創建保護健康組織同時破壞惡性組織的標靶藥物。因此，CLDN18在多種惡性腫瘤中的過度表現為癌症醫學領域提供了獨特的機會。

此外，利用CLDN18.2作為癌症治療標靶在降低抗藥性方面也有希望。透過專門針對導致癌症的精確蛋白質，抗藥性機制不太可能形成，治療也更有效。因此，CLDN18和CLDN18.2的潛力不容忽視。

Zolvetuximab 是一種針對 CLDN18 的一流研究型單株抗體，正在開發作為 CLDN18.2 陽性、HER2 陰性胃癌或胃食道交界癌患者的一線治療藥物。 2023年7月，zolvetuximab開發商安斯泰來製藥宣布，FDA已批准zolvetuximab的生物製品許可申請（BLA），並授予優先審查權。如果獲得批准，zolvetuximab 將成為美國第一個針對 CLDN18.2 的抗癌藥物。此外，安斯泰來已在日本、歐洲和中國申請佐維妥昔單抗的批准。該藥物正在針對胃癌、胃食道連接部腺癌和胰腺腺癌的多項後期臨床試驗中進行評估。

除了zolvetuximab等抗體外，針對CLDN18.2的嵌合抗原受體T細胞（CAR-T）療法也在開發中。這些基於細胞的療法代表了對抗表達 CLDN18.2 的癌症的前沿方法。 CAR-T療法對來自捐贈者或患者的T細胞進行基因改造，以識別和攻擊癌細胞，當應用於表達CLDN18.2的癌症時，該療法可以帶來很多期待。例如，青島大學醫院對9名患者進行了一項研究，評估iPD-1-Claudin 18.2-CAR-T療法XKDCT086治療表達Claudin 18.2的複發或難治性胃癌的安全性和耐受性。我們正在與參與者進行臨床試驗。這種新方法不僅凸顯了Claudin18.2作為治療標靶的適用性，也凸顯了精準醫學在癌症治療中的發展。

針對 CLDN18.2 的療法也有助於個人化癌症治療的發展。根據患者 CLDN18.2 水平量身定制的治療可能會顯著改善治療結果。此外，針對 CLDN18 或 CLDN18.2 的療法與現有療法合併使用時可能能夠提高療效。例如，CLDN18標靶療法和免疫療法的結合是一種強大的癌症治療策略，需要進一步研究。

製藥公司已經認識到 CLDN18 巨大改變市場的潛力，並正在投入大量資金進行 CLDN18 研究。專門從事 CLDN18 的創投公司可能對尋求製藥業前景的投資者有吸引力。致力於 CLDN18 療法的小型製藥公司也在製藥市場上獲得了關注。例如，KYM Biosciences於2023年2月宣布與全球製藥巨頭阿斯特捷利康簽署針對CLDN18.2的抗體藥物偶聯物CMG901的全球授權協議。阿斯特捷利康將負責 CMG901 的全球研發、製造和商業化。根據協議，阿斯特捷利康將在交易完成後向 KYM 支付 6,300 萬美元的預付款，並額外支付 11 億美元用於進一步的研究和商業裡程碑。

因此，CLDN18及其變異CLDN18.2是製藥業尤其是癌症治療領域的第一線希望。 CLDN18 存在於許多癌症中，研究和臨床試驗中令人鼓舞的結果繼續凸顯了其重要性。 CLDN18 作為治療標靶具有誘人的潛力，可能會改變我們治療癌症的方式。

Abpro Therapeutics
Antengene Corporation
Arovella Therapeutics
Astellas Pharma
AstraZeneca
Beijing Mabworks Biotech
BioNTech
Biotheus
CARsgen
Dragonboat Biopharmaceutical
Gracell Biotechnology
Harbour BioMed
Innovent Biologics
Integral Molecular
Klus Pharma
L and L Biopharma
LaNova Medicines Limited
Leap Therapeutics
Luye Pharma Group
Nanjing Bioheng Biotech
Nanjing KAEDI Biotech
NBE-Therapeutics
OriCell Therapeutics
Qilu Pharmaceutical
Shanghai Junshi Biosciences
Sparx Therapeutics
Tillead Therapeutics
TORL Biotherapeutics
Transcenta Holding
Zai Biopharmaceutical

簡介目錄圖表

“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

簡介目錄圖表

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