Zymeworks Hosts R&D Day Highlighting Continued Clinical Progress in Oncology Programs and Expansion into Autoimmune and Inflammatory Diseases
Zymeworks (NASDAQ: ZYME) announced significant progress in its oncology programs and expansion into autoimmune and inflammatory diseases during its R&D Day. The company is ahead of schedule in delivering five Investigational New Drug (IND) applications for its solid tumor strategy, achieving this goal 18 months earlier than planned.
Key highlights include the nomination of ZW209, a novel trispecific T cell engager, as the fifth development candidate in their solid tumor portfolio, and ZW1528, their first development candidate for autoimmune and inflammatory diseases, targeting respiratory inflammation in COPD.
The company's pipeline focuses on gynecological, thoracic, and digestive system cancers, with five drug candidates expected to advance into clinical trials by first half of 2026. The expansion leverages their clinically validated Azymetric™ technology platform and expertise in multispecific therapeutics.
Zymeworks (NASDAQ: ZYME) ha annunciato progressi significativi nei suoi programmi oncologici e un'espansione nelle malattie autoimmuni e infiammatorie durante il suo R&D Day. L'azienda è in anticipo sulla tabella di marcia nella presentazione di cinque domande Investigational New Drug (IND) per la sua strategia sui tumori solidi, raggiungendo questo obiettivo con 18 mesi di anticipo rispetto ai piani.
I punti salienti includono la nomina di ZW209, un innovativo attivatore di cellule T trispecifiche, come il quinto candidato allo sviluppo nel loro portafoglio per i tumori solidi, e ZW1528, il loro primo candidato allo sviluppo per malattie autoimmuni e infiammatorie, mirato all'infiammazione respiratoria nella BPCO.
Il portafoglio dell'azienda si concentra su tumori ginecologici, toracici e del sistema digestivo, con cinque candidati terapeutici attesi per avanzare nei trial clinici entro la prima metà del 2026. L'espansione sfrutta la loro piattaforma tecnologica Azymetric™ validata clinicamente e l'expertise in terapie multispecifiche.
Zymeworks (NASDAQ: ZYME) anunció avances significativos en sus programas de oncología y una expansión hacia enfermedades autoinmunes e inflamatorias durante su Día de I+D. La empresa va por delante de su cronograma en la presentación de cinco solicitudes de Nuevos Medicamentos en Investigación (IND) para su estrategia de tumores sólidos, alcanzando este objetivo 18 meses antes de lo previsto.
Los aspectos más destacados incluyen la nominación de ZW209, un novedoso activador de células T trispecíficas, como el quinto candidato en su cartera de tumores sólidos, y ZW1528, su primer candidato para enfermedades autoinmunes e inflamatorias, dirigido a la inflamación respiratoria en EPOC.
El pipeline de la empresa se centra en cánceres ginecológicos, torácicos y del sistema digestivo, con cinco candidatos a fármacos que se espera avancen a ensayos clínicos para la primera mitad de 2026. La expansión aprovecha su plataforma tecnológica Azymetric™ validada clínicamente y la experiencia en terapias multispecíficas.
Zymeworks (NASDAQ: ZYME)는 R&D Day에서 종양학 프로그램의 중대한 진전과 자가면역 및 염증성 질환으로의 확장을 발표했습니다. 이 회사는 고형 종양 전략에 대한 다섯 가지 임상 신약 신청서(IND)를 제출하는 데 있어 일정보다 앞서 있으며, 이 목표를 계획보다 18개월 일찍 달성했습니다.
주요 하이라이트에는 ZW209, 새로운 삼중특이적 T세포 결합제가 고형 종양 포트폴리오의 다섯 번째 개발 후보로 지명되었고, ZW1528가 자가면역 및 염증성 질환을 위한 첫 번째 개발 후보로 지목되어 COPD의 호흡기 염증을 타겟으로 하고 있다는 점이 포함되어 있습니다.
회사의 파이프라인은 여성 생식기, 흉부, 소화기계 암에 초점을 맞추고 있으며, 2026년 상반기까지 다섯 가지 약물 후보가 임상 시험으로 진행될 것으로 예상됩니다. 이 확장은 임상적으로 검증된 Azymetric™ 기술 플랫폼과 다특이적 치료 분야의 전문성을 활용합니다.
Zymeworks (NASDAQ: ZYME) a annoncé des progrès significatifs dans ses programmes en oncologie et une expansion vers les maladies auto-immunes et inflammatoires lors de sa journée de R&D. L'entreprise est en avance sur le calendrier pour soumettre cinq demandes de médicaments nouveaux en investigation (IND) pour sa stratégie de tumeurs solides, atteignant cet objectif avec 18 mois d'avance sur les prévisions.
Parmi les faits saillants, on note la nomination de ZW209, un nouvel activateur de cellules T trispecifiques, comme cinquième candidat au développement de leur portefeuille de tumeurs solides, et ZW1528, leur premier candidat au développement pour les maladies auto-immunes et inflammatoires, ciblant l'inflammation respiratoire dans la BPCO.
