Anaplastic Astrocytoma Pipeline: 15+ Biopharma Companies Advancing Targeted Therapies for High-Grade Gliomas | DelveInsight

The anaplastic astrocytoma treatment pipeline is gaining momentum with the introduction of precision therapies, immunotherapies, and novel alkylating agents. Companies like Orbus Therapeutics, Cothera Bioscience, Celgene, Wayshine Biopharm, Inc., OncoSynergy, and AEterna Zentaris are spearheading efforts to overcome resistance to standard chemotherapy and radiotherapy. With the integration of molecular diagnostics and targeted inhibitors, the pipeline focuses on IDH mutations, MGMT methylation status, and tumor-specific biomarkers to develop personalized treatment regimens that improve prognosis and extend survival in this aggressive brain cancer.

DelveInsight's "Anaplastic Astrocytoma Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the anaplastic astrocytoma 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 anaplastic astrocytoma drugs, the anaplastic astrocytoma pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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Key Takeaways from the Anaplastic Astrocytoma Pipeline Report
• DelveInsight's anaplastic astrocytoma pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for Anaplastic Astrocytoma treatment.
• The leading anaplastic astrocytoma companies include Orbus Therapeutics, Cothera Bioscience, Celgene, Wayshine Biopharm, Inc., OncoSynergy, AEterna Zentaris, Oncoceutics, DNAtrix, Novartis Pharmaceuticals, Curis, Inc., Everfront Biotech Co., Ltd., Pfizer, Kazia Therapeutics Limited, Bayer, Geneos Therapeutics, Cellix Bio, Mustang Bio, Deciphera Pharmaceuticals, Aveta Biomics, and others are evaluating their lead assets to improve the anaplastic astrocytoma treatment landscape.
• Key anaplastic astrocytoma pipeline therapies in various stages of development include Eflornithine, Zotiraciclib, CC-90010, WSD0922-FU, OS2966, Perifosine, ONC206, DNX-2401, Dabrafenib, Trametinib, Fimepinostat, Cerebraca wafer, Binimetinib, Encorafenib, GDC-0084, Regorafenib, GT-10, CLX-ONC-643, MB-109, DCC-2618, APG-157, and others.
• In March 2025, NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) announced that the FDA granted Rare Pediatric Disease Designation (RPDD) to perillyl alcohol (NEO100TM) for treating pediatric-type diffuse high-grade gliomas, a life-threatening condition affecting children and adolescents.
• In December 2024, Chimerix (NASDAQ: CMRX), a biopharmaceutical company focused on developing medicines for life-threatening diseases, announced the submission of a New Drug Application (NDA) to the FDA for accelerated approval of dordaviprone. The drug is intended for the treatment of patients with recurrent H3 K27M-mutant diffuse glioma in the U.S.
• 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".
• In November 2024, Mustang Bio, Inc. (Nasdaq: MBIO) announced that the FDA granted Orphan Drug Designation to its oncolytic virus, MB-108, for treating malignant glioma. MB-108 uses herpes simplex virus type 1 (HSV-1) and is part of Mustang's cell therapy portfolio targeting difficult-to-treat cancers.
• In May 2024, Imvax announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase IIb clinical trial of IGV-001 in patients with newly diagnosed glioblastoma.

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Anaplastic Astrocytoma Overview
Anaplastic Astrocytoma is a rare and aggressive form of brain cancer that develops from astrocytes, star-shaped cells in the brain that support and protect nerve cells. This tumor is classified as a glioma, which refers to tumors originating from glial tissue. The symptoms of Anaplastic Astrocytoma vary depending on the tumor's location and size, with many symptoms arising from increased pressure within the brain. The tumor can grow slowly or rapidly, and its exact cause remains unknown. However, researchers believe that genetic mutations, environmental factors (such as exposure to UV rays, chemicals, and radiation), diet, and stress may contribute to the development of the disease. Ongoing research aims to uncover the complex causes behind this rare and challenging cancer.

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Anaplastic Astrocytoma Treatment Analysis: Drug Profile
Eflornithine: Orbus Therapeutics
Eflornithine (α-diflurormethylornithine or DFMO) is a targeted therapy that irreversibly inhibits ornithine decarboxylase (ODC), an enzyme crucial for polyamine synthesis, DNA, and RNA function. Unlike multi-targeted tyrosine kinase inhibitors, eflornithine specifically targets ODC. Animal studies have demonstrated its ability to inhibit the growth of malignant tumors, including high-grade gliomas. It has also been shown to enhance the effectiveness of other chemotherapy drugs. In clinical trials, eflornithine oral solution improved survival rates in patients with newly diagnosed and recurrent anaplastic glioma. Common side effects include diarrhea and hearing impairment.

Zotiraciclib: Cothera Bioscience
Zotiraciclib is a potent, oral, spectrum-selective kinase inhibitor designed for cancer treatment. Discovered by S*BIO Pte Ltd in Singapore, zotiraciclib is a small molecule macrocycle that crosses the blood-brain barrier. It works by depleting Myc through the inhibition of cyclin-dependent kinase 9 (CDK9). In October 2021, Cothera Bioscience and Adastra Pharmaceuticals entered an agreement in which Cothera acquired zotiraciclib (ZTR).

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Anaplastic Astrocytoma 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
• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

By Molecule Type
• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Scope of the Anaplastic Astrocytoma Pipeline Report
• Coverage: Global
• Key Anaplastic Astrocytoma Companies: Orbus Therapeutics, Cothera Bioscience, Celgene, Wayshine Biopharm, Inc., OncoSynergy, AEterna Zentaris, Oncoceutics, DNAtrix, Novartis Pharmaceuticals, Curis, Inc., Everfront Biotech Co., Ltd., Pfizer, Kazia Therapeutics Limited, Bayer, Geneos Therapeutics, Cellix Bio, Mustang Bio, Deciphera Pharmaceuticals, Aveta Biomics, and others.
• Key Anaplastic Astrocytoma Pipeline Therapies: Eflornithine, Zotiraciclib, CC-90010, WSD0922-FU, OS2966, Perifosine, ONC206, DNX-2401, Dabrafenib, Trametinib, Fimepinostat, Cerebraca wafer, Binimetinib, Encorafenib, GDC-0084, Regorafenib, GT-10, CLX-ONC-643, MB-109, DCC-2618, APG-157, and others.

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

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