Tag: SYD985
Food and Drug Administration Issues Complete Response Letter for Byondis’ [Vic-]Trastuzumab...
Earlier this week, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for Byondis' Biological License Application (BLA) for the company's anti-HER2 antibody-drug conjugates [vic-] trastuzumab duocarmazine, also known as SYD985.
TULIP® Study in Patients With HER2+ Unresectable Locally Advanced or Metastatic...
Results from the Phase III TULIP® study, a multi-center, open-label, randomized clinical trial of Trastuzumab Duocarmazine (SYD985; Byondis Biopharmaceuticals), a next-generation antibody-drug conjugate confirms...
A Novel Platform for the Generation of Site-Specific Antibody−drug Conjugates
Antibody-drug conjugates (ADCs) combine the superior selectivity of antibodies with the high potency of cytotoxic agents. With 9 approved and commercially available ADCs for...
New Phase I Study Investigates [Vic-]Trastuzumab Duocarmazine + Niraparib in HER2-Expressing...
As part of a new study focusing on advanced targeting human epidermal growth factor receptor-2 (HER2-) expressing cancers, including locally advanced or metastatic solid...
Trastuzumab Duocarmazine Selected to be part of a New Investigational Treatment...
The Quantum Leap Healthcare Collaborative™, a 501c(3) charitable organization established as a collaboration between medical researchers at University of California, San Francisco, and Silicon...
Trastuzumab Duocarmazine for Treatment of HER2-Expressing Breast Cancer
Trastuzumab duocarmazine* (SYD985; Synthon) is a novel antibody-drug conjugate composed of the recombinant humanized anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab linked,...
Trastuzumab Duocarmazine Granted U.S. FDA Fast Track Designation for Pre-treated HER2+...
The United States Food & Drug Administration (FDA) has granted Fast Track designation for The Netherlands-based Synthon Biopharmaceuticals investigational anti-HER2 antibody-drug conjugate or ADC...
Anti-HER2 ADC SYD985 to be Evaluated in Expanded Cohort of HER2+...
Dutch pharmaceutical company Synthon Biopharmaceuticals has initiated the second part of an ongoing phase I clinical trial with its investigational anti-HER2 antibody-drug conjugate or ADC,...
Initial Results from Phase I Trial with anti-HER2 ADC SYD985 Shows...
Researchers working for Dutch pharmaceutical company Synthon Biopharmaceuticals based in Nijmegen, The Netherlands, report positive initial results from the dose-escalation part of its ongoing first-in-human trial...
Preclinical Data Confirms Therapeutic Potential of SYD985 in Patients with Low...
Preclinical data of SYD985, presented by Synthon Biopharmaceutical's Gijs Verheijden during the 37th Annual San Antonio Breast Cancer Symposium (SABCS), being held at The...
