IDH2

New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma

Retrieved on: 
Saturday, November 18, 2023
NDA, Glioma, Safety, TGR, Food, European Medicines Agency, Astrocytoma, Dana–Farber Cancer Institute, Progression-free survival, IDH2, Aes, Clinical trial, EMA, Data, Patient, Abstract, PFS, FDA, INDIGO, Division, Pembrolizumab, Merck, Neoplasm, IDH, IDH1, Growth, Merck & Co., Quality of life, Society, SNO, HIV disease progression rates, Medical imaging, Pharmaceutical industry, Laboratoires Servier

BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.

Key Points: 
  • We are honored and excited at the prospect of ushering in a new era of targeted treatment options for patients living with this devastating disease."
  • The safety lead-in was conducted to determine the recommended combination dose for the recently initiated perioperative phase of the study.
  • In this phase, approximately 60 patients will be randomized to the combination treatment, vorasidenib 40 mg once-daily alone, or no treatment prior to surgery.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

New Anti-Cancer Opportunities Revealed for Hepion Pharmaceuticals’ Rencofilstat in Cancer Screening Program

Retrieved on: 
Thursday, September 21, 2023
Immortalised cell line, PRISM, Weapon, Broad Institute, Therapy, NASH, Culture, Neoplasm, Clinical trial, Cancer, MAP3K, Research, Gene expression, MIT, Biomarker, Cell, Harvard University, TP63, Liver cancer, NOTCH1, Liver, PTPRB, ATM, HNF1A, Patient, Fatty liver disease, IDH2, Artificial intelligence, Gene, Mouse, Conditional sentence, HEPA, HCC, ALK, Pharmaceutical industry, Vaccine

EDISON, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced results from a study with in which the anti-cancer activity of Hepion’s lead drug candidate, rencofilstat, was tested in a high through-put screen on 850 cancer cell lines spanning 28 types of cancer at the PRISM lab at the Broad Institute of MIT and Harvard.

Key Points: 
  • The Broad Institute is one of the few institutions in the world with such an expansive cancer cell line screening program.
  • Rencofilstat was administered at eight concentrations to each cancer cell line in culture for 5 days, followed by measurement of surviving cells to determine how effectively the drug candidate killed or suppressed proliferation of the cancer cells.
  • Defining “anti-cancer responsiveness” as 50% or greater reduction in viability following treatment, 26% of all tested cancer cell lines (220/850) spanning 86% of cancer cell types (24/28) were responsive to rencofilstat.
  • Thus, administration of rencofilstat to cancer patients with the standard regimen of once-daily oral dosing may be efficacious for those with responsive types of cancer.

Chondrosarcoma Market Outlook to 2032: Emerging Therapies and Market Access Drive Growth in the 7MM, Addressing Unmet Needs in Rare Bone Cancer Treatment - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 9, 2023
Health, Oncology, TKI, EU4, Ivosidenib, Disease, Radiation, Chondrosarcoma, USD, NCCN, Patient, IDH2, IDH1, United Kingdom, Dasatinib, Drug pipeline, Pharmaceutical industry, Epidemiology

It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.

Key Points: 
  • It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.
  • Chondrosarcoma Cases and Market Size: As per NCCN Guidelines, nearly 65% of chondrosarcoma cases are related to IDH1 or IDH2 mutations.
  • Limited Treatment Options: Conventional chondrosarcomas, the major subtype, are considered resistant to chemotherapy and radiation, resulting in limited treatment options.
  • Market Access and Reimbursement: Reimbursement of rare disease therapies like chondrosarcoma can be limited due to high costs and lack of specific approaches to evaluating rare disease drugs.

HUTCHMED Highlights Presentations at American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Wednesday, April 12, 2023
Glioma, FGFR, Differentiable function, Brownstone, Isocitrate dehydrogenase, Acute myeloid leukemia, AML, Cancer, IDH2, IDH, IDH1, Malignant transformation, Chondrosarcoma, Cholangiocarcinoma, Vaccine

Mutant IDHs (“mIDHs”) cause accumulated 2-hydroxyglutarate, leading to blockage of cell differentiation, thereby inducing malignant transformation.

