Zymeworks Inc. (Nasdaq: ZYME) has outlined its strategic priorities and anticipated milestones for 2025 and 2026, focusing on advancing its pipeline of novel biotherapeutics for difficult-to-treat diseases.
Kenneth Galbraith, Chair and CEO of Zymeworks, stated, "2024 was a pivotal year for Zymeworks, marked by the first FDA approval of our internally developed product, zanidatamab, significant clinical progress with our novel, antibody-based therapeutic candidates in solid tumors and advancements in our emerging preclinical pipeline."
Clinical Development of Solid Tumor Pipeline
The company is actively progressing ZW171, a 2+1 trivalent T cell engager targeting mesothelin-expressing solid tumors, and ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α, in ongoing Phase 1 trials. These programs are part of Zymeworks’ ‘5 by 5’ R&D initiative, which aims to complete IND applications for five product candidates by the end of 1H-2026.
Expansion into New Therapeutic Areas
Zymeworks is leveraging its proprietary platforms to broaden its ADVANCE R&D strategy, diversifying its pipeline into autoimmune and inflammatory diseases (AIID) and hematological cancers. The first IND application in AIID is expected in 2H-2026 for ZW1528, which targets COPD patients by dual blockade of respiratory inflammation pathways.
Zanidatamab Regulatory Milestones
Zymeworks' partner, Jazz Pharmaceuticals, is expected to report top-line results from the Phase 3 HERIZON-GEA-01 trial of zanidatamab in first-line HER2-positive gastroesophageal adenocarcinoma (GEA) in 2Q-2025, with potential for a supplemental Biologics License Application (sBLA) submission later in the year. Regulatory decisions in the EU and China for zanidatamab in second-line biliary tract cancer (BTC) are anticipated as early as 2Q-2025.
Financial Position
As of December 31, 2024, Zymeworks reported approximately $324 million in cash resources. The company anticipates that these resources, combined with expected regulatory milestone payments, will fund planned operations into the second half of 2027.
