Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191

Zymeworks Inc., a clinical-stage biotechnology company, has announced the dosing of the first patient in its first-in-human Phase 1 trial (NCT06555744) to evaluate ZW191.

“Our team is excited to initiate this important clinical trial to assess the safety and tolerability of ZW191, our first antibody-drug conjugate utilizing ZD06519, our novel proprietary payload, in patients with difficult-to-treat cancers. This global study represents a significant milestone in our mission to bring innovative and urgently needed therapies to patients in need. This announcement also follows the recent initiation of our Phase 1 trial of ZW171, marking an additional important step forward in advancing the many promising therapies in our wholly-owned pipeline.” – said Jeff Smith, M.D., FRCP, Executive Vice President and Chief Medical Officer at Zymeworks

What is ZW191?

ZW191 is an innovative antibody-drug conjugate (ADC) developed by Zymeworks Inc., designed to target the folate receptor-α (FRα), a protein commonly expressed on the surface of certain tumor cells, including those found in ovarian, endometrial, and lung cancers.

The ADC’s unique design enables effective internalization into FRα-expressing cells, where it is capable of releasing its active payload—a topoisomerase-1 inhibitor (ZD06519). This proprietary payload, developed by Zymeworks, is intended to selectively kill tumor cells, potentially making ZW191 a promising therapeutic for cancers that overexpress the FRα protein.

About Zymeworks Inc.

Zymeworks is a global biotechnology company focused on the development of multifunctional biotherapeutics. The company is particularly committed to creating treatments for difficult-to-treat cancers and other serious diseases. Zymeworks has developed a suite of proprietary therapeutic platforms that allow for the engineering of highly differentiated antibody-based drugs.

One of the key technologies developed by Zymeworks is Azymetric™, which has been used to engineer zanidatamab, a bispecific antibody targeting HER2. Zanidatamab is being tested in multiple global clinical trials as a potential treatment for HER2-expressing cancers. Zymeworks has partnered with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab in different regions. Zanidatamab has already made significant progress, including an FDA Biologics License Application (BLA) submission for accelerated approval in HER2-positive biliary tract cancer (BTC).

Zymeworks also has a robust pipeline of antibody-based therapies in various stages of development, including ZW171 and ZW191, both of which are currently in active Phase 1 clinical trials.

The company’s strategy involves leveraging its proprietary platforms to address significant unmet medical needs, advancing a portfolio of antibody-drug conjugates (ADCs) and multispecific antibody therapeutics.

Zymeworks Inc.:

“We’re pleased to announce that the first patient has been dosed in our Phase 1 clinical trial evaluating our antibody-drug conjugate targeting folate receptor-⍺ expressing advanced solid tumors including ovarian, endometrial, and non-small cell lung (NSCLC) cancers.

This milestone highlights our ongoing commitment to bringing innovative therapies to patients with difficult-to-treat cancers and other serious diseases.

Learn more about this important trial and how it represents progress in our wholly-owned pipeline.”

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