Le pipeline de l'entreprise se concentre sur les cancers gynécologiques, thoraciques et du système digestif, avec cinq candidats médicaments devant entrer en essais cliniques d'ici la première moitié de 2026. L'expansion tire parti de leur plateforme technologique Azymetric™ validée cliniquement et de leur expertise en thérapies multispecifiques.
Zymeworks (NASDAQ: ZYME) hat während seines F&E-Tags bedeutende Fortschritte in seinen Onkologie-Programmen und eine Erweiterung in den Bereichen Autoimmun- und Entzündungserkrankungen bekannt gegeben. Das Unternehmen liegt bei der Einreichung von fünf Anträgen auf Zulassung neuer Arzneimittel (IND) für seine Strategie zu soliden Tumoren 18 Monate vor dem Zeitplan.
Zu den wichtigsten Highlights gehört die Nominierung von ZW209, einem neuartigen trispezifischen T-Zell-Engager, als fünften Entwicklungskandidaten in ihrem Portfolio für solide Tumoren, sowie ZW1528, ihrem ersten Entwicklungskandidaten für Autoimmun- und Entzündungserkrankungen, der auf Atemwegsentzündungen bei COPD abzielt.
Die Pipeline des Unternehmens konzentriert sich auf gynäkologische, thorakale und Verdauungstrakt-Krebsarten, wobei fünf Arzneimittelkandidaten bis zur ersten Jahreshälfte 2026 voraussichtlich in klinische Studien übergehen werden. Die Erweiterung nutzt ihre klinisch validierte Azymetric™-Technologieplattform und Expertise in multispezifischen Therapeutika.
- Accelerated delivery of '5 by 5' solid tumor strategy, 18 months ahead of schedule
- Expansion into new therapeutic areas (autoimmune, inflammatory diseases, and hematology)
- Strong financial position supporting broad R&D portfolio
- Multiple clinical trials initiations planned through 2026
- No immediate revenue generation from pipeline products
- Extended timeline to potential commercialization with earliest clinical data expected in 2025
Insights
The R&D Day update reveals significant acceleration in Zymeworks' development pipeline, with the company set to deliver five IND applications 18 months ahead of schedule. The expansion into autoimmune and inflammatory diseases (AIID) represents a strategic diversification beyond oncology. The company's solid financial position supports this broad R&D portfolio development, while maintaining flexibility for future partnerships.
The nomination of ZW209 as the fifth development candidate strengthens their solid tumor portfolio. The pipeline now includes multiple promising candidates:
- ZW171 - for mesothelin-expressing tumors
- ZW191 - targeting FR⍺-expressing cancers
- ZW220 - for NaPi2b-expressing cancers
- ZW251 - for GPC3-expressing liver cancer
The therapeutic portfolio demonstrates impressive scientific innovation across multiple modalities. The ZW209 TriTCE platform shows particular promise with its optimized design for controlled T-cell activation, potentially offering improved safety and efficacy in DLL3-expressing cancers. The expansion into AIID with ZW1528 targeting both IL-4R⍺ and IL-33 represents a novel approach to treating mixed-type COPD through dual pathway inhibition.
The company's proprietary TOPO1i-based payload technology, utilized in multiple ADC candidates (ZW191, ZW220, ZW251), shows encouraging preclinical tolerability profiles. The high maximum tolerated doses observed in animal studies suggest potential for improved therapeutic windows compared to existing ADC approaches. The strategic focus on both high and low target-expressing tumors could potentially address broader patient populations.
- Company on track to deliver five Investigational New Drug (IND) applications as part of ‘5 by 5’ solid tumor strategy 18 months ahead of original target
- Nomination of ZW209, a novel trispecific T cell engager, as fifth development candidate in the Company’s solid tumor portfolio
- Expansion into autoimmune and inflammatory diseases (AIID) and hematology oncology leverages the Company’s clinically validated Azymetric™ technology platform and expertise in multispecific therapeutics
- ZW1528, the Company’s first development candidate in AIID, demonstrates dual blockade of two complementary pathways of respiratory inflammation and offers potential benefit in mixed-type chronic obstructive pulmonary disease (COPD)
- In-person and virtual R&D Day featuring Zymeworks research leadership and key opinion leaders to be held today at 8:30 am Eastern Standard Time (EST)
VANCOUVER, British Columbia, Dec. 12, 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 highlights from its R&D Day reviewing the Company’s development progress on its wholly-owned pipeline assets and expansion into new therapeutic areas in hematological cancers and autoimmune and inflammatory diseases (AIID).
