Glioblastoma- Pipeline Insight, 2023

Glioblastoma- Pipeline Insight, 2023

DelveInsight’s, “Glioblastoma- Pipeline Insight, 2023” report provides comprehensive insights about 190+ companies and 200+ 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. GBM is often located in a region of the forebrain known as the cerebrum, which controls some of the most advanced process such as speech and emotions. While GBM is highly locally invasive (invading normal brain tissue), it rarely spreads to other organs beyond the brain. A highly aggressive, fast-growing cancer and treatment is often limited by the tumor location and the ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. There are different types of glioblastoma, namely astrocytoma, oligodendroglioma, mixed gliomas, optic pathway gliomas and ependymoma. In general, at the time of diagnosis, tumors could cause common neurological symptoms and major clinical signs depending on their localization. In rare instances, brain tumors could be manifested with unusual symptoms. GBM is the most common and aggressive type of primary brain tumor in humans, accounting for 52% of all primary brain tumor cases and 20% of all intracranial tumors. GBM can present with focal or generalized signs due to mass effect, parenchymal infiltration and destruction. 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. 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.

""Glioblastoma- Pipeline Insight, 2023"" 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

Enzastaurin: Denovo BioPharma

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).

Marizomib: Bristol-Myers Squibb

Marizomib (NPI-0052) is under development for the treatment of glioblastoma. The drug candidate is administered orally, intravenously. It is a next-generation naturally-occurring salinosporamide, isolated from the marine actinomycete Salinospora tropica, with potential antineoplastic activity. Marizomib irreversibly binds to and inhibits the 20S catalytic core subunit of the proteasome by covalently modifying its active site threonine residues; inhibition of ubiquitin-proteasome mediated proteolysis results in an accumulation of poly-ubiquitinated proteins, which may result in the disruption of cellular processes, cell cycle arrest, the induction of apoptosis, and the inhibition of tumor growth and angiogenesis. Currently, the drug is in the Phase III stage of its development for the treatment of Glioblastoma.

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).

ONC201: Chimerix, Inc.

ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist in mid-stage clinical development for glioblastoma. The development of ONC201 is focused on treating brain tumors with H3 K27M-mutations. The drug candidate has shown promising results in clinical trials for patients with brain tumors that have the H3 K27M-mutation, including significant tumor shrinkage and other clinical benefits. ONC201 is the founding member of the imipridone class of anti-cancer small molecules which selectively targets Dopamine Receptor D2 (DRD2) and ClpP. ONC201-mediated cell death occurs via induction of the integrated stress response and upregulation of apoptotic factors, such as tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL). It is dosed orally and has been well-tolerated and shown clinical activity in Phase I and II trials for specific advanced cancers. ONC201 has been shown to preferentially induce cell death in cancer cells by binding to and differentially altering activity of DRD2 and ClpP.

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. 190+ 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

DelveInsight’s report covers around 200+ 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 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

Candel Therapeutics

Symphogen A/S

MimiVax

Incyte Corporation

Istari Oncology

Immunomic Therapeutics

Sanofi

Incyte Corporation

Merck Sharp & Dohme LLC

Oblato, Inc.

GlaxoSmithKline

NuvOx Pharma

Biohaven Pharmaceuticals

Vigeo Therapeutics

TVAX Biomedical

Denovo Biopharma

Accendatech

Apollomics

IN8bio

Genenta Science

Sapience Therapeutics

VBI Vaccines

Karyopharm Therapeutics

Novartis

Grupo Español de Investigación en Neurooncología

Plus Therapeutics

Turning Point Therapeutics

Neonc Technologies

Key Products

CAN-2409

Enzastaurin

Sym004

SurVaxM

Retifanlimab

PVSRIPO

LAMP-pp65-DC

Plerixafor

Pemigatinib

Pembrolizumab

OKN-007

Niraparib

NanO2

Troriluzole

VT1021

TVI-Brain-1

ACT001

APL-101

INB-200

Temferon

ST101

VBI-1901

Selinexor

Ribociclib

TN-TC11G

Rhenium

Repotrectinib

Perillyl alcohol