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生物製剂分子标靶治疗学

市场调查报告书

商品编码

1551217

CD137 抗体临床试验与市场机会洞察：2027年

CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027

出版日期: 2024年09月01日 | 出版商:

KuicK Research | 英文 210 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

CD137，也称为 4-1BB，最近已成为癌症免疫治疗的一个有前景的标靶。 CD137标靶疗法的潜力在于其能够刺激和增殖细胞毒性T细胞，提高其杀死肿瘤细胞的能力，并维持长期免疫记忆。因此，该领域越来越受到研究人员和製药公司的关注，多篇研究论文显示这种癌症治疗方法的前景。此外，早期临床试验的资料已开始证明治疗效果，为针对 CD137 的药物开发提供即时验证。

CD137标靶治疗仍处于起步阶段，因为目前市场上还没有核准的药物。儘管如此，该产品线仍然充满了处于临床开发各个阶段的候选药物，其中第二阶段是最好的。 BioNTech、Genmab、Adagene 和Shanghai Henlius Biotech等主要製药和生物技术公司已经认识到该标靶的潜力，并积极开展药物开发计划。这为免疫肿瘤学领域的现有企业和新进业者提供了巨大的机会。

针对CD137的疗法可以克服免疫检查点抑制剂等现有免疫疗法的缺点。检查点抑制剂从根本上改变了癌症治疗，但只有一小部分患者和癌症类型对其有反应。 CD137促效剂扩大了可以从免疫疗法中受益的患者范围，并有可能增强或补充这些目前可用疗法的疗效。

临床开发中最先进的CD137 标靶疗法是促效剂抗体。这些化合物的预期作用是透过活化 CD137 讯号传导来刺激 T 细胞存活、增殖和效应活性。关于抗肿瘤功效和安全性，早期临床试验已显示出有希望的结果。 YH004、ADG106、ADG206 和 ATOR-1017 是目前进行临床试验的一些 CD137 促效剂抗体。然而，也存在一些挑战，包括某些候选药物的剂量限制性肝毒性。因此，研究其他可能提供更好安全性和有效性的策略，例如双特异性抗体和定製配体。

总之，CD137 标靶治疗代表了改变癌症和包括免疫系统的各种其他疾病治疗的重大机会。对 CD137 生物学特性的日益了解，以及抗体工程和组合策略的进步，为该领域的创新奠定了坚实的基础。针对 CD137 的疗法填补了医学界的重大空白，并有潜力占领癌症免疫疗法市场的很大一部分，为开发和创新提供了强有力的案例。

本报告调查了全球 CD137 抗体市场，并提供了市场概况，包括药物趋势、临床试验趋势、区域趋势以及进入市场的公司竞争格局。

Currently No Drug Commercially Available In Market
More Than 80 Drugs In Clinical Trials
Highest Clinical Trials Phase: Phase II (7 Drugs)
CD137 Drugs Market Opportunity In Initial 24 Months Of Launch: > US$ 400 Million
Global & Regional Trends (Clinical & Commercial)
CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase
CD137 Therapeutic Approaches By Antibodies Classification
Role Of CD137 & Clinical Progress By Indication

CD137, also known as 4-1BB, has emerged as a promising target for cancer immunotherapy in recent years. The potential of CD137-targeted therapies lies in their ability to stimulate and expand cytotoxic T cells leading to improved tumor cell killing and long-lasting immune memory. As a result, the field has gained attention from researchers and pharmaceutical companies alike, with several research publications hinting at a promising future for this cancer therapeutic approach. Moreover, data emerging from early clinical trials have already begun demonstrating therapeutic benefits, providing real-time validation of CD137-targeted drug development.

With no licensed medications currently on the market, CD137-targeted therapies are still in their infancy. Nonetheless, there is an abundance of candidates in the pipeline in different phases of clinical development, with phase 2 being the highest. Several major pharmaceutical companies and biotech firms, including BioNTech, Genmab, Adagene, and Shanghai Henlius Biotech, are actively pursuing drug development programs after recognizing the potential of this target. This presents a significant opportunity for both established players and newcomers in the field of immuno-oncology.

The ability of CD137-targeted treatments to get past some of the drawbacks of existing immunotherapies, like immune checkpoint inhibitors, is one of their main advantages. Although checkpoint inhibitors have fundamentally altered the way that cancer is treated, only a small percentage of patients and cancer types respond well to them. The range of individuals who can benefit from immunotherapy may be increased by CD137 agonists, which may enhance or supplement the effectiveness of these currently available treatments.

The most advanced CD137-targeted therapies in clinical development are agonistic antibodies. The intended effect of these compounds is to stimulate T cell survival, proliferation, and effector activities via activating CD137 signaling. Regarding anti-tumor effectiveness and safety characteristics, early clinical trials have produced encouraging results. YH004, ADG106, ADG206, and ATOR-1017 are a few CD137 agonistic antibodies that are now undergoing clinical trials. There have been challenges, nevertheless, such as dose-limiting hepatotoxicity seen in certain candidates. Due to this, other strategies are being investigated that might provide better safety and efficacy profiles, such as bispecific antibodies and tailored ligands.

