DLL3標的療法の世界市場：市場機会と治験の分析 (2024年)

DLL3（Delta Like Ligand 3：デルタ様リガンド3）が近年、がん治療標的として発見され、標的治療薬市場を決定付ける重要な出来事として浮上しています。非がんとがんの両方のシナリオにおけるDLL3の役割と経路を理解することで、画期的な治療オプションとしての可能性が見えてきました。DLL3は膜貫通タンパク質で、以前は非がん細胞プロセスでの役割で知られていたが、様々な悪性腫瘍、特に小細胞肺がん、膀胱がん、胃腸膵臓腫瘍などの神経内分泌がんで過剰発現していることから、有望ながん治療ターゲットとして浮上してきました。

DLL3標的治療薬市場は、タルラタマブを筆頭に急速に発展しています。がんにおけるDLL3の役割に関する知識の向上、進行中の研究開発イニシアティブ、イノベーションを促進する戦略的パートナーシップなどが成長の原動力となっています。将来は、この分野の利害関係者にとって、新規治療法、患者転帰の改善、がん治療の展望に対する変革的な影響など、大きな可能性と展望が待ち受けています。DLL3を標的とした治療法の開発が進むにつれ、協力、創意工夫、粘り強さががん治療領域の未来に影響を与え続けることは明らかです。

当レポートでは、世界のDLL3標的療法に関する治験の最新動向と今後の市場機会について分析し、治療法の概要や主な適応症、主な治療薬の治験の進捗状況 (15品目以上)、今後の研究開発・市場成長の見通し、治験参加企業 (14社) のプロファイルなどを調査しております。

目次

第1章 分析手法

第2章 DLL3標的療法の概要

• 概要
• DLL3標的療法の歴史と進化

第3章 診断・予後マーカーとしてのDLL3の役割

• 診断バイオマーカー
• 予後バイオマーカー

第4章 DLL3の標的アプローチ、メカニズム、商業的側面

• 抗体薬物複合体 (ADC)
• 抗体
• 細胞療法
• 抗体放射性核種複合体
• 抗体光吸収剤／光増感剤複合体

第5章 世界のDLL3標的療法の研究と市場動向：適応症別

• 小細胞肺がん
• 大細胞・神経内分泌がん
• 神経内分泌前立腺がん
• 消化管・膵神経内分泌腫瘍 (GEP-NET)
• 神経膠腫

第6章 DLL3標的療法の独自のプラットフォーム

• DLL3標的療法の開発に使用されるプラットフォーム
• DLL3標的療法開発のための潜在的なプラットフォーム

第7章 世界のDLL3標的薬：治験の概要

• 企業別
• ファストトラックの状況別
• 適応症別
• 部位別
• 患者セグメント別
• 相別 (フェーズ別)

第8章 世界のDLL3標的薬の治験：企業別・適応症別・相別

• 研究
• 前臨床
• 第I相
• 第I/II相
• 第II相
• 登録前

第9章 DLL3標的療法の市場動向と治験に関する洞察

• 現在の市場動向、開発、臨床試験の評価
• 将来の商品化の可能性

第10章 DLL3標的療法の調査と地域別の市場動向

• 米国
• 英国
• 欧州連合
• カナダ
• オーストラリア
• 中国

第11章 DLL3標的療法の市場力学

• 有利な市場・治験パラメーター
• 課題と制約条件

第12章 DLL3標的療法の研究開発に携わる主要企業

• 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

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

“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