Glioblastoma Multiforme (GBM) – Drug Pipeline Landscape, 2023
Glioblastoma Multiforme (GBM) is a fast-growing and most common type of cancer that starts in the brain, a central nervous system tumor that forms from supportive (glial) tissue of the brain and spinal cord, usually occurs in adults and affects the brain more often than the spinal cord. It is also called as Glioblastoma and Grade IV Astrocytoma.
The exact cause of Glioblastoma Multiforme is still unknown. Factors associated with Glioblastoma Multiforme risk are prior therapeutic radiation, decreased susceptibility to allergy and impaired immune response, hereditary cancer syndromes including Li-fraumeni syndrome and Lynch syndrome and mutations in genes within the tumor cells.
The most common symptoms of Glioblastoma Multiforme include headache, seizures, loss of balance/trouble in walking, nausea and vomiting, memory loss, difficulties in speech, changes in vision, weakness, trouble in concentrating, mood swings etc.
Glioblastoma Multiforme can be diagnosed by the doctors with initial examination about recent symptoms and personal and family history of disease. Diagnostic tests include MRI, CT scan, Magnetic resonance spectroscopy, needle biopsy.
The most common treatments for Glioblastoma Multiforme are surgery, Radiotherapy, Chemotherapy such as temozolomide, Targeted therapy such as Bevacizumab, Immunotherapy etc.
The pipeline of Glioblastoma Multiforme (GBM) treatment market consists of a great variable of drugs. Lysine Specific Demethylase 1 (LSD1) Inhibitors, Fatty Acid Synthase (FASN) Inhibitors, Phosphatidylinositol 3 Kinase (PI3K) Inhibitors, Poly (ADP-ribose) Polymerase 1 (PARP1) Inhibitors, Mesenchymal Epithelial Transition Factor (MET) Inhibitors, and some others are the most highlighted class of this indication. Ongoing research and current trials have the potential to change the market.
More than 100 key players, including pharma giants such as Astrazeneca, Nerviano Medical Sciences, In8bio Inc., MimiVax, LLC, Hoffmann-La Roche, and others are working to bring novel therapies that overcome the roadblocks of Glioblastoma Multiforme (GBM) treatment pipeline.
Report Highlights
Global Insight Service’s, “Glioblastoma Multiforme (GBM) – Drug Pipeline Landscape, 2023,” is an overview of the Glioblastoma Multiforme pipeline drugs. This report covers detailed insights on Glioblastoma Multiforme drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to gain insights and thus help industry participants for decision making. Glioblastoma Multiforme pipeline report helps gaining insights on drugs which are under development stage of drug development process across globally. Global Insight Services aims to cover all the drug attributes, deals, regulatory milestones and all the upcoming milestones.
Recent Developments
In February 2023, Beactica Therapeutics AB announced that U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BEA-17 for the treatment of glioblastoma (GBM).
In July 2022, Efineptakin Alfa (NT-I7) has been granted Orphan Drug Designation by U.S. Food and Drug Administration (FDA) for the treatment of Glioblastoma Multiforme.
In January 2022, Ascletis Pharma Inc dosed first patient in the Phase III registration study of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM).
In January 2021, the US Food and Drug Administration (FDA) accepted Biologics License Application (BLA) for Bio-Thera’s BAT1706 for the treatment of Recurrent Glioblastoma.
In September 2022, Nerviano Medical Sciences S.r.l. (NMS) entered into collaboration agreement with licensing option with Merck Healthcare KGaA (Merck) for brain-penetrant PARP1 inhibitor, NMS-03305293 (NMS-293).
In September 2021, Bio-Thera Solutions entered into a commercialization and license agreement with Sandoz to commercialize BAT1706 in all markets covered by the agreement upon regulatory approval.
In January 2021, Chimerix acquires Oncoceutics to expand pipeline with late-stage oncology program, including ONC201.
Key Products
BAT1706 (Bevacizumab Biosimilar) is an anti-VEGF antibody, being developed by Bio-Thera Solutions for the treatment of Glioblastoma Multiforme (GBM). In August 2020, Bio-Thera Solutions and BeiGene entered into license, distribution, and supply Agreement for BAT1706 in China. In September 2021, Bio-Thera entered into a commercialization and license agreement with Sandoz to commercialize BAT1706. European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) and US Food and Drug Administration (FDA) has accepted Biologics License Application (BLA) for BAT1706 for the treatment of Glioblastoma Multiforme.