Key Points: 
  • Mutant IDHs (“mIDHs”) cause accumulated 2-hydroxyglutarate, leading to blockage of cell differentiation, thereby inducing malignant transformation.
  • Thus, simultaneous inhibition on both mIDH1 and mIDH2 may be a promising strategy to overcome resistance and improve clinical efficacy.
  • HMPL-306, a dual inhibitor of mIDH1/mIDH2, developed by HUTCHMED, is being evaluated in clinical trials ( NCT04272957 , NCT04762602 , NCT04764474 ).
  • HMPL-453, a highly selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays potent activity in FGFR-altered tumor models

Servier's Pivotal Phase 3 INDIGO Trial Investigating vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of Progression-Free Survival (PFS) and Key Secondary Endpoint of Time to Next Intervention (TTNI)

Retrieved on: 
Tuesday, March 14, 2023
IDH, Clinical trial, Drug, Mutation, Caregiver, Doctor of Philosophy, Late-stage functionalization, IDH1, Progression-free survival, PFS, Patient, Oligodendroglioma, INDIGO, Food and Drug Administration, Glioma, FDA, IDH2, Science, Astrocytoma, Medical imaging, Nursing, Pharmaceutical industry

"Therapeutic progress in the low-grade glioma space has been stagnant for decades.

Key Points: 
  • "Therapeutic progress in the low-grade glioma space has been stagnant for decades.
  • "We are grateful to the patients, caregivers, investigators and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial."
  • The Phase 3 INDIGO trial results will be presented at an upcoming medical meeting.
  • Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule.

Servier's Pivotal Phase 3 INDIGO Trial Investigating vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of Progression-Free Survival (PFS) and Key Secondary Endpoint of Time to Next Intervention (TTNI)

Retrieved on: 
Tuesday, March 14, 2023
IDH, Clinical trial, Drug, Mutation, Caregiver, Doctor of Philosophy, Late-stage functionalization, IDH1, Progression-free survival, PFS, Patient, Oligodendroglioma, INDIGO, Food and Drug Administration, Glioma, FDA, IDH2, Science, Astrocytoma, Medical imaging, Nursing, Pharmaceutical industry

"Therapeutic progress in the low-grade glioma space has been stagnant for decades.

Key Points: 
  • "Therapeutic progress in the low-grade glioma space has been stagnant for decades.
  • "We are grateful to the patients, caregivers, investigators and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial."
  • The Phase 3 INDIGO trial results will be presented at an upcoming medical meeting.
  • Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule.

Nerviano Medical Sciences Strengthens Executive Team to Maximize IDH1/IDH2 Inhibitor Asset

Retrieved on: 
Friday, January 13, 2023
Research, Clinical Trials, Biotechnology, Biometrics, Health, Pharmaceutical, Other Science, Science, Oncology, University, Merck, Therapy, Merck Group, AML, Virtual, IPO, FDA, S.P. Bansal, NMS, Medicine, IDH2, BS, Merck Serono, Patient, Cholangiocarcinoma, Pharming, IDH1, Program management, Bicycle, MBA, University of Phoenix, Doctor of Philosophy, Pharmaceutical industry, Exelixis, New business development, Chemistry

Mr. West is a seasoned biopharma executive with over 25 years of experience in all levels of both public and private organizations leading and managing pipeline development across multiple therapeutic areas.

Key Points: 
  • Mr. West is a seasoned biopharma executive with over 25 years of experience in all levels of both public and private organizations leading and managing pipeline development across multiple therapeutic areas.
  • “With the addition of Terrence to the executive team, we are beginning to really establish our footprint in the Boston area,” stated Lisa Mahnke, M.D., PhD, Board Member and Chief Medical Officer of NMS S.r.l.
  • He previously served as Executive Director, Program Management at EMD Serono (a division of Merck KGaA), leading the development, global registration and commercialization of multiple oncology drugs.
  • Mr. West holds a MBA from the University of Phoenix, San Francisco and a BS in Chemistry from the University of Arizona.

