RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Fast Track (United States)

Structure/Sequence

Sequence Code 528522334

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Sequence Code 528522342

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Sequence Code 528522349

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Clinical Trials associated with Zanidatamab

NCT07494448

/ Not yet recruitingPhase 1/2

PHASE IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF ZANIDATAMAB IN COMBINATION WITH TUCATINIB AND CHEMOTHERAPY (CAPECITABINE OR ERIBULIN MESYLATE) IN HER2-POSITIVE ADVANCED BREAST CANCER

The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.

Start Date01 Jul 2026

Sponsor / Collaborator

Medica Scientia Innovation Research SL

NCT07477444

/ Not yet recruitingPhase 1/2IIT

Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b/2a Single-Arm Trial

The HER-OIC clinical trial is a Phase 1b/2a study investigating a new combination of treatments for patients with HER2-positive gastroesophageal cancer. Standard treatment for localized gastroesophageal cancer usually involves chemotherapy before and after surgery. This study aims to see if adding targeted therapy (zanidatamab) and immunotherapy (tislelizumab) to standard chemotherapy is safe and effectively eliminates the tumor. The goal is to improve the pathological complete response (pCR) rate, which is the percentage of patients who have no visible cancer cells remaining in the tissue removed during surgery.

Start Date01 Jun 2026

Sponsor / Collaborator

Universitaire Ziekenhuizen KU Leuven

NCT07290985

/ Not yet recruitingPhase 2

AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)

This study will test a new personalized treatment approach for patients with stomach or esophageal cancer. It will take place in two stages and aims to find the best combination of chemotherapy, immunotherapy, and targeted drugs based on each patient's tumor biomarkers.
Upon enrollment onto the study, patients will consent to tumor biomarker testing and may receive one cycle of standard chemotherapy while awaiting results. Those with a matching biomarker will join the corresponding treatment group that combines chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy. In Stage I of the study, treatment lasts about four months before surgery, followed by an additional eight months of therapy for a total of one year.
The most effective treatments from Stage I will be studied further in Stage II of the study to see whether some patients can safely avoid surgery. Those patients enrolled during Stage II will receive four months of the same combination treatment (chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy) but may be eligible to skip surgery if their cancer completely disappears after pre-surgery therapy. All patients will then receive an additional eight months of therapy and those who skipped surgery will be closely monitored with scans and endoscopies.

Start Date01 May 2026

Sponsor / Collaborator

American Association for Cancer Research

[+5]

100 Clinical Results associated with Zanidatamab

100 Translational Medicine associated with Zanidatamab

100 Patents (Medical) associated with Zanidatamab

Literatures (Medical) associated with Zanidatamab

16 Jan 2026·CLINICAL CANCER RESEARCH

Phase Ib/II Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma

Article

Author: Im, Young-Hyuck ; Ying, Jieer ; Oh, Do-Youn ; Kim, Jin Won ; Oh, Sang Cheul ; Chen, Ye ; Chen, Shengnan ; Chao, Yee ; Li, Vincent ; Jung, Minkyu ; Lee, Keun-Wook ; Cho, Jae Yong ; Bai, Li-Yuan ; Kang, Yoon-Koo

Abstract:

Purpose::

This phase Ib/II trial (NCT04276493) assessed the antitumor activity, safety, and pharmacokinetics (PK) of zanidatamab in combination with tislelizumab and chemotherapy in patients with advanced HER2-positive (HER2+) gastric cancer/gastroesophageal junction cancer (GEJC).

Patients and Methods::

Adult patients with previously untreated, unresectable, locally advanced/metastatic HER2+ gastric cancer/GEJC received zanidatamab 30 mg/kg i.v. (cohort A) or zanidatamab 1800 mg i.v. (weight <70 kg)/2,400 mg i.v. (weight ≥70 kg; cohort B) once every 3 weeks (Q3W). Both cohorts received tislelizumab 200 mg i.v. once every 3 weeks and standard chemotherapy [capecitabine and oxaliplatin (CAPOX)] once every 3 weeks. Primary endpoints were investigator-assessed confirmed objective response rate (cORR) per RECIST v1.1, in addition to the frequency and severity of adverse events (AE) and serious AEs. Secondary endpoints included investigator-assessed progression-free survival (PFS), duration of response (DoR), overall survival (OS), PK, and immunogenicity of zanidatamab.