Paxalisib (GDC-0084) is a Phosphatidylinositol 3 kinase (PI3K) inhibitor under development by Kazia Therapeutics for the treatment of Glioblastoma Multiforme (GBM). In October 2016, Kazia entered into a worldwide exclusive license agreement with Genentech for Paxalisib. US Food and Drug Administration (FDA) has granted Orphan Drug Designation in February 2018, and Fast Track Designation in August 2020 to Paxalisib for the treatment of Glioblastoma.
NMS-03305293 (NMS-293) is under development for the treatment of recurrent Glioblastoma (GBM). In September 2022, Nerviano Medical Sciences S.r.l. (NMS) entered into collaboration agreement with licensing option with Merck for brain-penetrant PARP1 inhibitor, NMS-293. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293 and during the option period, NMS and Merck will collaborate on the clinical development of the drug.
Figure: Number of Drugs For The Treatment of Glioblastoma Multiforme (GBM) Under Each Stage of Development
| Drugs | Company | Phase | Molecule Type | MoA | RoA |
|---|---|---|---|---|---|
| BAT1706 | Bio-Thera Solutions | Pre-Registration | Monoclonal Antibody | Vascular Endothelial Growth Factor (VEGF) Inhibitor | Intravenous |
| ASC40 | Ascletis Pharmaceuticals Co., Ltd. | Phase III | Small Molecule | Fatty Acid Synthase (FASN) Inhibitor | Oral |
| NMS-03305293 | Nerviano Medical Sciences | Phase II | Small Molecule | Poly (ADP-ribose) Polymerase 1 (PARP1) Inhibitor | Oral |
| AZD1390 | AstraZeneca | Phase I | Small Molecule | Ataxia Telangiectasia Mutated Kinase (ATM) Inhibitor | Oral |
| DSP-0390 | Sumitomo Pharma Oncology, Inc. | Phase 0 | Small Molecule | Emopamil-binding Protein (EBP) Inhibitor | Oral |
Methodology
The research process includes extensive secondary research on public domain and other authentic sources carried out to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, clinical trials registries.
Scope
The pipeline landscape report consists of pipeline product based on several stages of development ranging from discovery to Pre-Registration. The report provides a review of pipeline therapeutics for Glioblastoma Multiforme (GBM) by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of Glioblastoma Multiforme therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals and key upcoming milestones.
Reasons to Buy
Helps to find and recognize significant therapeutics under development for Glioblastoma Multiforme (GBM). Thorough understanding of Glioblastoma Multiforme pipeline structure and helps in developing corrective measures for pipeline projects.
Effective R&D strategies can be developed with deep knowledge on competitor information, analysis, and insights.
Plan of collaborations from various industry partners that have role in some or the other stage of drug development like contract manufacturing, co-development, contract research organization and commercialization etc.
Helps to create in-licensing and out-licensing opportunities by identifying prospective partners with attractive projects to expand business potential and scope.
Frequently Asked Questions
• What is Glioblastoma Multiforme (GBM)?
• What are the Causes, Signs and Symptoms of Glioblastoma Multiforme (GBM)?
• How is Glioblastoma Multiforme (GBM) diagnosed?
• What are the most common treatments available for Glioblastoma Multiforme (GBM)?
• How many/which companies are developing Glioblastoma Multiforme (GBM) drugs?
• How many Glioblastoma Multiforme (GBM) drugs are under development by each company and their stage of development?
• How many emerging drugs are in late-stage, mid-stage and early-stage of development for the Glioblastoma Multiforme (GBM) treatment?
• What are the key collaborations, mergers and acquisitions, licensing activities related to the Glioblastoma Multiforme (GBM) therapeutics?
• What are the molecule types, target, mechanism of action and route of administration of emerging drugs under development for the treatment of Glioblastoma Multiforme (GBM)?
• What are the clinical studies available for Glioblastoma Multiforme (GBM) and their status?
• What are the key regulatory designations that have been granted to the treatment emerging drugs?
