EGFR

Azitra, Inc. to Present New Data at Three Upcoming Scientific Conferences in May 2024

Retrieved on: 
Thursday, April 18, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Toxicity, Staphylococcus, Skin, EGFR, Staphylococcus epidermidis

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it will be presenting promising new preclinical data from its platform built (or optimized) to discover treatments for serious skin diseases at three upcoming scientific and medical conferences:

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it will be presenting promising new preclinical data from its platform built (or optimized) to discover treatments for serious skin diseases at three upcoming scientific and medical conferences:
    Title: Preclinical development of ATR04-484, an auxotrophic strain of Staphylococcus epidermidis, for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity

BostonGene and Saga University Announce Collaboration to Uncover Biomarkers for Improved Immunotherapy Response in Lung Cancer Patients

Retrieved on: 
Tuesday, April 16, 2024
Research, Technology, Medical Devices, Genetics, Health Technology, Biotechnology, Health, Science, Oncology, Artificial Intelligence, NEC, Cancer, Immunotherapy, Recurrence, MD, Tumor microenvironment, Saga University, ICIS, ICI, Patient, IO, Toxicity, Multimedia, Standard of care, Biomarker, EGFR, NSCLC, TME, Lung cancer, Pharmaceutical industry

Still, acquired resistance often leads to recurrence within 1 to 2 years, presenting a challenge for post-treatment optimization.

Key Points: 
  • Still, acquired resistance often leads to recurrence within 1 to 2 years, presenting a challenge for post-treatment optimization.
  • However, combination therapy with ICIs and anti-angiogenic agents has shown promise in EGFR-positive lung cancer.
  • By partnering with BostonGene, we aim to uncover novel biomarkers to revolutionize how we approach immunotherapy treatment in EGFR-positive lung cancer, ultimately improving patient outcomes,” said Dr. Naoko Aragane, Professor of Saga University.
  • “Our collaboration with Saga University underscores our dedication to advancing the standard of care in Japan by bringing novel technologies to the region.

Natera Announces Publication of Largest Prospective dd-cfDNA Study in Kidney Transplantation

Retrieved on: 
Thursday, April 11, 2024
Health, Surgery, Genetics, Clinical Trials, Research, Science, Biotechnology, Nucleic acid thermodynamics, University, NTRA, Risk, MD, Transplant, EGFR, DNA, Oportunidades, Patient, Microbiology, Biopsy, Maryland School, ProActive, Dentistry

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA (dd-cfDNA) test as a leading indicator of kidney transplant rejection.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced a new publication from the ProActive study in Transplantation supporting the use of the Prospera Kidney donor-derived cfDNA (dd-cfDNA) test as a leading indicator of kidney transplant rejection.
  • The ProActive study is the largest prospective dd-cfDNA study in kidney transplant recipients, with roughly 5,000 patients enrolled at 54 participating transplant centers.
  • These data further support the Prospera Kidney test’s value as an early indicator of rejection vs biopsy.
  • Natera remains excited to continue pursuing additional clinical evidence and optimizing the management of kidney transplant patients for improved long-term outcomes.”

Alpine Immune Sciences Shares Updated Clinical Data from Povetacicept in IgA Nephropathy

Retrieved on: 
Wednesday, April 10, 2024
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FDA, Congress, Immunoglobulin G, ALPN, University, Glomerular filtration rate, Proteinuria, Survival, Cytokine, MD, Hematuria, UPCR, Webcast, Immunoglobulin A, EGFR, Disease, Nephrology, Patient, WCN, Alpine, Inflammation, Multimedia, Infection, Biomarker, Exhibition, University of Leicester, Autoimmunity, BAFF, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.
  • RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, where povetacicept is administered subcutaneously (SC) once every four weeks.
  • As of March 01, 2024, 41 patients with IgAN had received povetacicept 80 or 240 mg subcutaneously every 4 weeks.
  • These data strongly support the inhibition of APRIL/BAFF pathways by povetacicept and its efficacy in the treatment of IgAN as well as the need for further clinical development.

Biodesix to Present New Data on Liquid Biopsy Technologies at AACR 2024 Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Artificial Intelligence, Technology, Nucleic acid thermodynamics, Trial of the century, Plasma, DdPCR, Digital, DNA, Patient, AACR, EGFR, NSCLC, AstraZeneca, Liquid biopsy, Medical imaging

Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California.

Key Points: 
  • Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California.
  • These presentations highlight advancements in liquid biopsy technologies that detect cell free DNA (cfDNA) and the clinical value of rapid turnaround time to detect actionable tumor mutations in a real-world clinical setting.
  • Biodesix supported this research by providing the EGFRm testing using Droplet Digital™ PCR* (ddPCR™) on plasma samples collected prior to treatment and three and six weeks after treatment initiation.
  • EGFRm testing is offered in a clinical setting by Biodesix as part of the GeneStrat® ddPCR targeted mutation test.

