CD137 抗體臨床試驗與市場機會洞察：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個工作天內

價格

簡介目錄圖表

CD137，也稱為 4-1BB，最近已成為癌症免疫治療的一個有前景的標靶。 CD137標靶療法的潛力在於其能夠刺激和增殖細胞毒性T細胞，提高其殺死腫瘤細胞的能力，並維持長期免疫記憶。因此，該領域越來越受到研究人員和製藥公司的關注，多篇研究論文顯示這種癌症治療方法的前景。此外，早期臨床試驗的資料已開始證明治療效果，為針對 CD137 的藥物開發提供即時驗證。

CD137標靶治療仍處於起步階段，因為目前市場上還沒有核准的藥物。儘管如此，該產品線仍然充滿了處於臨床開發各個階段的候選藥物，其中第二階段是最好的。 BioNTech、Genmab、Adagene 和Shanghai Henlius Biotech等主要製藥和生物技術公司已經認識到該標靶的潛力，並積極開展藥物開發計劃。這為免疫腫瘤學領域的現有企業和新進業者提供了巨大的機會。

針對CD137的療法可以克服免疫檢查點抑制劑等現有免疫療法的缺點。檢查點抑制劑從根本上改變了癌症治療，但只有一小部分患者和癌症類型對其有反應。 CD137促效劑擴大了可以從免疫療法中受益的患者範圍，並有可能增強或補充這些目前可用療法的療效。

臨床開發中最先進的CD137 標靶療法是促效劑抗體。這些化合物的預期作用是透過活化 CD137 訊號傳導來刺激 T 細胞存活、增殖和效應活性。關於抗腫瘤功效和安全性，早期臨床試驗已顯示出有希望的結果。 YH004、ADG106、ADG206 和 ATOR-1017 是目前進行臨床試驗的一些 CD137 促效劑抗體。然而，也存在一些挑戰，包括某些候選藥物的劑量限制性肝毒性。因此，研究其他可能提供更好安全性和有效性的策略，例如雙特異性抗體和定製配體。

總之，CD137 標靶治療代表了改變癌症和包括免疫系統的各種其他疾病治療的重大機會。對 CD137 生物學特性的日益了解，以及抗體工程和組合策略的進步，為該領域的創新奠定了堅實的基礎。針對 CD137 的療法填補了醫學界的重大空白，並有潛力佔領癌症免疫療法市場的很大一部分，為開發和創新提供了強有力的案例。

本報告調查了全球 CD137 抗體市場，並提供了市場概況，包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司競爭格局。

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

簡介目錄圖表

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