Results::

As of December 7, 2023, 33 patients (cohort A, n = 19; cohort B, n = 14) received treatment. The confirmed objective response rate was 75.8%; the median duration of response, progression-free survival, and overall survival were 23.3, 16.7, and 32.4 months, respectively. The most common treatment-related AEs (TRAEs) were diarrhea (100%), nausea (63.6%), and decreased appetite (48.5%). Treatment-related AEs of grade ≥3 were reported in 22 (66.7%) patients; diarrhea was the most common (27.3%).

Conclusions::

Zanidatamab, in combination with tislelizumab and CAPOX, demonstrated clinically meaningful antitumor activity with a manageable safety profile as first-line therapy for patients with HER2+ gastric cancer/GEJC. These results support a further development of zanidatamab and tislelizumab with chemotherapy in this patient population in the ongoing phase III HERIZON-GEA-01 trial (NCT05152147).

01 Jan 2026·JAMA Oncology

Zanidatamab in HER2-Positive Metastatic Biliary Tract Cancer

Article

Author: Kim, Jin Won ; Yin, Xiaoyu ; Jary, Marine ; Beg, Muhammad ; Alonso, Rosa Rodriguez ; Fernandez, Paula Ribera ; Bao, Yuanyuan ; Martin, Andrés J. Muñoz ; Yan, Qiang ; Marathe, Omkar ; Zhao, Yi ; King, Gentry George ; Sadeghi, Saeed ; Layos, Laura ; Metges, Jean-Phillippe ; Aguirre, Paula Carrasco ; Bridgewater, John ; Ying, Jie’er ; Gbolohon, Olumide ; Pazo Cid, Roberto ; Ducreux, Michel ; Cheng, Ying ; Kang, Jung Hun ; Chen, Emerson Y. ; Wasan, Harpreet ; Abou-Alfa, Ghassan K ; Xie, Feng ; Macarulla, Teresa ; Javle, Milind ; Fenocchio, Elisabetta ; Baron, Ari ; Mondaca, Sebastian ; Park, Joon Oh ; Harding, James J. ; De Braud, Filippo ; Garfin, Phillip M. ; Oh, Do-Youn ; Sun, Hui-Chuan ; Scott, Aaron ; Lee, Myung-Ah ; Fan, Jia ; Gable, Jonathon ; Liang, Tingbo ; Tougeron, David ; Bao, Lequn ; Gillmore, Roopinder ; Dahan, Laetitia ; Lonardi, Sara ; Li, Daneng ; Tejani, Mohamedtaki A. ; Chen, Eric ; Jiang, Yixing ; Alfonso, Jorge Adeva ; Choi, Hye Jin ; Wu, Xiaotian ; Kundranda, Madappa ; Aglietta, Massimo ; Pant, Shubham ; Chang, Heung-Moon ; Gracián, Antonio Cubillo ; Zhao, Haitao ; Tan, Benjamin ; Rimassa, Lorenza

This follow-up analysis of the phase 2 HERIZON-BTC-01 trial evaluates the efficacy, patient-reported outcomes, and safety profile of zanidatamab in patients with ERBB2 -amplified biliary tract cancer with a HER2 immunohistochemistry score of 3+ or 2+ after 33 months of follow-up.

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

293

News (Medical) associated with Zanidatamab

10 Apr 2026

·www.biospace.com

BostonGene to Present 13 Abstracts at the American Association for Cancer Research Annual Meeting 2026 Showcasing AI-Platform for Drug Development

