DelveInsight’s, “Glioma Pipeline Insight 2023,” report provides comprehensive insights about 190+ companies and 130+ pipeline drugs in the Glioma pipeline landscape. It covers the Glioma pipeline drug profiles, including Glioma clinical trials and nonclinical stage products. It also covers the Glioma pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
For Glioma Emerging Drugs, the 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 Glioma pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.
In the Glioma Pipeline Report, a detailed description of the drug is given which includes the mechanism of action of the drug, Glioma clinical trials studies, Glioma NDA approvals (if any), and product development activities comprising the technology, Glioma Disease collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.
Key Takeaways from the Glioma Pipeline Report
- DelveInsight’s Glioma pipeline report depicts a robust space with 190+ active players working to develop 130+ pipeline therapies for glioma treatment.
- The leading glioma companies include Denovo Biopharma, AstraZeneca, Pfizer, Chimerix, Bristol-Myers Squibb, Orbus Therapeutics, Northwest Biotherapeutics, Day One Biopharmaceuticals, AiVita Biomedical, Ascletis Pharma Inc., Bristol Myers Squibb, 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, Celgene, 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, and others.
- Promising Glioma pipeline therapies include ONC 201, DSP-7888, AV-GBM-1, DB102, BGB-290, , Perillyl alcohol, Selumetinib, Terameprocol, Icapamespib, Sym004, Niraparib, ivosidenib, BMX-001, DNX-2401, fb-PMT, FT-2102, OKN-007, NUV-422, rhIL-7-hyFc, Anlotinib hydrochloride, Epacadostat, PRT811, AloCELYVIR, MTX110, SONALA-001, PTC596, Nivolumab, L19TNF, NTX-301, Mirdametinib, AB-218, PVSRIPO, PLB1001, ERC1671, Berubicin Hydrochloride, BXQ-350, TG02, Pembrolizumab, OS2966, GNC-039, ABI-009, DAY101, VB 111, Tumor Infiltrating Lymphocytes (TIL), LY2157299, PTC596 CAN-2409, CAN-3110, GDC-0084, LY3410738, PF-07799933, VAL-083, 9-ING-41, Sotigalimab , Tinostamustine, BI 907828, ERAS-801, RO7428731, C5252, ADI-PEG20, TAS2940, BDTX-1535, Sabatolimab, Afatinib, Zimberelimab, TPI 287, PT2385, INO-5401 and others.
- The Glioma Pipeline companies and academics that are working to assess challenges and seek opportunities that could influence Glioma R&D. The Glioma Pipeline therapies under development are focused on novel approaches to treat/improve the disease condition.
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Glioma Overview
A glioma is a tumor that forms in the brain or spinal cord. Neuroglial cells also known as glial cells or glia are quite different from nerve cells. They do not participate directly in synaptic interactions and electrical signaling, although their supportive functions help define synaptic contacts and maintain the signaling abilities of neurons.
Recent Developmental Activities in the Glioma Treatment Landscape
- In June 2022, Day One announced positive initial data from the pivotal FIREFLY-1 trial of Tovorafenib (DAY101) in relapsed pediatric low-grade Glioma. Data show an overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in the first 22 evaluable patients treated with monotherapy tovorafenib. Topline results from the full FIREFLY-1 trial population are expected in Q1 2023. Day One plans to initiate a pivotal Phase 3 clinical trial of tovorafenib in front-line pediatric low-grade glioma (pLGG), with the first patient dose expected in Q3 2022.
- In June 2022, Kintara Therapeutics announced that it received fast-track designation from FDA for dianhydrogalactitol (VAL-083) for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM). VAL-083 is a first-in-class small molecule therapeutics with a novel mechanism of action. The agent has displayed clinical activity against various cancers, including the central nervous system, ovarian, and other solid tumors.
- In June 2022, CNS Pharmaceuticals announced that it received approval from the US Food and Drug Administration (FDA) for its ongoing potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine (Gleostine) administered after first-line therapy for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.
- In April 2022, Moleculin Biotech received the US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application to initiate Phase I trial the clinical trial of WP1066 to treat recurrent malignant glioma. WP1066 is intended to induce the immune response to tumors by hindering the errant activity of Regulatory T-Cells (TRegs).
- In February 2022, Kazia Therapeutics commenced a Phase II clinical trial of its investigational new drug, paxalisib, along with metformin and a ketogenic diet to treat recently diagnosed and recurrent glioblastoma, a type of primary brain cancer. The company intends to conclude subject recruitment in the second half of CY2023.
- In January 2022, Ascletis Pharma announced the dosing of the first patient in the Phase III registration clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM). ASC40 is an oral, selective inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis (DNL). ASC40 inhibits energy supply and disturbs membrane phospholipid composition of tumor cells by blocking de novo lipogenesis.
- In December 2021, The FDA granted a fast-track designation to ST101, a peptide antagonist of C/EBPβ, for the treatment of patients with recurrent glioblastoma. ST101 is currently being evaluated in an ongoing Phase I/II clinical study in patients with advanced unresectable and metastatic solid tumors, which includes a GBM expansion cohort.
