{"id":48278,"date":"2022-09-12T23:02:18","date_gmt":"2022-09-12T21:02:18","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\/"},"modified":"2022-09-12T23:02:18","modified_gmt":"2022-09-12T21:02:18","slug":"zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\/","title":{"rendered":"Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Company to hold conference call and webcast on Monday, September 12<sup>th<\/sup> at 4:30 PM Eastern Standard Time (EST)<\/i>\n<\/li>\n<\/ul>\n<p>VANCOUVER, British Columbia &amp; SEATTLE&#8211;(BUSINESS WIRE)&#8211;Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company\u2019s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. The presentation, entitled \u201c<span class=\"bwuline\"><i><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fcslide.ctimeetingtech.com%2Fesmo2022%2Fattendee%2Fconfcal%2Fpresentation%2Flist%3Fq%3Dzw49&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=Preliminary+Results+From+a+Phase+1+Study+Using+the+Bispecific%2C+Human+Epidermal+Growth+Factor+2+%28HER2%29-targeting+Antibody-drug+Conjugate+%28ADC%29+zanidatamab+zovodotin+%28ZW49%29+in+Solid+Cancers%26%238221%3B&amp;index=1&amp;md5=c733c66dbd433b5baeca4053ed1c889f\" rel=\"nofollow noopener\" shape=\"rect\">Preliminary Results From a Phase 1 Study Using the Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid Cancers\u201d<\/a><\/i><\/span>, was presented by Komal Jhaveri, MD, FACP, medical oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a mini-oral presentation today during the European Society for Medical Oncology Annual Congress at the Paris Expo Porte de Versailles in Paris, France.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220912005256\/en\/183056\/5\/Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220912005256\/en\/183056\/21\/Logo.jpg\"><\/a><\/p>\n<p>\nA total of 77 patients were enrolled in this first-in-human trial, which was designed to determine the maximum tolerated dose of zanidatamab zovodotin, characterize its safety and tolerability, and evaluate anti-tumor activity in HER2-expressing cancers as monotherapy. The patients represented a variety of HER2-expressing cancers including breast, gastroesophageal, ovarian, endometrial, bladder, biliary tract, anal, colorectal, pancreatic and lung. At the time of the analysis, the maximum tolerated dose had not yet been reached.\n<\/p>\n<p>\nCommenting on the data, Dr. Jhaveri noted, \u201cThe preliminary results of this trial are very encouraging. Zanidatamab zovodotin dosed on an every three week (Q3W) schedule is active and has a manageable safety profile. I am excited to see further clinical development of zanidatmab zovodotin across a variety of HER2-expressing cancers.\u201d\n<\/p>\n<p>\nIn the trial, zanidatamab zovodotin was shown to have a manageable safety profile with the majority of adverse events being Grade 1 or 2 in severity. In patients with HER2-positive cancers treated with zanidatamab zovodotin at 2.5 mg\/kg Q3W (dose escalation + dose expansion), the confirmed objective response rate was 31% and the disease control rate was 72%. The Phase 1 clinical trial is ongoing and continues to enroll patients to study safety, tolerability and activity for an alternate qW dosing regimen. The Company expects to present results of this dosing regimen at a medical meeting in 2023.\n<\/p>\n<p>\n\u201cWe are grateful to the patients who participated in this trial and appreciate the collaborative efforts and dedication of the outstanding group of clinical investigators who are participating in this Phase 1 study,\u201d said Neil Josephson, MD, Chief Medical Officer of Zymeworks. \u201cThese promising results provide significant momentum for the further clinical development of zanidatamab zovodotin, as a monotherapy, and in combination with standard of care agents, for the treatment of cancers expressing HER2 or harboring HER2 gene alterations.\u201d\n<\/p>\n<p>\n<b>Conference Call<\/b>\n<\/p>\n<p>\nDr. Jhaveri\u2019s complete presentation at the ESMO 2022 Congress is available for review on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.zymeworks.com%2Fpublications&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=Zymeworks%26%238217%3B+website&amp;index=2&amp;md5=0eb90edf489a412ad045ef8d41176df8\" rel=\"nofollow noopener\" shape=\"rect\">Zymeworks\u2019 website<\/a>. Zymeworks will hold a conference call to discuss Dr. Jhaveri\u2019s presentation and future clinical development plans for zanidatamab zovodotin on Monday, September 12<sup>th<\/sup> at 4:30 pm EST. Interested parties can access the live webcast via Zymeworks\u2019 website at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fir.zymeworks.com%2Fevents-and-presentations&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=https%3A%2F%2Fir.zymeworks.com%2Fevents-and-presentations&amp;index=3&amp;md5=eef4fd2aaba9ce0c682f2129e33976e2\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/ir.zymeworks.com\/events-and-presentations<\/a>. A recorded replay will be accessible after the event through the Zymeworks website.\n<\/p>\n<p>\nDisclosure: Dr. Jhaveri has a consulting relationship with Zymeworks.\n<\/p>\n<p>\n<b>About Zymeworks Inc.