Glioma Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Glioma Pipeline Insight, 2025" report provides comprehensive insights about 180+ companies and 200+ pipeline drugs in Glioma pipeline landscape. It covers the Glioma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Glioma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Glioma Pipeline Report

* In March 2025, Chimerix announced a phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
* In March 2025, Day One Biopharmaceuticals, Inc . announced a phase 3 study trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
* In March 20245, Daiichi Sankyo Co., Ltd . announced a phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
* In March 2025, Laminar Pharmaceuticals announced a study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recommended Phase 2 Dose (RP2D).
* DelveInsight's Glioma pipeline report depicts a robust space with 180+ active players working to develop 200+ pipeline therapies for Glioma treatment.
* The leading Glioma Companies such as CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others.
* Promising Glioma Pipeline Therapies such as DS-1001b, Nimotuzumab, Radiotherapy, AP23573, BLZ-100, LY2157299, Temozolomide, Safusidenib, ONC201, PLB1001, YYB-103 , and others.

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Glioma Emerging Drugs Profile

* AV-GBM-1: Aivita Biomedical, Inc.

AV-GBM-1 is an innovative immunotherapy developed by AIVITA Biomedical, Inc., specifically targeting glioblastoma (GBM), one of the most aggressive forms of brain cancer. This treatment utilizes autologous dendritic cells that are loaded with autologous tumor neoantigens derived from tumor-initiating cells. The therapy is administered through a series of subcutaneous injections and aims to enhance the immune response against the patient's unique cancer profile. Currently, the drug is in phase III stage of its clinical trial for the treatment of Glioma.

* DB 107: Denovo BioPharma

Denovo BioPharma's DB107 is an investigational gene therapy designed to treat high-grade gliomas, including glioblastoma (GBM), a particularly aggressive form of brain cancer. The therapy utilizes a novel biomarker-guided approach, leveraging the Denovo Genomic Marker 7 (DGM7) to identify patients who are likely to benefit from the treatment. Currently, the drug is in phase II stage of its clinical trial for the treatment of Glioma.

* MDNA55: Medicenna Therapeutics, Inc.

MDNA55 is 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. Currently, the drug is in phase II stage of its clinical trial for the treatment of Glioma.

* Abemaciclib: Eli Lilly and Company

Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with Fulvestrant. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma.

* NMS-03305293: Nerviano Medical Sciences

NMS-293 is a second generation PARP inhibitor that differentiates from other approved or advanced molecules in its unique selectivity for PARP1 vs. PARP2 enzymes and low DNA trapping activity, both features potentially linked to lower hematological toxicity and higher potential for combination with DNA damaging agents in a wide range of tumors, covering high unmet medical needs. It also has a superior ability to penetrate the blood-brain barrier, a very important feature supporting its utilization in CNS tumors and brain metastases. The drug has shown high anti-tumor activity as single agent in BRCA mutated preclinical tumor models and synergy and tolerability in combination with chemotherapy. Based on the findings, NMS-293 is currently in clinical developmental Phase II in combination with temozolomide in recurrent glioblastoma.

* CAN-3110: Candel Therapeutics

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase I investigator-sponsored clinical trial in patients with recurrent HGG. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Glioma.

* MB-101: Mustang Bio

MB-101 is an IL13R2-targeted CAR T cell therapy developed by Mustang Bio, aimed at treating recurrent glioblastoma (GBM) and high-grade gliomas. Currently, the drug is in Phase I stage of clinical trial for the treatment of Glioma.

The Glioma Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Glioma with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Glioma Treatment.
* Glioma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Glioma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Glioma market

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Glioma Companies

CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others.

Glioma 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
* Oral
* Parenteral
* Subcutaneous
* Topical
* Transdermal

Glioma Products have been categorized under various Molecule types such as

* Oligonucleotide
* Peptide
* Small molecule

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Scope of the Glioma Pipeline Report

* Coverage- Global
* Glioma Companies- CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others.
* Glioma Pipeline Therapies- DS-1001b , Nimotuzumab, Radiotherapy, AP23573, BLZ-100, LY2157299, Temozolomide, Safusidenib, ONC201, PLB1001, YYB-103 , and others.
* Glioma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Glioma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Glioma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Glioma Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/glioma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Glioma Disease: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Glioma Disease- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* AV-GBM-1: Aivita Biomedical, Inc.
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* DB 107: Denovo BioPharma
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* MB-101: Mustang Bio
* Preclinical Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* Glioma Disease Key Companies
* Glioma Disease Key Products
* Glioma Disease- Unmet Needs
* Glioma Disease- Market Drivers and Barriers
* Glioma Disease- Future Perspectives and Conclusion
* Glioma Disease Analyst Views
* Glioma Disease Key Companies
* Appendix

About Us

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