全球 Menin 抑制剂市场：临床试验与未来机会 (2023)

Global Menin Inhibitor Drugs Clinical Trials & Future Opportunity Insight 2023

出版日期: 2023年09月01日 | 出版商:

KuicK Research | 英文 75 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

Menin 是新一代蛋白质，已被用作多种疾病，特别是癌症的治疗标靶。透过对 1 型多发性内分泌肿瘤 (MEN1) 的研究，menin 蛋白首次与良性肿瘤联繫起来，现在正在研究其在癌症和糖尿病中的作用，发现在这两种疾病中都具有潜在的用途。因此，需要开发可用于治疗这些疾病的menin抑制剂。儘管尚未批准 Menin 抑制剂，但 menin 抑制剂管道中有多种有前景的候选药物，每种都有可能成为市场上第一类获得批准的 menin 抑制剂。

儘管menin抑制剂在多种癌症中的作用已被确定，但白血病一直是研究和开发的焦点，因为menin在这种血癌中的作用已在其使用的所有适应症中得到确定。menin蛋白是混合谱系白血病（MLL）基因融合蛋白的重要辅助因子，其突变与急性白血病的发生有关。这种与流行癌症的关联引发了人们对该领域的兴趣，并导致了许多潜在抑制剂的开发。

几种menin抑制剂目前正处于治疗白血病的早期临床试验中，其中levmenib（以前称为SNDX-5613）是目前最有前途的候选药物之一。Revumenib 由 Syndax Pharmaceuticals 开发，是一种高效的 menin 抑制剂，在该公司正在进行的临床试验中已显示出令人信服的临床特征。正在进行的 AUGMENT-101 临床试验正在评估 levmenib 作为急性白血病的单一疗法，而 AUGMENT-102 临床试验正在研究 menin 抑製剂与既定的白血病标准治疗的协同作用。Wymenib 正在与化疗联合进行测试。

2022年12月，FDA授予levmenib突破性疗法认定，用于治疗携带KMT2A重排的复发性或难治性急性白血病患者。它还获得了 FDA 的快速通道指定，用于治疗患有 NPM1 基因突变的复发性或难治性急性髓性白血病 (AML) 或急性淋巴细胞白血病 (ALL) 的成人和青少年。快速通道指定加快了 FDA 对研究药物的审查，并可能使 Revumenib 成为第一个获得上市批准的 menin 抑制剂。在获得 FDA 指定之前，levmenib 还于 2021 年 12 月获得 EMA 的孤儿药物指定，用于治疗急性髓性白血病。

本报告调查了全球menin抑制剂市场并提供了市场概况，包括menin抑制剂的作用机制、其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。

Research Methodology
Menin Inhibitors Drugs In Clinical Trials: > 10 Drugs
Highest Clinical Trials Phase: Phase-II
Global Menin Inhibitors Drugs Clinical Trials By Company, Indication & Phase
Clinical Significance Of Menin Inhibitors
Menin Inhibitors Clinical Research Innovation Trends By Region : US, Europe & Canada

Menin represents a new generation of proteins that have found application as a therapeutic target in several prevalent diseases, especially cancer. First linked with benign tumors through the studies on multiple endocrine neoplasia type 1 (MEN1), the menin protein is now being studied for its role in cancer and diabetes, finding potential use in both. This has generated the need for development of menin inhibitors that can be used to treat these diseases. Though no menin inhibitor has received approval yet, the pipeline of menin inhibitors is populated with multiple promising candidates, each having the potential to become the first-in-class menin inhibitor to receive market approval.

The role of menin inhibitors has been confirmed in multiple cancers, out of which leukemia is dominating the research and development landscape because menin's role in this hematological cancer is the most well characterized out of all indications it has found use in. The menin protein acts as an important cofactor for the fusion proteins of mixed lineage leukemia (MLL) gene, mutations in which are linked to the development of acute leukemia. This association with a prevalent cancer sparked interest in this field and has led to the development of many potential inhibitors.

Several menin inhibitors are now undergoing early phase clinical trials in leukemia, out of which Revumenib, previously known as SNDX-5613, is one of the most promising candidates currently. Revumenib was developed by Syndax Pharmaceuticals, and is a highly potent inhibitor of menin, which has shown a convincing clinical profile in the company's ongoing clinical trials. The ongoing AUGMENT-101 clinical trials is assessing Revumenib as a monotherapy in acute leukemias and the AUGMENT-102 clinical trial is testing Revumenib in combination with chemotherapy to determine the synergized effects of menin inhibitors with established standard of care for leukemia.

The FDA designated Revumenib as a breakthrough therapy in December 2022 the treatment of patients with relapsed or refractory acute leukemia who have a KMT2A rearrangement. In addition, it also has the Fast Track designation from the FDA for the treatment of adults and adolescents with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) with an NPM1 mutation. The fast track designation expedites the review of investigational drugs by the FDA, which puts forth Revumenib as the potential first menin inhibitor to receive marketing approval. Prior to these FDA designations, Revumenib was also granted the orphan drug designation by the EMA in December 2021 for treating acute myeloid leukemia.