Leveraging an AI-powered omnimodal foundation model to accelerate drug discovery, optimize patient stratification, and de-risk clinical development WALTHAM, Mass.--(BUSINESS WIRE)-- BostonGene , a developer of the leading AI foundation model for tumor and immune biology, today announced that 13 abstracts have been selected for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026 , held from April 17 - 22, at the San Diego Convention Center in San Diego, CA. BostonGene will be exhibiting at booth #4613. BostonGene will demonstrate how its leading AI foundation model for tumor and immune biology is redefining the drug development lifecycle by providing biopharma partners with a biologically grounded roadmap from early discovery through late-stage clinical trials. Integrating genomic, transcriptomic, and spatial insights, BostonGene’s presentations highlight a sophisticated suite of AI-driven capabilities designed to accelerate and de-risk the pharmaceutical pipeline. Key research includes the use of ReadyScore and Lymphly for precision patient stratification and target identification, RNA-aware diffusion models to predict drug-induced tissue dynamics, and AI-based image batch correction to ensure trial data integrity by focusing on true biologic signals. Furthermore, in collaboration with leading institutions, BostonGene will showcase how longitudinal multiomic profiling identifies actionable biomarkers and resistance pathways often missed by traditional methods. Details of BostonGene’s presentations at AACR are below: Oral presentation Session: CT012 Title: A phase 2 single-arm open-label trial evaluating zanidatamab in patients with early-stage HER2-positive breast cancer: The NeoZanHER study Date & time: April 18 | 12:50 PM - 1:00 PM Presenter: Funda Meric-Bernstam, MD , UT MD Anderson BostonGene’s integrated whole exome sequencing (WES) and RNA-seq platform was applied to uncover markers of response to HER2-targeting zanidatamab in a small cohort of patients with early-stage HER2-positive breast cancer. Early findings revealed high efficacy and manageable safety pro select patients, underscoring the feasibility of de-escalating to HER2-targeted therapy alone for this cancer. Research done in collaboration with UT MD Anderson Poster presentations Poster: 114 Title: Unraveling tumor- and tissue-specific gene expression patterns from plasma-derived cfRNA Date & time: Sunday, April 19 | 2:00 PM - 5:00 PM Presenter: Desiree Schenk, BostonGene BostonGene explored the utility of minimally invasive plasma-derived cell-free RNA (cfRNA) profiling for deconvolving tumor- and tissue-specific signals from a single blood draw. We uncovered tumor- and tissue-specific expression patterns in cfRNA that correlated with donor health or cancer status. Our findings support cfRNA signatures as a clinically relevant resource for optimizing patient stratification, trial design, discovery of novel drug targets and plasma-based biomarkers, and disease and treatment response monitoring. Poster: 0452 Title: Therapeutic potential of AURKA inhibition in ER+ inflammatory breast cancer Date & time: April 19 | 2:00 PM - 5:00 PM Presenter: Surbhi Shivhare, PhD, UT MD Anderson Applying BostonGene’s Tumor Portrait TM to analyze samples from ER+ inflammatory breast cancer (IBC) tumors, researchers at MD Anderson discovered amplified AURKA expression and an inverse relationship between AURKA and SMARCA4 expression. These findings suggest SMARCA4 as a putative synthetic lethality partner of AURKA, where therapeutic targeting of both could lead to cell death. BostonGene’s Tumor Portrait TM integrated genomic and transcriptomic data with clinical data to generate biologically grounded, actionable insights. Research done in collaboration with UT MD Anderson Poster: 2437 Title: A comparative scoring framework for BCMA-, GPRC5D- and CD38-targeted therapies in multiple myeloma Date & time: Monday, April 20 | 9:00 AM - 12:00 PM Presenter: Konstantin Chernyshov, PhD, BostonGene BostonGene leveraged ReadyScore, a proprietary, next-generation sequencing-based scoring framework for BCMA-, GPRC5D-, and CD38-targeted therapies in multiple myeloma. This molecular stratification tool integrates tumor and microenvironment features to provide a comprehensive readiness pro predict CAR-T response, T-cell engagers and monoclonal antibodies. By highlighting target readiness and treatment resistance pathways, the framework enables more precise biomarker-driven patient selection, informs therapeutic prioritization, and offers potential utility for optimizing trial design and translational decision-making. Poster: 1451 Title: Visualizing the genotype–phenotype link: Predicting drug-induced tissue dynamics with RNA-based diffusion models Date & time: Monday, April 20 | 9:00 AM - 12:00 PM Presenter: Alexander Bagaev, PhD, BostonGene BostonGene presents an RNA-aware diffusion model that predicts tissue morphology from gene expression to better understand genotype–phenotype relationships in cancer. The model integrates RNA embeddings from over 20,000 genes with histological image generation, trained on extensive paired RNA and H&E datasets. It produced realistic tissue images and successfully simulated drug-induced gene expression changes, capturing biologically meaningful tissue dynamics such as tertiary lymphoid structures and B-cell signatures. The approach helps predict how drugs affect tissue architecture, improving drug candidate selection, guiding early trial design, and reducing risks in drug development. Poster: 3877 Title: Integrative application of Lymphly reveals shared molecular landscape across B-cell lymphomas Date & time: Monday, April 20 | 2:00 PM - 5:00 PM Presenter: Konstantin Chernyshov, PhD, BostonGene BostonGene applied Lymphly, a unique, stable genetic classification framework for diffuse large B-cell lymphoma (DLBCL). When applied to ~3,500 samples, it uncovered previously unrecognized molecular relationships between DLBCL subtypes and other B-cell lymphomas. The analysis identified distinct subtype–disease links and shared genetic patterns, improving understanding of how lymphomas may transform into DLBCL and highlighting potential therapeutic targets