Zymeworks Outlines Strategic Priorities and Outlook for 2026

 

The global Phase 1 clinical trial investigating ZW191 in solid tumors is ongoing with dose optimization of ZW191 in ovarian cancer. Additional data from the Phase 1 trial is anticipated to be presented at a major medical meeting in 2026;

The global Phase 1 clinical trial investigating ZW251 in solid tumors is actively recruiting. The Company presented a Trial-in-Progress poster for ZW251, at ASCO Gastrointestinal Cancers Symposium (ASCO GI) on January 9, 2026;

INDs for multispecific programs, ZW209 and ZW1528, remain on track for submission in 2026, as we continue evaluating partnership opportunities before the commencement of clinical studies; and,

Development of wholly-owned preclinical candidates from our multispecific antibody portfolio to provide for one planned IND filing per annum commencing in 2028.

Ziihera® (zanidatamab-hrii)

 

Late-breaking HERIZON-GEA-01 clinical data presented at ASCO GI by partner Jazz Pharmaceuticals on January 8, 2026. The study found:

Both investigational arms, Ziihera plus tislelizumab and chemotherapy and Ziihera plus chemotherapy, led to a statistically significant and clinically meaningful prolongation of progression-free survival (PFS) with approximately 35% reduction in the risk of disease progression or death versus trastuzumab plus chemotherapy. This resulted in a median PFS of more than one year, representing a greater than four month improvement compared to the control arm.

Ziihera plus tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of more than two years (26.4 months), the longest reported in a Phase 3 trial in GEA, representing a greater than seven-month improvement in median OS and a 28% reduction in the risk of death versus trastuzumab plus chemotherapy.

At this first interim analysis, Ziihera plus chemotherapy showed a median OS of more than two years, with a strong trend toward statistical significance, favoring Ziihera plus chemotherapy versus trastuzumab plus chemotherapy. An additional planned OS interim analysis for Ziihera plus chemotherapy is currently expected in mid-2026.

The OS and PFS benefits were generally consistent across major prespecified subgroups including geographic region and PD-L1 status for both investigational arms.

Based on the topline results from HERIZON-GEA-01, Jazz plans to submit a supplemental Biologics License Application in 1H-2026 for zanidatamab in the U.S. as first-line treatment for HER2+ locally advanced or metastatic GEA; and,

Zymeworks has the potential to receive substantial near-term milestone payments related to future anticipated regulatory approvals in GEA totaling $440.0 million, as follows: U.S. - $250.0 million; EU - $100.0 million; Japan - $75.0 million; China - $15.0 million.

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Sumber: globe newswire