For further information, refer to the detailed Glioma Drugs Launch, Glioma Developmental Activities, and Glioma News, click here for Glioma Ongoing Clinical Trial Analysis
Glioma Emerging Drugs Profile
- Tofacitinib: Pfizer
Tofacitinib is an immunosuppressant. It is a first-generation, orally bioavailable pan-Jak inhibitor. Tofacitinib was mainly developed for use as an immunosuppressant for organ transplantation and possibly for the treatment of autoimmune diseases. Tofacitinib suppresses the Jak family members at IC50s as follows: Jak1, Jak2, and Jak3, in a cell-free kinase assay. In addition, Tofacitinib effectively suppresses common γ-chain cytokines involving IL-2, IL-4, IL-15 and IL-21. Furthermore, the most common side effects include headaches, upper respiratory infections, diarrhea, and nasopharyngeal inflammation, elevation in low-density lipoprotein and cholesterol levels and reduction in neutrophil numbers. Serious infections including pneumonia, cellulitis and urinary tract infections have been described in patients treated with Tofacitinib.
It has been observed that Tofacitinib upregulates BIN3 results in a better prognosis and resulted in non-invasive tumors. The drug is currently being investigated in the Phase III stage of development for the treatment of Glioma Disease.
- Enzastaurin: Denovo BioPharma
DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received Orphan Drug Designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA and Fast Track Designation from the FDA. DB102 is the world’s first oral small-molecule kinase inhibitor targeting PKC. A retrospective analysis found that it has significant curative effects in high-risk DLBCL patients who are DGM1 positive.
The company has initiated a biomarker guided Phase III clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme (GBM).
- MDNA55: Medicenna Therapeutics, Inc.
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. The drug is currently under Phase II of development.
- Sym004: Symphogen A/S
Sym004 induces rapid internalization and degradation of the EGFR that leads to down-modulation of EGFR and subsequent inhibition of cancer cell growth. The inhibition of EGFR with two antibodies contained in Sym004 results in a mechanism of action that is distinct from the more limited actions of single anti-EGFR antibodies. In preclinical models of GBM in which EGFR amplification is present, Sym004 demonstrated promising efficacy. In general, up to 50 percent of GBM patients have amplified EGFR. By removing the EGFR receptors from the surface of the tumor cell and thus preventing tumor growth, Sym004 may provide a new treatment option for GBM patients. A Phase II clinical trial evaluating Sym004 in patients with Glioma has been completed.
- MN-166: MediciNova
MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses the pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6 and might up-regulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity, or NME, in the United States and Europe, it involves the redirection of an approved drug, ibudilast, which was first approved in Japan more than 20 years ago. Ibudilast has been prescribed to over 3.2 million patients and has a good post-marketing safety profile. Currently, the drug is in Phase I/II trial for the treatment of Glioblastoma.
Glioma Pipeline Therapeutics Assessment
There are approx. 190+ key companies which are developing the therapies for Glioma Disease. The companies which have their Glioma Disease drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma.
Find out more about the Glioma Pipeline Segmentation, Therapeutics Assessment, and Glioma Emerging Drugs @ Glioma Treatment Landscape
Scope of the Glioma Pipeline Report
- Coverage- Global
- Glioma Companies- Denovo Biopharma, AstraZeneca, Pfizer, Chimerix, Bristol-Myers Squibb, Orbus Therapeutics, Northwest Biotherapeutics, Day One Biopharmaceuticals, AiVita Biomedical, Ascletis Pharma Inc., Bristol Myers Squibb, 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, Celgene, 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, and others.
- Glioma Pipeline Therapies- ONC 201, DSP-7888, AV-GBM-1, DB102, BGB-290, Perillyl alcohol, Selumetinib, Terameprocol, Icapamespib, Sym004, Niraparib, ivosidenib, BMX-001, DNX-2401, fb-PMT, FT-2102, OKN-007, NUV-422, rhIL-7-hyFc, Anlotinib hydrochloride, Epacadostat, PRT811, AloCELYVIR, MTX110, SONALA-001, PTC596, Nivolumab, L19TNF, NTX-301, Mirdametinib, AB-218, PVSRIPO, PLB1001, ERC1671, Berubicin Hydrochloride, BXQ-350, TG02, Pembrolizumab, OS2966, GNC-039, ABI-009, DAY101, VB 111, Tumor Infiltrating Lymphocytes (TIL), LY2157299, PTC596 CAN-2409, CAN-3110, GDC-0084, LY3410738, PF-07799933, VAL-083, 9-ING-41, Sotigalimab, Tinostamustine, BI 907828, ERAS-801, RO7428731, C5252, ADI-PEG20, TAS2940, BDTX-1535, Sabatolimab, Afatinib, Zimberelimab, TPI 287, PT2385, INO-5401 and others.
- Glioma Pipeline Segmentation: Product Type, Molecule Type, Route of Administration
Dive deep into rich insights for drugs for Glioma Pipeline Companies and Therapies, click here @ Glioma Unmet Needs and Analyst Views
Table of Content
- Introduction
- Executive Summary
- Glioma Disease: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Glioma Disease– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Enzastaurin: Denovo BioPharma
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- MDNA55: Medicenna Therapeutics, Inc.
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I/II)
- Zotiraciclib: Adastra Pharmaceuticals
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- RGN6024: Reglagene, Inc.
- 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
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