across the B-cell lymphoma landscape. Poster: 1468 Title: Germline whole exome sequencing implicates homologous recombination repair pathway genes as risk factors in SMARCB1 deficient renal medullary phenotypes without sickle hemoglobinopathies Date & time: April 20 | 9:00 AM - 12:00 PM Presenter: Pankaj Kumar Chauhan, PhD, UT MD Anderson BostonGene’s genomic analysis explored two rare and aggressive kidney cancers: renal medullary carcinoma (RMC) and renal cell carcinoma with medullary phenotype (RCCU-MP). The study found that while both cancers showed similar immune-rich tumor environments, distinct genomic alterations were present in RCCU-MP that were absent in RMC. These results point to new genetic risk factors in RCCU-MP and support broader germline testing for patients with RCCU-MP. Research done in collaboration with UT MD Anderson Poster: 3763 Title: CCR7 expression and spatial distribution in inflammatory breast cancer: A baseline characterization for therapeutic targeting Date & time: April 20 | 2:00 PM - 5:00 PM Presenter: Surbhi Shivhare, PhD, UT MD Anderson In collaboration with The University of Texas MD Anderson Cancer Center, BostonGene applied its multimodal molecular profiling platform to advance target discovery in inflammatory breast cancer. By integrating genomic, transcriptomic, and spatial data, BostonGene uncovered key biological features of CCR7 that support its therapeutic relevance. This work highlights BostonGene’s ability to generate clinically actionable insights to prioritize targets, refine patient selection strategies, and accelerate oncology drug development. Research done in collaboration with UT MD Anderson Poster: 5251 Title: Precise description of metabolomic states using NGS uncover new potential biomarkers of response to TKIs in ccRCC Date & time: Tuesday, April 21 | 9:00 AM - 12:00 PM Presenter: Nikita Kotlov, PhD, BostonGene BostonGene developed specific metabolic gene signatures to inform prediction of tyrosine kinase inhibitor (TKI) response in patients with clear cell renal cell carcinoma (ccRCC). Our refined metabolic signatures uniquely integrate transcriptomic and metabolic data to reveal strong associations with TKI response, overall survival and tumor microenvironment subtypes, representing potent candidate biomarkers for early-phase clinical trial design and patient stratification aimed at overcoming TKI resistance. Poster: 4164 Title: Implementation of a diffusion-based color checker for histological image batch correction Date & time: Tuesday, April 21 | 9:00 AM - 12:00 PM Presenter: Alexander Bagaev, PhD, BostonGene BostonGene will present a novel AI-powered tool to enhance histological image analysis through batch correction. Leveraging stable diffusion models, the tool standardizes whole slide images collected on different scanners by mitigating technical variations and artifacts. The diffusion-based framework optimizes AI-driven image analysis workflows, offering a scalable solution for harmonizing large multi-site histological datasets. Poster: 5421 Title: Determining the benefit of comprehensive molecular testing in advanced cancers: BostonGene and Exigent Genomic INsight (BEGIN) study Date & time: Tuesday, April 21 | 9:00 AM - 12:00 PM Presenter: Sibel Blau, MD, Northwest Medical Specialties The BEGIN study, a collaboration between BostonGene and the Exigent Research Network, evaluated integrated DNA/RNA genomic profiling in community oncology practices. Among patients with advanced cancers, 93% had actionable findings, with many identified through RNA sequencing only. Comprehensive results influenced treatment decisions, including matching patients to standard of care and ongoing trial options, highlighting the patient-level impact of combined DNA/RNA testing in expanding precision oncology options in community settings. Research done in collaboration with Exigent Research Network Investigators Poster: CT277 Title: IvoLoC trial: A phase II trial evaluating the efficacy of ivonescimab in metastatic endocrine refractory HR-positive HER2-negative or triple negative invasive lobular carcinoma (ILC) Date & time: Tuesday, April 21 | 2:00 PM - 5:00 PM Presenter: Jason Mouabbi, MD , UT MD Anderson In an ongoing clinical trial with MD Anderson Cancer Center, BostonGene performed multimodal longitudinal blood and tissue analysis of metastatic invasive lobular carcinoma patients receiving the bispecific antibody targeting PD-1 and VEGF, ivonescimab. Beyond efficacy and durability, this study evaluated the molecular correlates linking clinical outcomes with tumor microenvironment subtypes while assessing circulating tumor DNA dynamics, biomarkers of response and resistance, and predictive responder scores. Research done in collaboration with UT MD Anderson Poster: 7935 Title: Multimodal immunotherapy remodels the tumor microenvironment in hepatocellular carcinoma: Integrative spatial and transcriptomic profiling from a Phase II trial Date & time: April 22 | 9:00 AM - 12:00 PM Presenter: Lionel Aurelien Kankeu Fonkoua, MD, Mayo Clinic Cancer Center BostonGene’s spatial and transcriptomic analysis was used in a Phase II trial to show that combining radiotherapy, dendritic cell vaccination, PD-L1 blockade, and VEGF inhibition could reshape the tumor environment in hepatocellular carcinoma (HCC). This multimodal approach helped turn immune-resistant “cold” tumors into immune-active states, improving T-cell responses and vascular health. The findings highlight promising strategies to overcome treatment resistance in HCC and reinforce BostonGene’s role in advancing precision immunotherapy. Research done in collaboration with Mayo Clinic The abstracts will be published in an online-only Proceedings supplement to the AACR journal Cancer Research . To learn more or to schedule a meeting with BostonGene during AACR, please contact Hannah Oman at events@bostongene.com . About BostonGene Corporation BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s foundation model for tumor and immune biology integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation. For more information, visit . Contacts Media Contact: BostonGene Erin Keleher +1-617-283-2285 Erin.Keleher@BostonGene.com

