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Glioma Pipeline, Clinical Trial Analysis and NDA Approvals | 150+ Companies and 150+ Drugs

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Glioma Pipeline, Clinical Trial Analysis and NDA Approvals | 150+ Companies and 150+ Drugs

January 18
19:09 2023
Glioma Pipeline, Clinical Trial Analysis and NDA Approvals | 150+ Companies and 150+ Drugs

DelveInsight’s, “Glioma Pipeline Insight, 2022,” report provides comprehensive insights about 150+ companies and 150+ pipeline drugs in Glioma pipeline landscape. It covers the Glioma pipeline drug profiles, including Glioma clinical trial and nonclinical stage products. It also covers the Glioma pipeline therapeutics assessment by product type, stage, Glioma route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

In the Glioma pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, Glioma NDA approvals (if any), and product development activities comprising the technology, Glioma 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 150+ active players working to develop 150+ pipeline therapies for glioma treatment.
  • Leading glioma companies such as Oncoceutics, Sumitomo Pharma, AiVita Biomedical, Denovo Biopharma, BeiGene, NEONC Technologies, AstraZeneca, Erimos Pharmaceuticals, Samus Therapeutics, GlaxoSmithKline, Symphogen, BioMimetix,  DNAtrix, NanoPharmaceuticals, Forma Therapeutics, Oblato, Nuvation Bio, Jiangsu Chia Tai Tianqing Pharmaceutical, Incyte Corporation, Prelude Therapeutics, Orgenesis, Midatech, PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, Beijing Pearl Biotechnology, Epitopoietic Research Corporation, SonALAsense, CNS Pharmaceuticals, Adastra Pharmaceuticals, Bexion Pharmaceuticals, Inc., Merck & Co,  OncoSynergy, SystImmune, Abraxis Bioscience, Day One Biopharmaceuticals, VBL Therapeutics, Shanghai Juncell Therapeutics, Eli Lilly and Company,  Erimos Pharmaceuticals, PTC therapeutics, Candel Therapeutics, Kazia Therapeutics, Nereus Pharmaceuticals, Pfizer, Actuate Therapeutics and Kintara Therapeutics, Hutchison MediPharma, Apexigen, Mundipharma EDO, Boehringer Ingelheim, Erasca, Roche, ImmVira Pharma, Polaris Group, Taiho Oncology,  Black Diamond Therapeutics, Arcus Biosciences, Cortice Biosciences, Peloton Therapeutics, Inovio Pharmaceuticals, others are evaluating novel glioma treatment drugs candidate to improve the treatment landscape.
  • Key glioma pipeline therapies in various stages of development 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.

 

To explore more information on the latest breakthroughs in the Glioma Pipeline treatment landscape of the report, click here @ Glioma Pipeline Outlook

 

Latest Developmental Activities of 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.

 

Glioma Overview

Glioma is the most common form of central nervous system (CNS) neoplasm that originates from glial cells. In the United States, there are six cases of gliomas diagnosed per 100,000 people every year. Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. Glioblastoma is the most malignant type while pilocytic astrocytomas are the least malignant brain tumors. In the past, these diffuse gliomas were classified into different subtypes and grades based on histopathologies such as a diffuse astrocytoma, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. Recently, gliomas were classified based on molecular and genetic markers. These advances have more specific prognostic and therapeutic benefits for patients with gliomas. In addition to molecular and genetic markers, gliomas are classified in grade I to IV based on the degree of proliferation indicated by the mitotic index and the presence or absence of necrosis. There are three common types of gliomas, which are classified based on the phenotypic cell characteristics: astrocytomas, ependymomas, and oligodendrogliomas.

 

Request a sample and discover the recent advances in Glioma Ongoing Clinical Trial Analysis and Medications, click here @ Glioma Treatment Landscape

 

Glioma Emerging Drugs Profile

 

ONC 201: Chimerix

ONC201 is the founding member of the imipridone class of anti-cancer small molecules which selectively targets Dopamine Receptor D2 (DRD2) and ClpP. ONC201-mediated cell death occurs via induction of the integrated stress response and upregulation of apoptotic factors, such as tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL). It is dosed orally and has been well-tolerated and shown clinical activity in Phase I and II trials for specific advanced cancers. Clinical trials of ONC201 in glioma patients with the H3 K27M-mutation are underway at several locations in the U.S.

 

DSP-7888: Sumitomo Dainippon Pharma

Ombipepimut-S Emulsion (DSP-7888) is an investigational WT1 immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T-lymphocytes (WT1-CTL) and helper T-cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that adding a peptide to induce helper T cells may improve outcomes compared to a treatment regimen based on a killer peptide alone. Currently, it is in Phase III stage of clinical trial evaluation to treat Glioblastoma multiforme.

 

AV-GBM-1: AIVITA Biomedical

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections. The treatment is uniquely pan-antigenic, targeting multiple antigens from autologous tumor-initiating cells that are responsible for the rapid growth of the disease.

