MCL1 抑制剂的全球市场：临床试验和商业化机会（2023 年）

Global MCL1 Inhibitor Drug Clinical Trials & Commercialization Opportunity Insights 2023

出版日期: 2023年09月01日 | 出版商:

KuicK Research | 英文 78 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

MCL-1 已被确定为多种癌症（主要是造血系统恶性肿瘤）发病机制中的核心蛋白。MCL-1 是一种动态且独特的蛋白质，参与多种细胞功能，包括细胞週期进程、代谢和分化。然而，BCL-2 作为防止细胞凋亡的促生存成员的作用已被强调为有希望的癌症治疗标靶。此外，MCL-1过度表现也透过各种讯号机制促进实体肿瘤和血液恶性肿瘤中对各种化疗药物的抗药性。因此，MCL-1因其在促进细胞存活和治疗抗药性方面的重要作用而成为一个有前途的治疗靶点，研究人员目前正在致力于寻找抑制MCL-1的策略，并且正在发挥作用。

与其他蛋白相比，标靶抑制MCL-1具有更多优势。MCL-1 在许多癌症中过度表达，包括乳癌和肺癌，这两种癌症的发生率和死亡率最高。MCL-1抑制癌细胞的凋亡过程并促进存活，导致肿瘤负荷增加。在临床前研究中，MCL-1 的抑制被证明会诱导细胞死亡。此外，它还提高了与 MCL-1 抑制剂合併使用的其他抗癌药物的疗效。

此外，MCL-1 与目前治疗产生抗药性有关。特别是在血液癌症中，治疗抗药性在癌症患者中很常见，这对治疗结果和患者存活提出了挑战。MCL-1 的过度表现在其中发挥了作用，因为它抵消了诱导细胞凋亡的药物的作用。标靶 MCL-1 可以克服这种抗药性并提高用于治疗造血系统癌症的化疗的有效性。此外，透过将MCL-1抑制剂与其他标靶治疗药物或抗癌药物合併使用，可望对癌细胞产生协同作用，促进细胞死亡，改善治疗效果。

许多有前景的候选化合物的临床前和临床测试已经显示出有希望的结果。S63845是第一批进入临床前试验的候选药物之一，迄今已在多种实体癌症和造血系统癌症中进行了评估，显示出有希望的结果。Servier和Novartis共同开发了S64315/MIK665，这是S63845的临床试验版本。如前所述，MCL-1 抑制剂是理想的组合药物。因此，S64315 也正在与化疗药物氮胞甘和研究中的 BCL-2 抑制剂 VOB560 联合用于造血系统癌症患者进行评估。

关于MCL-1抑制剂在癌症治疗的应用，除了S63845外，许多在研候选化合物的临床前试验均取得了良好的结果，令人信服。此外，MCL-1有潜力用作各种恶性肿瘤的治疗靶点，这些候选药物在实体瘤中的部署结果证明了这一点。儘管MCL-1抑制剂的研发仍是一个新兴领域，但Amgen、Novartis、AstraZeneca等知名製药公司也正在投资开发这些候选化合物，展现了MCL-1抑制剂的潜力和潜力。这证实了未来几年意想不到的市场成长。MCL-1 抑制剂仍存在需要解决的缺点，以实现 MCL-1 抑制剂市场的成长潜力。

本报告调查了全球MCL1抑制剂市场，并提供了市场概况，以及MCL1抑制剂的作用机制、它们在癌症治疗中的作用、区域趋势、临床试验趋势以及进入市场的公司的竞争趋势。提供

Research Methodology
ML1 Inhibitor Drug In Clinical Trials: > 12 Drugs
Commercially Approved MCL1 Inhibitor Drug: 1 (Synribo)
ML1 Inhibitor Drug Clinical Trials Insight By Company, Indication & Phase
Global MCL1 Inhibitor Drug Market Opportunity Outlook
MCL1 Inhibitor Drug Clinical Innovation & Development Trends By Different Cancers

MCL-1 has been identified as a central protein in the pathogenesis of several cancers, majorly hematopoietic malignancies. It is a dynamic and unique protein, which is involved in a variety of cellular functions, including cell cycle progression, metabolism, and differentiation among others. However, its role as a pro-survival member of the BCL-2 that prevents apoptosis is what has brought it into the limelight as a promising therapeutic target for cancer. In addition, overexpression of MCL-1 also promoted drug resistance of both solid tumors and hematological malignancies to various chemotherapeutic agents through different signaling mechanisms. Therefore, due its key role in promoting cell survival and the resistance to treatment, MCL-1 has emerged as a promising therapeutic target, and researchers are now working to find strategies to inhibit MCL-1.

Compared to other proteins, targeted inhibition of the MCL-1 is has more advantages. The protein is overexpressed in a number of cancers including breast and lung cancers, two cancers having the highest incidence and mortality rates. MCL-1 can prevent the process of apoptosis in cancer cells and promote survival, leading to increase in tumor mass. In preclinical trials, inhibition of the MCL-1 was shown to induce cell death. Additionally, it also increased the efficacy of other anticancer drugs administered in combination with the MCL-1 inhibitor.

