High-Grade Glioma Pipeline: DelveInsight Reports 150+ Innovators Driving Breakthrough Therapies | Kazia Therapeutics, Medicenna Therapeutics, Immunomic Therapeutics, Mimivax, CNS Pharmaceuticals

DelveInsight's "High-Grade Glioma Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the High-Grade Glioma market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging High-Grade Glioma drugs, the High-Grade Glioma pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the High-Grade Glioma Pipeline Report
• DelveInsight's High-Grade Glioma Pipeline analysis depicts a robust space with 150+ active players working to develop 150+ pipeline drugs for High-Grade Glioma treatment.
• The leading High-Grade Glioma companies include Mateon Therapeutics, BioMimetix, Oblato, Inc, PTC Therapeutics, Lee's Pharmaceutical Limited, Nuvation Bio, Inc., Laminar Pharmaceuticals, Basilea Pharmaceutica, Aadi, LLC, Erimos Pharmaceuticals, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, Orbus Therapeutics, Tvax Biomedical, Recursion Pharmaceuticals, Vigeo Therapeutics, Eli Lilly, Incyte Corporation, Kazia Therapeutics, Medicenna Therapeutics, Immunomic Therapeutics, Mimivax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Imvax, BeiGene, Enterome, VBI Vaccines, Genenta Science, TME Pharma, Inovio Pharmaceuticals, Istari Oncology, Plus Therapeutics, and others are evaluating their lead assets to improve the High-Grade Glioma treatment landscape.
• Key High-Grade Glioma pipeline therapies in various stages of development include ONC201, AV-GBM-1, Enzastaurin, DCVAX-L, Eflornithine, TVI-BRAIN-1, LAM561, REC-2282, VT1021, Verzenio, Pemazyre, Paxalisib, BMX-001, Bizaxofusp, ITI-1000, Survaxm, OKN-007, Berubicin, Gliovac/Sitoiganap, IGV-001, BGB-290, EO2401, VBI-1901, Temferon, Cemiplimab, Lerapolturev, Rhenium Obisbemeda, PTC596, OT101, and others.
• In Feb 2025, the FDA accepted a new drug application for accelerated approval of dordaviprone (ONC201; Chimerix) as a treatment for recurrent H3 K27M-mutant diffuse glioma.
• In January 2025, Chimerix submitted an NDA for accelerated approval of dordaviprone for patients with recurrent H3K27M-mutant diffuse glioma. The company has requested priority review, aiming for a target action date in Q3 2025 under PDUFA. Dordaviprone previously received a rare pediatric disease designation for this indication.
• In December 2024, MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company, announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a "rare pediatric disease."

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High-Grade Glioma Overview
A glioma is a type of tumor that originates in the glial cells, which serve as the supportive cells of the nervous system. These tumors can develop in any part of the brain and may also occur in the spinal cord. In children, gliomas account for more than half of all brain tumors. There are several types of gliomas, and the terms "glioma" and "astrocytoma" are often used interchangeably by physicians.
High-grade gliomas are characterized by rapid growth and are classified as either World Health Organization (WHO) grade 3 or grade 4 tumors. These higher-grade tumors grow and spread more aggressively compared to lower-grade gliomas.
Among grade 3 tumors, anaplastic astrocytoma is the most common, while glioblastoma multiforme is the most prevalent grade 4 tumor. Other complex high-grade gliomas include oligoastrocytoma, pleomorphic xanthoastrocytoma, and gliosarcoma.

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High-Grade Glioma Treatment Analysis: Drug Profile
OT101: Mateon Therapeutics
OT101, 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.

PTC596: PTC Therapeutics
PTC596 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 inthe phase I stage of development.

ONC201: Chimerix/Oncoceutics
ONC201 is a highly selective antagonist of dopamine receptor D2 (DRD2) and ClpP agonist that can penetrate the blood-brain barrier effectively. ONC201 engages proven anticancer pathways that lead to apoptosis in cancer cells. It is a small molecule originally identified as a TNF-related apoptosis-inducing ligand (TRAIL) - inducing compound. ONC201 is being evaluated in the Phase III ACTION trial for treating patients with diffuse glioma, or diffuse midline glioma (DMG), which harbor an H3 K27M mutation.
The company anticipates the interim overall survival data by 2025 and the final overall survival data by 2026 from the Phase III ACTION study of ONC201.

