Glioma - Competitive Landscape, 2023

This “Glioma - Competitive landscape, 2023” report provides comprehensive insights about 200+ companies and 220+ drugs in Glioma Competitive landscape. It 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

Glioma: Understanding

Glioma: Overview

Glioma is the most common form of central nervous system (CNS) neoplasm that originates from glial cells. The three types of glial cells including astrocytes, oligodendrocytes, and ependymal cells are the site of origin for brain cancer or glioma. The type of tumors that initiate in astrocytes are called astrocytoma or glioblastoma while those tumors that start in oligodendrocytes are referred to as oligodendrogliomas. Ependymomas are those tumors that originate in ependymal glial cells. Glioblastoma is the most malignant. Gliomas commonly appear in older individuals, but they can affect young patients also. The symptoms produced by gliomas are related to the invasion or compression of adjacent central nervous system structures or the elevation of intracranial pressure. Headache, seizures, weakness in the arms, face, and legs, numbness, personality changes, problems with speech, nausea, vomiting, vision loss, and dizziness are among the major symptoms faced by glioma patients. Amongst brain tumors, glial tumors comprise 60% of the tumors. They are a common cause of mortality and morbidity in both the young and old both.

The diagnosis of glioma starts with checking the medical history of the patient, followed by physical and neurological exams. The neurological exam involves checking the vision, hearing, speech, strength, sensation, balance, coordination, reflexes, and other neurological characteristics of the patient. Magnetic resonance Imaging (MRI) and Computed Tomography (CT) are the two most common scans used for the diagnosis of glioma. A biopsy is another test performed for the detection of a brain tumor. Post-diagnosis, depending upon the site of the tumor, symptoms, patient characteristics, risks, and other crucial aspects, the grade of the tumor is defined for further treatment.

Based on their histopathological features, gliomas are traditionally classified by the World Health Organization (WHO) as grade I and II (low-grade gliomas), grade III (anaplastic), and IV (glioblastoma), which indicate different degrees of malignancy. Grade I tumors are generally benign and frequently curable with complete surgical resection, occur primarily in children, and are believed to represent an entity separate from grade II-IV which is seen primarily in adults. Adult grade II tumors (Low-Grade Gliomas (LGG) include astrocytomas, oligo-astrocytomas or mixed gliomas, and oligodendrogliomas. Astrocytomas and oligodendrogliomas consist of astrocytes or oligodendrocytes, respectively, while mixed gliomas contain a mixture of the two cell types. Essentially all Grade II lesions eventually progress to High-Grade Glioma (grade III/IV or HGG). Grade IV tumors (glioblastoma (GBM)) that arise from LGG are termed “secondary GBM” to differentiate them from “primary” or “de-novo” GBM as the pathway leading to these two GBM types differs by several genetic abnormalities and clinical characteristics. Most patients initially receive surgical resection/biopsy at the time of diagnosis and then radiation therapy (XRT) and/or the single chemotherapeutic agent temozolamide (TMZ) at some point.

Glioma treatment is customized to the individual patient and may include surgery, radiation therapy, and chemotherapy. Even after surgery recurrence, the rate is quite higher for glioma patients. Although there have been recent advances in the diagnosis and treatment of malignancy, the prognosis of gliomas is still poor, especially for those patients with malignant and invasive gliomas.

Report Highlights

• In February 2023, Kite, a Gilead Company announced the completion of the previously announced transaction to acquire Tmunity Therapeutics (Tmunity), a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies.
• In February 2023, Genenta Science entered into a development and manufacturing service agreement (MSA) with AGC Biologics S.p.A. to manufacture cell therapy lentivirus-based product for Genenta's ongoing clinical programs. AGC Biologics offers end-to-end global viral vector and cell therapy development, manufacturing, and quality/regulatory services, supported by scientists with more than 30 years of knowledge and experience.
• In October 2022, ITM Isotope Technologies Munich SE announced the execution of an exclusive licensing option for LuCaFab (now ITM-31), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma.
• In October 2022, VBI Vaccines Inc., and Agenus, announced a collaboration to evaluate the combination of VBI-1901, in primary glioblastoma (GBM) patients as part of the adaptive platform trial, INSIGhT.
• In September 2022, Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Day One Biopharmaceuticals a clinical-stage biopharmaceutical company announced a collaboration to develop FoundationOne®CDx as a companion diagnostic for Day One's lead investigational therapy, tovorafenib (DAY101). If tovorafenib, and Foundation Medicine's companion diagnostic are approved, this would be the first companion diagnostic indication for FoundationOne CDx in pediatric oncology.
• In September 2022, Merck announced a collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. (NMS) for NMS-293. Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to US$65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