• What are the key upcoming milestones for Glioblastoma Multiforme (GBM) drugs?
• How many drugs are under Inactive or Discontinued for the treatment of Glioblastoma Multiforme (GBM)?
Table of Contents
List of Tables
List of Figures
1. Introduction
1.1 Glioblastoma Multiforme (GBM) – Pipeline Drugs, 2023 – Coverage
2. Disease Overview – Glioblastoma Multiforme (GBM)
2.1 Causes
2.2 Signs and Symptoms
2.3 Diagnosis
2.4 Disease Management
3. Glioblastoma Multiforme (GBM) – Pipeline Drugs Development – Overview
3.1 Comparative Analysis by Stage of Development
3.2 Number of Products under Development by Companies, 2023
3.3 Products under Development by Companies, 2023
4. Assessment of Therapeutics
4.1 Assessment by Target
4.2 Assessment by Mechanism of Action
4.3 Assessment by Molecule Type
4.3 Assessment by Route of Administration
5. Drug Profiles
5.1 Late Stage Drugs – Pre-Registration
5.1.1. BAT1706
5.1.2. XXX
5.1.3. XXX
5.2 Clinical Stage Drugs – Phase III
5.2.1 ASC40
5.2.2 DCVax-L
5.2.3 Enzastaurin Hydrochloride
5.2.4 Paxalisib
5.2.5 Regorafenib
5.2.6 Siroquine
5.2.7 Tofacitinib
5.2.8 Troriluzole
5.2.9 VAL-083
5.2.10 VT1021
5.2.11 XXX
5.2.12 XXX
5.2.13 XXX
5.3 Clinical Stage Drugs – Phase II
5.3.1 APL-101
5.3.2 AV-GBM-1
5.3.3 Berubicin
5.3.4 Efineptakin Alfa
5.3.5 INO-5401
5.3.6 Lenvatinib
5.3.7 NMS-03305293
5.3.8 ONC201
5.3.9 SurVaxM
5.3.10 VXM01
5.3.11 XXX
5.3.12 XXX
5.3.13 XXX
5.4 Clinical Stage Drugs – Phase I
5.4.1 AZD1390
5.4.2 BDTX-1535
5.4.3 BI 907828
5.4.4 CHM 1101
5.4.5 ERAS-801
5.4.6 INB-200
5.4.7 PhOx430
5.4.8 PRT3645
5.4.9 RO7428731
5.4.10 TAS2940
5.4.11 XXX
5.4.12 XXX
5.4.13 XXX
5.5 Early Stage Drugs – Phase 0
5.5.1 Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy
5.5.2 DSP-0390
5.5.3 Fimepinostat
5.5.4 Niraparib
5.5.5 Tinostamustine
5.5.6 XXX
5.5.7 XXX
5.5.8 XXX
5.6 Early Stage Drugs – Preclinical
5.6.1 BEA-17
5.6.2 BEN-28010
5.6.3 BVA 501
5.6.4 CYT 501
5.6.5 INB-410
5.6.6 JCXH-211
5.6.7 ONCR-719
5.6.8 RZ 001
5.6.9 RZ 002
5.6.10 WPD101
5.6.11 XXX
5.6.12 XXX
5.6.13 XXX
5.7 Early Stage Drugs – Discovery
5.7.1 EPC 003
5.7.2 ERXC103
5.7.3 LBI-1123
5.7.4 OC-4
5.7.5 Transforming Growth Factor Beta (TGF-β) CAR Bispecific Program
5.7.6 Undisclosed Antisense Oligonucleotide
5.7.7 XXX
5.7.8 XXX
5.7.9 XXX
6. Key Regulatory Designations
7. Key Deals
8. Key Upcoming Milestones
9. Key Companies Involved
9.1 Aivita Biomedical, Inc.
9.2 Apollomics Inc.
9.3 Ascletis Pharmaceuticals Co., Ltd.
9.4 AstraZeneca
9.5 Bayer
9.6 Beactica Therapeutics AB
9.7 BenevolentAI
9.8 Biohaven Pharmaceuticals, Inc
9.9 Biorchestra
9.10 Bio-Thera Solutions
9.11 Biovista
9.12 Black Diamond Therapeutics, Inc.
9.13 Boehringer Ingelheim
9.14 Chimeric Therapeutics
9.15 Chimerix
9.16 CNS Pharmaceuticals, Inc
9.17 Curis, Inc.