Global Isocitrate Dehydrogenase (IDH) inhibitors Pipeline Research Report 2022 Featuring Bayer, Agios Pharma, Daiichi Sankyo, & Ohm Oncology - ResearchAndMarkets.com

Retrieved on: 
Friday, July 29, 2022
Pharmaceutical, Health, Clinical Trials, III, Isocitrate dehydrogenase, INDIGO, Route, Enzyme, TCA, Discovery, IDH, IDH2, News, Clinical trial, Agios Pharmaceuticals, Administration, AML, IDH1, Patient, Acute myeloid leukemia, Therapy, Mutation, Route of administration, II, Pharmaceutical industry, TET

The "Isocitrate Dehydrogenase (IDH) inhibitors- Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Isocitrate Dehydrogenase (IDH) inhibitors- Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This "Isocitrate Dehydrogenase (IDH) inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Isocitrate Dehydrogenase (IDH) inhibitors pipeline landscape.
  • This segment of the report provides insights about the different Isocitrate Dehydrogenase (IDH) inhibitors drugs segregated based on following parameters that define the scope of the report.
  • Isocitrate Dehydrogenase (IDH) inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

NuProbe Technology Showcases Quantitative PCR for Simultaneous Enrichment and Identification of Multiple Rare Variants below 0.1% VAF

Retrieved on: 
Tuesday, January 18, 2022
PCR, Research, Technology, IDH2, Precision medicine, General manager, NGS, Genomics, GLOBE, AML, DNA, Acute myeloid leukemia, BDA, Real-time, Liquid biopsy, Limiting factor, Sanger, Lod, Mutation, DdPCR, VAF, Medical imaging

The new allele-specific BDA technology (As-BDA) uses qPCR to detect mutations down to 0.01% variant allele fraction (VAF) within 2 hrs.

Key Points: 
  • The new allele-specific BDA technology (As-BDA) uses qPCR to detect mutations down to 0.01% variant allele fraction (VAF) within 2 hrs.
  • Blocker Displacement Amplification (BDA), one of NuProbes core technology, removes wildtype sequences from the library and selectively enriches rare variants, achieving a limit of detection (LoD) of 0.1% VAF in multiplexed real-time PCR and NGS.
  • With standard BDA and real-time PCR, mutations within the blocker enrichment region can be identified with more reactions or another sequencing technology such as Sanger sequencing.
  • As-BDA improves upon BDA by precisely reporting the specific mutations within a sample at an improved limit of detection.

HUTCHMED Highlights HMPL-523 Clinical Data to be Presented at the 2021 ASH Annual Meeting

Retrieved on: 
Monday, November 8, 2021
Safety, Cancer, HCM, Lymphatic system, Private Securities Litigation Reform Act, Lymphoma, U.S. Securities and Exchange Commission, Tyrosine-protein kinase SYK, Glioma, Acute myeloid leukemia, Protocol, COVID-19, Forward-looking statement, AIM, Shanghai Stock Exchange, IDH, IDH2, LinkedIn, IDH1, Waiha, Lymphoid leukemia, Degenerative disease, Stock exchange, Patient, Bleeding, Risk, ITP, Adult, Vaccine, Pharmaceutical industry

HMPL-523 is also being studied in indolent non-Hodgkins lymphoma and multiple subtypes of B-cell malignancies in China ( NCT02857998 ), the U.S. and Europe ( NCT03779113 ).

Key Points: 
  • HMPL-523 is also being studied in indolent non-Hodgkins lymphoma and multiple subtypes of B-cell malignancies in China ( NCT02857998 ), the U.S. and Europe ( NCT03779113 ).
  • A trial to study HMPL-523 in patients with warm autoimmune hemolytic anemia (wAIHA), another autoimmune disorder, is also planned.
  • HMPL-306 is an investigative and selective small molecule inhibitor of IDH1 and IDH2, and the companys sixth novel oncology candidate to enter global clinical development.
  • HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.