Glioma: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Novartis

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, the innovative science and digital technologies to create transformative treatments in areas of great medical need and find new medicines, the company consistently rank among the world's top companies investing in research and development.

Product Description: Tafinlar + Mekinist

The combination of Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition research and patients reached, helps in slowing tumor growth by blocking signals associated with the BRAF and MEK kinases that are implicated in the growth of various types of cancer. Tafinlar + Mekinist has been studied in more than 6,000 BRAF-positive patients in more than 20 ongoing and completed trials, including in pediatric patients 1 year of age and older, and has been prescribed to more than 200,000 patients worldwide.

2. Company Overview: NX Development Corp.

NX Development Corp. (NXDC) is a life sciences company based in Lexington, KY dedicated to the development of ALA HCl for tumor visualization. NXDC is a wholly-owned subsidiary of photonamic GmbH & Co. KG (Head office: Pinneberg, Germany; "PHN"). PHN is the licensor of GleolanTM (aminolevulinic acid HCl [ALA HCl]) to NXDC. The companies share an eight-year working relationship and are wholly-owned by SBI Holdings Inc. (Tokyo, Japan).

Product Description: GLEOLAN

GLEOLAN (ALA HCl) is an FDA-approved optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Exogenous administration of ALA HCl leads to accumulation of its metabolite protoporphyrin IX (PpIX) in tumor cells. Under an operating microscope adapted with a specific blue emitting light source and filters, tumor tissue is visualized as red fluorescence. Tissue lacking sufficient PpIX concentrations appears blue. Because of its unique mechanism-of-action, GLEOLAN may allow neurosurgeons to see malignant tissue during surgery under blue light that they may not see under standard white light.

 

Glioma: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Bristol-Myers Squibb

The Bristol-Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the Fortune 500 list of the largest U.S. corporations. Bristol Myers Squibb manufactures prescription pharmaceuticals and biologics in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis, and psychiatric disorders.

Product Description: Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo's leading global development program is based on Bristol Myers Squibb's scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

2. Company Overview: Orbus Therapeutics

Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The company is focused and passionate about bringing a more positive outcome to patients facing life threatening or significantly life altering diseases.

Product Description: Eflornithine

Eflornithine, also known as α-diflurormethylornithine (DFMO), selectively targets and irreversibly inhibits ornithine decarboxylase (ODC), an enzyme essential for polyamine synthesis, and DNA and RNA function. Unlike multi-targeted tyrosine kinase inhibitors on the market or in development, eflornithine targets only one specific enzyme, ODC. In animal studies, eflornithine has been shown to inhibit the growth of malignant tumors, including intra cerebral mid- and high-grade gliomas. Eflornithine administration has also been shown to potentiate the anti-tumor activity of other chemotherapy agents. In single-arm and controlled, randomized clinical trials, eflornithine oral solution increased survival in patients with both newly diagnosed and recurrent anaplastic glioma. The primary and reversible side effects of eflornithine were diarrhea and hearing impairment.