Further, MCL-1 is also indicated in the development of resistance to current treatments. Especially in blood cancers, resistance to treatment is a common event occurring in cancer patients, and is something that has been challenging the treatment outcomes and survival of patients. Overexpression of MCL-1 plays a role in this as its upregulation can counteract the effects of drugs that induce apoptosis otherwise. Targeting the MCL-1 can overcome this resistance and enhance the effectiveness of chemotherapies used in treating hematopoietic cancers. Adding on to this, the combination of MCL-1 inhibitors with other targeted therapies and anticancer drugs can have a synergic effect on cancer cells, leading to enhanced cell death and improved treatment outcomes.

Research has also found that while normal cells rely on several survival mechanisms, most cancer cells become highly dependent on MCL-1 for their survival. Therefore, it is hypothesized that targeting the MCL-1 will be a highly targeted strategy specific towards cancer cells, and it will leave non-cancer cells unharmed. To some extent, results from clinical and preclinical trials conducted by researchers and drug developers have been able to justify this. Though there remain some limitations such as the emergence of unforeseen adverse effects such as cardiac problems, the potential of MCL-1 as a therapeutic target cannot be denied, and is an avenue that needs to be explored more with potential candidates.

Results from preclinical and clinical trials for many promising candidates have returned encouraging outcomes. S63845 was among the first candidates to enter preclinical trials, and till date it has been assessed in a number of solid and hematopoietic cancers, and has shown promising results. Servier and Novartis jointly developed S64315/MIK665, the clinical-trial version of S63845. As mentioned above, MCL-1 inhibitors can act as ideal combinatorial agents. Therefore, S64315 too is being assessed in combination with azacitidine, a chemotherapeutic drug, and VOB560, an investigational BCL-2 inhibitor, in patients with hematopoietic cancers.

A compelling case has been made for the use of MCL-1 inhibitors in the treatment of cancer by the positive preclinical trial results of numerous other investigational candidates besides S63845. MCL-1 also has the potential to be used as a therapeutic target for a variety of malignancies, as evidenced by the outcomes of the expansion of these candidates to solid tumors. Research and development of MCL-1 inhibitors is still an emerging field, however, prominent pharmaceutical companies like Amgen, Novartis, and AstraZeneca have also invested in the development of these candidates, which vouches for the future potential of MCL-1 inhibitors and the unanticipated market growth in the coming years. There still remain certain drawbacks associated with MCL-1 inhibitors that need to be addressed to realize the prospective growth potential of the MCL-1 inhibitors market.

1. Research Methodology

2. Introduction To MCL1 Inhibitors

2.1. MCL1 as Therapeutic Target
2.2. Role of MCL1 in Cancer

3. MCL1 Inhibitors - Mechanism of Action

3.1. Indirect Inhibition of MCL1
3.2. Direct Inhibition of MCL1

4. MCL1 Inhibitor Drug Clinical Innovation by Indication

4.1. Leukemia
4.2. Lymphoma
4.3. Multiple Myeloma
4.4. Solid Cancers
- 4.4.1. Breast cancer
- 4.4.2. Lung Cancer
- 4.4.3. Melanoma
- 4.4.4. Colorectal cancer

5. Global MCL1 Inhibitor Drug Market Opportunity Outlook

5.1. Current Clinical Research Landscape
5.2. MCL1 Inhibitor Drug Future Commercialization Opportunities

6. Global MCL1 Inhibitor Drugs Clinical Trials Overview

6.1. By Company
6.2. By Country
6.3. By Indication
6.4. By Patient Segment
6.5. By Phase

7. Global MCL1 Inhibitor Drugs Clinical Trials Insight By Company, Indication & Phase

7.1. Preclinical
7.2. Phase-I
7.3. Phase-I/II
7.4. Phase-II

8. Marketed MCL1 Inhibitor Drug Clinical Insight

9. Competitive Landscape

9.1. Amgen
9.2. Ascentage Pharma
9.3. Broad Institute
9.4. Captor Therapeutics
9.5. Cyclacel Pharmaceuticals
9.6. Gilead Sciences
9.7. Prelude Therapeutics
9.8. Servier
9.9. Sirnaomics
9.10. Teva Pharmaceutical Industries
9.11. University Of Innsbruck
9.12. Vernalis
9.13. Vichem Chemie

简介目录图表

List of Figures

Figure 4-1: S63845/MIK665 - Phase I Study & Phase I/II Study (NCT04702425 & NCT04629443) Initiation & Completion Year
Figure 4-2: AMG 176 Phase I Study (NCT05209152) - Initiation & Completion Year
Figure 4-3: AMG 176 Phase I Study (NCT02675452) - Initiation & Completion Year
Figure 4-4: MIK665 - Study Initiation & Completion Year
Figure 4-5: PRT1419 - Study Initiation & Completion Year
Figure 4-6: AMG 176 Phase I Study (NCT02675452) - Initiation & Completion Year
Figure 4-7: MIK665 Phase I Study (NCT04702425) - Initiation & Completion Year
Figure 6-1: Global - MCL1 Inhibitor Drugs Trials by Company (Numbers), 2023
Figure 6-2: Global - MCL1 Inhibitor Drugs Trials by Country (Numbers), 2023
Figure 6-3: Global - MCL1 Inhibitor Drugs Trials by Indication (Numbers), 2023
Figure 6-4: Global - MCL1 Inhibitor Drugs Trials by Patient Segment (Numbers), 2023
Figure 6-5: Global - MCL1 Inhibitor Drugs Trials by Phase (Numbers), 2023