ESCC

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Incidence, Progression-free survival, European Commission, Tislelizumab, Anemia, Quality of life, Food, File, ESCC, BLA, Nausea, Vomiting, BGNE, Platelet, Safety, Stomach, Civil service commission, Death, Patient, Survival, Biologics license application, Appetite, Cancer, Pharmaceutical industry

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • 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.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

FDA Grants Fast Track Designation to 9MW2821

Retrieved on: 
Tuesday, February 27, 2024
DCR, Carcinoma, Immunotherapy, Cervical cancer, FDA, Food, ESCC, Fast track (FDA), PD-1, Apoptosis, ADC, FTD, UC, Cell membrane, Patient, Esophageal cancer, Fine chemical

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").

Key Points: 
  • SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").
  • 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC.
  • After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.
  • 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world.

Dragos Appoints Bill Fehrman and Ekta Singh-Bushell to Board of Directors

Retrieved on: 
Wednesday, January 31, 2024
Data Management, Technology, Manufacturing, Security, Other Manufacturing, Apps, Applications, Software, Networks, Packaging, Hardware, Chemicals, Plastics, BHE, EKTA, Growth, Knowledge, Civilization, Inc., Fehrman, Safety, Electricity, Berkshire Hathaway Energy, Ernst & Young, ESCC, Chairperson, CSA, Organization, Federal Reserve Bank, Federation, Risk, Unicorn, MOU, Berkshire Hathaway, OT, EY, Management

("Bill") Fehrman, President and CEO of Centuri Group, Inc., and Ekta Singh-Bushell, who has served in management and board roles at Federal Reserve Bank of New York, EY, and high-growth startups, have joined the Dragos Board of Directors.

Key Points: 
  • ("Bill") Fehrman, President and CEO of Centuri Group, Inc., and Ekta Singh-Bushell, who has served in management and board roles at Federal Reserve Bank of New York, EY, and high-growth startups, have joined the Dragos Board of Directors.
  • Fehrman and Singh-Bushell bring decades of industry experience in leadership and advisory positions at world-leading companies and will add further depth and breadth of knowledge to Dragos’s executive board.
  • “Cyber threats targeting industrial infrastructure and their supply chains are intensifying while under-resourced security teams struggle to keep pace,” said Fehrman.
  • “Dragos is a mission-focused company and clear market leader in the industrial cybersecurity space and I’m thrilled to be joining its board of directors.

Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Retrieved on: 
Tuesday, November 14, 2023
Biotechnology, FDA, Medical Devices, Health, Oncology, MSD, HNSCC, PD-L1, Trastuzumab, NYSE, Cervical cancer, Head, Incidence, Patient, Triple-negative breast cancer, Agilent Technologies, Stomach cancer, Stomach, Pembrolizumab, Lung cancer, PD-1, Adenocarcinoma, Partnership, ESCC, Cancer, Merck & Co., Physician, CPS, GEJ, TNBC, NSCLC, Pharmaceutical industry, Vaccine, Merck

Agilent Technologies Inc. (NYSE: A) today announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.

Key Points: 
  • Agilent Technologies Inc. (NYSE: A) today announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.
  • PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic that can identify gastric or GEJ adenocarcinoma patients suitable for treatment with KEYTRUDA in combination with chemotherapy and trastuzumab plus fluoropyrimidine.
  • This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval.
  • PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

Coherus Presents Data from Next-generation Immuno-oncology Programs at 38th Annual Meeting of Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Friday, November 3, 2023
Regulatory T cell, IRF1, Neoplasm, CCR8, FDA, Survival, PD-L1, HCC, NSCLC, Chemokine, Food, Renal cell carcinoma, Biomarker, ESCC, Head, PD-1, CHRS, Teff, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Cell, NPC, RCC, Interleukin, CD8, SITC, Poster, Nasopharyngeal carcinoma, Apoptosis, NK, Immunity, Immune system, Gene, Tumor microenvironment, Lung cancer, SHP2, Cancer, Hepatocellular carcinoma, GBP5, TME, Drug resistance, Patient, IL-27, Gene expression, Vaccine, Pharmaceutical industry, Office supplies, SHP1, HNSCC

REDWOOD CITY, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from three immuno-oncology pipeline programs at the 38th Annual Meeting of SITC taking place November 1 - 5, 2023 at the San Diego Convention Center in San Diego, CA. Preclinical data presented support differentiated mechanisms of its next-generation immunotherapies potentially enabling the antitumor immune activation in more cancer patients and enhanced treatment outcomes.

