INDIGO

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

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水曜日, 2月 21, 2024
Orbis, Classification, PFS, European Commission, EMA, Traffic barrier, Progression-free survival, Confidence interval, Committee, Enzyme, MAA, Research and development, ASCO, Malignancy, Physician, FDA, PDUFA, Society, Glioma, TGR, Microsoft Access, Safety, INDIGO, Prognosis, Civil service commission, HR, CHMP, SNO, IDH, Patient, Medicine, BIRC, Public, Disease, Diagnosis, Mutation, Development, NDA, Priority review, Pharmaceutical industry

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

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

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土曜日, 11月 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.

EQS-News: Evotec and Dewpoint Therapeutics enter strategic partnership in oncology

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火曜日, 11月 7, 2023
MDAX, IND, Therapy, ISIN, Frankfurt Stock Exchange, INDIGO, EVO, Risk, Partnership, A.I, Hotel des Indes (The Hague), Dew point, IndiGo, Sales, Pharmaceutical industry, Evotec

The partnership brings together Dewpoint’s advanced oncology pipeline programmes discovered using its groundbreaking condensate biology and A.I.

Key Points: 
  • The partnership brings together Dewpoint’s advanced oncology pipeline programmes discovered using its groundbreaking condensate biology and A.I.
  • Dr Matthias Evers, Chief Business Officer of Evotec, commented: “We are excited to enter this strategic development partnership with Dewpoint.
  • By combining our complementary expertise, Evotec’s development platform will serve as the capital-efficient IND engine for this highly collaborative partnership.
  • We look forward to working closely together with their team to make Dewpoint’s groundbreaking innovations available to patients.”
    “Dewpoint’s strategic partnership with Evotec leverages the world-class speed of their development platform to accelerate our oncology assets into the clinic.

Egypt Sherrod Launches INDIGO ROAD home furnishings: Where Comfort & Luxury Align

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木曜日, 9月 28, 2023
INDIGO, Sherrod, Beauty, Collection, First Baptist Church (East Lamoine, Maine), HGTV, Family, Interior design, Egypt Sherrod

ATLANTA, Sept. 28, 2023 /PRNewswire/ -- Egypt Sherrod, the beloved HGTV star, accomplished interior designer, and renowned real estate expert, is taking a bold step into the world of home decor, introducing a new era of accessible luxury for homeowners with her INDIGO ROAD by Egypt Sherrod home furnishing imprint.

Key Points: 
  • Egypt Sherrod, HGTV star, interior designer, and real estate expert, introduces her INDIGO ROAD home furnishing imprint.
  • "At Indigo Road, there's a sense of everyday, livable luxury," explains Egypt Sherrod who proudly unveils the Indigo Road furniture line, a collaboration with East at Main, a Jeffan International company.
  • "The Indigo Road collection is where comfort & luxury align.
  • As part of her expanding portfolio, Egypt is also introducing the Indigo Road by Egypt Sherrod x NuWallpaper collection, in collaboration with Wallpops.

Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma

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日曜日, 6月 4, 2023
Glioma, The New England Journal of Medicine, Malignancy, BIRC, INDIGO, Oligodendroglioma, Survival, Clinical trial, Enzyme, NDA, Drug, Mutation, Traffic barrier, Brain, PFS, Astrocytoma, ASCO, Patient, HR, Seizure, IDH, Memorial Sloan Kettering Cancer Center, Toxic encephalopathy, FDA, Society, Disease, Medical imaging, Pharmaceutical industry

BOSTON, June 4, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing innovative therapies to the patients we serve, today presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only. INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.

Key Points: 
  • We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma."
  • INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment.
  • Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo).
  • Servier is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.

Servier Targets Transformative Treatment of Cancer at ASCO 2023

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木曜日, 5月 25, 2023
Glioma, Bevacizumab, Capecitabine, INDIGO, Central European Summer Time, European Hematology Association, Survival, American Society of Clinical Oncology, Research, Acute myeloid leukemia, ASCO, MDS, AML, Azacitidine, Patient, Trifluridine/tipiracil, Cancer, EHA, IDH, IDH1, Chondrosarcoma, Safety, Society, European Commission, Cholangiocarcinoma, Dietary supplement, Nursing, Pharmaceutical industry, Laboratoires Servier

BOSTON and PARIS, May 25, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will showcase new data across its robust oncology portfolio at the American Society of Clinical Oncology (ASCO) annual meeting June 2-6, 2023. These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.

Key Points: 
  • These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.
  • Among the data to be presented is a late breaking abstract featuring the results from the Phase 3 INDIGO study of vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma.
  • "Servier is leading the scientific research with IDH inhibition across a variety of difficult to treat cancers, and this year at ASCO, we are excited to showcase data that has the potential to shift the treatment paradigm for patients with IDH-mutant glioma," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier.
  • Servier abstracts being presented at EHA are listed below (all times in Central European Summer Time) and are available online on the EHA website here .

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)

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火曜日, 3月 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: 
火曜日, 3月 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.

Zenas BioPharma Announces First Patient Dosed in Phase 3 Clinical Study of Obexelimab for the Treatment of Immunoglobulin G4-Related Disease (IgG4-RD)

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水曜日, 1月 11, 2023
Degenerative disease, IgG4-related disease, Death, Safety, Zenas, Patient, CD19, INDIGO, End organ damage, Autoantibody, Pharmaceutical industry, Vaccine

WALTHAM, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced that the first patient has been dosed in the INDIGO Phase 3 registrational study of obexelimab. The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare. Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.

Key Points: 
  • The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare.
  • Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.
  • “There are no currently approved treatments for patients living with IgG4-RD.
  • Based upon the promising data from a Phase 2 study of obexelimab in IgG4-RD patients, we are excited to continue to evaluate the potential of obexelimab in the INDIGO study.”

INDIGO Biosciences Receives Approval from California Water Boards for Use of Its Bioassays in Recycled Water Monitoring

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火曜日, 11月 15, 2022
Health, Aryl hydrocarbon receptor, Environment, Estradiol, California State Water Resources Control Board, ER, Water, CECS, Hydrocarbon, Estrogen, INDIGO, Cancer, Pesticide, CEO, Drug discovery, Science, Estrogen receptor alpha, Environmental remediation, Assay

STATE COLLEGE, Pa., Nov. 15, 2022  /PRNewswire-PRWeb/ -- INDIGO Biosciences, Inc. has received approval from the California Water Boards, State Water Resources Control Board, for the use of two of its bioassays in recycled water monitoring. INDIGO has been approved for the use of its Aryl Hydrocarbon Receptor (AhR) and Estrogen Receptor Alpha (ERα) bioassays as bioanalytical screening tools for Constituents of Emerging Concern (CECs) in recycled water.

Key Points: 
  • STATE COLLEGE, Pa., Nov. 15, 2022 /PRNewswire-PRWeb/ -- INDIGO Biosciences, Inc. has received approval from the California Water Boards, State Water Resources Control Board , for the use of two of its bioassays in recycled water monitoring.
  • INDIGO has been approved for the use of its Aryl Hydrocarbon Receptor (AhR) and Estrogen Receptor Alpha (ER) bioassays as bioanalytical screening tools for Constituents of Emerging Concern (CECs) in recycled water.
  • We look forward to developing additional bioassays that can help water boards and regulators everywhere monitor for contaminants that pose potential environmental and health risks."
  • As part of the approval process, INDIGO submitted validation packages for both its AhR and ER assays.