GEJ

Transcenta Announces Collaboration with Agilent to Develop a Claudin18.2 Companion Diagnostic to Support Osemitamab (TST001) Global Phase III Trial

Retrieved on: 
Tuesday, April 9, 2024
IHC, Nivolumab, Partnership, CDX, Patient, Research, Medicine, Agilent Technologies, HKEX, Immunohistochemistry, Therapy, Adenocarcinoma, GEJ, Vaccine

Transcenta has developed a mouse anti-CLDN18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN18.2 but not CLDN18.1.

Key Points: 
  • Transcenta has developed a mouse anti-CLDN18.2 monoclonal antibody, clone 14G11 which specifically binds to CLDN18.2 but not CLDN18.1.
  • Transcenta has been collaborating with Agilent, a world leader in CDx development, to further develop this antibody for use in a companion diagnostic assay.
  • Agilent and Transcenta presented the early results of the Claudin18.2 IHC 14G11 pharmDx assay at AACR Annual Meeting.
  • "We are excited to be working with Transcenta on the development of the Claudin18.2 IHC 14G11 pharmDx companion diagnostic assay," said Dr. Paul Beresford, VP/GM of CDx, Agilent.

Zai Lab Announces Full-Year 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, February 27, 2024
Oncology, Mental Health, Health, Infectious Diseases, Neurology, Pharmaceutical, Biotechnology, NSCLC, TED, Blood pressure, Cervical cancer, Psoriasis, Cetuximab, Infection, New Drug Application, SCLC, MAA, National Medical Products Administration, PMA, CIDP, NTRK, FDA, Nivolumab, Food, GEJ, Shanda, Schizophrenia, PDUFA, CRC, Bristol Myers Squibb, BMS, ADP, Safety, Mirati, TPS, Disease, HKT, Patient, Clinical trial, METIS, Fusion, Pancreatic cancer, NDA, NMPA, Pharmaceutical industry

The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.

Key Points: 
  • The New Drug Application (NDA) that Zai Lab submitted to the NMPA for this indication is under priority review.
  • Zai Lab has joined the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy in first-line gastric or GEJ cancer in Greater China.
  • Zai Lab to submit an sBLA to the NMPA for efgartigimod SC in CIDP in the first half of 2024.
  • Zai Lab to complete patient enrollment in the China bridging study in schizophrenia in the fourth quarter of 2024.

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

Retrieved on: 
Friday, February 23, 2024
IIT, ESMO, ASCO, FDA, GEJ, Acceptability, ODD, Stomach, GC, Society, GI, Bone marrow, Patient, Clinical trial, CDE, Oncology, IND, Chinese, Epithelial cell adhesion molecule, Pharmaceutical industry

SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

Key Points: 
  • EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low.
  • IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ".
  • She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China.
  • Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells.

First Refractory Gastric Cancer Patient Dosed in Phase 2 Trial with Novel Combination of MiNK’s Allogeneic INKT Cell Therapy and Agenus’ Botensilimab and Balstilimab

Retrieved on: 
Wednesday, February 14, 2024
Gastrointestinal cancer, Cancer, GEJ, Mink, Stomach, GI, Therapy, Paclitaxel, Patient, Disease, Tissue, Pharmaceutical industry

The trial builds upon findings from MiNK’s recently published clinical trial ( Carneiro et al .

Key Points: 
  • The trial builds upon findings from MiNK’s recently published clinical trial ( Carneiro et al .
  • 2024 Oncogene) demonstrating that agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer.
  • "AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors.
  • This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024
GEJ, Immunoglobulin A, GPRC5D, Government, Trastuzumab, Daiichi Sankyo, DME, BRCA, FDA, Spacecraft, Health, Haemophilia, Abiraterone acetate, Infection, PDE, Crohn's disease, CLVT, Drug discovery, Breast cancer, Breast, Data, Budesonide, AMD, PARP, Metastasis, PDE4, DXD, Safety, NSCLC, Health care, RSV, DR, AstraZeneca, EMA, CRISPR, Chronic obstructive pulmonary disease, Adenocarcinoma, Multiple myeloma, Civil service commission, Artificial intelligence, Patient, Stada Arzneimittel, Intelligence, CD3, Ulcerative colitis, SCD, Lung cancer, European Commission, Sickle cell disease, Gilead Sciences, Respiratory syncytial virus, Research, Diabetic retinopathy, Mirikizumab, COPD, COVID-19, Conditional sentence, Genentech, Thalassemia, Organization, Zolbetuximab, ADC, Pharmaceutical industry

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for New First-Line Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS ≥1) and Advanced Biliary Tract Cancer

Retrieved on: 
Monday, December 18, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Cisplatin, PD-L1, NYSE, European Commission, Risk, Civil service commission, Gastrointestinal cancer, Neoplasm, Committee, Advanced Therapy Medicinal Product, HER2, Adenocarcinoma, Death, BTC, OS, CPS, GEJ, MRK, Pharmaceutical industry, Merck

In patients whose tumors expressed PD-L1 (CPS ≥1), KEYTRUDA plus chemotherapy reduced the risk of death by 26% (HR=0.74 [95% CI, 0.65-0.84]; p

Key Points: 
  • In patients whose tumors expressed PD-L1 (CPS ≥1), KEYTRUDA plus chemotherapy reduced the risk of death by 26% (HR=0.74 [95% CI, 0.65-0.84]; p
  • Median OS was 13.0 months (95% CI, 11.6-14.2) for patients treated with KEYTRUDA plus chemotherapy vs 11.4 months (95% CI, 10.5-12.0) for chemotherapy alone.
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • In KEYNOTE-859, the incidence of Grade 3-5 adverse reactions in patients with gastric cancer was 75% for KEYTRUDA plus chemotherapy and 70% for chemotherapy.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Retrieved on: 
Thursday, November 16, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Death, Risk, GEJ, NYSE, Food, HER2, MRK, Pharmaceutical industry, Merck

Median overall survival (OS) was 12.9 months (95% CI, 11.9-14.0) for KEYTRUDA plus chemotherapy versus 11.5 months (95% CI, 10.6-12.1) for chemotherapy alone.

Key Points: 
  • Median overall survival (OS) was 12.9 months (95% CI, 11.9-14.0) for KEYTRUDA plus chemotherapy versus 11.5 months (95% CI, 10.6-12.1) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.
  • Ninety-seven percent of patients had metastatic disease (stage IV) and 3% had locally advanced unresectable disease.

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.