Combining CD137-targeted therapies with other immunomodulatory drugs is one highly intriguing area of investigation. CD137 agonists have been shown to have synergistic benefits when paired with checkpoint inhibitors, chemotherapy, targeted therapy, or even radiation therapy, according to preclinical research and early phase clinical evidence. These combination approaches may result in more potent and more persistent anti-tumor responses, which would fulfill the unmet demand for efficient treatments for malignancies that are challenging to treat.

The market potential for effective CD137 antibodies is significant, considering the wide range of applications of CD137-targeted treatments in cancer. New and efficient treatment modalities are highly sought after, as the global market for cancer immunotherapy is expected to grow to many billions of dollars in the next several years. A sizeable portion of this market may be taken up by CD137-targeted treatments, especially if they show greater efficacy and can treat conditions where immunotherapies have not been very successful.

Furthermore, the versatility of CD137 as a target extends beyond oncology. Recent studies point to possible uses in transplantation, autoimmune diseases, inflammatory disorders, and infectious diseases. This wide-ranging therapeutic potential could open up additional market opportunities for drug developers, willing to explore these indications.

Despite the promising outlook, several challenges need to be addressed in the development of CD137-targeted therapies. These include optimizing dosing regimens to balance efficacy and safety, identifying predictive biomarkers for patient section, and developing strategies to overcome potential resistance mechanisms. Overcoming these hurdles will be crucial for the successful translation of CD137-targeted therapies from bench to bedside.

In conclusion, CD137-targeted therapies represent a significant opportunity to transform treatment of cancer and various other diseases involving the immune system. The increasing comprehension of CD137 biology, in conjunction with developments in antibody engineering and combination strategies, offers a robust basis for novelty in this domain. CD137-targeted therapies have the potential to fill a significant gap in the medical community and gain a significant portion of the cancer immunotherapies market, which presents a strong case for development and innovation.

1. Brief Introduction To CD137

1.1 Clinical Overview
1.2 Biological History Of CD137
1.3 CD137 Hosting An Era Of Agonists Over Antagonists
1.4 Bi-Directional Signaling In CD137

2. Global CD137 Antibody Market Outlook

2.1 Current Research & Market Scenario
2.2 Future Commercialization Opportunities

3. CD137 Antibody Clinical Developments by Regions

3.1 China
3.2 US
3.3 South Korea
3.4 Europe
3.5 Australia

4. Role Of CD137 & Clinical Progress By Indication

4.1 Cancer
- 4.1.1 Leukemia
- 4.1.2 Lymphoma
- 4.1.3 Lung Cancer
- 4.1.4 Melanoma
- 4.1.5 Breast Cancer
- 4.1.6 Colorectal Cancer
4.2 Autoimmune & Inflammatory Diseases
4.3 Microbial Infections
- 4.3.1 Viral Infections
- 4.3.2 Bacterial infections

5. Global CD137 Antibodies Clinical Trials Overview

5.1 By Company
5.2 By Country
5.3 By Indication
5.4 By Phase
5.5 By Patient Segment

6. CD137 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase

6.1 Research
6.2 Preclinical
6.3 Phase I
6.4 Phase I/II
6.5 Phase II

7. CD137 Targeting Proprietary Technology Platforms By Companies

8. CD137 Therapeutic Approaches By Antibodies Classification

8.1 Monoclonal Antibody Based Strategies
8.2 Bispecific Antibody Centered Approaches
8.3 Trispecific Antibody Established Strategies
8.4 Tetraspecific Antibody Strategies

9. Combination Therapies With CD137 Antibodies

10. Competitive Landscape

10.1 ABL Bio
10.2 Adagene
10.3 Alligator Bioscience
10.4 BeiGene
10.5 Bicycle Therapeutics
10.6 BioNTech
10.7 Biotheus
10.8 Crescendo Biologics
10.9 Eutilex
10.10 F-star Therapeutics
10.11 Genmab
10.12 I-MAB Biopharma
10.13 Lyvgen Biopharma
10.14 OriCell Therapeutics
10.15 Pieris Pharmaceuticals
10.16 Shanghai Henlius Biotech
10.17 Sichuan Baili Pharmaceutical
10.18 SystImmune