3. Company Overview: Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines.

Product Description: DCVax-L

DCVax® is a platform technology that uses activated dendritic cells (the master cells of the immune system), and is designed to reinvigorate and educate the immune system to attack cancers. Unlike conventional cancer drugs, which use one active agent to hit one target on the cancer, DCVax uses many active agents to hit many targets on the cancer. For DCVax-L, the monocytes are differentiated into dendritic cells, and matured, activated and loaded with biomarkers (“antigens”) from the patient's own tumor tissue (which is collected in a simple kit at the time of surgery to remove the tumor). The loading of biomarkers into the dendritic cells “educates” them about what the immune system needs to attack. The activated, educated dendritic cells are then isolated with very high purity and comprise the DCVax-L personalized vaccine. DCVax -L is administered to the patient through a simple intra-dermal injection in the upper arm, similar to a flu shot. The dendritic cells then convey the tumor biomarker information to the rest of the immune system agents (T cells, B cells and others), as “marching orders,” and the immune system agents then fan out through the body searching for anything with these biomarkers and attacking it.

4. Company Overview: Medicenna Therapeutics

Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines. Medicenna's long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding without CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating cancer killing effector T cells and NK cells. Medicenna's early-stage BiSKITs™ program, (Bifunctional SuperKine ImmunoTherapies) is designed to enhance the ability of Superkines to treat immunologically “cold” tumors. Medicenna's IL-4 Empowered Superkine, MDNA55, has been studied in 5 clinical trials including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer.

 

Product Description: MDNA55

MDNA55 is an Empowered Superkine developed as a therapeutic for recurrent glioblastoma multiforme (rGBM), a uniformly fatal form of brain cancer. By using a highly specific IL-4 Superkine as the vehicle to deliver a potent bacterial toxin to the tumor cells, MDNA55 has the potential to purge bulk tumors and disrupt their supporting networks, while reactivating the immune system to tackle cancer. MDNA55 is designed to be a molecular trojan horse. It is a genetic fusion of two molecules: a circularly permuted IL-4 Superkine and the catalytic domain of the pseudomonas exotoxin A. Genetic fusion allows MDNA55 to harness the selectivity of the Superkine for cancers that overexpress the target IL-4 receptor (IL-4R) and deliver the cell-killing toxin directly into the tumor, its microenvironment and cancer stem cells. Since the IL-4 receptor is not found in a healthy brain and the exotoxin is only active in the cancer cell cytoplasm, this helps ensure that healthy cells are unaffected. When MDNA55 binds the target IL-4R, it is swallowed inside the tumor cell through a process called endocytosis. Once inside the tumor, proteases cleave the drug and activate the catalytic domain of the exotoxin to begin the process of apoptosis (cell death) involving a protein called elongation factor-2.

5. Company Overview Adastra Pharmaceuticals

Adastra Pharmaceuticals Inc. is an innovative, private, clinical-stage biopharmaceutical company committed to providing responsible solutions to advance patient care in oncology. The company's vision is to identify, develop and deliver to patients important new therapies for diseases with significant unmet need. Adastra possesses a rich history of institutional and academic collaboration, including ongoing clinical research programs with the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC).

Product Description: Zotiraciclib

Zotiraciclib (TG02) is a potent oral spectrum selective kinase inhibitor for the treatment of cancer. It was discovered in Singapore by S*BIO Pte Ltd and falls under the category of small molecule macrocycles. It crosses the blood brain barrier and acts by depleting Myc through the inhibition of cyclin-dependent kinase 9 (CDK9). Zotiraciclib has been granted orphan drug designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of gliomas. As of January 2020, zotiraciclib is being evaluated by Adastra Pharmaceuticals in two separate Phase 1b clinical trials for the treatment of glioblastoma multiforme (GBM). Zotiracicib is also being developed as a potential treatment for diffuse intrinsic pontine glioma (DIPG), a rare pediatric cancer. Both forms of brain cancer are characterized by Myc overexpression. It is currently being investigated in Phase I/II clinical trial to treat patients with Recurrent High-Grade Gliomas with Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations.

6. Company Overview: Onxeo

Onxeo is a French clinical-stage biotechnology company designing and developing novel oncology drugs targeting tumor DNA-binding functions. The company's therapeutic strategy focuses on fighting tumor resistance to treatments which poses ever-greater therapeutic challenges, further more so in aggressive or rare cancers. The approach is based upon unique mechanisms of action on DNA Damage Response and immune response and focuses on bringing first-in-class and disruptive compounds from translational research to proof-of-concept in man in cancer indications with high unmet needs.

