Glioblastoma - Pipeline Insight, 2024

This “Glioblastoma- Pipeline Insight, 2024” report provides comprehensive insights about 195+ companies and 210+ pipeline drugs in Glioblastoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Glioblastoma: Understanding

Glioblastoma: Overview

Glioblastoma Multiforme (GBM) is the most frequently occurring type of primary tumors of the central nervous system (CNS) mostly in adults, and its poor prognosis has not been significantly improved despite the fact that the innovative diagnostic strategies and new therapies have been developed. Somatic evolution promotes the progression of cancer in which the genome of the cancer cell is being deviated from that of the healthy cell due the accumulation of mutations. There is a remarkable development in GBM because it occurs via a complex network of various different molecular and genetic aberrations, which leads to significant changes in major signaling pathways. GBMs, as they extensively disperse throughout the parenchyma, making maximal surgical resection unattainable and having high level of vascularization, are lethal in nature.

The glioblastoma multiforme preferentially invades along myelinated axons, vascular basement membranes, and the subependyma, mostly occurring in the subcortical matter of the cerebrum (65%). Within the cerebrum, the tumors proliferate through the temporal (31%), parietal (24%), frontal (23%), and occipital (16%) lobes. However, tumor formation is rarely isolated exclusively to one of these lobes, instead presenting in a combination of these lobes within the cerebrum. GBM also forms in the hypothalamus-thalamus area (20%) and the cerebellum and posterior fossa (15%). In addition, GBM can also potentially develop in the brain stem and the spinal cord, though these cases are extremely rare. The propagation of the glioblastoma multiforme is closely linked to the microvascular proliferation in hypoxic areas of the brain, often due to the over-expression of the vascular endothelial growth factor (VEGF). This microvascularization is another key feature in differentiating glioblastoma multiforme from fibrillary astrocytoma and anaplastic astrocytoma. Once the gliobastoma has established itself within the subcortical matter, it extends to the adjacent cerebral cortex and basal ganglia. As the tumor spreads across the corpus callosum, the lesion becomes bilaterally symmetric, resulting in its characteristic butterfly shape when imaged.

A patient with any neurological symptoms will first be given a physical exam that includes neurologic function tests (reflexes, muscle strength, eye and mouth movement, coordination and alertness). If a tumor is suspected, the patient will have imaging tests so that doctors can look into the brain for any abnormality. A neurological exam alone is not sufficient to make a glioblastoma diagnosis, but the results will indicate whether additional testing is needed. If the results of a neurological exam suggest a potential glioblastoma diagnosis, imaging tests may then be used to produce an in-depth picture of the brain.

Treatment for glioblastoma multiforme usually includes a combination of surgery, chemotherapy, radiation, or stereotactic radiosurgery. Surgery is usually one of the most important aspects of treatment, although rarely used alone. Since glioblastomas develop very rapidly, they are often difficult to remove in their entirety. Therefore, surgery is performed to achieve a maximum safe resection - removing as much of the tumor as possible while preserving the patient’s brain function and sparing healthy tissues. Residual cancer cells can be targeted with additional treatments, such as chemotherapy or radiation therapy, after surgery. Radiation therapy and chemotherapy usually follow surgery once the diagnosis or name of the tumor is determined. These treatments are called adjuvant treatments. Because this multispecialty approach can cause several side effects, steroids are often provided as another essential part of glioblastoma treatment, used to help alleviate the side effects of other therapies. Steroid treatment can be used to reduce a swelling or antiseizure medication.

Glioblastoma- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Glioblastoma pipeline landscape is provided which includes the disease overview and Glioblastoma treatment guidelines. The assessment part of the report embraces, in depth Glioblastoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Glioblastoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Glioblastoma R&D. The therapies under development are focused on novel approaches to treat/improve Glioblastoma.

Glioblastoma Emerging Drugs Chapters

This segment of the Glioblastoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Glioblastoma Emerging Drugs

Enzastaurin: Denovo Bio Pharma DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received Orphan Drug Designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA and Fast Track Designation from the FDA. DB102 is the world's first oral small-molecule kinase inhibitor targeting PKC. A retrospective analysis found that it has significant curative effects in high-risk DLBCL patients who are DGM1 positive. The company has initiated a biomarker guided Phase III clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme(GBM).

Tofacitinib: Pfizer Tofacitinib (Xeljanz, Jaquinus) is an immunosuppressant. It is a first-generation, orally bioavailable pan-Jak inhibitor. Tofacitinib was mainly developed for use as an immunosuppressant for organ transplantation and possibly for the treatment of autoimmune diseases. Tofacitinib suppresses the Jak family members at IC50s as follows: Jak1, Jak2, and Jak3, in a cell-free kinase assay. In addition, Tofacitinib effectively suppresses common ?-chain cytokines involving IL-2, IL-4, IL-15 and IL-21. Furthermore, the most common side effects include headaches, upper respiratory infections, diarrhea, and nasopharyngeal inflammation, elevation in low-density lipoprotein and cholesterol levels and reduction in neutrophil numbers. Serious infections including pneumonia, cellulitis and urinary tract infections have been described in patients treated with Tofacitinib. Currently, the drug is in the Phase III stage of its development for the treatment of glioblastomamultiforme.

