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Zymeworks Inc. (NYSE: ZYME) announced that Janssen Biotech has dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks' proprietary platforms. This marks the second bispecific program from Janssen to enter clinical trials in 2023. Zymeworks will receive milestone payments as part of a licensing agreement, which includes an upfront payment of US$50 million and potential milestones totaling US$1.4 billion. The Azymetric™ and EFECT™ platforms enhance the efficacy of therapeutics and are pivotal to Zymeworks' drug development efforts.
Positive
Zymeworks received US$50 million upfront from Janssen and is eligible for up to US$1.4 billion in milestone payments.
The dosing of the first patient with JNJ-78306358 signifies progress in the partnership with Janssen, enhancing Zymeworks' pipeline.
Zymeworks has nine biopharmaceutical partners utilizing its platforms, leading to six therapeutics in clinical development.
Negative
None.
VANCOUVER, British Columbia--(BUSINESS WIRE)--
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that Janssen Biotech, Inc. (“Janssen”) dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks’ Azymetric™ and EFECT™ therapeutic platforms. This is the second Janssen bispecific program utilizing Zymeworks’ proprietary technology platforms to enter the clinic this year, following the announcement in August of Janssen’s dosing of the first patient with JNJ-78278343.
“At Zymeworks, we are delighted to see our collaborator’s therapies reaching patients in the clinic, and we extend our congratulations to everyone at Janssen on this achievement,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “Today, our therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies, with a total of six novel therapeutics having entered clinical development to date.”
Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen. Under the terms of that agreement, Zymeworks provided Janssen with a worldwide, royalty-bearing license to research, develop and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks’ Azymetric and EFECT platforms. Janssen is responsible for all research, development, and commercial activities under the licensing agreement. Zymeworks received an upfront payment of US$50 million and is eligible to potentially receive up to US$282 million in development milestone payments and up to US$1.12 billion in commercial milestone payments, as well as tiered royalties on potential sales.
About the Azymetric™ Platform
The Azymetric platform enables the transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets. This unique technology enables the development of multifunctional therapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and internalization and increase tumor-specific targeting. These features are designed to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric therapeutics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes that deliver high yields and purity, potentially reducing drug development costs and timelines.
About the EFECT™ Platform
The EFECT platform is a library of antibody Fc modifications engineered to activate or suppress the antibody-mediated immune response. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization and optimization of therapeutic responses for different diseases.
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, is a novel Azymetric™ HER2-targeted bispecific antibody which is currently enrolling in two pivotal clinical trials, one for HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) for which it has been granted Breakthrough Therapy designation by the FDA. Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, and breast cancers. Zymeworks’ second clinical candidate, ZW49, is a novel bispecific HER2-targeting antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker and 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 additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
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 press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding the receipt of payments under its licensing agreement with Janssen, the continued importance of Zymeworks’ platform technologies to its business model, and other information that is not historical information. When used herein, words such as “will”, “potential” 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, 2021 (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.
What is the latest news regarding Zymeworks (ZYME)?
Zymeworks announced that Janssen Biotech has dosed the first patient with JNJ-78306358, a bispecific antibody using Zymeworks' technology.
What financial benefits will Zymeworks receive from the partnership with Janssen?
Zymeworks will receive an upfront payment of US$50 million and is eligible for up to US$1.4 billion in milestone payments.
How does the Azymetric platform benefit Zymeworks' therapeutics?
The Azymetric platform enables the creation of bispecific antibodies that can target multiple disease pathways simultaneously, enhancing therapeutic efficacy.
What are the next steps for Zymeworks following this announcement?
Zymeworks will continue to support the clinical development of JNJ-78306358 and monitor other projects with its biopharmaceutical partners.
When was the first patient dosed with JNJ-78306358?
The first patient was dosed recently as part of Janssen's clinical trial with this bispecific antibody.