9.18 Cytovia Therapeutics, Inc
9.19 Denovo Biopharma LLC
9.20 Elpis Biopharmaceuticals
9.21 EnduRx Pharmaceuticals
9.22 Erasca, Inc.
9.23 GSK Plc
9.24 HebaBiz Biotech
9.25 Hebei Senlang Biotechnology Inc., Ltd.
9.26 Hoffmann-La Roche
9.27 I-Mab Biopharma Co. Ltd.
9.28 Immorna
9.29 ImmPACT Bio
9.30 In8bio Inc.
9.31 Inovio Pharmaceuticals
9.32 Kazia Therapeutics Limited
9.33 Kintara Therapeutics, Inc.
9.34 Luminus Biosciences
9.35 Merck Sharp & Dohme LLC
9.36 MimiVax, LLC
9.37 Mundipharma Research Limited
9.38 Nerviano Medical Sciences
9.39 Northwest Biotherapeutics
9.40 Oncorus Inc
9.41 OneChain Immunotherapeutics
9.42 Pfizer
9.43 Phost’In Therapeutics
9.44 Prelude Therapeutics
9.45 Rznomics
9.46 Sumitomo Pharma Oncology, Inc.
9.47 Taiho Oncology, Inc.
9.48 Vaximm GmbH
9.49 Vigeo Therapeutics, Inc.
9.50 WPD Pharmaceuticals
9.51 XXX
9.52 XXX
9.53 XXX
10. Dormant Drugs
10.1 Inactive Drugs
10.2 Discontinued Drugs
11. Appendix
List of Tables
Table 1.1 Number of Products under Development by Glioblastoma Multiforme (GBM)
Table 1.2 Number of Products under Development by Companies
Table 1.3 Products under Development by Companies
Table 1.4 Products by Targets
Table 1.5 Products by Mechanism of Action
Table 1.6 Products by Molecule Type
Table 1.7 Products by Route of Administration
Table 2.1 Clinical Trial Details – ASC40/Ascletis Pharmaceuticals Co., Ltd.
Table 2.2 Clinical Trial Details – DCVax-L/Northwest Biotherapeutics
Table 2.3 Clinical Trial Details – Enzastaurin Hydrochloride/Denovo Biopharma LLC
Table 2.4 Clinical Trial Details – Paxalisib/Kazia Therapeutics Limited
Table 2.5 Clinical Trial Details – Regorafenib/Bayer
Table 2.6 Clinical Trial Details – Siroquine/HebaBiz Biotech
Table 2.7 Clinical Trial Details – Tofacitinib/Pfizer
Table 2.8 Clinical Trial Details – Troriluzole/Biohaven Pharmaceuticals, Inc
Table 2.9 Clinical Trial Details – VAL-083/Kintara Therapeutics, Inc.
Table 2.10 Clinical Trial Details – VT1021/Vigeo Therapeutics, Inc.
Table 2.11 Clinical Trial Details – APL-101/Apollomics Inc.
Table 2.12 Clinical Trial Details – AV-GBM-1/Aivita Biomedical, Inc.
Table 2.13 Clinical Trial Details – Berubicin/CNS Pharmaceuticals, Inc
Table 2.14 Clinical Trial Details – Efineptakin Alfa/I-Mab Biopharma Co. Ltd.
Table 2.15 Clinical Trial Details – INO-5401/Inovio Pharmaceuticals
Table 2.16 Clinical Trial Details – Lenvatinib/Merck Sharp & Dohme LLC
Table 2.17 Clinical Trial Details – NMS-03305293/Nerviano Medical Sciences
Table 2.18 Clinical Trial Details – ONC201/Chimerix
Table 2.19 Clinical Trial Details – SurVaxM/MimiVax, LLC
Table 2.20 Clinical Trial Details – VXM01/Vaximm GmbH
Table 2.21 Clinical Trial Details – AZD1390/AstraZeneca
Table 2.22 Clinical Trial Details – BDTX-1535/Black Diamond Therapeutics, Inc.
