High-Grade Glioma Pipeline Insight 2025: Over 150+ Therapies Target Aggressive Brain Tumors with Novel Modalities and Precision Approaches

High-grade gliomas (HGGs), including glioblastoma multiforme (GBM), represent some of the most aggressive and treatment-resistant brain tumors in oncology. Characterized by rapid progression, poor prognosis, and limited response to conventional therapies, these malignancies continue to pose a major clinical challenge. Despite aggressive surgical resection, radiation, and chemotherapeutic regimens, median survival remains dismal-particularly in GBM, where it typically ranges between 12 and 15 months post-diagnosis.

As of 2025, the global high-grade glioma pipeline has expanded substantially, with 150+ active drug candidates in various stages of development. These investigational therapies span a wide range of mechanisms and modalities, reflecting the urgency to address both tumor heterogeneity and the immunosuppressive microenvironment. Among these, immune checkpoint inhibitors, CAR-T cell therapies, oncolytic viruses, peptide vaccines, and dendritic cell therapies are under active exploration, often in combination with standard-of-care agents.

Noteworthy candidates include EGFRvIII-targeted therapies, IDH inhibitors for biomarker-driven subgroups, and small molecules modulating DNA damage repair pathways such as PARP, ATR, and WEE1 inhibitors. Several ADCs (antibody-drug conjugates) and bispecific antibodies are also in early development. Companies are pursuing both systemic and intracranial delivery platforms to overcome the blood-brain barrier (BBB) and enhance therapeutic penetration.

Recent breakthroughs in 2025 include encouraging early-phase data for personalized neoantigen vaccines and tumor-agnostic agents that exploit common glioma mutations. Meanwhile, AI-driven drug discovery and spatial transcriptomics are enabling better patient stratification and target validation. While major hurdles like tumor recurrence, drug resistance, and BBB penetration remain, the robust and diverse pipeline reflects a renewed hope in tackling high-grade gliomas more precisely and effectively.

Interested in learning more about the current treatment landscape and the key drivers shaping the high-grade glioma pipeline? Click here: https://www.delveinsight.com/report-store/high-grade-glioma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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 August 2025, the FDA granted accelerated approval to MODEYSO (dordaviprone), a novel systemic treatment for diffuse midline glioma (DMG) with an H3 K27M mutation.
• In June 2025, Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for REYOBIQTM (Rhenium Re186 Obisbemeda).
• 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 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
High-grade gliomas (HGGs) are aggressive brain tumors arising from glial cells, with glioblastoma (GBM) being the most common and lethal form. These tumors are characterized by rapid growth, resistance to therapy, and poor prognosis. HGGs can occur in both adults and children, often presenting with neurological symptoms such as headaches, seizures, and cognitive decline.

Standard treatment typically includes surgical resection followed by radiation and chemotherapy, but recurrence is common and survival rates remain low. Due to limited effective therapies, there is an urgent need for novel treatments targeting the tumor's molecular and immune environment.

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High-Grade Glioma Treatment Analysis: Drug Profile
OT101: Mateon Therapeutics
OT101 is a first-in-class RNA therapeutic targeting TGF-beta 2 to counteract its immunosuppressive effects. In a completed Phase II trial, it showed meaningful single-agent activity, with durable complete and partial responses in adults with recurrent or refractory High-Grade Glioma, including GBM. Its continued development may offer hope as a salvage therapy for pediatric DIPG, a rare and fatal disease.

PTC596: PTC Therapeutics
PTC596 is an oral small molecule that targets cancer stem cells by disrupting the BMI1 protein via phosphorylation. It has shown strong BMI1 inhibition and preferentially eliminated chemo-resistant cancer stem cells in vitro, particularly in fibrosarcoma, prostate, and colon cancer lines. In contrast, standard chemotherapies increased stem cell populations. PTC596 is currently in Phase I development.

Learn more about the novel and emerging high-grade glioma pipeline therapies @ https://www.delveinsight.com/report-store/high-grade-glioma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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
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This release was published on openPR.