EGFR

Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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水曜日, 4月 24, 2024
Nephrology, Kidney disease, Kidney, Div, Proteinuria, European Commission, Kidney failure, CHMP, Irbesartan, Immunoglobulin A, European, EGFR, Patient, CSL Vifor, CSL, Committee, Civil service commission, RAAS, Teaching hospital, Head, Therapy, CMA, SAN, Pharmaceutical industry

SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • “The approval of this innovative treatment is based on data from the only head-to-head phase 3 clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.

ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC

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月曜日, 4月 15, 2024
CNS, Progression-free survival, Patient, EGFR, ESMO, Safety, SAN, HER2, Lung cancer, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications. Based upon these data, ORIC selected the two provisional recommended Phase 2 dose (RP2D) levels of ORIC-114 at 80 mg and 120 mg QD, which are being further evaluated in three dose expansion cohorts for dose optimization and final RP2D selection. These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations. The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC.

Key Points: 
  • These expansion cohorts have now been initiated in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 (EGFR exon 20 inhibitor naïve), HER2 exon 20, or EGFR atypical mutations.
  • The company also announced the initiation of an extension cohort for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC.
  • “Following the positive dose escalation data reported at ESMO 2023, we are excited to announce the advancement of ORIC-114 into Phase 1b dose expansion,” said Pratik Multani, M.D., chief medical officer of ORIC.
  • Patients previously treated with an exon 20 targeted agent were eligible, including patients with CNS metastases that were either treated or untreated but asymptomatic.

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2024

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水曜日, 5月 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Doctor of Philosophy, PFS, Paranal Observatory, Table, License, Summit, Investment, ELCC, Progression-free survival, Research, Intraparenchymal hemorrhage, Immunotherapy, Trial of the century, Webcast, Cohort, Forecasting, PD-1, NGS, TKI, Patient, GRAIL, Brain, SMMT, Neoplasm, EGFR, VEGF, GAAP, Royal institute, Neuro, Lung cancer, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.
  • In January 2024, followed by a presentation at ELCC 2024 in March 2024, Akeso announced updates from its Phase II AK112-201 trial data.
  • Also at ELCC 2024, Summit and Akeso highlighted promising ivonescimab Phase II data in NSCLC patients with brain metastases.
  • Operating cash outflow for the three months ended March 31, 2024 and 2023 was $30.1 million and $13.1 million, respectively.

The U.S. Food & Drug Administration (FDA) Approves Updated LUPKYNIS® (voclosporin) Label to include Long-Term Data from the AURORA Clinical Program

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火曜日, 4月 30, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Other Health, Language, Safety, Woman, Proteinuria, SCRR, EGFR, Patient, Physician, Breastfeeding, Clinical trial, Breast milk, MMF, Lactation, Pharmaceutical industry

The updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year.

Key Points: 
  • The updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year.
  • The updated LUPKYNIS label supports quarterly monitoring of eGFR after the first year of treatment, which is more consistent with current standard clinical care.
  • The safety profile of LUPKYNIS in the updated label remains unchanged and is aligned with the safety findings in the AURORA Clinical Program.
  • The updated label also provides additional lactation data on the transfer of LUPKYNIS to breast milk based on a twice daily dosing regimen.

Global Clinical Biomarkers Industry Research, 2023-2024 & 2033 - Discovery of Novel Biomarkers Expanding Precision Medicine Horizons, Increase in Industrial Activity in Clinical Biomarker Landscape - ResearchAndMarkets.com

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月曜日, 4月 29, 2024
Health, Oncology, Biometrics, Breast cancer, Cancer, Genomics, Investment, Lung cancer, Blood, Prognosis, Malignancy, Infection, Region, Software, TPA, PSA, Glycoprotein, Research, NGS, Prostate cancer, ChromeOS, SSC, Serum, Thermo Fisher Scientific, Diagnosis, Drug discovery, Biomarker, Neoplasm, EGFR, Biotechnology, Growth, Gene, Medical imaging

The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market.

Key Points: 
  • The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market.
  • Key players in the clinical biomarkers market analyzed and profiled in the study involve established players that offer various kinds of products and services.
  • As per this research, the global clinical biomarkers market includes manufacturers and service providers offering proprietary biomarkers testing products and services for clinical diagnostics and research purposes.
  • Based on product, the global clinical biomarkers market was led by the product segment, with a 76.59% share in 2022.

Black Diamond Therapeutics Announces Changes to Board of Directors

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木曜日, 4月 11, 2024
Diamond, Bayer, University, Executive, Ithaca College, University of Pennsylvania, Flagship Pioneering, Scripps Research, Pharmacia, Harvard Business School, Novartis, Therapy, Abbott Laboratories, IMD, Patient, Medicinal chemistry, Immunology, Takeda Oncology, EGFR, Cancer, NSCLC, Partnership, Management

The Company also announced that Wendy Dixon, Ph.D., and Alex Mayweg, Ph.D., have stepped down as members of its Board of Directors.

