Zymeworks BC, Inc.

4月2日，美国生物技术公司Zymeworks表示公司已经于3月31日罢免了首席财务官Christopher Astle，但是在美国证券交易委员会（SEC）的文件中没有提供罢免原因。Zymeworks首席执行官Kenneth Galbraith将担任公司临时首席财务官，直到找到接替者。“经过公司的深思熟虑，为了实现继续增长和成功的承诺，我们决定寻找一位拥有特定经验、专业知识和远见的新首席财务官，以有效地推动我们的业务战略向前发展，”Zymeworks的一位发言人对此表示。2023年公司财报显示，截止2023年12月31日，公司现金流为4.563亿美元，预计可以支持公司持续到2027年下半年。平台被大厂青睐Zymeworks成立于2003年，将蛋白质工程和药物化学领域行业领先的专业知识整合到其自身专有的多特异性抗体和ADC治疗模式中，并与疾病生物学相结合，开发主要用于治疗癌症以及自免疫性疾病和炎症性疾病的新一代抗体疗法。自2017年于纽交所上市后，Zymeworks就一直受到市场的关注，虽然没有产品获批上市，但是默沙东、辉瑞和GSK等大药企相继与其签订合作协议。大厂们看重的是Zymeworks的多抗和ADC技术平台。正所谓，单抗看靶点，双抗、ADC看平台。经过20多年的不断发展，该公司目前已经拥有四项专利技术平台：Azymetric、ZymeLink、EFECT和ProTECT。Azymetric平台可以将单特异性抗体，转化为双特异性抗体，同时结合同一目标上的多个不重叠表位，起到提高肿瘤特异性靶向和疗效，同时降低毒性和耐药性的可能性。与此同时，Azymetric 开发的双特异性抗体，还保留了单克隆抗体的理想药物样特性，包括长半衰期、稳定性和低免疫原性潜力。ZymeLink平台则是一套专有的细胞毒素、稳定的接头和偶联技术，有望提供增加递送效果，和减少脱靶效应等优势。凭借这一技术，Zymeworks获得2019年世界ADC奖最佳平台技术奖冠军。PROTECT平台能够在减少全身毒性的同时提高疗效，EFFECT平台主要作用是定制和优化免疫反应。且这几大平台可以相互搭配使用，例如，Azymetric与ZymeLink结合，可以开发双特异性ADC药物。好平台也需要好产品2017年上市之初，Zymeworks市值不到5亿，但随后市值不断攀升。2021年3月，在生物科技投资热潮顶峰时刻，公司市值一度达到36.4亿美金。但是由于一直没有产品获批上市，候选产品临床表现平平，在到达巅峰后，Zymeworks的股价就走了下坡路，如今市值6.51美元，和刚上市相差无几。Zymeworks最核心的产品是ZW25（Zanidatamab）和ZW49。Zanidatamab是一款通过Azymetric平台研发的新型靶向HER2双抗，可以同时靶向HER2胞外区域的亚基2和亚基4的两个不同表位，有可能带来更好的治疗效果。ZW49则是基于Zanidatamab开发的一款双靶点HER2 ADC，将 zanidatamab 的独特设计与专有的ZymeLink细胞毒素和可切割接头相结合。但是ZW49似乎没有想象中的那么好，2022年公布的ZW49治疗HER2+患者的一期临床数据显示，ZW49虽然起到了减毒的效果，不到10%患者产生3级以上副作用，但其疗效却未达到预期。29名接受2剂治疗的患者，ORR（客观缓解率）仅为28%。相比之下，DS8201各适应症ORR基本都超过50%。2018年，Zymeworks与百济就HER2双抗（ZW25）和HER2双抗ADC（ZW49）达成合作，Zymeworks授予百济在亚洲（不包括日本）、澳大利亚和新西兰进行ZW49的研究、开发和商业化的独家许可。可能是ZW49的临床数据差强人意，去年11月，百济神州退回ZW49的权利。除了百济神州，第一三共、BMS、强生、默沙东等公司也引进了Zymeworks的技术平台或产品。不过，2023年3月17日，Zymeworks子公司Zymeworks BC在一份提交给美国证券交易委员会（SEC）的文件中表示，第一三共已终止引进其双特异性抗体技术平台的许可协议。3月6日，Zymeworks在2023年财报中透露，由于临床情况仍在不断变化，在进一步明确之前，ZW49计划中的II期研究不再优先启动，公司将继续探索其潜在的开发和商业合作。小结再好的技术平台，没有足够硬的产品，依然不能说服市场，纵使很多大厂都钟意Zymeworks的抗体技术平台，但是其产品临床数据难以令人满意，不断走下坡路也在意料之中。参考来源：1.https://www.zymeworks.com/patients/#clinical-trials本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处···

DUBLIN--( BUSINESS WIRE )--The "Non-Small-Cell Lung cancer (NSCLC) - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 100+ companies and 120+ pipeline drugs in Non-Small-Cell Lung cancer (NSCLC) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The reportoutlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Non-Small-Cell Lung cancer (NSCLC) pipeline landscape is provided which includes the disease overview and Non-Small-Cell Lung cancer (NSCLC) treatment guidelines. The assessment part of the report embraces, in depth Non-Small-Cell Lung cancer (NSCLC) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Non-Small-Cell Lung cancer (NSCLC) collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Non-Small-Cell Lung cancer (NSCLC) R&D. The therapies under development are focused on novel approaches to treat/improve Non-Small-Cell Lung cancer (NSCLC) . Non-Small-Cell Lung cancer (NSCLC) Emerging Drugs Chapters This segment of the Non-Small-Cell Lung cancer (NSCLC) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Non-Small-Cell Lung cancer (NSCLC) Emerging Drugs V940: Merck Sharp & Dohme LLC V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient's tumor. It is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. The drug is in Phase III stage for the treatment of NSCLC. QL1706: Qilu Pharmaceutical Co., Ltd. QL1706 is an