Zolbetuximab

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

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Monday, January 8, 2024
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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.

Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023

Retrieved on: 
Sunday, October 15, 2023
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TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers. A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Key Points: 
  • Data include three late-breaking abstracts, underscoring Astellas' efforts to potentially redefine expectations for patients across its oncology portfolio
    TOKYO, Oct. 15, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company's focus on making a meaningful difference for people living with hard-to-treat cancers.
  • A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.
  • "At Astellas, we're working to change the course of cancer care, including through scientific advancements to address pressing unmet needs.
  • During ESMO, we will share updated data from two Phase 3 clinical studies, highlighting important clinical data of zolbetuximab in gastric and GEJ cancer patients whose tumors are CLDN18.2-positive."

Claudin 18.2-Targeted Immunotherapy Research Report 2023: Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from An Industry Perspective - ResearchAndMarkets.com

Retrieved on: 
Wednesday, September 27, 2023
Health, Pharmaceutical, Incidence, Partnership, ADCC, Bi-specific T-cell engager, TCE, Hook effect, Overalls, Survival, Big Pharma, Business, Research, Appetite, History, Immunotherapy, Zolbetuximab, CDC, Vomiting, CAR, Science, Patient, Corporation, Antibody, Cancer, European, ADCP, Spacecraft, BDL, R, Stomach, GLOW, III, Bispecific monoclonal antibody, Safety, Sales, Vaccine, Pharmaceutical industry, Fine chemical, Risk management, Medical imaging, Dietary supplement

The "Claudin 18.2-Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from An Industry Perspective" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Claudin 18.2-Targeted Immunotherapy: A Landscape Analysis of Stakeholders, Drug Modalities, Pipeline and Business Opportunities from An Industry Perspective" report has been added to ResearchAndMarkets.com's offering.
  • This comprehensive report offers valuable insights into the world of claudin 18.2 (CLDN18.2)-targeted antibody and cell therapy candidates, as of August 2023.
  • You'll delve into the industry landscape surrounding innovative claudin18.2-targeted antibody and cell therapy candidates.
  • The report shines a light on 48 companies actively engaged in research and development within this field, highlighting 68 unique product candidates.

Astellas Submits New Drug Application for Zolbetuximab in Japan

Retrieved on: 
Friday, June 9, 2023
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TOKYO, June 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.

Key Points: 
  • If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients.
  • "Astellas' submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare for zolbetuximab demonstrates critical momentum in addressing the unmet needs of patients with gastric cancer in Japan."
  • The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.
  • The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

Syndax Pharmaceuticals Announces Appointment of Steve Sabus as Chief Commercial Officer

Retrieved on: 
Friday, December 2, 2022
SNDX, COVID-19, Safety, BMS, Medication, Turning Point, Acute myeloid leukemia, Therapy, Cancer, Risk, Growth, Sabus, Johnson & Johnson, Marketing, Chief commercial officer, Zolbetuximab, Organization, Fine chemical, Pharmaceutical industry, Enfortumab vedotin, Astellas Pharma

Sabus brings to Syndax more than 30 years of commercial experience launching drugs and building sales and marketing organizations within the biopharmaceutical industry.

Key Points: 
  • Sabus brings to Syndax more than 30 years of commercial experience launching drugs and building sales and marketing organizations within the biopharmaceutical industry.
  • Sabuswill oversee all commercial functions, including the development of critical launch initiatives, sales planning and commercial strategy.
  • "Steve is an accomplished executive who has launched and grown several important products within oncology, and I look forward to his contributions," saidMichael A. Metzger, Chief Executive Officer.
  • Prior to joining Syndax, Mr. Sabus servedas Chief Commercial Officer at Turning Point Therapeutics, before being acquired by BMS.

Claudin18.2, a shining star in gastric cancer, Transcenta's TST001 stands at the global forefront

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Wednesday, September 28, 2022
Control, Bristol Myers Squibb, II, Therapy, Safety, Stomach, ADCC, Cholangiocarcinoma, European Society for Medical Oncology, Capecitabine, Neoplasm, Pfizer, Causality, Antibody, Company, Poster, Population, HER2, GI, IHC, CAPOX, Industry, VEGF, Survival, Patient, Attention, III, 2021 Essex County Council election, Oncology, VEGFR, AstraZeneca, Progression-free survival, Congress, Monoclonal antibody, Research, PFS, Cancer, Health authority, Executive, ESMO, Pharmaceutical industry, Vaccine, Zolbetuximab, Oxaliplatin, Ribociclib

Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated.

Key Points: 
  • Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated.
  • A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned.
  • In this study, TST001 also demonstrated a clear dose proportional pharmacokinetic profile, is consistent with those observed with TST001 monotherapy and in US patients.
  • As TST001 data continue to mature, Transcenta progresses TST001 towards phase III trial and has initiated Health authority consultations.

Turning Point Therapeutics Announces Appointment of Steve Sabus as Chief Commercial Officer

Retrieved on: 
Monday, May 16, 2022
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SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, today announced the appointment of Steve Sabus as Chief Commercial Officer, effective as of May 31, 2022.

Key Points: 
  • SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, today announced the appointment of Steve Sabus as Chief Commercial Officer, effective as of May 31, 2022.
  • Before Astellas, Steve spent 16 years at Johnson & Johnson in roles of increasing responsibility in the commercial organization.
  • I look forward to joining the Turning Point team at this important time, said Mr. Sabus.
  • These forward-looking statements are based upon Turning Point Therapeutics current expectations and involve assumptions that may never materialize or may prove to be incorrect.

FDA granted CMG901 Fast Track Designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies

Retrieved on: 
Wednesday, April 20, 2022
IND, CDC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Stomach, Pancreatic cancer, Food, Claudin, Review, Apoptosis, MMAE, ADCC, Safety, FDA, ADC, Zolbetuximab, Pharmaceutical industry, Vaccine

CHENGDU, China, April 20, 2022 /PRNewswire/ -- Keymed Biosciences (2162.HK) announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies.

Key Points: 
  • CHENGDU, China, April 20, 2022 /PRNewswire/ -- Keymed Biosciences (2162.HK) announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies.
  • Among all the Claudin 18.2-targeted drugs, CMG901 is the first and only one which received this FDA designation so far.
  • This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of CMG901.
  • Preclinical studies suggest that CMG901 can effectively kill gastric cancer cells with much stronger antitumor potency than zolbetuximab analog or the unconjugated antibody of CMG901.

CMG901 for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma was granted the Orphan-drug Designation by the Food and Drug Administration of the United States

Retrieved on: 
Tuesday, April 12, 2022
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CHENGDU, China, April 12, 2022 /PRNewswire/ --Keymed Biosciences (2162.HK) announced that its new drug candidate CMG901 (the "Claudin 18.2 antibody drug conjugates") for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the "FDA") recently.

Key Points: 
  • CHENGDU, China, April 12, 2022 /PRNewswire/ --Keymed Biosciences (2162.HK) announced that its new drug candidate CMG901 (the "Claudin 18.2 antibody drug conjugates") for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the "FDA") recently.
  • Previously, in March 2021, the Company received the clinical trial application approval of CMG901 from the FDA for the clinical trial in gastric cancer and gastroesophageal junction adenocarcinoma in the United States.
  • CMG901 can cause tumor cell death by several mechanism:
    CMG901 binds to Claudin 18.2 positive cell via its monoclonal antibody portion.
  • Preclinical studies suggest that CMG901 can effectively kill gastric cancer cells with much stronger antitumor potency than zolbetuximab analog or the unconjugated antibody of CMG901.