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DLL3標靶治療的全球市場：市場機會與臨床試驗分析（2024年）
市場調查報告書
商品編碼
1416205

DLL3標靶治療的全球市場：市場機會與臨床試驗分析（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個工作天內

價格

DLL3（Delta Like Ligand 3）最近被發現作為癌症治療靶點，並已成為決定標靶治療藥物市場的重要事件。了解 DLL3 在非癌症和癌症場景中的作用和途徑已顯示出其作為突破性治療選擇的潛力。DLL3 是一種跨膜蛋白，以前因其在非癌細胞過程中的作用而聞名，但在各種惡性腫瘤中過度表達，特別是神經內分泌癌，如小細胞肺癌、膀胱癌和胃腸道胰腺腫瘤。因此，它已成為一個有前途的癌症治療標靶。

DLL3標靶藥物市場正在快速發展，其中tarlatamab處於領先地位。成長的推動因素包括對 DLL3 在癌症中作用的了解的加深、持續的研究和開發計劃以及推動創新的戰略合作夥伴關係。未來為該領域的利益相關者帶來了巨大的機會和前景，包括新的治療方法、改善的患者治療結果以及對癌症治療領域的變革性影響。隨著 DLL3 標靶療法的開發不斷取得進展，很明顯，協作、獨創性和堅持將繼續影響癌症治療領域的未來。

本報告分析了全球DLL3標靶治療的最新臨床試驗趨勢和未來市場機會，並概述了主要治療藥物（超過15種藥物）的治療方法、主要適應症、臨床試驗進展，我們正在調查研發前景、市場成長以及參與臨床試驗的公司（14家公司）的概況。

目錄

第一章 分析方法

第二章 DLL3標靶治療概述

  • 概述
  • DLL3標靶治療的歷史與演變

第 3 章 DLL3 作為診斷/預後標記的作用

  • 診斷生物標記
  • 預後生物標記

第 4 章 DLL3 的目標方法、機制與商業面

  • 抗體藥物偶聯物 (ADC)
  • 抗體
  • 細胞療法
  • 抗體放射性核種結合物
  • 抗體光吸收劑/光敏劑複合物

第五章 全球 DLL3 標靶治療研究與市場趨勢：依適應症分類

  • 小細胞肺癌
  • 大細胞/神經內分泌癌
  • 神經內分泌前列腺癌
  • 胃腸道/胰臟神經內分泌腫瘤（GEP-NET）
  • 神經膠質瘤

第 6 章 DLL3 標靶治療的獨特平台

  • 用於開發DLL3標靶療法的平台
  • DLL3標靶治療開發的潛在平台

第七章 全球DLL3標靶藥物：臨床試驗概述

  • 按公司
  • 按快速通道狀態
  • 按指示
  • 按部分
  • 按患者細分
  • 愛別（按階段）

第八章 全球DLL3標靶藥物的臨床試驗：依公司、適應症及階段分類

  • 研究
  • 臨床前
  • 第一階段
  • 一期/二期
  • 第二階段
  • 註冊前

第九章 DLL3標靶治療市場趨勢及臨床試驗洞察

  • 當前市場趨勢、發展和臨床試驗的評估
  • 未來商業化的可能性

第10章 DLL3標靶治療及各地區市場趨勢調查

  • 美國
  • 英國
  • 歐洲聯盟
  • 加拿大
  • 澳大利亞
  • 中國

第十一章 DLL3標靶治療市場動態

  • 有利的市場/試驗參數
  • 挑戰和限制

第十二章 參與DLL3標靶治療研發的主要公司

  • 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