Breakthrough in Lung Cancer Treatment: Dizal to Unveil Groundbreaking Results of Sunvozertinib for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations at 2024 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 24, 2024
Neoplasm, Cancer, Part, Lung cancer, Safety, NDA, Abstract, Doctor of Philosophy, ASCO, Patient, Society, EMA, Annual general meeting, EGFR, NSCLC, Plasma, Platinum, Pharmaceutical industry

SHANGHAI, April 24, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, announced today that two abstracts featuring the latest data on sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31 through June 4 in Chicago.

Key Points: 
  • In a featured oral presentation, Dizal will highlight topline results from its WU-KONG1 Part B study.
  • "We are very pleased that the inaugural global pivotal study of sunvozertinib is selected for oral presentation at the 2024 ASCO Annual Meeting again" said Xiaolin Zhang, PhD, CEO of Dizal.
  • It was subsequently approved in China, making sunvozertinib the world first and only oral drug for the treatment of lung cancer patients with EGFR exon20ins mutations.
  • This poster will focus on plasma ctDNA biomarker analysis in patients with EGFR exon20ins NSCLC who have undergone treatment with sunvozertinib.

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

Retrieved on: 
Wednesday, April 24, 2024
Nephrology, Kidney disease, PROTECT, Proteinuria, European Commission, Kidney failure, Professor, CHMP, Irbesartan, European, EGFR, Senior, Patient, Kidney, CSL Vifor, CSL, Medicine, Committee, Civil service commission, RAAS, Teaching hospital, Clinical trial, Therapy, CMA, SAN, Pharmaceutical industry

ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary 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.
  • Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.
  • "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

Pillar Biosciences oncoReveal™ CDx pan-cancer solid tumor IVD now FDA approved for general tumor profiling on the Illumina MiSeq™ Dx System

Retrieved on: 
Tuesday, April 23, 2024
Pillar, FDA, PIK3CA, NMPA, Food, Colorectal cancer, Health, CRC, Partnership, NGS, BRAF, CDX, Genome, Medicine, EGFR, NSCLC, PMA, IVD, Gene, CE, Lung cancer, Pharmaceutical industry

NATICK, Mass., April 23, 2024 /PRNewswire/ -- Pillar Biosciences, Inc., the leader in Decision Medicine™, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and testing costs, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD). The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.

Key Points: 
  • The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.
  • "We are pleased to have expanded the clinical utility of oncoReveal™ Dx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said Gang Song, Founder and Executive Chairman of Pillar Biosciences.
  • "Illumina is proud to partner with Pillar Biosciences to expand diagnostic offerings on the MiSeq™ Dx," said Kevin Keegan, General Manager of Oncology at Illumina.
  • The oncoReveal™ CDx pan-cancer solid tumor IVD, which has been validated and approved for use on the Illumina MiSeq™ Dx System, was developed for tumor profiling and therapy selection and includes actionable targets on most common solid cancer types.

GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

Retrieved on: 
Friday, April 19, 2024
FDA, Total, Colorectal cancer, Mutation, Immunology, Lung cancer, Priority review, NMPA, National Medical Products Administration, Cetuximab, Progression-free survival, New Drug Application, Irinotecan, Oxaliplatin, Recurrence, RAS, CRC, ESMO, Medicine, ASCO, Canadian International Council, Disease, Incidence, Patient, Liver, Peritoneum, Food and Drug Administration, BTD, Lung, Death, Biology, Clinical trial, EGFR, Therapy, Cancer, NSCLC, Breakthrough therapy, Prevalence, Pharmaceutical industry

"We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.

Key Points: 
  • "We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.
  • We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients.
  • Targeting KRAS G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver, International Journal of Molecular Science, Mar.
  • Disease Burden of Total and Early-Onset Colorectal Cancer in China from 1990 to 2019 and Predictions of Cancer Incidence and Mortality, Clinical Epidemiology, Feb. 2023
    4.

Calliditas Therapeutics Presents Additional Data Analyses from the Phase 3 NeflgArd trial of Nefecon in Primary IgA Nephropathy at the ISN World Congress of Nephrology 2024

Retrieved on: 
Thursday, April 18, 2024
Congress, CALT, UPCR, Immunoglobulin A, EGFR, Patient, Budesonide, ISN, Pharmaceutical industry

STOCKHOLM, April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024.

Key Points: 
  • STOCKHOLM, April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024.
  • "We were pleased to share additional analyses from the 2-year Phase 3 NeflgArd trial of Nefecon in IgAN at this year's World Congress of Nephrology," said Richard Philipson, Chief Medical Officer of Calliditas.
  • "These additional data further reinforce the impact of Nefecon across the entire study population, irrespective of baseline UPCR levels or patient's racial and ethnic backgrounds."
  • These findings strongly suggest preserved kidney function and provide support for Nefecon as a disease-modifying therapy in patients with IgAN.