GNAQ

IDEAYA Biosciences Receives Orphan Drug Designation for Darovasertib, a PKC Inhibitor, for the Treatment of Uveal Melanoma

Retrieved on: 
Monday, May 2, 2022
Pfizer, ODD, GNA11, U.S. Securities and Exchange Commission, NASDAQ, Biomarker, Food, Drug discovery, Patient, Hepatocellular carcinoma, FDA, MUM, Annual report, Therapy, GNAQ, Clinical Oncology, Medical Affairs Bureau, Precision medicine, PKC, Disease, Uveal melanoma, View, Research, KRAS, Crizotinib, Large-cell lung carcinoma, Multimedia, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 2, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma.

Key Points: 
  • Food and Drug Administration(FDA) has granted orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma.
  • As of May 1, 2022, Darovasertib has been evaluated in over 200 patients, including 74 patients in combination with crizotinib.
  • The company is targeting a clinical data update for darovasertib and crizotinib combination in mid-2022, including tolerability and clinical efficacy.
  • IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality which represents an emerging class of precision medicine targets.

Data Published in Ocular Oncology and Pathology Demonstrates Highly Accurate Performance of DecisionDx®-UMSeq for Patients with Uveal Melanoma

Retrieved on: 
Wednesday, January 12, 2022
Oncology, Health, Genetics, Research, Science, Optical, Biotechnology, Atopic dermatitis, Securities Exchange Act of 1934, Journal of the National Comprehensive Cancer Network, LinkedIn, SEC, DecisionDx-UM, American Joint Committee on Cancer, UM, PLCB4, List of life sciences, J. William Harbour, Melanoma, RNA, Biopsy, COVID-19, GNA11, Adult, Collection, Instagram, Disease management, Nasdaq, University of Texas Southwestern Medical Center, Company, PRAME, EIF1AX, National Comprehensive Cancer Network, Patient, Pathology, Metastasis, Indel, BAP1, Uveal melanoma, Gene, Health, DNA, Cancer, PPA, GNAQ, AJCC, Neoplasm, Professor, Personal Data Privacy and Security Act of 2009, CYSLTR2, Securities Act of 1933, SNV calling from NGS data, NGS, FNAB, Wilms' tumor, Exon, Department, Tissue, Risk, Twitter, GEP, Physician, SF3B1, Medical imaging, Vaccine, Ophthalmology, Facebook, DecisionDx-UMSeq, DecisionDx-UM, DecisionDx-PRAME, Castle Biosciences, DECISIONDX-UMSEQ, DECISIONDX-UM, DECISIONDX-PRAME, CASTLE BIOSCIENCES

DecisionDx-UMSeq is Castles 7-gene test that uses next-generation sequencing (NGS) to identify somatic mutations relevant to uveal melanoma.

Key Points: 
  • DecisionDx-UMSeq is Castles 7-gene test that uses next-generation sequencing (NGS) to identify somatic mutations relevant to uveal melanoma.
  • DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States.
  • The study titled, Analytical validation and performance of a 7-gene next-generation sequencing panel in uveal melanoma, was recently published in the peer-reviewed journal Ocular Oncology and Pathology.
  • Elevated expression of PRAME has been associated with an increased risk of metastasis in patients with uveal melanoma.

Updated Phase 1 Clinical Trial Monotherapy Data for IDE196 in Metastatic Uveal Melanoma to be Presented at AACR Conference

Retrieved on: 
Friday, March 29, 2019
Melanoma, Medicine, RTT, Clinical medicine, Health, Antineoplastic drugs, Cancer, Uveal melanoma, Targeted therapy, GNAQ, J. William Harbour, Selumetinib

IDE196, coded LXS196 by Novartis, is a potent small molecule protein kinase C (PKC) inhibitor which IDEAYA plans to develop for the treatment of cancers with GNAQ and GNA11 mutations.

Key Points: 
  • IDE196, coded LXS196 by Novartis, is a potent small molecule protein kinase C (PKC) inhibitor which IDEAYA plans to develop for the treatment of cancers with GNAQ and GNA11 mutations.
  • Notably, approximately 90% of metastatic uveal melanoma patients harbor activating mutations in GNA11 or GNAQ.
  • Novartis is conducting an ongoing Ph1 clinical trial, entitled "A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma" (ClinicalTrials.gov Identifier: NCT02601378).
  • IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.

IDEAYA Licenses Phase 1 Compound LXS196 For The Treatment Of Cancers With GNAQ And GNA11 Mutations

Retrieved on: 
Tuesday, October 23, 2018
Melanoma, RTT, Cancer, Medicine, Uveal melanoma, Clinical medicine, Metástasis, GNAQ, J. William Harbour

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2018 /PRNewswire/ --IDEAYA Biosciences, Inc., has entered into an exclusive license agreement with Novartis to develop and commercialize Novartis' LXS196, a Phase 1 protein kinase C (PKC) inhibitor for the treatment of cancers with GNAQ and GNA11 mutations.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Oct. 23, 2018 /PRNewswire/ --IDEAYA Biosciences, Inc., has entered into an exclusive license agreement with Novartis to develop and commercialize Novartis' LXS196, a Phase 1 protein kinase C (PKC) inhibitor for the treatment of cancers with GNAQ and GNA11 mutations.
  • MUM is an orphan disease of high unmet medical need, with median overall survival of approximately 10 months and no FDA approved therapies.
  • IDEAYA will continue development in metastatic uveal melanoma and will also explore a tumor agnostic basket study of solid tumors with mutations of GNAQ and GNA11.
  • Notably, approximately 90% of metastatic uveal melanoma patients harbor activating mutations in GNA11 or GNAQ.