<\/b>\n<\/p>\n<p>\nZymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks\u2019 suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks\u2019 lead clinical candidate, zanidatamab, is a novel Azymetric\u2122 HER2-targeted bispecific antibody currently being evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks\u2019 second clinical candidate, zanidatamab zovodotin (ZW49), is a novel bispecific HER2 \u2011targeted antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks\u2019 proprietary ZymeLink\u2122 linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with global biopharmaceutical companies. For more information on our ongoing clinical trials visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.zymeworksclinicaltrials.com%2F&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=www.zymeworksclinicaltrials.com&amp;index=4&amp;md5=7fb6592be500e7b1444f0ea010b0a82f\" rel=\"nofollow noopener\" shape=\"rect\">www.zymeworksclinicaltrials.com<\/a>. For additional information about Zymeworks, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.zymeworks.com%2F&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=www.zymeworks.com&amp;index=5&amp;md5=269133c526ae219e81942fe9a6a82928\" rel=\"nofollow noopener\" shape=\"rect\">www.zymeworks.com<\/a> and follow <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FZymeworksInc&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=%40ZymeworksInc&amp;index=6&amp;md5=f9cf3b19b339e70b2be0c5a9566b1e83\" rel=\"nofollow noopener\" shape=\"rect\">@ZymeworksInc<\/a> on Twitter.\n<\/p>\n<p>\n<b>Cautionary Note Regarding Forward-Looking Statements<\/b>\n<\/p>\n<p>\nThis press release includes \u201cforward-looking statements\u201d within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and \u201cforward-looking information\u201d within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential therapeutic effects of zanidatamab, zanidatamab zovodotin and Zymeworks\u2019 other product candidates; Zymeworks\u2019 clinical development of its product candidates and enrollment in its clinical trials; anticipated clinical data presentations; and other information that is not historical information. When used herein, words such as \u201cwill\u201d, \u201cplans\u201d, \u201cmay\u201d, \u201cpotential\u201d, 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\u2019 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: the impact of the COVID-19 pandemic on Zymeworks\u2019 business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks\u2019 behalf, may be more severe and more prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of Zymeworks\u2019 or its collaborators\u2019 product candidates; any of Zymeworks\u2019 or its partners\u2019 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; inability to maintain or enter into new partnerships or strategic collaborations and the factors described under \u201cRisk Factors\u201d in Zymeworks\u2019 quarterly and annual reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for its quarter ended June 30, 2022 (a copy of which may be obtained at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=7&amp;md5=80ef6e5f5d53eebf7b131f1323d9eddc\" rel=\"nofollow noopener\" shape=\"rect\">www.sec.gov<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sedar.com&amp;esheet=52881835&amp;newsitemid=20220912005256&amp;lan=en-US&amp;anchor=www.sedar.com&amp;index=8&amp;md5=71560e368c2cc3cd47ac3399d55af988\" rel=\"nofollow noopener\" shape=\"rect\">www.sedar.com<\/a>). Consequently, forward-looking statements should be regarded solely as Zymeworks\u2019 current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any 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, except as may be required by law.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nJack Spinks<br \/>\n<br \/>(604) 678-1388<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#111;&#x3a;&#105;&#x72;&#64;&#x7a;y&#109;&#x65;&#119;&#x6f;r&#x6b;&#x73;&#46;&#x63;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#105;&#x72;&#64;&#x7a;&#121;&#x6d;&#101;&#x77;&#111;&#x72;&#107;&#x73;&#46;&#x63;&#111;&#x6d;<\/a>\n<\/p>\n<p>\nMedia Inquiries:<br \/>\n<br \/>Diana Papove<br \/>\n<br \/>(604) 678-1388<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;l&#x74;&#111;&#x3a;&#109;e&#x64;i&#x61;&#64;&#x7a;&#121;&#x6d;&#101;w&#x6f;r&#x6b;&#115;&#x2e;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#101;&#100;i&#x61;&#x40;&#122;y&#x6d;&#x65;&#119;o&#x72;&#x6b;&#115;&#46;&#x63;&#x6f;&#109;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Company to hold conference call and webcast on Monday, September 12th at 4:30 PM Eastern Standard Time (EST) VANCOUVER, British Columbia &amp; SEATTLE&#8211;(BUSINESS WIRE)&#8211;Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company\u2019s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48278","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Company to hold conference call and webcast on Monday, September 12th at 4:30 PM Eastern Standard Time (EST) VANCOUVER, British Columbia &amp; SEATTLE&#8211;(BUSINESS WIRE)&#8211;Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company\u2019s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-12T21:02:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20220912005256\/en\/183056\/21\/Logo.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress\",\"datePublished\":\"2022-09-12T21:02:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/\"},\"wordCount\":1168,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20220912005256\\\/en\\\/183056\\\/21\\\/Logo.jpg\",\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/zymeworks-reports-preliminary-phase-1-trial-results-for-zanidatamab-zovodotin-zw49-at-european-society-for-medical-oncology-annual-congress\\\/\",\"name\":\"Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress - 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(NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today presented preliminary results from the company\u2019s Phase 1 clinical trial evaluating zanidatamab zovodotin (ZW49) for the treatment of HER2-positive tumors. ... 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