Tislelizumab

BeiGene to Present Clinical Data on BRUKINSA in Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting

Retrieved on: 
Thursday, November 4, 2021
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Safety, CLL, Research, Technology, Disease, BTK, Global health, Goal, European Union, Twitter, Completeness, Patient, Private Securities Litigation Reform Act, SLL, Mantle cell lymphoma, Disease burden, Associated, U.S. Securities and Exchange Commission, Adult, Marketing, MCL, Novartis, Risk, WM, Company, Bristol Myers Squibb, COVID-19, Tissue, Lymphocytosis, Union, Pharmacokinetics, Chronic lymphocytic leukemia, Lymphoid leukemia, Tislelizumab, Half-life, Jazz Pharmaceuticals, PARP, Therapy, Intellectual property, Health insurance, Pharmaceutical industry, Medical device, Dentistry, BRUKINSA, BeiGene, BRUKINSA, BEIGENE

Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

Key Points: 
  • Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
  • Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries.

Zymeworks Reports 2021 Third Quarter Financial Results

Retrieved on: 
Wednesday, November 3, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Safety, CD47, Breast cancer, Engineering, MD Anderson Cancer Center, Research, Technology, University, Drug development, Gastrointestinal cancer, Twitter, Patient, Interest, HER2/neu, Private Securities Litigation Reform Act, Compte rendu, FDA, NYSE, Inc., Income, Quarter, Forward-looking statement, Investment, CEO, Zymeworks, Program, Oncology, Breast, News, Tislelizumab, Breakthrough therapy, Financial toxicity, European Society for Medical Oncology, GEA, Fine chemical, Pharmaceutical industry, Medical imaging, Air cargo

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the third quarter ended September 30, 2021.

Key Points: 
  • Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the third quarter ended September 30, 2021.
  • Revenue for the third quarter of 2021 included a development milestone and research and development support under cost sharing arrangements.
  • However, Zymeworks ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.
  • As of September 30, 2021, Zymeworks had $307.8 million in cash resources consisting of cash, cash equivalents and short-term investments.

Zymeworks Announces Webcast to Present HERIZON-GEA-01 Pivotal Trial Design and Zanidatamab Commercial Strategy in Gastrointestinal Cancers

Retrieved on: 
Tuesday, October 26, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Priority review, Engineering, Orphan drug, Drug development, Gastrointestinal cancer, European Medicines Agency, Twitter, Phagocytosis, White Light Rock & Roll Review, Patient, Interest, Private Securities Litigation Reform Act, Compte rendu, FDA, NYSE, Inc., BTC, Forward-looking statement, Standard of care, Trastuzumab, Multimedia, Epitope, News, Breast, HER2, Tislelizumab, Breakthrough therapy, Accelerated approval (FDA), Biliary tract, GEA, Pharmaceutical industry, Zanidatamab, Zymeworks Inc., ZANIDATAMAB, ZYMEWORKS INC.

Interested parties can access a live webcast via a link from Zymeworks website at http://ir.zymeworks.com/events-and-presentations , which will also host recorded replays available afterwards.

Key Points: 
  • Interested parties can access a live webcast via a link from Zymeworks website at http://ir.zymeworks.com/events-and-presentations , which will also host recorded replays available afterwards.
  • Zanidatamab is a bispecific antibody, based on Zymeworks Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding.
  • Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.
  • Zymeworks suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates.

Zanidatamab Phase 2 Clinical Trial Demonstrates Promising Response Rate and Durability in First-Line HER2-Positive Gastroesophageal Adenocarcinoma (GEA) at the European Society for Medical Oncology (ESMO) Annual Congress

Retrieved on: 
Thursday, September 16, 2021
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, MSK, Standard of care, European Medicines Agency, HER2, Incidence, Trastuzumab, Zymeworks, CEO, Engineering, FDA, Drug development, Forward-looking statement, Biliary tract, Breakthrough therapy, Trial of the century, Accelerated approval (FDA), Patient, Corr, ESMO, DCR, Mortality, Private Securities Litigation Reform Act, Epitope, NYSE, HIV disease progression rates, GEA, BTC, Priority review, Trae tha Truth, Inc., BeiGene, Multimedia, Memorial Sloan Kettering Cancer Center, Tislelizumab, Twitter, Phagocytosis, Interest, Orphan drug, Diarrhea, PD-1, Compte rendu, Disease, News, CAPOX, Breast, White Light Rock & Roll Review, Pharmaceutical industry, Vaccine, Zanidatamab, Zymeworks Inc., ZANIDATAMAB, ZYMEWORKS INC.

These data were presented today by lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual Congress.

Key Points: 
  • These data were presented today by lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual Congress.
  • These data support further evaluation of zanidatamab plus chemotherapy in a randomized pivotal trial in first-line HER2-positive GEA.
  • As we embark on our second pivotal trial and prepare for commercialization, these data represent a landmark moment for zanidatamab and for Zymeworks.
  • Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress

Retrieved on: 
Thursday, September 16, 2021
PD-L1, Therapy, DKK1, European Society for Medical Oncology, CA, ITT, Management of prostate cancer, Investor, Securities Exchange Act of 1934, Patient, ESMO, Company, Drug Quality and Security Act, Private Securities Litigation Reform Act, Korea, Risk, SD, Harvard Medical School, Distinguishing, Faculty, Neoplasm, Annual report, Part, ORR, Mitt, Video, South Korea, Hospital, MD, PR, Growth, COVID-19, Progression-free survival, Tislelizumab, Partnership, MD Anderson Cancer Center, Securities Act of 1933, Population, Massachusetts General Hospital, SEC, EDGAR, Oncology, Congress, Pharmaceutical industry, Palladium

The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

Key Points: 
  • The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.
  • "Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment.
  • "Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers."
  • Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data.

Leap Therapeutics to Present New Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO 2021 Congress

Retrieved on: 
Monday, September 13, 2021

The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

Key Points: 
  • The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.
  • The study is being conducted in two parts, in the United States and the Republic of Korea.
  • Further results will be presented at the ESMO 2021 Congress from September 16 to 21, 2021.
  • Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data.

BeiGene Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

Retrieved on: 
Monday, September 13, 2021
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Key Points: 
  • This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.
  • Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there.
  • We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world.
  • The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

BeiGene to Present Latest Findings in Robust Lung Cancer Portfolio at ESMO Congress 2021

Retrieved on: 
Sunday, September 12, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology

Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries.

Key Points: 
  • Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries.
  • Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development.
  • BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs.
  • BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Nasopharyngeal Cancer

Retrieved on: 
Monday, August 23, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Nasopharyngeal Cancer (NPC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NASOPHARYNGEAL CANCER (NPC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.

Key Points: 
  • The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.
  • BeiGene expects to present results from the RATIONALE 309 trial at an upcoming medical conference.
  • BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.
  • In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Esophageal Squamous Cell Carcinoma (ESCC)

Retrieved on: 
Thursday, July 8, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Clinical medicine, Gastrointestinal cancer, Medicine, Cancer, Esophageal cancer, ESCC, Squamous cell carcinoma, Breakthrough therapy, Pembrolizumab, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.

Key Points: 
  • We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.
  • We look forward to further communication with CDE and hope this medicine will benefit Chinese patients with locally advanced or metastatic ESCC soon.
  • In China, more than 95% of patients are esophageal squamous cell carcinomaii.
  • https://gco.iarc.fr/today/explore
    ii Guidelines for diagnosis and treatment of esophageal cancer in 2018, Health Commission of the people's Republic of China.