 

DB102: Denovo Biopharma

Lilly conducted many clinical studies with enzastaurin in a variety of tumor indications, including Phase 3 clinical trials in diffuse large B cell lymphoma (DLBCL) and glioma (GBM), and has received orphan drug certification in the U.S. and Europe. Denovo acquired global rights to enzastaurin from Lilly, including development, production and commercialization. Denovo has completed the identification of the biomarker, which is significantly correlated with the expected therapeutic effects on DLBCL and GBM patients, and has filed international patent applications. Denovo initiated a pivotal Phase 3 global DLBCL clinical trial in 2018 with data readout expected in mid-2022. In 2018 Denovo licensed the rights to use DB102 for Pulmonary Arterial Hypertension (PAH) from Stanford University.

 

AB-218: AnHeart Therapeutics

AB-218 is a mIDH1 inhibitor that has reported blood brain barrier penetration for multiple solid tumors with mIDH1 mutations. Phase 1 clinical trials of AB-218 in glioma patients have demonstrated promising efficacy and safety profiles in 12 non-enhancing and 35 enhancing glioma patients. The objective response rate (ORR) was 33% and 17.1% in non-enhancing and enhancing patients, respectively.

 

Glioma Pipeline Therapeutics Assessment

There are approx. 150+ key companies which are developing the therapies for Glioma. The companies which have their Glioma drug candidates in the most advanced stage, i.e. phase II include, Chimerix.

 

For further information, refer to the detailed Glioma Unmet Needs, Glioma Market Drivers, and Glioma Market Barriers, click here for Glioma Ongoing Clinical Trial Analysis

 

Glioma Phases

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Glioma Pre-clinical and Discovery stage candidates
  • Glioma Discontinued & Inactive candidates

 

Scope of the Glioma Pipeline Report

  • Coverage- Global
  • Glioma Companies: Oncoceutics, Sumitomo Pharma, AiVita Biomedical, Denovo Biopharma, BeiGene, NEONC Technologies, AstraZeneca, Erimos Pharmaceuticals, Samus Therapeutics, GlaxoSmithKline, Symphogen, BioMimetix,  DNAtrix, NanoPharmaceuticals, Forma Therapeutics, Oblato, Nuvation Bio, Jiangsu Chia Tai Tianqing Pharmaceutical, Incyte Corporation, Prelude Therapeutics, Orgenesis, Midatech, PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, Beijing Pearl Biotechnology, Epitopoietic Research Corporation, SonALAsense, CNS Pharmaceuticals, Adastra Pharmaceuticals, Bexion Pharmaceuticals, Inc., Merck & Co,  OncoSynergy, SystImmune, Abraxis Bioscience, Day One Biopharmaceuticals, VBL Therapeutics, Shanghai Juncell Therapeutics, Eli Lilly and Company,  Erimos Pharmaceuticals, PTC therapeutics, Candel Therapeutics, Kazia Therapeutics, Nereus Pharmaceuticals, Pfizer, Actuate Therapeutics and Kintara Therapeutics, Hutchison MediPharma, Apexigen, Mundipharma EDO, Boehringer Ingelheim, Erasca, Roche, ImmVira Pharma, Polaris Group, Taiho Oncology,  Black Diamond Therapeutics, Arcus Biosciences, Cortice Biosciences, Peloton Therapeutics, Inovio 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: Phases, Product Type, Mechanism of action, Route of Administration

 

Dive deep into rich insights for drugs for Glioma Market Drivers and Glioma Market Barriers, click here @ Glioma Unmet Needs and Analyst Views

 

Table of Content

  1. Introduction
  2. Glioma Executive Summary
  3. Glioma: Overview
  4. Glioma Pipeline Therapeutics
  5. Glioma Therapeutic Assessment
  6. Glioma – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. VB 111: VBL Therapeutics
  9. Mid Stage Products (Phase II)
  10. ONC 201: Chimerix
  11. Early Stage Products (Phase I)
  12. Autologous tumour infiltrating lymphocytes: Shanghai Gencells Therapeutics
  13. Preclinical and Discovery Stage Products
  14. Autologous T-cell therapy: Kairos Pharma
  15. Inactive Products
  16. Glioma Key Companies
  17. Glioma Key Products
  18. Glioma- Unmet Needs
  19. Glioma- Market Drivers and Barriers
  20. Glioma- Future Perspectives and Conclusion
  21. Glioma Analyst Views
  22. Glioma Key Companies
  23. Appendix

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Glioma drugs?
  • How many Glioma drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Glioma?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Glioma therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Glioma and their status?
  • What are the key designations that have been granted to the emerging drugs?

 

Got Queries? Find out the related information on Glioma mergers and acquisitions, Glioma licensing activities, Glioma emerging drugs, and Glioma recent trends @ Glioma Market Drivers and Barriers

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