Phase 2Clinical ResultImmunotherapyAACR

09 Apr 2026

·www.biospace.com

Zymeworks Announces Additional Leadership Appointments to Advance Next Phase of Growth

• Adam Schayowitz, Ph.D., MBA appointed as Head of R&D • Scott Platshon appointed as Chief Business Officer VANCOUVER, British Columbia, April 09, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced the full-time appointments of Dr. Adam Schayowitz and Mr. Scott Platshon as of April 9, 2026, from their previously interim roles. Both Dr. Schayowitz and Mr. Platshon will report directly to Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “These appointments come at a pivotal time for Zymeworks as we enter a year focused on execution across our pipeline, partnerships, and broader corporate strategy,” said Galbraith. “Adam’s deep oncology and R&D expertise will accelerate our clinical development and unlock additional value, while Scott’s investment acumen and strategic vision will be instrumental in helping to expand our asset portfolio and drive long-term returns. Together with the recent appointment of Ms. Kristin Stafford as Chief Financial Officer, these leadership additions better position Zymeworks to execute on its strategy and deliver sustained value for patients and shareholders.” Dr. Schayowitz has been appointed as Executive Vice President and Head of Research & Development. He will work closely with Zymeworks’ R&D and Business Development teams to advance the Company’s portfolio of product candidates, while supporting its strategy to integrate partnerships and collaborations into its wholly-owned R&D pipeline. With nearly two decades of experience in oncology drug development, Dr. Schayowitz will play a key role in advancing programs in areas of high unmet need and preparing additional product candidates for progression into clinical studies. Mr. Platshon will serve as Executive Vice President and Chief Business Officer and continue to lead Zymeworks’ asset aggregation strategy while managing expected future cash flows from Ziihera® (zanidatamab-hrii) and other licensed healthcare assets, including pasritamig, which is being advanced into Phase 3 registration studies by Johnson & Johnson Innovative Medicine. In his full-time role as Chief Business Officer, he is responsible for executing Zymeworks’ strategy to build and actively manage a diversified portfolio of revenue-generating assets to help drive long-term shareholder value. Dr. Schayowitz and Mr. Platshon both join the executive leadership team from EcoR1 Capital, a significant shareholder in Zymeworks. Recent milestones, including the Phase 1 study initiation for ZW251 and expanding global approvals of zanidatamab, underscore Zymeworks’ continued momentum across its development pipeline and strategic partnerships. The Company remains focused on disciplined execution while advancing a differentiated strategy that integrates R&D innovation with strategic collaborations. Building on this progress, Zymeworks is advancing a diversified portfolio of revenue-generating assets supported by its asset aggregation strategy. Positive Phase 3 HERIZON-GEA-01 data for zanidatamab further strengthens the Company’s position to drive long-term value through a balanced approach that combines internal pipeline advancement with active management and expansion of its royalty and licensed asset portfolio. This integrated model is designed to optimize future cash flows while supporting continued investment in innovative therapeutics. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and long-term strategy to maximize value creation; the expected contributions of personnel to Zymeworks’ clinical development, strategic goals and long-term shareholder value for patients and shareholders; the anticipated benefits of strategic partnerships; Zymeworks’ and its partners’ clinical development and advancement of product candidates; future regulatory filings and approvals; the commercial potential of technology platforms and product candidates; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, “position” 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: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and ). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no 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. Contacts: Investor Inquiries: Shrinal Inamdar Vice President, Investor Relations (604) 678-1388 ir@zymeworks.com Media Inquiries: Diana Papove Vice President, Corporate Communications (604) 678-1388 media@zymeworks.com