Table 2.23 Clinical Trial Details – BI 907828/Boehringer Ingelheim
Table 2.24 Clinical Trial Details – CHM 1101/Chimeric Therapeutics
Table 2.25 Clinical Trial Details – ERAS-801/Erasca, Inc.
Table 2.26 Clinical Trial Details – INB-200/In8bio Inc.
Table 2.27 Clinical Trial Details – PhOx430/Phost’In Therapeutics
Table 2.28 Clinical Trial Details – PRT3645/Prelude Therapeutics
Table 2.29 Clinical Trial Details – RO7428731/Hoffmann-La Roche
Table 2.30 Clinical Trial Details – TAS2940/Taiho Oncology, Inc.
Table 2.31 Clinical Trial Details – Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy/Hebei Senlang Biotechnology Inc., Ltd.
Table 2.32 Clinical Trial Details – DSP-0390/Sumitomo Pharma Oncology, Inc.
Table 2.33 Clinical Trial Details – Fimepinostat/Curis, Inc.
Table 2.34 Clinical Trial Details – Niraparib/GSK Plc
Table 2.35 Clinical Trial Details – Tinostamustine/Mundipharma Research Limited
Table 2.36 Clinical Trial Details – XXX Drug/ABC Company
Table 2.37 Clinical Trial Details – XXX Drug/ABC Company
Table 2.38 Clinical Trial Details – XXX Drug/ABC Company
Table 2.39 Clinical Trial Details – XXX Drug/ABC Company
Table 2.40 Clinical Trial Details – XXX Drug/ABC Company
Table 3.1 Regulatory Designations
Table 4.1 Inactive Drugs
Table 4.2 Discontinued Drugs
List of Figures
Figure 1.1 Number of Products under Development for Glioblastoma Multiforme (GBM), 2023
Figure 1.2 Products by Top 5 Targets and Stage of Development for Glioblastoma Multiforme (GBM), 2023
Figure 1.3 Products by Top 5 Mechanism of Action for Glioblastoma Multiforme (GBM), 2023
Figure 1.4 Products by Top 5 Molecule Type for Glioblastoma Multiforme (GBM), 2023
Figure 1.5 Products by Top 5 Route of Administration for Glioblastoma Multiforme (GBM), 2023
Key Players
- Aivita Biomedical, Inc.
- Apollomics Inc.
- Ascletis Pharmaceuticals Co., Ltd.
- AstraZeneca
- Bayer
- Beactica Therapeutics AB
- BenevolentAI
- Biohaven Pharmaceuticals, Inc
- Biorchestra
- Bio-Thera Solutions
- Biovista
- Black Diamond Therapeutics, Inc.
- Boehringer Ingelheim
- Chimeric Therapeutics
- Chimerix
- CNS Pharmaceuticals, Inc
- Curis, Inc.
- Cytovia Therapeutics, Inc
- Denovo Biopharma LLC
- Elpis Biopharmaceuticals
- EnduRx Pharmaceuticals
- Erasca, Inc.
- GSK Plc
- HebaBiz Biotech
- Hebei Senlang Biotechnology Inc., Ltd.
- Hoffmann-La Roche
- I-Mab Biopharma Co. Ltd.
- Immorna
- ImmPACT Bio
- In8bio Inc.
- Inovio Pharmaceuticals
- Kazia Therapeutics Limited
- Kintara Therapeutics, Inc.
- Luminus Biosciences
- Merck Sharp & Dohme LLC
- MimiVax, LLC
- Mundipharma Research Limited
- Nerviano Medical Sciences
- Northwest Biotherapeutics
- Oncorus Inc
- OneChain Immunotherapeutics
- Pfizer
- Phost’In Therapeutics
- Prelude Therapeutics
- Rznomics
- Sumitomo Pharma Oncology, Inc.
- Taiho Oncology, Inc.
- Vaximm GmbH
- Vigeo Therapeutics, Inc.
- WPD Pharmaceuticals
Report Segmentation
- Assessment by Stage of Development
- Assessment by Companies
- Assessment by Target
- Assessment by Mechanism of Action
- Assessment by Molecule Type
- Assessment by Route of Administration