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Zymeworks Announces Participation in Upcoming Conferences
Globenewswire· 2025-12-02 21:05
Core Insights - Zymeworks Inc. is actively participating in significant upcoming conferences, including the ASCO Gastrointestinal Cancers Symposium and the J.P. Morgan Annual Healthcare Conference, showcasing its innovative biotherapeutics and clinical trials [1][5]. Conference Participation - Zymeworks will present a Trial-in-Progress poster for ZW251, a GPC3-targeting antibody-drug conjugate for hepatocellular carcinoma, at the ASCO GI Symposium on January 9, 2026 [2]. - The company will also highlight the late-breaking HERIZON-GEA-01 presentation, focusing on Ziihera® in HER2-driven gastrointestinal cancers, at the same symposium [1][3]. Presentation Details - The ZW251 presentation will be part of a multicenter study involving participants with hepatocellular carcinoma, scheduled for January 9, 2026, from 11:30 am to 1:00 pm PT [2]. - The HERIZON-GEA-01 study results will be presented on January 8, 2026, during the Oral Abstract Session A, focusing on advanced HER2-positive gastroesophageal adenocarcinoma [3]. Company Overview - Zymeworks is a biotechnology company focused on developing a diverse pipeline of multifunctional biotherapeutics aimed at improving treatment for difficult diseases, including cancer [6]. - The company utilizes its proprietary Azymetric™ technology to engineer Ziihera®, a HER2-targeted bispecific antibody, and has established partnerships for its commercialization [6].
Zymeworks Announces Positive HERIZON-GEA-01 Phase 3 Results Supporting Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma
Globenewswire· 2025-11-17 11:00
Core Insights - Zymeworks Inc. announced positive topline results from the Phase 3 HERIZON-GEA-01 trial for Ziihera (zanidatamab-hrii) in combination with chemotherapy for HER2-positive gastroesophageal adenocarcinoma, indicating a significant advancement in treatment options for this patient population [1][5][6] Trial Results - Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in progression-free survival (PFS) compared to trastuzumab and chemotherapy [6][7] - Ziihera plus Tevimbra (tislelizumab) and chemotherapy demonstrated statistically significant improvements in overall survival (OS) and PFS versus the control arm [6][7] - The trial results support Ziihera's potential as the preferred HER2-targeted agent in first-line gastroesophageal adenocarcinoma [6][7] Safety Profile - The safety profile of Ziihera in combination with chemotherapy, with or without Tevimbra, was consistent with known safety profiles, with no new safety signals observed [3] Future Plans - Jazz Pharmaceuticals plans to submit the trial data for presentation at a major medical meeting in Q1 2026 and for publication in a peer-reviewed journal [4] - A supplemental Biologics License Application is expected to be submitted in the first half of 2026 to support Ziihera as a first-line treatment [5][6] Regulatory Designations - Zanidatamab has received Breakthrough Therapy designation and Fast Track designations from the FDA for various indications, including first-line gastroesophageal adenocarcinoma [9] Commercial Strategy - Zymeworks is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales of Ziihera from Jazz and BeOne [8] - The company is advancing a robust pipeline of product candidates and leveraging strategic partnerships to enhance its market position [10]
Zymeworks to Report Third Quarter 2025 Financial Results and Host Conference Call on November 6, 2025
Globenewswire· 2025-10-16 10:00
Core Viewpoint - Zymeworks Inc. is set to report its third quarter 2025 financial results on November 6, 2025, followed by a conference call and webcast to discuss the results and provide a corporate update [1][2]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel, multifunctional biotherapeutics aimed at improving treatment for difficult-to-treat diseases such as cancer, inflammation, and autoimmune diseases [3]. - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, a HER2-targeted bispecific antibody, which has received accelerated approval from the U.S. FDA and conditional approvals in China and Europe for treating specific types of cancer [3]. - Zymeworks is advancing a robust pipeline of product candidates, including ZW191, which is currently in a Phase 1 study, and ZW251, expected to enter clinical trials in 2025 [3]. - The company has established strategic partnerships with global biopharmaceutical companies to leverage its therapeutic platforms [3].
Zymeworks Announces Decision to Discontinue Clinical Development of ZW171, a Mesothelin-directed T cell Engager
Globenewswire· 2025-09-02 10:00
Core Viewpoint - Zymeworks Inc. has decided to voluntarily discontinue the clinical development of ZW171, a T cell engager targeting specific cancers, after evaluating the results from the Phase 1 trial, which indicated that further development would not support a favorable benefit-risk profile [1][3][4]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][5]. - The company utilizes proprietary technologies, such as Azymetric™, to engineer and develop differentiated antibody-based therapeutic candidates [5]. Clinical Development Update - The decision to halt ZW171's development was based on the completion of planned cohorts in the Phase 1 trial, where a maximum tolerated dose was established, but dose-limiting toxicities were observed [3]. - Ongoing participants in the trial will continue treatment at the discretion of their investigators, while those who have discontinued will undergo safety follow-up as per the study protocol [3]. Future Pipeline - Despite the setback with ZW171, Zymeworks is advancing its broader product pipeline, including the ongoing Phase 1 trial of ZW191 and the expected initiation of a Phase 1 study for ZW251 in 2025 [4]. - The company is also preparing an IND filing for ZW209, a DLL3-directed trispecific T cell engager, planned for the first half of 2026 [4]. Product Achievements - Zymeworks has developed zanidatamab, a HER2-targeted bispecific antibody, which has received accelerated approval from the U.S. FDA and conditional approvals in China and Europe for treating specific cancer types [5]. - Zanidatamab is being evaluated in multiple global clinical trials as a potential best-in-class treatment for various HER2-expressing cancers [5]. Strategic Partnerships - The company has entered into agreements with BeOne Medicines Ltd. and Jazz Pharmaceuticals, granting them exclusive rights to develop and commercialize zanidatamab in different territories [5].
Zymeworks to Report Second Quarter 2025 Financial Results and Host Conference Call on August 7, 2025
Globenewswire· 2025-07-17 10:00
Core Viewpoint - Zymeworks Inc. is set to report its second quarter 2025 financial results on August 7, 2025, and will participate in several investor conferences during July and August, highlighting its commitment to advancing its biotherapeutics pipeline for difficult-to-treat diseases [1][2]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel, multifunctional biotherapeutics aimed at improving care for conditions such as cancer, inflammation, and autoimmune diseases [2]. - The company has developed zanidatamab, a HER2-targeted bispecific antibody, which has received accelerated approval from the U.S. FDA and conditional approvals from China's NMPA and the European Commission for treating adults with unresectable or metastatic HER2-positive biliary tract cancer [2]. - Zanidatamab is the first dual HER2-targeted bispecific antibody approved for this indication in the U.S., Europe, and China, and is being evaluated in global clinical trials for multiple HER2-expressing cancers [2]. Upcoming Events - Zymeworks will host a conference call and webcast on August 7, 2025, at 4:30 pm ET to discuss its financial results and provide a corporate update [1]. - The company will participate in the BTIG Virtual Biotechnology Conference on July 29, 2025, and the Stifel Biotech Summer Summit from August 11-13, 2025, including a fireside chat on August 13 at 9:00 am ET [3]. Pipeline Development - Zymeworks is advancing a robust pipeline of wholly-owned product candidates, with Phase 1 studies for ZW171 and ZW191 actively recruiting, and an investigational new drug application for ZW251 planned for mid-2025 [2]. - The company leverages its therapeutic platforms through strategic partnerships with global biopharmaceutical companies to enhance its drug development capabilities [2].