Glioblastoma - Pipeline Insight, 2022

March 2022 | 100 pages | ID: G8E9C93013B9EN
DelveInsight

Abstracts

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DelveInsight’s, “Glioblastoma - Pipeline Insight, 2022,” report provides comprehensive insights about 100+ companies and 100+ 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 is an aggressive type of cancer that can occur in the brain or spinal cord. Glioblastoma forms from cells called astrocytes that support nerve cells.It can occur at any age, but tends to occur more often in older adults. It can cause worsening headaches, nausea, vomiting and seizures.Glioblastoma, also known as glioblastoma multiforme. Glioma is a type of tumor that occurs in the brain and spinal cord. Gliomas begin in the gluey supportive cells (glial cells) that surround nerve cells and help them function. Three types of glial cells can produce tumors. Gliomas are classified according to the type of glial cell involved in the tumor, as well as the tumor's genetic features, which can help predict how the tumor will behave over time and the treatments most likely to work. The symptoms of glioma vary by tumor type as well as the tumor's size, location and rate of growth. Common signs and symptoms of gliomas include: headache, nausea or vomiting, confusion or a decline in brain function, memory loss, personality changes or irritability and difficulty with balance. Like most primary brain tumors, the exact cause of gliomas is not known. Treatments may slow progression of the cancer and reduce signs and symptoms.

'Glioblastoma - Pipeline Insight, 2022' report by DelveInsight 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

• TVB2640:Ascletis Pharma

TVB2640 is an oral, selective fatty acid synthase (FASN) inhibitor, TVB2640 hinders energy supply and interrupts membrane phospholipid composition of tumour cells by hindering novo lipogenesis (DNL). FASN is a crucial enzyme that controls DNL. It is in Phase 3 stage of development for the treatment of Glioblastoma.

• Trabedersen: Oncotelic Therapeutics

Trabedersen is an antisense against TGF-?2 – for the treatment of solid tumors with focus on brain cancer in adult and DIPG in children. Trabedersen, also referred to OT101, is a novel antisense oligodeoxynucleotide (ODN) developed by Oncotelic for the treatment of patients with pancreatic carcinoma, malignant melanoma, colorectal carcinoma, high-grade glioma (HGG), and other transforming growth factor beta 2 (TGF-?2) overexpressing malignancies (e.g., prostate carcinoma, renal cell carcinoma, etc.).Trabedersen is a synthetic 18-mer phosphorothioate oligodeoxynucleotide (S-ODN) complementary to the messenger ribonucleic acid (mRNA) of the human TGF-?2 gene. Cancers overexpress TGF-?, which suppresses host innate immune response to the cancers. Treatment with OT-101 lifts the TGF-? cloaking effect and allows innate or therapeutic immunity to attack and eliminate the cancers. Trabedersen is in Phase 3 stage of development for the treatment of Glioblastoma.

• Selinexor: Karyopharm Therapeutics

Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. Selinexor is in open-label, multicenter, Phase 2 study, to evaluate the efficacy and safety of selinexor in patients with recurrent gliomas.

• Onfekafuspalfa: Philogen

Onfekafuspalfa is also known as Fibromun (L19TNF) Fibromun(L19TNF)is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). (Recombinant TNF has so far been approved only for certain clinical applications). The fusion of TNF to the L19 antibody specific to the EDB domain of fibronectin results in a tumor-targeted product, which selectively localizes at the site of disease, while sparing healthy organs.

Fibromun has shown potent anti-tumor activity, both as single agent and in combination with other drugs, in several immunocompetent preclinical models inducing in most cases long-lasting complete responses. Fibromun has also shown promising activity in orthotopic mouse models of glioblastoma and in high-grade glioma patients (studies performed in collaboration with the University Hospital Zurich). On the basis of the promising results observed in a phase I/II monotherapy study in patients with recurrent glioma, two clinical studies with registration potential have recently been started in newly diagnosed and in recurrent glioblastoma patients, respectively.

