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
Allianz Delivers Record Result and Is Well on Track to Achieve Its Targets7.8.2026 07:10:00 CEST | Press release
2Q 2026 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806509750/en/ Oliver Bäte, Chief Executive Officer of Allianz SETotal business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth. Operating profit rises 10.6 percent to a record level of 4.9 billion euros. Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent. 6M 2026Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management. Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros. Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment effec
Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 22:49:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th
Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release
The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
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