Another candidate that has garnered significant attention is BMF-219, a menin inhibitor developed by Biomea Fusion. BMF-219 made name for itself as the first menin inhibitor to enter clinical trials for the treatment of solid cancers. In contrast to other menin inhibitors in the clinical trials, Biomea has expanded the clinical assessment of BMF-219 to KRAS-driven non-small cell lung cancer, pancreatic cancer, and colorectal cancer. The interaction pathways between menin, KRAS and MYC have been established in research studies, which has allowed for this expansion in clinical trials for BMF-219. The trial is still in early clinical phase with the first patient receiving BMF-219 dosage in January this year.

BMF-219 is also an important menin inhibitor in sense that along with solid cancers, it is also the first menin inhibitor to undergo clinical trial for type 2 diabetes mellitus. The candidate showed glycemic control in patients ever after the treatment was stopped, which has been attributed to disruption of menin activity by the drug. In addition, Biomea has also planned a clinical trial to assess BMF-219 in type 1 diabetes. BMF-219 therefore represents a potential force that may be used to improve treatment outcomes of diabetic patients.

Therefore, menin inhibitors represent a significant breakthrough in the management of some prominent diseases marked by high prevalent rates, high mortality rates and a dearth of effective treatments. Ongoing research has been linking menin activities with several other gene products, which can potentially expand the use of menin inhibitors to several other indications. That being said, the global market for menin inhibitors is still in its nascent stage, with companies like Biomea Fusion and Syndax Pharmaceuticals emerging as pioneers of menin inhibitors research. The market holds immense future potential, both clinically and commercially, which needs to be tapped to exploit this newfound commercial opportunity.

1. Research Methodology

2. Introduction To Menin Inhibitors

2.1. Overview & Clinical Evolution
2.2. Clinical Development

3. Clinical Significance Of Menin Inhibitors

4. Menin Inhibitors Mechanism of Action

4.1. Overview
4.2. Mechanism of Action For key Drugs In Clinical Trials

5. Menin Inhibitors Application & Clinical Trials By Indication

5.1. Hematological Cancers
- 5.1.1. Leukemia
- 5.1.2. Lymphoma
- 5.1.3. Multiple Myeloma
5.2. Solid Cancers
5.3. Diabetes

6. Menin Inhibitors Clinical Research Innovation Trends By Region

6.1. US
6.2. Europe
6.3. Canada

7. Global Menin Inhibitors Market Landscape

7.1. Current Market Scenario
7.2. Future Clinical & Commercialization Opportunities

8. Global Menin Inhibitors Drugs Clinical Trials Overview

8.1. By Company
8.2. By Country
8.3. By Indication
8.4. By Patient Segment
8.5. By Phase

9. Global Menin Inhibitors Drugs Clinical Trials By Company, Indication & Phase

9.1. Preclinical
9.2. Phase-I
9.3. Phase-I/II
9.4. Phase-II

10. Competitive Landscape

10.1. Biomea Fusion
10.2. BioNova Pharmaceuticals
10.3. Daiichi Sankyo Company
10.4. Easton Biopharmaceuticals
10.5. Eilean Therapeutics
10.6. HitGen
10.7. Janssen Research & Development
10.8. Sumitomo Pharma

简介目录图表

List of Figures

Figure 4-1: Ziftomenib - Mechanism of Action in Menin-KMT2A Pathway
Figure 4-2: Revumenib - Mechanism of Action in KMT2A-Rearranged AML
Figure 4-3: Revumenib - Mechanism of Action in NPM1-Mutant AML
Figure 4-4: BMF-219 - Mechanism of Action in Leukemia
Figure 4-5: BMF-219 - Mechanism of Action in Type 2 Diabetes Mellitus
Figure 5-1: AUGMENT-101 Phase I/II Study - Initiation & Completion Years
Figure 5-2: AUGMENT-102 Phase I Study - Initiation & Completion Years
Figure 5-3: AALL2121 Phase II Study - Initiation & Completion Years
Figure 5-4: Revumenib - FDA Designation Years
Figure 5-5: KOMET-001 Phase I/II Study - Initiation & Completion Years
Figure 5-6: KOMET-007 Phase I Study - Initiation & Completion Years
Figure 5-7: KOMET-008 Phase I Study - Initiation & Completion Years
Figure 5-8: COVALENT-101 Phase I Study - Initiation & Completion Years
Figure 5-9: COVALENT-101 Phase I Study - Initiation & Completion Years
Figure 5-10: COVALENT-102 Phase I Study - Initiation & Completion Years
Figure 5-11: COVALENT-111 Phase I Study - Initiation & Completion Years
Figure 8-1: Global - Menin Inhibitor Drugs Clinical Trials by Company (Numbers), 2023
Figure 8-2: Global - Menin Inhibitor Drugs Clinical Trials by Country (Numbers), 2023
Figure 8-3: Global - Menin Inhibitor Drugs Clinical Trials by Indication (Numbers), 2023
Figure 8-4: Global - Menin Inhibitor Drugs Clinical Trials by Patient Segment (Numbers), 2023
Figure 8-5: Global - Menin Inhibitor Drugs Clinical Trials by Phase (Numbers), 2023