High-Grade Glioma - Pipeline Insight, 2024

This “High-grade Glioma - Pipeline Insight, 2024,” report provides comprehensive insights about 150+ companies and 150+ pipeline drugs in High-grade Glioma 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

High-grade Glioma Understanding

High-grade Glioma: Overview

A glioma is a name for tumours of the glial cells. These are the supporting cells of the nervous system. Gliomas can arise in any part of the brain and may also be found in the spinal cord. More than half of all brain tumours in children are gliomas. There are different types of gliomas. Physicians use the terms “glioma” and “astrocytoma” interchangeably.

High grade means that the glioma is growing rapidly. High grade gliomas are either World Health Organization (WHO) grade 3 tumours or grade 4. Grade 3 and 4 tumours tend to grow rapidly and spread faster than tumours of a lower grade.

The most common grade 3 tumour is anaplastic astrocytoma and the most common grade 4 tumour is glioblastoma multiforme. Other more complex high grade gliomas include: oligoastrocytoma, pleiomorphic xanthoastrocytoma, and gliosarcoma.

Symptoms
Children with supratentorial high grade gliomas show signs and symptoms that depend on which area of the brain is involved. There may be neurological deficits, seizures, accompanied by signs and symptoms of increased intracranial pressure:

• Headaches, mostly in the morning
• Nausea and vomiting, mostly in the morning
• Blurred or decreased vision
• Sluggishness or drowsiness
• Changes in behaviour
• Seizures

Diagnosis
Typical imaging techniques such as MRI or CT may be used to determine that there is a tumour present, but the actual diagnosis of a supratentorial high grade glioma depends on histological testing. Histological testing is when a biopsy is done to remove a small sample of the tumour from the brain, and the sample is studied under the microscope for the presence or absence of certain characteristics. Complete staging, using MRI of the spine and examination of the cerebrospinal fluid, is not usually a part of the initial diagnostic testing. However, high grade gliomas can spread, and if there are any concerns, complete staging will be considered.

Treatment
Treatment of high grade gliomas include:

• Surgery is the main form of treatment and is combined with radiation and chemotherapy in children older than three years old.
• Chemotherapy has not yet been shown to have a proven benefit in the treatment of this tumour type.

High-grade Glioma Emerging Drugs Chapters

This segment of the High-grade Glioma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

High-grade Glioma Emerging Drugs

OT101: Mateon TherapeuticsOT101, a first-in-class RNA therapeutic, is designed to abrogate the immunosuppressive actions of TGF-beta 2. In a completed Phase II clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult high-grade glioma patients, including adults with GBM. Further development of OT-101 may offer renewed hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease.

BMX-001: BioMimetixBMX-001 is being studied in a phase II randomized trial studying the safety and efficacy of the investigational drug in patients with newly diagnosed high-grade glioma patients who are being treated with brain radiation and temozolomide. The concluded Phase I study provided the following:

• A clean safety profile
• Clear evidence for bone marrow protection
• Early indications for protection of cognitive function
• Survival data consistent with a positive trend
• The dose and regimen for Ph2 and clinical practice

OKN-007: Oblato, Inc.OKN-007 is being developed by Oblato, Inc for the treatment of High-grade Glioma. It is currently in phase I/II stage of development.

PTC596: PTC TherapeuticsPTC596 is an orally active small molecule that targets tumor stem cell populations by reducing the function, activity and amount of BMI1. PTC596 acts by altering and destroying the BMI1 protein through a process called phosphorylation. PTC596 has potently inhibited BMI1 function in multiple tumor cell lines. In in vitro tests, PTC596 has preferentially targeted chemotherapy resistant cancer stem cells. Specifically, PTC596 preferentially depleted cancer stem cells in assays with tumor cell lines from fibrosarcoma, prostate and colon cancers. Conversely, the cytotoxic chemotherapies carboplatin, temozolomide, methotrexate and indibulin enriched the population of cancer stem cells in this assay. It is currently in phase I stage of development.

High-grade Glioma: Therapeutic Assessment

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

Major Players in High-grade Glioma

There are approx. 150+ key companies which are developing the therapies for High-grade Glioma. The companies which have their High-grade Glioma drug candidates in the most advanced stage, i.e. phase III include Mateon Therapeutics and others

Phases

This report covers around 150+ products under different phases of clinical development like

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

Route of Administration

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

• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravenous
• Oral
• Parenteral
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

Product Type

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

High-grade Glioma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase III, II, I, preclinical and discovery stage. It also analyses High-grade Glioma 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 High-grade Glioma drugs.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence High-grade Glioma R&D. The therapies under development are focused on novel approaches to treat/improve High-grade Glioma.
• In October 2018, Oblato acquired all rights from OMRF to OKN-007, an investigational drug for the treatment of glioblastoma, a deadly form of brain cancer.
• In September 2019, Mateon Therapeutics announced that the US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG) as a drug for a “rare pediatric disease.”

High-grade Glioma Report Insights

• High-grade Glioma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

High-grade Glioma 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 High-grade Glioma drugs?
• How many High-grade Glioma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of High-grade Glioma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the High-grade Glioma 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 High-grade Glioma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Mateon Therapeutics
• BioMimetix
• Oblato, Inc
• PTC Therapeutics
• Lee's Pharmaceutical Limited
• Nuvation Bio, Inc.
• Laminar Pharmaceuticals
• Basilea Pharmaceutica
• Aadi, LLC
• Erimos Pharmaceuticals

Key Products

• OT101
• BMX-001
• OKN-007
• PTC596
• TG02
• NUV-422
• 2-OHOA
• BAL101553
• ABI-009
• Terameprocol