investigational bifunctional antibody with additional anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibody could increase the anti-tumor effect of anti-programmed cell death 1 (PD-1) antibody. QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD-1 IgG4 and anti-CTLA4 IgG1 antibodies produced by a single cell line. The drug is in Phase III stage for the treatment of NSCLC. Zenocutuzumab (MCLA-128): Merus N.V. Zenocutuzumab (MCLA-128; Zeno) is a Biclonics antibody that overcomes HER3 mediated NRG1 (or NRG1 fusion) signaling in tumor cells. Zeno docks on HER2, then binds to and blocks the NRG1 fusion-HER3 interaction and HER3 heterodimerization with HER2. It has a dual mechanism against cancer, as it prevents NRG1 fusions from binding to the protein HER3 and it blocks the interaction of HER3 with HER2, which the cancer cells depend on to survive and multiply. Currently, the drug is in Phase II stage for the treatment of NSCLC. ZW49: Zymeworks BC Inc. ZW49 (zanidatamab zovodotin) is a bispecific anti-HER2 ADC that is based on the same antibody framework as ZW25 but armed with a cytotoxic payload. A biparatopic (targeting two different non-overlapping epitopes on ERBB2, on extracellular domains 2 (ECD2) and 4 (ECD4). ZW25 is an anti-HER2 biparatopic antibody which binds to the same domains as trastuzumab and pertuzumab. ZW25 simultaneously binds two distinct sites on HER2, a protein expressed on many types of cancer cells. This unique design results in multiple mechanisms of action, including dual HER2 signal blockade, increased antibody binding, receptor clustering, and removal of HER2 from the cell surface, and potent e?ector function. ZW49 is in Phase I of clinical trials for the treatment of non-small cell lung cancer. Non-Small-Cell Lung cancer (NSCLC): Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Non-Small-Cell Lung cancer (NSCLC) therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non-Small-Cell Lung cancer (NSCLC) drugs. Non-Small-Cell Lung cancer (NSCLC) : Therapeutic Assessment Major Players in Non-Small-Cell Lung cancer (NSCLC) There are approx. 100+ key companies which are developing the therapies for Non-Small-Cell Lung cancer (NSCLC). The companies which have their Non-Small-Cell Lung cancer (NSCLC) drug candidates in the most advanced stage, i.e. Phase III include, Merck Sharp & Dohme LLC. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Non-Small-Cell Lung cancer (NSCLC) Report Insights Non-Small-Cell Lung cancer (NSCLC) Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Non-Small-Cell Lung cancer (NSCLC) Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Merck Sharp & Dohme LLC Suzhou Puhe Pharmaceutical Technology Co., LTD Merus N.V. Zymeworks BC Inc. Cytos Biotechnology Exelixis ProfoundBio US Co. Beijing Pearl Biotechnology Limited Liability Company Pfizer OncoResponse, Inc. Next Point Therapeutics, Inc. Light Chain Bioscience - Novimmune SA Medolution Ltd. Immunitas Therapeutics Shanghai Henlius Biotech Key Products V940 YK-029A Zenocutuzumab (MCLA-128) ZW49 CMP 001 XL092 PRO1184 PLB1001 PF-07257876 OR2805 NPX267 NI-1801 Keynatinib IMT-009 HLX301 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/w14gce About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Five abstracts accepted for poster presentation highlight company’s differentiated antibody-drug conjugate and multispecific