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