ZYMEWORKS
19.11.2020 14:32:12 CET | Business Wire | Press release
Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer.
“We are encouraged by the European Commission’s and European Medicines Agency’s recognition of the benefit that zanidatamab can provide in the treatment of HER2-expressing gastric cancers as we continue to expand our clinical development globally,” said Diana Hausman, M.D., Chief Medical Officer at Zymeworks.
The EC grants Orphan Drug designation to therapies that represent a significant benefit over existing treatments, are intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease, and where prevalence of the condition in the European Union (EU) is less than 5 in 10,000 persons. Orphan drug designation gives companies certain benefits, including 10 years of market exclusivity following regulatory approval, reduced regulatory fees, clinical protocol assistance, and access to research grants.
“While gastric cancer is a rare disease, European countries experience the highest incidence rates among all Western countries,” said James Priour, Senior Vice President, Commercial, at Zymeworks. “The European Commission’s granting of Orphan Drug designation for zanidatamab represents an important step towards bringing this promising investigational medicine to patients in Europe and around the world.”
Zymeworks previously received Orphan Drug designations for zanidatamab in gastric, biliary tract and ovarian cancers from the US FDA, as well as two Fast Track designations from the FDA for zanidatamab.
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 US FDA has granted two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line Gastroesophageal Adenocarcinoma (GEA). Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the US FDA, in addition to Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, zanidatamab (ZW25), is a novel Azymetric™ bispecific antibody currently in a registration-enabling clinical trial for refractory HER2+ biliary tract cancer as well as several Phase 2 clinical trials for HER2+ gastroesophageal and breast cancers. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker-cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For more information, visit www.zymeworks.com .
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to the anticipated benefits of orphan drug designation, the potential therapeutic benefit that zanidatamab can provide, Zymeworks’ clinical and preclinical development of its product candidates, and other information that is not historical information. When used herein, words such as “plan”, “expect”, “may”, “can”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2020 (a copy of which may be obtained at www.sec.gov and www.sedar.com ). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201119005410/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Signaloid Joins CERN openlab's Heterogeneous Architectures Testbed to Explore the Future of Scientific Computing30.9.2026 06:00:00 CEST | Press release
British deep-tech company Signaloid joins CERN openlab as an Industrial Member, contributing its probabilistic computing technology to the CERN openlab Heterogeneous Architectures Testbed.CERN and Signaloid will jointly evaluate whether Signaloid's UxHw® technology can accelerate Monte Carlo event generation for the High-Luminosity Large Hadron Collider.The collaboration reflects a broader shift towards heterogeneous computing architectures designed to meet the growing demands of next-generation scientific computing. British computing company Signaloid has joined CERN openlab, the public-private partnership through which CERN evaluates emerging information technologies for scientific computing. As part of the collaboration, CERN and Signaloid will evaluate Signaloid's distribution-extended compute hardware (UxHw®) technology within the CERN openlab Heterogeneous Architectures Testbed, which explores new processor technologies for future scientific computing infrastructures. This press
FPT Named in Forrester’s The SAP Services Landscape Report30.9.2026 05:00:00 CEST | Press release
Global technology corporation FPT has been included among the notable providers in The SAP Services Landscape, Q3 2026, published by Forrester Research, Inc. The report provides an overview of SAP services providers, examining their market focus, geographic presence, and business specializations to support enterprises in evaluating potential technology partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929359531/en/ The report includes FPT as a systems integrator with an Asia Pacific geographic focus and an industry focus spanning financial services and insurance, healthcare, and manufacturing. FPT identified SAP Business Data Cloud, SAP Enterprise Resource Planning (ERP), and SAP Supply Chain Management (SCM) as its three primary extended business scenario focus areas, what FPT believes reflects its emphasis on modernizing core enterprise systems and enabling more integrated, data-driven operations. Building on mor
SES Successfully Prices €500 million Eurobond30.9.2026 04:41:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMENT (SEE “OFFER AND DISTRIBUTION RESTRICTIONS” BELOW). SES today announced the successful launch and pricing of a bond offering in which the company has agreed to sell senior unsecured fixed rate notes due in 2031 for a total amount of EUR 500 million. The new notes will bear a coupon of 5.625% and were priced at 99.667% of their nominal value. SES is rated Ba1 (stable) and BBB- (
Murata Begins Mass Production of World’s Smallest 0201-inch Size Three-Terminal Low-ESL MLCCs30.9.2026 04:00:00 CEST | Press release
New series cuts mounting area by approximately 64%, supporting high-performance smartphones and wearables Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has begun mass production of the LLD series, the world’s smallest* three-terminal low-equivalent series inductance (ESL) multilayer ceramic capacitors (MLCC). Measuring just 0201-inch size (0.6 × 0.3 mm), the new products reduce mounting area by approximately 64% compared with Murata’s previous smallest 0402-inch size (1.0 × 0.5 mm), freeing up valuable PCB space in compact devices such as smartphones and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929596419/en/ [Murata Manufacturing Co., Ltd.] Three-Terminal Low-ESL MLCCs As smartphones and wearables incorporate increasingly powerful ICs, maintaining a stable power supply becomes more challenging. High-speed operation causes current demand to change rapidly, which can lead to fluctuations
Lattice to Showcase AI-Driven Low Power FPGA Innovation at FPGA Horizons Conference29.9.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its participation in the upcoming FPGA Horizons conference, taking place on October 6 – 7, 2026 in London. As part of the conference’s technical program, Lattice will deliver a Tech Talk presentation and a hands-on workshop, and host a demo showcase focused on how its low power FPGA solutions are advancing AI at the edge. Who: Lattice Semiconductor What / When (GMT+2): Oct. 6, 2026 Demo showcase including Lattice Holoscan Sensor Bridge solution and Lattice Prompt™ AI-driven FPGA design tool Tech Talk (10:10 – 10:30 a.m.), Shaw Theater: Practical Security Fundamentals for FPGA Engineers Oct. 7, 2026 Workshop (1:30 – 4:40 p.m.), Hyde Park room Lattice Nexus™-based FPGA hands-on Lattice Prompt™ agentic AI workflow Where: FPGA Horizons Conference, Pullman London St Pancras, Euston Road, London NW1 FPGA Horizons is a UK-based conference for FPGA industry specialists. Supporting Res
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom