On December 10, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place virtually on January 15 – 17, 2021 (Press release, Zymeworks, DEC 10, 2020, View Source [SID1234572610]).
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The presentations highlight updated clinical data for the HER2-targeted bispecific antibody, zanidatamab, in HER2-expressing gastroesophageal adenocarcinoma (both as monotherapy and in combination with chemotherapy) and in HER2-expressing/amplified biliary tract cancer (as monotherapy). Zymeworks is currently recruiting globally in a pivotal clinical trial in patients with HER2-amplified biliary tract cancer for which a "trial in progress" poster will also be presented during the meeting.
Oral Presentation Session
Title: Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA):
Results from a phase I study
Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX
Abstract: 164
Rapid Abstract Session: Esophageal and Gastric Cancer
Date and Time: January 15, 2021 at 11:30 am – 12:15 pm ET
Poster Presentations
The poster presentations will be available on Friday, January 15 at 8:00 am ET on the conference website as well as the Zymeworks website.
Title: Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study.
Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX
Abstract: 299
Poster Session: Hepatobiliary Cancer
Title: A phase IIb, open-label, single-arm study of zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers (BTCs).
Lead Author: Shubham Pant, MD, UT MD Anderson Cancer Center, TX
Abstract: TPS352
Trials in Progress Poster Session: Hepatobiliary Cancer
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade,
increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.