ITI-1000: Immunomic Therapeutics
Immunomic Therapeutics is developing ITI-1000 (pp65 DC vaccine), which is a cancer cell vaccine consisting of autologous dendritic cells (DCs) loaded with mRNA encoding the human cytomegalovirus (CMV) matrix protein pp65 as a fusion protein with the short lysosome-associated membrane protein (shLAMP), with potential immunostimulatory and antineoplastic activities. ITI-1000 is being tested in a randomized, blinded, and placebo-controlled Phase II study in patients with newly diagnosed GBM.

Key High-Grade Glioma Therapies and Companies
• ONC201: Chimerix
• AV-GBM-1: AIVITA Biomedical
• Enzastaurin (DB-102): Denovo Biopharma
• DCVax-L: Northwest Therapeutics
• Eflornithine: Orbus Therapeutics
• TVI-BRAIN-1: TVAX Biomedical
• LAM561 (2-OHOA): Laminar Pharmaceuticals
• REC-2282: Recursion Pharmaceuticals
• VT1021: Vigeo Therapeutics
• Verzenio (Abemaciclib): Eli Lilly
• Pemazyre (Pemigatinib): Incyte Corporation
• Paxalisib (GDC-0084): Kazia Therapeutics
• BMX-001: Biomimetix
• Bizaxofusp (MDNA55): Medicenna Therapeutics
• ITI-1000 (PP65 DC Vaccine): Immunomic Therapeutics
• SurVaxM: MimiVax
• OKN-007: Oblato
• Berubicin: CNS Pharmaceuticals
• Gliovac/Sitoiganap: Epitopoietic Research Corporation (ERC)
• IGV-001: Imvax
• BGB-290: BeiGene
• EO2401: Enterome
• VBI-1901: VBI Vaccines
• Temferon: Genenta Science
• NOX-A12 (Olaptesed Pegol): TME Pharma
• INO-5401 + INO-9012 + Libtayo (Cemiplimab): Inovio Pharmaceuticals
• Lerapolturev: Istari Oncology
• Rhenium (186Re) Obisbemeda: Plus Therapeutics

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High-Grade Glioma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravenous
• Oral
• Parenteral
• Subcutaneous

By Molecule Type
• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

Scope of the High-Grade Glioma Pipeline Report
• Coverage: Global
• Key High-Grade Glioma Companies: Mateon Therapeutics, BioMimetix, Oblato, Inc, PTC Therapeutics, Lee's Pharmaceutical Limited, Nuvation Bio, Inc., Laminar Pharmaceuticals, Basilea Pharmaceutica, Aadi, LLC, Erimos Pharmaceuticals, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, Orbus Therapeutics, Tvax Biomedical, Recursion Pharmaceuticals, Vigeo Therapeutics, Eli Lilly, Incyte Corporation, Kazia Therapeutics, Medicenna Therapeutics, Immunomic Therapeutics, Mimivax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Imvax, BeiGene, Enterome, VBI Vaccines, Genenta Science, TME Pharma, Inovio Pharmaceuticals, Istari Oncology, Plus Therapeutics, and others.
• Key High-Grade Glioma Pipeline Therapies: ONC201, AV-GBM-1, Enzastaurin, DCVAX-L, Eflornithine, TVI-BRAIN-1, LAM561, REC-2282, VT1021, Verzenio, Pemazyre, Paxalisib, BMX-001, Bizaxofusp, ITI-1000, Survaxm, OKN-007, Berubicin, Gliovac/Sitoiganap, IGV-001, BGB-290, EO2401, VBI-1901, Temferon, Cemiplimab, Lerapolturev, Rhenium Obisbemeda, PTC596, OT101, and others.

Dive deep into rich insights for drugs used for High-Grade Glioma treatment; visit @ https://www.delveinsight.com/report-store/high-grade-glioma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. High-Grade Glioma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. High-Grade Glioma Pipeline Therapeutics
6. High-Grade Glioma Pipeline: Late-Stage Products (Phase III)
7. High-Grade Glioma Pipeline: Late-Stage Products (Phase III)
8. High-Grade Glioma Pipeline: Mid-Stage Products (Phase II)
9. High-Grade Glioma Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.