Phase 3Executive ChangePhase 1

01 Apr 2026

·www.biospace.com

Zymeworks Appoints Kristin Stafford as Chief Financial Officer

VANCOUVER, British Columbia, April 01, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced the appointment of Ms. Kristin Stafford as Chief Financial Officer, effective April 1, 2026. “Kristin brings deep experience across the life sciences industry, with a strong track record in strategic planning, disciplined capital allocation, and executing complex capital markets and strategic transactions, including acquisitions, during her time at Royalty Pharma,” said Kenneth Galbraith, Chair and Chief Executive Officer. “We are excited to welcome her to the team and look forward to her contributions as we continue building a differentiated and durable business at Zymeworks.” Ms. Stafford recently served as Senior Vice President, Chief Accounting Officer for Royalty Pharma plc, since December 2018. Prior to this position, she served as Vice President, Finance of Royalty Pharma and Chief Financial Officer of BioPharma Credit plc, an affiliate of Royal Pharma, from 2016 to 2018. Previously, Ms. Stafford was a director at Ernst & Young LLP Capital Markets in London, specializing in U.S. transactions involving European life sciences companies. She also previously managed the external SEC reporting for iHeartMedia and was an auditor at Deloitte. Ms. Stafford is currently a Board Member at Novocure. She is a CPA and holds a B.Sc. degree in business administration from Sonoma State University. “I’m excited to join Zymeworks at such an important moment as the company advances its pipeline and executes on its strategic priorities,” said Ms. Stafford. “Zymeworks has built a strong foundation with a differentiated business model and high-quality assets, and I look forward to partnering with the leadership team to drive disciplined capital allocation, operational excellence, and long-term value creation.” About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and long-term strategy to maximize value creation; the expected contributions of personnel to Zymeworks’ strategic goals and long-term shareholder value; the anticipated benefits of strategic partnerships; Zymeworks’ and its partners’ clinical development of product candidates; future regulatory filings and approvals; the commercial potential of technology platforms and product candidates; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, 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: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and ). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no 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. Contacts: Investor Inquiries: Shrinal Inamdar Vice President, Investor Relations (604) 678-1388 ir@zymeworks.com Media Inquiries: Diana Papove Vice President, Corporate Communications (604) 678-1388 media@zymeworks.com

Executive Change

100 Deals associated with Zanidatamab

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KEGG	Wiki	ATC	Drug Bank
D12011	-	-	DB15471