VT1021: Vigeo Therapeutics Vigeo's lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or cold, tumors that don't respond to immuno-oncology agents, to immuno-stimulated, or hot, tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. Vigeo Therapeutics is advancing VT1021 into a Phase II/III registrational study through the company’s collaboration with the Global Coalition for Adaptive Research (GCAR).

Varlilumab: Celldex Therapeutics Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes. CD27 can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and may result in fewer toxicities due to its restricted expression and regulation.

Varlilumab is a potent anti-CD27 agonist that induces activation and proliferation of human T cells when combined with T cell receptor stimulation. Varlilumab has completed a Phase I dose-escalation study, demonstrating potent immunologic activity consistent with its mechanism of action and anti-tumor activity in patients with advanced, refractory disease. No maximum tolerated dose was reached and minimal toxicities were observed. Celldex initiated a broad development program for varlilumab to explore its role as an immune activator in combination with a number of complementary investigational and approved oncology drugs. Currently, the drug is in the Phase II stage of its development for the treatment of glioblastoma multiforme.

Debio 0123: Debiopharm Debio 0123 is a Wee1 kinase inhibitor. The compound is being developed based on the deepened understanding of the DNA damage response (DDR) of cancer cells. Inhibition of WEE1 prevents cells to arrest or repair DNA damages and force them to prematurely continue through the cell cycle, therefore accumulating unrepaired DNA damages ultimately leading to cell death. The compound is being developed in light of the need to improve cancer patients’ treatment response and to overcome treatment resistance to current therapies. Pre-clinical models have shown anti-tumor activity both as a single agent and in combination with carboplatin. The advancement of Debio 0123 into clinical studies will assess the therapeutic results for cancer patients in various tumor types. Currently, the drug is in the Phase I/II stage of its development for the treatment ofGlioblastoma.

PRT3645: Prelude Therapeutics PRT3645 is Prelude’s next generation CDK4/6 inhibitor with high tissue distribution and brain penetration. In preclinical studies, PRT3645 treatment resulted in concentration-dependent inhibition of cell proliferation in both glioblastoma (GBM) cell lines and in ER+/HER2- and HER2+ breast cancer lines. In vivo, orally administered PRT3645 was well tolerated and highly efficacious in a dose-dependent manner in orthotopic human breast cancer brain metastasis and GBM models. Currently, the drug is in the Phase I stage of its development for the treatment of Glioblastoma.

Glioblastoma: Therapeutic Assessment

This segment of the report provides insights about the different Glioblastoma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Glioblastoma

• There are approx. 195+ key companies which are developing the therapies for Glioblastoma. The companies which have their Glioblastoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma.

Phases

This report covers around 210+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Glioblastoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Glioblastoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Glioblastoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Glioblastoma drugs.

Glioblastoma Report Insights

• Glioblastoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Glioblastoma Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Glioblastoma drugs?
• How many Glioblastoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Glioblastoma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Glioblastoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Glioblastoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Denovo BioPharma
• Pfizer
• Vigeo Therapeutics
• Celldex Therapeutics
• Debiopharm
• Prelude Therapeutics
• Ai VitaBiomedical
• Ascletis Pharma
• Kintara Therapeutics
• Bayer AG
• Kazia Therapeutics
• GlaxoSmithKline
• Candel Therapeutics
• Symphogen A/S
• Sanofi
• Oblato
• Jiangsu Hengrui Medicine
• BPGbio, Inc.
• Alaunos Therapeutics
• Eli Lilly and Company
• Actuate Therapeutics
• Oncotelic Therapeutics
• The Menarini Group
• SonALAsense
• Novartis
• Allarity Therapeutics
• PharmAbcine
• I-Mab Biopharma Co. Ltd.
• Aadi Bioscience, Inc.
• Matrix Biomed
• Photonamic GmbH & Co. KG
• Lixte
• Black Diamond Therapeutics
• Tmunity Therapeutics
• SOM Biotech
• Moleculin
• Xynomic Pharmaceuticals
• OncoSynergy

Key Products

• Enzastaurin
• Tofacitinib
• VT1021
• Varlilumab
• Debio 0123
• PRT3645
• AV-GBM-1
• ASC40
• VAL-083
• Regorafenib
• Paxalisib
• Pazopanib
• CAN-2409
• Sym004
• Plerixafor
• OKN-007
• CAN008
• Camrelizumab
• BPM 31510
• Ad-RTS-hIL-12
• Abemaciclib
• Elraglusib
• OT-101
• SL-701
• SONALA-001
• Lutathera
• 2X-111
• TTAC-0001
• TJ107
• ABI-009
• MBM-02
• 5-aminolevulinic Acid
• LB-100
• BDTX-1535
• CART-EGFR-IL13Ra2
• SOM0777
• WP1122
• PCI 24781
• OS2966

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