Key Points: 
  • The Company also announced that Wendy Dixon, Ph.D., and Alex Mayweg, Ph.D., have stepped down as members of its Board of Directors.
  • “On behalf of the board, I am excited to welcome Shannon and Prakash, both seasoned executives who bring deep and highly relevant oncology expertise to our board as we advance BDTX-1535, a potential first and best-in-class fourth-generation EGFR inhibitor,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics.
  • He currently serves as Chief Executive Officer of a stealth biopharma company working on novel protein therapeutics in Oncology and Immunology.
  • Previously, he was President and Chief Executive Officer of Ribon Therapeutics, a biopharmaceutical company focused on small molecule drugs for Oncology and Immunology.

Data Presented at AACR 2024 Showcase Precede Biosciences’ Power to Impact Precision Medicine from a Simple Blood Test

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水曜日, 4月 10, 2024
MET, Hospital, HER2, HER3, Breast, MD, CEACAM5, Patient, CLDN18, Lung, Health, Biology, AACR, EGFR, Massachusetts General Hospital, Plasma, Pharmaceutical industry

Data further underscore potential to inform therapy selection for antibody drug conjugates and other target-directed therapies across breast, lung, and gastro-esophageal cancers

Key Points: 
  • Data further underscore potential to inform therapy selection for antibody drug conjugates and other target-directed therapies across breast, lung, and gastro-esophageal cancers
    Targets revealed from a single 1mL plasma sample include B7H4, CEACAM5, CLDN18, EGFR, HER2, HER3, MET, NECTIN4, and TROP2
    BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Precede Biosciences, a company impacting the development and use of precision medicines with a first-in-class comprehensive epigenomic liquid biopsy platform, today shared three scientific poster presentations from the 2024 American Association for Cancer Research (AACR) Annual Meeting.
  • “The data presented at AACR 2024 add to the growing body of evidence supporting our platform’s unique ability to provide genome-wide insight into the activation status of therapeutic targets, pathways, and resistance mechanisms, all from a simple blood draw,” said Carl Barrett, Chief Scientific Officer of Precede Bio.
  • “As such, we have a significant opportunity to better inform patient selection and enable indication expansion for the many promising agents addressing these targets and pathways with our platform.”
    “Our study highlights the need for new approaches to profile the biology of gastro-esophageal adenocarcinoma, an aggressive disease in which patients can progress quickly,” said Samuel Klempner, MD, medical oncologist at Massachusetts General Hospital and senior author for the abstract on gastro-esophageal cancers.
  • “Precede Bio’s liquid biopsy platform could represent an important advance enabling informed treatment decisions and personalized patient care throughout the cancer journey for this difficult-to-treat cancer.”
    Precede Bio’s posters from AACR 2024 can be found in the presentations section of the company website and are linked directly below:

Apollomics Presents Vebreltinib Data at the 2024 American Association for Cancer Research (AACR) Annual Meeting

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水曜日, 4月 10, 2024
AACR, MET, EGFR, Cancer, Patient, Doctor of Philosophy, NSCLC, Hepatocyte growth factor, Medical imaging

FOSTER CITY, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, presented two posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting, held April 5-10, 2024 in San Diego, Calif.

Key Points: 
  • FOSTER CITY, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, presented two posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting, held April 5-10, 2024 in San Diego, Calif.
  • Copies of the posters are available on the Apollomics website at ir.apollomicsinc.com/news-events/presentations .
  • “Vebreltinib’s selectivity and high in vivo potency against multiple tumor types in a variety of patient-derived tumor models demonstrate its potential to treat a variety of MET-altered tumors, as a single agent or in combination,” said Guo-Liang Yu, PhD, Chairman and Chief Executive Officer of Apollomics.
  • The second poster presented, titled, “Dependence of EGFR-mutant NSCLC on MET as demonstrated by vebreltinib, a novel and selective brain-penetrating MET kinase inhibitor,” demonstrated that adding vebreltinib to EGFR therapies overcomes MET-amplification dependent resistance with durable effect or prevents MET-dependent resistance to maximize therapeutic benefits.

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

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火曜日, 4月 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan

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月曜日, 4月 22, 2024
Technology, Clinical Trials, Health Technology, Software, Biotechnology, Pharmaceutical, Health, Data Management, Oncology, Artificial Intelligence, Education, National Cancer Center, MET, D.C, Lung cancer, Woman, PMID, Progression-free survival, Harmonic, Machine learning, AME Publishing Company, ClinicalTrials.gov, Collection, Artificial intelligence, IPhone, Adenocarcinoma, ROS1, Disease, Incidence, Patient, Pemetrexed, TMB, SOC, Neoplasm, Lung, ALK, EGFR, NSCLC, Carboplatin, Overalls, Gene, TK, Pharmaceutical industry

Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).

Key Points: 
  • Approximately one third of all lung cancer patients in East Asia are never-smokers and the proportion of lung cancer in never smokers (LCINS) has been increasing gradually over time, according to a publication in Translational Lung Cancer Research (1).
  • LCINS are histologically, mutationally, and epidemiologically distinct from smoking-related lung cancers and occur almost exclusively as adenocarcinomas and most commonly in women and individuals of Asian ancestry.
  • Dr. Goto will now lead the trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States.
  • In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.