Key Points: 
  • Preclinical data presented support differentiated mechanisms of its next-generation immunotherapies potentially enabling the antitumor immune activation in more cancer patients and enhanced treatment outcomes.
  • CCR8 is a chemokine receptor predominantly expressed by tumor infiltrating Tregs that suppress the body’s natural anti-cancer immune response.
  • Targeting CCR8 is a promising potential therapeutic strategy designed to deplete Tregs, reshape the tumor microenvironment and enhance anti-tumor immune response.
  • Data presented compare mechanistic data for LOQTORZI™ to commercially available anti-PD-1 monoclonal antibodies and demonstrate higher expression of key immune system biomarkers with LOQTORZI™.

Molecular Templates Announces First Patient Dosed in Phase 1 Trial Evaluating MT-8421, a Novel Engineered Toxin Body Targeting CTLA-4, in Advanced Solid Tumors

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, HCC, NSCLC, PD, Renal cell carcinoma, Therapy, Cancer, ESCC, SCCHN, Head, MSI-H, RCC, Pharmacokinetics, Mesothelioma, Lung cancer, Melanoma, Safety, Hepatocellular carcinoma, TME, Patient, Carcinoma, Neck, Pharmaceutical industry

AUSTIN, Texas, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology with potent differentiated mechanisms of action, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating MT-8421, a novel engineered toxin body targeting CTLA-4, for the treatment of advanced solid tumors.

Key Points: 
  • AUSTIN, Texas, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology with potent differentiated mechanisms of action, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating MT-8421, a novel engineered toxin body targeting CTLA-4, for the treatment of advanced solid tumors.
  • The Phase 1 study is a multi-center open-label, dose-escalation, dose-expansion, and a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary efficacy of MT-8421.
  • Approximately 24-30 patients are anticipated to enroll in Part A dose escalation with a starting dose of 32 mcg/kg.
  • “We look forward to this approach providing patient benefit in this first-in-human study.”

Henlius Deepens Collaboration with Intas to bring Henlius' Novel anti-PD-1 mAb Serplulimab to Europe and India

Retrieved on: 
Friday, October 27, 2023
JAMA, Name, FDA, Trastuzumab, SCLC, Policy, Stomach, Food, European Commission, Cancer, ESCC, Intas Pharmaceuticals, American Medical Association, Independence, Lung cancer, MSI-H, European Medicines Agency, MSI, EC, Regulation of tobacco by the U.S. Food and Drug Administration, Carcinoma, Research, Commonwealth, Journal, Senior, Civil service commission, Growth, Clinical trial, Partnership, EMA, ASEAN, Patient, Nature Medicine, Fosun Pharma, Pharmaceutical industry, Accord

In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.

Key Points: 
  • In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.
  • Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018.
  • Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius.
  • This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide.

KYOCERA AVX Provided Key Components for the Historic Chandrayaan-3 Lunar Mission

Retrieved on: 
Tuesday, October 24, 2023
MIL, Tantalum, ESR, ESCC, AVX, Filtration, ESA, Global production network, Engineering, EMI, Electrolytic capacitor, Water resources, TCHS, Spacecraft, MLCC, Electronics, Rover, KYOCERA, NASA, Noetics, TCH, Printed circuit board, Communications satellite, Electric battery, Moon, ISRO

FOUNTAIN INN, S.C., Oct. 24, 2023 /PRNewswire/ -- KYOCERA AVX, a leading global manufacturer of advanced electronic components engineered to accelerate technological innovation and build a better future, is proud to announce that it provided several key components for the Indian Space Research Organization's (ISRO's) historic Chandrayaan-3 lunar mission.

Key Points: 
  • KYOCERA AVX contributed several components to the Pragyaan lunar rover, including stacked TCH Series surface-mount capacitors that became the first polymer capacitors to ever be used in a space mission.
  • FOUNTAIN INN, S.C., Oct. 24, 2023 /PRNewswire/ -- KYOCERA AVX , a leading global manufacturer of advanced electronic components engineered to accelerate technological innovation and build a better future, is proud to announce that it provided several key components for the Indian Space Research Organization's (ISRO's) historic Chandrayaan-3 lunar mission.
  • KYOCERA AVX contributed several vital components to the mission, including tantalum capacitors, MLCCs, and EMI filters.
  • "We're extremely proud to be a small part of the Indian Space Research Organization's historic Chandrayaan-3 lunar mission," said Allen Mayar, Global Product Manager – Electrolytic Capacitors, KYOCERA AVX.