• AZD1390: AstraZeneca

AZD1390 is a highly potent, brain penetrant ataxia telangiectasia mutant (ATM) kinase inhibitor that blocks ATM-dependent signaling and repair of DNA double strand breaks (DSBs) in the genome. AZD1390 therefore exhibits powerful activity in combination with agents such as irradiation and chemotherapies that induce DSBs. ATM inhibition may also generate an exploitable DDR dependency against tumour cells with other DDR pathway defects.AZD1390 is an ATP-competitive kinase inhibitor with a cellular IC50 of 0.78 nM and is highly selective against other PIKKs including ATR, DNAPK, and mTOR. AZD1390 hyper-sensitizes a wide range of cancer cells to radiation in vitro, blocks the DDR to DSBs in cells and results in tumour regressions and survival improvement in orthotopic brain tumour models in vivo. AZD1390 establishes a PK-PD-efficacy relationship by linking dose-dependent plasma and brain concentrations to target engagement (pRAD50) and phenotypic tumour anti-proliferation and cell death markers.AZD1390 exhibits significant CNS penetration. AZD1390 is in Phase1 stage of development for treatment of Glioblastoma.

• YTX7739: Yumanity Therapeutics

YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in cellular and preclinical models YTX-7739 demonstrates efficacy, including increased median overall survival, both as a single agent and in combination with temozolomide, the standard-of-care for Glioblastoma.YTX7739 is in pre-clinical stage of development.

Further product details are provided in the report……..

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. 100+ key companies which are developing the therapies for Postoperative Pain. The companies which have their Postoperative Pain drug candidates in the most advanced stage, i.e. phase III include, Oncotelic Theraputics.

• Phases

DelveInsight’s report covers around 100+ 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• 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 Postoperative Pain 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

• Array Biopharma
• AstraZeneca
• Doule bond Pharmaceuticals
• Philogen
• Immatics N.V
• BioNTech
• InovioPharma
• Noxxon Pharma
• Celgene Corporation
• Karyo Pharma
• Neugate Theranostics
• Novartis
• Orphelia Pharma
• Merck
• Acerta Pharma
• Genenta Science
• CNS Pharmaceutical
• Pfizer
• Roche
• Oncotelic Therapeutics
• Autotelic Therapeutics
• ACADIA Pharmaceuticals
• Mayo Clinic
• Cytogel
• Xgene Pharmaceutical
• Ascletis
• 3-V Biosciences
• Yumanity Therapeutics

Key Products

• Onfekafuspalfa
• PLX3397
• APVAC1
• INO5401
• Olaptesed pegol
• Selinexor
• L19TNF
• H1PV
• NG101m
• ACP196
• Temferon
• Berubicin Hydrochloride
• VXM01
• Avelumab
• Trabedersen
• TVB2640
• AZD1390
• YTX7739
• WP1122

Contents

Introduction
Executive Summary
Glioblastoma: Overview
  Causes
  Mechanism of Action
  Signs and Symptoms
  Diagnosis
  Disease Management
Pipeline Therapeutics
  Comparative Analysis
Therapeutic Assessment
  Assessment by Product Type
  Assessment by Stage and Product Type
  Assessment by Route of Administration
  Assessment by Stage and Route of Administration
  Assessment by Molecule Type
  Assessment by Stage and Molecule Type
Glioblastoma – DelveInsight’s Analytical Perspective
Late Stage Products (Phase III)
  Comparative Analysis
Trabedersen: Oncotelic Therapeutics
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  Comparative Analysis
Selinexor: KaryoPharm Therapeutics
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
  Comparative Analysis
AZD1390: AstraZeneca
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
  Comparative Analysis
YTX7739: Yumanity Therapeutics
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
  Comparative Analysis
Glioblastoma -Key Companies
Glioblastoma -Key Products
Glioblastoma - Unmet Needs
Glioblastoma - Market Drivers and Barriers
Glioblastoma- Future Perspectives and Conclusion
Glioblastoma -Analyst Views
Glioblastoma -Key Companies
Appendix

List Of Tables

LIST OF TABLES

Table 1 Total Products for Glioblastoma
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

List Of Figures

LIST OF FIGURES

Figure 1 Total Products for Glioblastoma
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products