Zymeworks (ZYME) eports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at ESMO

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company’s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. The presentation, entitled “Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers”, was presented by Komal Jhaveri, MD, FACP, medical oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation today during the European Society for Medical Oncology Annual Congress at the Paris Expo Porte de Versailles in Paris, France.

A total of 77 patients were enrolled in this first-in-human trial, which was designed to determine the maximum tolerated dose of zanidatamab zovodotin, characterize its safety and tolerability, and evaluate anti-tumor activity in HER2-expressing cancers as monotherapy. The patients represented a variety of HER2-expressing cancers including breast, gastroesophageal, ovarian, endometrial, bladder, biliary tract, anal, colorectal, pancreatic and lung. At the time of the analysis, the maximum tolerated dose had not yet been reached.

Commenting on the data, Dr. Jhaveri noted, “The preliminary results of this trial are very encouraging. Zanidatamab zovodotin dosed on an every three week (Q3W) schedule is active and has a manageable safety profile. I am excited to see further clinical development of zanidatmab zovodotin across a variety of HER2-expressing cancers.”

In the trial, zanidatamab zovodotin was shown to have a manageable safety profile with the majority of adverse events being Grade 1 or 2 in severity. In patients with HER2-positive cancers treated with zanidatamab zovodotin at 2.5 mg/kg Q3W (dose escalation + dose expansion), the confirmed objective response rate was 31% and the disease control rate was 72%. The Phase 1 clinical trial is ongoing and continues to enroll patients to study safety, tolerability and activity for an alternate qW dosing regimen. The Company expects to present results of this dosing regimen at a medical meeting in 2023.

“We are grateful to the patients who participated in this trial and appreciate the collaborative efforts and dedication of the outstanding group of clinical investigators who are participating in this Phase 1 study,” said Neil Josephson, MD, Chief Medical Officer of Zymeworks. “These promising results provide significant momentum for the further clinical development of zanidatamab zovodotin, as a monotherapy, and in combination with standard of care agents, for the treatment of cancers expressing HER2 or harboring HER2 gene alterations.”

Conference Call

Dr. Jhaveri’s complete presentation at the ESMO 2022 Congress is available for review on Zymeworks’ website. Zymeworks will hold a conference call to discuss Dr. Jhaveri’s presentation and future clinical development plans for zanidatamab zovodotin on Monday, September 12th at 4:30 pm EST. Interested parties can access the live webcast via Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. A recorded replay will be accessible after the event through the Zymeworks website.

Disclosure: Dr. Jhaveri has a consulting relationship with Zymeworks.

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