antibody clinical product candidatesStrong preclinical activity across multiple FRα-expressing indications for ZW191, a FRα-targeting antibody-drug conjugateNext generation trispecific T cell engager platforms with integrated CD28 costimulation demonstrate durable anti-tumor activity VANCOUVER, British Columbia, March 05, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced acceptance of five abstracts for poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place at the San Diego Convention Center in San Diego, CA from April 5-10, 2024. “Our team is especially excited to participate in AACR this year to highlight some recent advancements in the development of our next generation antibody-drug conjugate and multispecific antibody therapeutics,” said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. “Five abstracts being accepted underscores the strong progress we continue to make in advancing multiple development programs based on our proprietary engineering platforms and integrated technologies.” Presentation Details Antibody-Drug Conjugates Title: ZW191 - a FRα-targeting antibody drug conjugate with strong preclinical activity across multiple FRα-expressing indicationsAbstract: 1862Session Category: Experimental and Molecular TherapeuticsSession Title: Antibody-Based Technologies and New Inhibitors Title: Screening novel format antibodies to design bispecific ADCs that address target heterogeneityAbstract: 2052Session Category: Experimental and Molecular TherapeuticsSession Title: New Technologies Title: Development of three-dimensional cancer cell line spheroid models for the in vitro functional characterization of cytotoxic antibody-drug conjugatesAbstract: 3127Session Category: Experimental and Molecular TherapeuticsSession Title: Antibody-Drug Conjugates Multispecific Antibody Therapeutics Title: DLL3 TriTCE Co-Stim: A next generation trispecific T cell engager with integrated CD28 costimulation for the treatment of DLL3-expressing cancersAbstract: 6716Session Category: ImmunologySession Title: Targeted ICEs Title: TriTCE Co-Stim: A next generation trispecific T cell engager platform with integrated CD28 costimulation, engineered to improve responses in the treatment of solid tumors Abstract: 6719Session Category: ImmunologySession Title: Targeted ICEs About Zymeworks Inc.Zymeworks is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com 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 anticipated preclinical and clinical data presentations; Zymeworks’ preclinical pipeline; potential therapeutic effects and commercial potential of zanidatamab and Zymeworks’ other product candidates; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the ability to advance product candidates into later stages of development; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “progress”, 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: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; 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; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission from time to time (copies of which may be obtained at www.sec.gov and www.sedar.com). 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. Investor inquiries:Shrinal InamdarDirector, Investor Relations(604) 678-1388ir@zymeworks.com Media inquiries:Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@zymeworks.com