Product Description: AsiDNA

A first-in-class product candidate in the leading field of DNA Damage Response (DDR), AsiDNA disrupts and exhausts the ability of tumor cells to repair their DNA by acting upstream of multiple repair pathways. AsiDNA and its technology originate from three major French academic centers: Curie Institute, CNRS, and the Museum of Natural History. It aims to offer new treatment options for patients suffering from various types of cancer. AsiDNA is a short double-stranded DNA fragment (oligonucleotide) that acts as a decoy, mimicking double-strand breaks in the DNA of the tumor cell. AsiDNA molecules trigger false DNA break signals to activate and attract DNA repair proteins, which prevents their recruitment to the site of actual DNA damage. As a result, damages to tumor cells' DNA remain unrepaired. As cancer cells have lost the ability to regulate cell division, they will continue dividing with damaged DNA, ultimately leading to cancer cell death (mitotic catastrophe). Healthy cells, on the other hand, will halt cell division until the compound is no longer present and damaged DNA can be repaired. AsiDNA mechanism is significantly differentiated in the field of DNA Damage Response as it does not inhibit specific enzymes (such as PARP inhibitors) but targets the entire DNA repair process, acting upstream of multiple DDR pathways as an agonist through a decoy mechanism. An extensive and robust preclinical package has been built highlighting the differentiated properties of AsiDNA, notably the absence of resistance after repeated treatment, the prevention and reversion of resistance to PARP inhibitors and a strong synergy with other anti-cancer agents such as PARP inhibitors or platinum-based chemotherapies. AsiDNA Children, sponsored by Institut Curie, is a phase I/II study designed to assess the effect of AsiDNA with combination with radiotherapy to treat children affected with recurrent high grade glioma.

Glioma Analytical Perspective

In-depth Commercial Assessment: Glioma Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Glioma Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Glioma Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

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

 

Key Players

• Denovo Biopharma
• AstraZeneca
• Pfizer
• Chimerix
• Bristol-Myers Squibb
• Orbus Therapeutics
• Northwest Biotherapeutics
• Day One Biopharmaceuticals
• AiVita Biomedical
• Ascletis Pharma Inc
• Kazia Therapeutics
• HebaBiz Biotech
• Biohaven Pharmaceuticals
• Vigeo Therapeutics
• Hoffman-La-Roche
• TVAX Biomedical
• Laminar Pharmaceuticals
• Kintara Therapeutics
• Medicenna Therapeutics
• Symphogen A/S
• MimiVax
• Incyte Corporation
• Istari Oncology
• Immunomic Therapeutics
• Sanofi
• Merck Sharp & Dohme LLC
• Oblato, Inc.
• GlaxoSmithKline
• NuvOx Pharma
• Epitopoietic Research Corporation
• AnHeart Therapeutics
• DNAtrix
• Arog Pharmaceuticals
• CANbridge Pharmaceuticals
• Jiangsu Hengrui Medicine
• BPGbio, Inc.
• BioMimetix
• CNS Pharmaceuticals
• Ever Supreme Bio Technology
• Chia Tai Tianqing Pharmaceutical Group
• CytoVac

Key Products

• Enzastaurin
• Selumetinib
• Tofacitinib
• ONC201
• Opdivo
• Eflornithine
• DCVax-L
• DAY101
• AV-GBM-1
• ASC40
• Paxalisib
• JP001
• Troriluzole
• VT1021
• Vemurafenib
• TVI-Brain-1
• LAM561
• VAL-083
• MDNA55
• Sym004
• SurVaxM
• Retifanlimab
• PVSRIPO
• LAMP-pp65-DC
• Plerixafor
• Pembrolizumab
• OKN-007
• Niraparib
• NanO2
• ERC1671
• AB-218
• DNX-2401
• Crenolanib
• CAN008
• Camrelizumab
• BPM 31510
• BMX-001
• Berubicin
• ADCV01
• Anlotinib
• ALECSAT

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