DLL3标靶治疗的全球市场:市场机会与临床试验分析(2024年)
市场调查报告书
商品编码
1416205

DLL3标靶治疗的全球市场:市场机会与临床试验分析(2024年)

Global DLL3 Targeted Therapies Market Opportunities & Clinical Trials Insight 2024

出版日期: | 出版商: KuicK Research | 英文 140 Pages | 商品交期: 最快1-2个工作天内

价格

DLL3(Delta Like Ligand 3)最近被发现作为癌症治疗靶点,并已成为决定标靶治疗药物市场的重要事件。了解 DLL3 在非癌症和癌症场景中的作用和途径已显示出其作为突破性治疗选择的潜力。DLL3 是一种跨膜蛋白,以前因其在非癌细胞过程中的作用而闻名,但在各种恶性肿瘤中过度表达,特别是神经内分泌癌,如小细胞肺癌、膀胱癌和胃肠道胰腺肿瘤。因此,它已成为一个有前途的癌症治疗标靶。

DLL3标靶药物市场正在快速发展,其中tarlatamab处于领先地位。成长的推动因素包括对 DLL3 在癌症中作用的了解的加深、持续的研究和开发计划以及推动创新的战略合作伙伴关係。未来为该领域的利益相关者带来了巨大的机会和前景,包括新的治疗方法、改善的患者治疗结果以及对癌症治疗领域的变革性影响。随着 DLL3 标靶疗法的开发不断取得进展,很明显,协作、独创性和坚持将继续影响癌症治疗领域的未来。

本报告分析了全球DLL3标靶治疗的最新临床试验趋势和未来市场机会,并概述了主要治疗药物(超过15种药物)的治疗方法、主要适应症、临床试验进展,我们正在调查研发前景、市场成长以及参与临床试验的公司(14家公司)的概况。

目录

第一章 分析方法

第二章 DLL3标靶治疗概述

  • 概述
  • DLL3标靶治疗的历史与演变

第 3 章 DLL3 作为诊断/预后标记的作用

  • 诊断生物标记
  • 预后生物标记

第 4 章 DLL3 的目标方法、机制与商业面

  • 抗体药物偶联物 (ADC)
  • 抗体
  • 细胞疗法
  • 抗体放射性核种结合物
  • 抗体光吸收剂/光敏剂复合物

第五章 全球 DLL3 标靶治疗研究与市场趋势:依适应症分类

  • 小细胞肺癌
  • 大细胞/神经内分泌癌
  • 神经内分泌前列腺癌
  • 胃肠道/胰臟神经内分泌肿瘤(GEP-NET)
  • 神经胶质瘤

第 6 章 DLL3 标靶治疗的独特平台

  • 用于开发DLL3标靶疗法的平台
  • DLL3标靶治疗开发的潜在平台

第七章 全球DLL3标靶药物:临床试验概述

  • 按公司
  • 按快速通道状态
  • 按指示
  • 按部分
  • 按患者细分
  • 爱别(按阶段)

第八章 全球DLL3标靶药物的临床试验:依公司、适应症及阶段分类

  • 研究
  • 临床前
  • 第一阶段
  • 一期/二期
  • 第二阶段
  • 註册前

第九章 DLL3标靶治疗市场趋势及临床试验洞察

  • 当前市场趋势、发展和临床试验的评估
  • 未来商业化的可能性

第10章 DLL3标靶治疗及各地区市场趋势调查

  • 美国
  • 英国
  • 欧洲联盟
  • 加拿大
  • 澳大利亚
  • 中国

第十一章 DLL3标靶治疗市场动态

  • 有利的市场/试验参数
  • 挑战和限制

第十二章 参与DLL3标靶治疗研发的主要公司

  • Abdera Therapeutics
  • Allogene Therapeutics
  • Amgen
  • Boehringer Ingelheim
  • Chugai Pharmaceutical
  • Gensun Biopharma
  • Harpoon Therapeutics
  • ImaginAb Inc
  • Legend Biotech
  • Molecular Partners
  • Phanes Therapeutics
  • Qilu Pharmaceutical
  • Shanghai Affinity Biopharmaceutical
  • ZAI Lab