简介目录图表

List of Figures

Figure 1-1: Anti-CD137 Monoclonal Antibody - Immune Regulation Mechanisms
Figure 1-2: Schematic Depiction Of Bidirectional Signaling By CD137-CD137L
Figure 2-1: CD137 First Approval Sales Estimate - First 12 Months & First 24 Months (US$ Million)
Figure 4-1: GNC-035-105 Phase Ib/II (NCT05944978) - Initiation & Completion Year
Figure 4-2: GNC-035-101 Phase I (NCT05944978) - Initiation & Completion Year
Figure 4-3: GNC-038-101 Phase I (NCT04606433) - Initiation & Completion Year
Figure 4-4: ACIT001 Phase Ib/II (NCT03938987) - Initiation & Completion Year
Figure 4-5: BP41072 Phase I/II (NCT04077723) - Initiation & Completion Year
Figure 4-6: YH004 Phase I (NCT05564806) - Initiation & Completion Year
Figure 4-7: EU-CTS101-I-01 Phase I/II (NCT04903873) - Initiation & Completion Year
Figure 4-8: GCT1046-04 Phase 2 (NCT05117242) - Initiation & Completion Year
Figure 4-9: GCT1046-04 Phase 2 (NCT05117242) - Initiation & Completion Year
Figure 4-10: GCT1046-04 Phase II (NCT05117242) - Initiation & Completion Year
Figure 4-11: Phase I/II (NCT03809624) - Initiation & Completion Year
Figure 4-12: INBRX-105 Phase I (NCT03809624) - Initiation & Completion Year
Figure 4-13: C-1100-01 Phase I (NCT04121676) - Initiation & Completion Year
Figure 4-14: QLF31907-201 Phase 2 (NCT05823246) - Initiation & Completion Year
Figure 4-15: AVIATOR Phase 2 (NCT03414658) - Initiation & Completion Year
Figure 4-16: ADG106-T6002 Phase 1/2 (NCT05275777) - Initiation & Completion Year
Figure 4-17: YH32367-101 Phase I/II (NCT05523947) - Initiation & Completion Year
Figure 4-18: GNC-035-103 Phase 1 (NCT05160545) - Initiation & Completion Year
Figure 4-19: BP42675 Phase Ib (NCT04826003) - Initiation & Completion Year
Figure 4-20: EU-CTS101-I-01 Phase I/II (NCT04903873) - Initiation & Completion Year
Figure 4-21: 2017-0180 Phase 1 (NCT03290937) - Initiation & Completion Year
Figure 5-1: Global - CD137 Targeting Antibodies Clinical Pipeline by Company (Numbers), 2024
Figure 5-2: Global - CD137 Targeting Antibodies Clinical Pipeline by Country (Numbers), 2024
Figure 5-3: Global - CD137 Targeting Antibodies Clinical Pipeline by Indication (Numbers), 2024
Figure 5-4: Global - CD137 Targeting Antibodies Clinical Pipeline by Phase (Numbers), 2024
Figure 5-5: Global - CD137 Targeting Antibodies Clinical Pipeline by Patient Segment (Numbers), 2024
Figure 7-1: Adagene - Anti CD137 NEObody ACG106
Figure 7-2: Adagene - Anti CD137 POWERbody ADG206
Figure 7-3: Genmab - DUObody Production Process
Figure 7-4: Crescendo Biologics - Humabody Structure
Figure 7-5: Crescendo Biologics - CB307 Structure
Figure 7-6: Numab Therapeutics - MATCH Format
Figure 7-7: Systimmune - GNC-039 Structure
Figure 7-8: Systimmune - GNC-035 Structure
Figure 7-9: Systimmune - GNC-038 Structure
Figure 7-10: Merus - Multiclonics Structure
Figure 7-11: Chugai Pharmabody Research - Dual-Ig(R) Technology
Figure 7-12: Eutilex - Costim Platform Technology
Figure 8-1: ATOR-1017 - Mechanism Of Action
Figure 8-2: EU101 - Mode Of Action
Figure 8-3: LVGN6051 - Mechanism Of Action
Figure 8-4: ABL503 - Structure & Mechanism Of Action
Figure 8-5: FS120 - Improving PD-1 & Chemotherapy Responses
Figure 8-6: MP0310 - Mechanism Of Action

List of Tables

Table 4-1: Lymphoma - Clinical Trials Underway for GNC-038 & GNC-035
Table 8-1: Bispecific Antibodies Targeting CD137/4-1BB in Clinical Trials
Table 8-2: Trispecific Antibodies Targeting CD137/4-1BB in Clinical Trials
Table 8-3: Tetraspecific Antibodies Targeting CD137/4-1BB in Clinical Trials
Table 9-1: Ongoing Clinical Trials Evaluating CD137 Antibody Combinations

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CD137 抗体临床试验与市场机会洞察：2027年

CD137 Antibodies Clinical Trials & Market Opportunity Insight 2027

目录

第1章 CD137 概论

第2章全球CD137抗体市场展望

第3章 CD137 抗体的临床开发，依地区

第4章 CD137 的作用与依适应症划分的临床进展

第5章全球CD137抗体临床试验概述

第6章 CD137抑制剂临床试验讨论（依公司、国家、适应症、阶段）

第7章 CD137 公司目标技术平台

第8章 CD137抗体型治疗

第9章使用CD137抗体的合併治疗

第10章竞争态势