Business Wire

Zymeworks Receives Orphan Drug Designation From the European Commission for HER2-Targeted Bispecific Antibody Zanidatamab in Patients With Gastric Cancer

Share

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.

Contact information

Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Tiffany Tolmie
(604) 678-1388
ir@zymeworks.com

Media Inquiries:
Mary Klem
(604) 678-1388
media@zymeworks.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Luxembourg to Start Real Life Testing of an International Standard for a Digital Circularity Fingerprint for Products27.11.2020 14:00:00 EETPress release

The Ministry of the Economy of Luxembourg just launched phase two of the development of an international standard. It provides information on the circularity of products to all stakeholders involved along their value chains. A first viable version of the standard is being tested in real life, allowing to identify the most suitable governance model, the audit scheme and reliable IT systems for its management. Luxembourg started the Circularity Dataset Initiative in 2018 to address the difficulty for industry and consumers to access reliable data on the circular properties of a product. A lot of circularity information is missing, as its generation and handling requires too many human and financial resources. Furthermore, trade secrets are hindering transparency and reporting standards are lacking, forcing manufacturers to send out different data sets in diverse formats to customers and product platforms. To tackle these challenges, the Luxembourg government is working with multinational

Chengdu Continues to Enhance Trade Links and Cultural Exchanges to Expand Circle of Friends Around the World27.11.2020 12:24:00 EETPress release

The Chengdu-Europe railway line spans over 10,000 kilometers across countless rivers and mountains, transporting goods to vast numbers of people across the Eurasian landmass. With increased trade, cultural links between Chengdu and Europe are also growing stronger. Against this backdrop, Chengdu-Eurasia National Pavilion Cluster (CENPC) has emerged in the Qingbaijiang District of Chengdu to further promote trade and cultural exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005270/en/ Head of CENPC’s pavilion for France and the Netherlands Xu Dandan at work (Photo: Business Wire) CENPC is an important platform for trade exhibition and cultural exchange between countries along the Belt and Road. With trade promotion as a foundation, the project, which is expected to feature over 40 national pavilions, aims to deepen Sichuan’s global cooperation in fields such as culture, talent, education, and science and techno

Chengdu-Europe Railway Adds Momentum to Chengdu's Rise as an International Hub, Leading to Closer Cooperation Between Chengdu and Tilburg27.11.2020 12:14:00 EETPress release

Chengdu in China's Sichuan Province and Tilburg in The Netherlands, the two cities at the opposite ends of the Eurasian landmass, are now closely connected via an intercontinental railway that spans nearly 11,000 kilometers. In a recent interview with Xinhuanet, Roland Verbraak, general manager of GVT Group of Logistics - the Dutch partner of the Chengdu-Europe Railway, praised: "Not only are our relationships with Chinese partners getting closer, but the two cities of Chengdu and Tilburg have also become sister cities. Chengdu's international development is progressing well at a rapid pace." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005267/en/ Roland Verbraak, general manager of GVT Group of Logistics (Photo: Business Wire) Goods shuttling along the Chengdu-Europe Railway line have not only spurred economic growth in China and The Netherlands but also deepened links between Chengdu and places along the route, add

REPLY: Reply enters into eSports27.11.2020 11:00:00 EETPress release

Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS

Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 11:00:00 EETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O

Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 22:55:00 EETPress release

Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti

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