“Global DLL3 Targeted Therapies Market Opportunities & Clinical Trials Insight 2024” Report Finding & Highlights:

  • Role of DLL3 As Diagnostic & Prognostic Markers
  • DLL3 Targeting Approaches, Mechanism & Commercial Aspects
  • Insight On Current & Potential DLL3 Targeted Therapies Proprietary Platforms: > 10 Platform
  • DLL3 Targeted Drugs Clinical Trials Insight By Company, Indication & Phase: > 15 Drugs
  • Global DLL3 Targeted Therapies Research & Market Trends By Indication
  • DLL3 Targeted Therapies Research & Market Trends by Region
  • Insight On Companies Involved In R&D Of DLL3 Targeted Therapies: 14 Companies

In recent years, the discovery of Delta Like Ligand 3 (DLL3) as a therapeutic cancer target has emerged as key defining moment in the targeted therapy landscape. Understanding DLL3's role and pathways in both non cancer and cancer scenarios has shed light on its potential as a groundbreaking treatment option. DLL3, a transmembrane protein previously known for its role in non-cancerous cellular processes, has emerged as a promising cancer treatment target due to its overexpression in a variety of malignancies, particularly neuroendocrine cancers such as small-cell lung cancer, bladder cancer, and gastroenteropancreatic tumors.

Stemcentrx, now a subsidiary of AbbVie, led the development of Rovalpituzumab tesirine (Rova-T), which was a pioneering endeavor in the field of DLL3 targeted therapies. Rova-T, an antibody-drug combination containing a DLL3-targeting antibody coupled to a cytotoxic chemical, was designed to take advantage of the specific overexpression of DLL3 in cancer cells. Despite initial enthusiasm, the cessation of Rova-T in later-phase clinical trials due to negative results presented both challenges and lessons.

Despite being discontinued in later stage clinical studies, Rova-T has left an indelible mark on the landscape of DLL3 targeted therapeutics, acting as a catalyst for the discovery and development of novel pharmacological classes. Following Rova-T's journey, its legacy lives on with Rovalpituzumab being the primary antibody component in a variety of antibody-drug conjugates, indicating a paradigm change in cancer therapy. These conjugates, which carry a variety of payloads such as radionuclides, photoabsorbers, and photosensitizers, have emerged as viable candidates in ongoing scientific research and clinical trials.

By combining Rova-T's DLL3-targeting antibody Rovalpituzumab into these innovative conjugates, scientists have leveraged the potential of diverse payloads to enhance the precision and efficacy of cancer treatment. Incorporating radionuclides, providing tailored radiation therapy, and using photoabsorbers and photosensitizers for photodynamic therapy are all exciting options that have shown great promise in preclinical and early clinical trials.

The dynamic evolution of DLL3 targeted therapies is characterized by a wide range of candidates in clinical trials, extending far beyond Rovalpituzumab conjugates. The current landscape encompasses a wide range of novel approaches, from bispecific and trispecific antibodies to cutting-edge cell therapies like CAR T and CAR NK cell therapies. While many of these candidates are still in early stages of development, significant exceptions, like as Amgen's Tarlatamab, have advanced to phase 3 trials. Tarlatamab's advancement to this pivotal stage not only reflects the accelerated pace of research in DLL3 targeted therapies, but also establishes a significant benchmark for the field, indicating a critical step toward the potential translation of these novel therapeutic modalities from experimental concepts to clinically validated treatments.

Tarlatamab has reached key milestones on its extraordinary path, first receiving orphan drug designation for small cell lung cancer (SCLC) in 2018 and then breakthrough therapy designation in October 2023. These accolades highlight its potential as a novel therapeutic approach for a cancer with few treatment alternatives. More recently, in December 2023, it was granted the FDA Priority Review; the FDA Target Action Date for Tarlatamab is June 12, 2024, putting this innovative therapy on the verge of making history as the first BiTE® (bispecific T cell engager) therapy for a major solid tumor and potentially clinching the coveted title of the first FDA-approved DLL3 targeted therapy.

The culmination of these designations and impending regulatory decisions not only demonstrates Tarlatamab's clinical promise, but also emphasizes its critical role in shaping the future landscape of cancer treatment, particularly in the context of DLL3 targeted therapies, as it approaches potential approval and clinical integration.

Several major pharmaceutical companies, including Roche (via Chugai Pharmaceutical), Boehringer Ingelheim, and Novartis, are actively working on DLL3 targeted therapies, demonstrating the significant interest and potential in this therapeutic area. Partnerships and license agreements highlight the field's collaborative character, with significant examples include the current collaboration between Boehringer Ingelheim and Oxford BioTherapeutics, as well as newer collaborations with Novartis and Legend, MediLink Therapeutics, and Zai Lab.

The DLL3 targeted therapeutic market is rapidly evolving, with Tarlatamab at the forefront. Growth is being driven by a better knowledge of the role of DLL3 in cancer, ongoing research and development initiatives, and strategic partnerships that promote innovation. The future contains enormous possibilities and prospects for stakeholders in this sector, including the promise of novel therapy modalities, improved patient outcomes, and a transformative impact on the cancer treatment landscape. As the development of DLL3 targeted therapies progresses, it becomes obvious that collaboration, ingenuity, and tenacity will continue to influence the future of cancer therapies domain.

Table of Contents

1. Research Methodology

2. Introduction to DLL3 Targeted Therapies

  • 2.1. Overview
  • 2.2. History & Evolution of DLL3 Targeted Therapies

3. Role of DLL3 As Diagnostic & Prognostic Markers

  • 3.1. Diagnostic Biomarker
  • 3.2. Prognostic Biomarker

4. DLL3 Targeting Approaches, Mechanism & Commercial Aspects

  • 4.1. Antibody Drug Conjugates
  • 4.2. Antibodies
  • 4.3. Cell therapies
  • 4.4. Antibody Radionuclide Conjugates
  • 4.5. Antibody Photoabsorber/Photosensitizer Conjugate

5. Global DLL3 Targeted Therapies Research & Market Trends By Indication

  • 5.1. Small Cell Lung Cancer
  • 5.2. Large Cell Neuroendocrine Cancer
  • 5.3. Neuroendocrine Prostate Cancer
  • 5.4. Gastroenteropancreatic Neuroendocrine Tumors
  • 5.5. Glioma

6. DLL3 Targeted Therapies Proprietary Platforms

  • 6.1. Platforms Used To Develop DLL3 Targeted Therapies
  • 6.2. Potential Platforms for DLL3 Targeted Therapies Development

7. Global DLL3 Targeted Drugs Clinical Trials Overview

  • 7.1. By Company
  • 7.2. By Fast Track Status
  • 7.3. By Indication
  • 7.4. By Location
  • 7.5. By Patient Segment
  • 7.6. By Phase

8. Global DLL3 Targeted Drugs Clinical Trials By Company, Indication & Phase

  • 8.1. Research
  • 8.2. Preclinical
  • 8.3. Phase-I
  • 8.4. Phase-I/II
  • 8.5. Phase-II
  • 8.6. Preregistration

9. DLL3 Targeted Therapies Market Trends & Clinical Trials Insights

  • 9.1. Current Market Trends, Developments & Clinical Trials Assessment
  • 9.2. Future Commercialization Opportunity

10. DLL3 Targeted Therapies Research & Market Trends by Region

  • 10.1. US
  • 10.2. UK
  • 10.3. EU
  • 10.4. Canada
  • 10.5. Australia
  • 10.6. China

11. DLL3 Targeted Therapies Market Dynamics

  • 11.1. Favorable Market & Clinical Development Parameters
  • 11.2. Challenges & Restraints