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Bile Duct Neoplasms	Canada	Jazz Pharmaceuticals Plc	01 Jan 2026
HER2 positive Biliary Tract Neoplasms	United States	Jazz Pharmaceuticals Ireland Ltd.	20 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Adenocarcinoma of Esophagus	NDA/BLA	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	13 Apr 2026
HER2 positive Gastroesophageal Junction Adenocarcinoma	NDA/BLA	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	13 Apr 2026
HER2 Positive Stomach Adenocarcinoma	NDA/BLA	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	13 Apr 2026
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	United States	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Japan	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Australia	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Austria	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Belgium	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Brazil	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Canada	Jazz Pharmaceuticals Plc	13 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05152147 (HERIZON-GEA-01, ASCO2026) Manual	Phase 3	HER2 Positive Gastroesophageal Adenocarcinoma First line HER2 Positive	914	Trastuzumab + CT	lkzpjfjwib(nqpwjxkxot) = aoddttxkpb zjrbsyutsr (usoahgsgxs, 7.0 - 8.9) View more	Positive	08 Jan 2026
				Zanidatamab + CT	lkzpjfjwib(nqpwjxkxot) = ccxeaxhrdx zjrbsyutsr (usoahgsgxs, 9.8 - 14.5) View more
NCT04466891 (HERIZON-BTC-01, ASCO_GI2026)	Phase 2	Advanced biliary tract cancer HER2-positive	62	Zanidatamab (Responders)	brpssdrvin(qeudsjehak): HR = 0.4 (95.0% CI, 0.19 - 0.83) View more	Positive	08 Jan 2026
				Zanidatamab (SD)
NCT05152147 (HERIZON-GEA-01, PRNewswire) Manual	Phase 3	HER2 Positive Gastroesophageal Adenocarcinoma First line PD-L1 Positive \| PD-L1 Negative \| HER2 Positive	914	Ziihera+chemotherapy+tislelizumab	oqmhfqhnbn(mwerqaasny) = Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements, benefit was observed in the Ziihera plus tislelizumab and chemotherapy arm in both PD-L1 positive and PD-L1 negative subgroups. phmbemocjq (zoyhhwzolq ) View more	Positive	17 Nov 2025
				Ziihera+chemotherapy
NCT06695845 (DiscovHER PAN-206, ESMO2025)	Phase 2	Neoplasms HER2-expressing	1,028	Zanidatamab	ccngqaxacm(ibbsqngmfk) = ifznhnvoid nhkakrzuak (vqdvsguwlw ) View more	Positive	17 Oct 2025
NCT03929666 (ESMO2025)	Phase 2	HER2 Positive Colorectal Cancer First line HER2-expressing	13	Zanidatamab + mFOLFOX6	txcchgzfwf(zhgbdcunkd) = bsmqttrejg wkfrpbmagg (lblcbjierp, NE - NE) View more	Positive	17 Oct 2025
NCT04466891 (HERIZON-BTC-01, PRNewswire) Manual	Phase 2	HER2 positive Biliary Tract Neoplasms HER2 Expression	-	泽尼达妥单抗	pfzoadthux(hxiqkioocb) = nmimktgwia xvhxjzaevl (guuvsvsfir, 38.6 - 64.5) View more	Positive	04 Aug 2025
NCT03929666 (ZWI-ZW25-201, ESMO_GI2025)	Phase 2	Biliary Tract Neoplasms First line HER2-expressing	15	Zanidatamab + Cisplatin-Gemcitabine	srgpeisrnw(akwzopjyzk) = xejibszrpi zyggmhupzk (fghsmyhhjw, 18 - 71) View more	Positive	03 Jul 2025
NCT03929666 (Pubmed) Manual	Phase 2	HER2 Positive Gastroesophageal Adenocarcinoma HER2 Positive	46	Zanidatamab + chemotherapy (CAPOX [capecitabine plus oxaliplatin], FP [5-fluorouracil [5-FU] plus cisplatin], or modified FOLFOX6 [mFOLFOX6; leucovorin, 5-FU, and oxaliplatin])	gcjyjwivwl(sctdcjlotk) = wxirojezwt qafrtojrxa (ngznxkxvbs, 60.5 - 87.9) View more	Positive	01 Jun 2025
NCT04466891 (HERIZON-BTC-01, ASCO2025)	Phase 2	HER2 positive Biliary Tract Neoplasms Second line HER2-positive (IHC3+)	62	Zanidatamab-hrii	oaqxvrrbst(twpcgfdvwe) = lunlmdharu slszosmyjs (bjnbzffefo ) View more	Positive	30 May 2025
				Chemotherapy	oaqxvrrbst(twpcgfdvwe) = tpcbeabgmy slszosmyjs (bjnbzffefo ) View more
NCT02892123 (Phase I trial, ESMO_BC2025)	Phase 1	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-expressing	46	Zanidatamab + Paclitaxel	yzoohinznj(lzbfauxwkh) = fdvdpzinys zpgpptusmv (kgsupnxshm ) View more	Positive	16 May 2025
				Zanidatamab + Capecitabine	yzoohinznj(lzbfauxwkh) = uzruoybeiy zpgpptusmv (kgsupnxshm ) View more

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