Zymeworks
🇨🇦Canada
- Country
- 🇨🇦Canada
- Ownership
- -
- Employees
- 277
- Market Cap
- $822M
- Introduction
Zymeworks, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Its product includes Zanidatamab, which is a novel bispecific antibody that targets two distinct domains of the human epidermal growth factor receptor 2 (HER2). Zanidatamab's unique binding properties result in multiple mechanisms of action that may enable it to address unmet need in patient populations with HER2-expressing cancers. The company was founded on September 8, 2003 and is headquartered in Middletown, DE.
Zai Lab to Present Phase 1 Data on Novel DLL3-Targeted ADC for Small Cell Lung Cancer at ASCO 2025
• Zai Lab will showcase updated results from its Phase 1a/1b trial of ZL-1310, a potentially best-in-class DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer at the 2025 ASCO Annual Meeting.
• The novel ADC utilizes TMALIN® technology platform to overcome limitations of first-generation ADCs by leveraging the tumor microenvironment, with the FDA granting Orphan Drug Designation in January 2025.
• ZL-1310 combines a humanized anti-DLL3 monoclonal antibody with a novel camptothecin derivative payload, targeting an antigen overexpressed in aggressive neuroendocrine tumors associated with poor outcomes.
Luveltamab Tazevibulin Shows Promising Results in Platinum-Resistant Ovarian Cancer with Low to High FRα Expression
• Luveltamab tazevibulin demonstrated a 32% overall response rate in platinum-resistant ovarian cancer patients with FRα expression ≥25%, showing similar efficacy in both low-medium and high expression subgroups.
• The antibody-drug conjugate achieved a remarkable 96% disease control rate when administered at 5.2 mg/kg with G-CSF prophylaxis for the first two cycles, then 4.3 mg/kg in subsequent cycles.
• Common side effects included arthralgia, nausea, and neutropenia, with researchers selecting the optimized dose regimen for the ongoing phase 3 portion of the REFRΑME-O1 trial.
Praxis Therapeutics' Essential Tremor Drug Faces Setback in Phase 3 Interim Analysis
• Praxis Therapeutics announced that their lead drug candidate for essential tremor failed to meet primary endpoints in an interim Phase 3 analysis, marking a significant setback for the company's development program.
• Despite the disappointing interim results, the company has decided to continue the Phase 3 trial to completion, citing the need for comprehensive data analysis and potential insights from the full study population.
• Essential tremor remains a challenging neurological condition with limited treatment options, highlighting the continued unmet medical need in this therapeutic area.
Jazz Pharmaceuticals Acquires Global Rights to Zanidatamab in $1.76 Billion Deal with Zymeworks
• Jazz Pharmaceuticals secures exclusive development and commercialization rights to zanidatamab, a novel HER2-targeted bispecific antibody, in a deal potentially worth $1.76 billion plus royalties.
• Zanidatamab shows promising anti-tumor activity in HER2-expressing cancers and has received FDA Breakthrough Therapy designation for biliary tract cancer treatment.
• The agreement includes a $50 million upfront payment, with potential additional payments of $525 million for regulatory milestones and $862.5 million for commercial achievements.
Zymeworks Announces Strategic Priorities and Pipeline Expansion for 2025-2026
• Zymeworks is set to advance ZW171 and ZW191 in Phase 1 trials for solid tumors, part of their '5 by 5' R&D program.
• The company plans to submit an IND application for ZW1528 in 2H-2026, targeting autoimmune and inflammatory diseases like COPD.
• Regulatory decisions for zanidatamab in second-line biliary tract cancer in the EU and China are expected as early as 2Q-2025.
• Zymeworks anticipates a cash runway into the second half of 2027, supported by $324 million in resources and milestone payments.
Multispecific Antibodies Market Set to Exceed $40 Billion as Next-Generation Cancer Therapies Advance
• The multispecific antibodies market has surpassed $8.6 billion in sales as of Q3 2024, with 16 approved therapies demonstrating efficacy across oncology and other therapeutic areas.
• Bispecific antibodies currently dominate the market, while more complex trispecific and tetraspecific antibodies are emerging in early development phases with potential for enhanced therapeutic advantages.
• Over 900 multispecific antibodies are currently in clinical trials, reflecting substantial investment from pharmaceutical companies and biotechnology firms seeking to address complex diseases through multi-target approaches.
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
• The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
• Approval was based on a 52% objective response rate and a median duration of response of 14.9 months in the HERIZON-BTC-01 trial.
• Ziihera is the first dual HER2-targeted bispecific antibody and chemotherapy-free treatment option for patients with HER2-positive BTC.
• A confirmatory Phase 3 trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone.
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