12. Key Companies Involved In Research & Development Of DLL3 Targeted Therapies

  • 12.1. Abdera Therapeutics
  • 12.2. Allogene Therapeutics
  • 12.3. Amgen
  • 12.4. Boehringer Ingelheim
  • 12.5. Chugai Pharmaceutical
  • 12.6. Gensun Biopharma
  • 12.7. Harpoon Therapeutics
  • 12.8. ImaginAb Inc
  • 12.9. Legend Biotech
  • 12.10. Molecular Partners
  • 12.11. Phanes Therapeutics
  • 12.12. Qilu Pharmaceutical
  • 12.13. Shanghai Affinity Biopharmaceutical
  • 12.14. ZAI Lab

List of Figures

  • Figure 4-1: Antibody Drug Conjugates - Mechanism Of Action
  • Figure 4-2: BiTE - Amgen
  • Figure 4-3: HPN328 - Structure
  • Figure 4-4: Rova-IR700 - Mechanism
  • Figure 5-1: DLL3 - Small Cell Lung Cancer
  • Figure 5-2: DeLLphi-301 Phase 2 Study - Initiation & Completion Year
  • Figure 5-3: DeLLphi-304 Phase 2 Study - Initiation & Completion Year
  • Figure 5-4: DAREON™-5 Phase 2 Study - Initiation & Completion Year
  • Figure 5-5: PT217X1101 Phase 1 Study - Initiation & Completion Year
  • Figure 5-6: HPN328 Phase 1 Study - Initiation & Completion Year
  • Figure 5-7: LB2102-1001 Phase 1 Study - Initiation & Completion Year
  • Figure 5-8: NCT05507593 Phase 1 Study - Initiation & Completion Year
  • Figure 5-9: DLL3 - Large Cell Neuroendocrine Cancer
  • Figure 6-1: T-Charge Platform - Features
  • Figure 6-2: BiTE® Antibody Construct
  • Figure 6-3: TMALIN - ADC Advantages
  • Figure 6-4: TMALIN - ADC Structure
  • Figure 6-5: TriTAC - T-Cell Engagers Structure
  • Figure 6-6: TriTAC - Advantages
  • Figure 6-7: PACbody™ Platform
  • Figure 6-8: ATACCbody™ Platform
  • Figure 6-9: SPECpair™ Platform
  • Figure 6-10: ROVEr Platform - Process
  • Figure 6-11: RPT - Advantages
  • Figure 6-12: Dual-Ig Technology - Antibody Structure & Mechanism
  • Figure 6-13: AlloCAR T - Process
  • Figure 6-14: AlloCAR T - Features
  • Figure 6-15: Alluminox™ Platform - Drug Structure
  • Figure 6-16: Rakuten Medical - Photoimmunotherapy Process
  • Figure 7-1: Global - DLL3 Targeted Drugs Clinical Trials By Company (Number), 2024
  • Figure 7-2: Global - DLL3 Targeted Drugs Clinical Trials By Fast Track Status (Number), 2024
  • Figure 7-3: Global - DLL3 Targeted Drugs Clinical Trials By Indication (Number), 2024
  • Figure 7-4: Global - DLL3 Targeted Drugs Clinical Trials By Location (Number), 2024
  • Figure 7-5: Global - DLL3 Targeted Drugs Clinical Trials By Patient Segment (Number), 2024
  • Figure 7-6: Global - DLL3 Targeted Drugs Clinical Trials By Phase (Number), 2024
  • Figure 11-1: DLL3 Targeted Therapies - Market Drivers & Opportunities
  • Figure 11-2: DLL3 Targeted Therapies - Market Challenges & Restraints

List of Tables

  • Table 5-1: Large Cell Neuroendocrine Cancer - Candidates In Clinical Trials
  • Table 5-2: Neuroendocrine Prostate Cancer - Candidates IIn Clinical Trials
  • Table 5-3: Gastroenteropancreatic Neuroendocrine Tumors - Candidates In Clinical Trials
  • Table 5-4: Glioma - Candidates In Clinical Trials
  • Table 10-1: US - FDA Designated DLL3 Targeted Therapies