“We are pleased to provide an update on our continued clinical progress with our solid tumor product portfolio, including the nomination of our fifth development candidate, ZW209, a novel, potential best-in-class, trispecific T cell engager that targets DLL3-expressing tumor cells. Importantly, the acceleration of our goal to build the initial ‘5 by 5’ solid tumor portfolio in five years – 18 months ahead of our initial target – highlights the strength of Azymetric™, our clinically validated, proprietary technology platform, and our ability to efficiently advance innovative therapies, with a productive R&D organization,” said Paul Moore, PhD, Chief Scientific Officer of Zymeworks. “This milestone demonstrates our team’s significant drug discovery capabilities and unwavering commitment to bringing transformative therapies to patients who urgently need new treatment options. The Company’s strong financial position provides the basis to properly support investment in an active and broad, wholly-owned R&D portfolio with strict criteria for continued investment based on results of early-clinical studies. A deep and diversified R&D portfolio in selected therapeutic categories in solid tumors, hematological cancers, and AIID provides significant optionality over future partnership and collaboration arrangements and our strategy to retain significant product rights in our R&D portfolio.”
“We are excited about the potential of our growing R&D pipeline of novel, differentiated, and multifunctional antibody-based therapeutics as we work to address difficult-to-treat diseases with traditionally poor outcomes and look forward to being able to share initial clinical data from our solid tumor product portfolio, starting potentially during 2025.”
Along with highlights from the Company’s pipeline, the event will feature three key opinion leaders who will discuss the clinical landscape and unmet medical needs for patients with gynecological, thoracic, and digestive system cancers:
- Jaffer A. Ajani, MD, Professor of Medicine, MD Anderson Cancer Center
- Susana Banerjee, MBBS MA PhD FRCP, Professor and Medical Oncologist, The Royal Marsden NHS Foundation Trust
- Hatim Husain, MD, Medical Oncologist and Associate Professor in the Department of Medicine, UC San Diego Health
Solid Tumor R&D Portfolio
Zymeworks is on track to advance five drug candidates into clinical trials in solid tumors including gynecological, thoracic, and digestive system cancers by the first half of 2026. This is approximately 18 months ahead of the Company’s original stated schedule of five IND applications by the end of 2027.
ZW209: Novel trispecific T cell engager targeting DLL3
ZW209, the Company’s fifth development candidate, is a novel trispecific T cell engager (TriTCE) targeting DLL3-expressing tumor cells with an optimized design using the clinically validated Azymetric™ and EFECT™ platforms. By leveraging obligate cis-T cell binding and conditional CD28 engagement, this first-in-class molecule has been designed to prevent unintended T cell activation, while enabling tumor-targeted cytotoxicity. The innovative design has demonstrated differentiated long-term cytotoxicity in vitro at low E:T ratios, with enhanced T cell proliferation and survival, offering significant potential to increase durability of responses in DLL3-expressing cancers. The Company expects to submit an IND and non-U.S. applications to commence Phase 1 clinical studies for ZW209 in 1H-2026.
ZW171: Mesothelin x CD3 targeted 2+1 format bispecific antibody
ZW171, a T cell-engaging bispecific antibody for the treatment of mesothelin (MSLN)-expressing solid tumors, was built using the Azymetric™ platform. ZW171’s unique geometry, with two single-chain fragment variable (scFv) arms targeting MSLN and one Fab arm targeting the cluster of differentiation 3 protein (CD3) component of the T cell receptor, redirects the body’s natural immune system to fight cancer cells.
A Phase 1 trial (NCT06523803) evaluating the safety and tolerability of ZW171 in advanced or metastatic ovarian cancer, non-small cell lung cancer (NSCLC), and other MSLN-expressing cancers was initiated in 2H-2024.
ZW191: Folate receptor-alpha (FR⍺) targeted topoisomerase I antibody-drug conjugate (ADC)
ZW191, a drug to antibody ratio (DAR) 8 ADC that targets FR⍺-expressing tumors including ovarian cancer, other gynecological cancers, and NSCLC, was built using the Company’s drug conjugate platforms, including its novel topoisomerase I inhibitor (TOPO1i) based payload technology, ZD06519. The FR⍺ monoclonal antibody incorporated in ZW191 was generated in-house and selected based on enhanced internalization characteristics to enable targeting of high, mid, and low levels of FR⍺ expression. ZW191 is associated with greater anti-tumor activity compared to benchmark in FRα-expressing tumor models and is well-tolerated in cynomolgus monkeys up to 60 mg/kg1.
ZW191 potentially offers a unique and differentiated profile compared to other FR⍺-targeted ADCs currently in development with potential activity in breadth of FR⍺-expressing tumors.
A Phase 1 trial (NCT06555744) evaluating the safety and tolerability of ZW191 in advanced FR⍺-expressing solid tumors including ovarian cancer, endometrial cancer, and NSCLC was initiated in 2H-2024.
ZW220: NaPi2b targeted topoisomerase I ADC
ZW220, a DAR4 ADC that targets sodium-dependent phosphate transporter 2b (NaPi2b)-expressing ovarian cancer and NSCLC, was built using the Company’s proprietary TOPO1i-based payload technology, ZD06519. The NaPi2b-targeting monospecific antibody incorporated in ZW220 was generated in-house and selected based on a favorable binding profile and enhanced internalization properties to enable targeting of both high- and low-expressing NaPi2b-expressing tumors. ZW220 potentially offers a differentiated safety profile compared to other NaPi2b-targeted ADCs currently in development, demonstrating high tolerability in animal studies, suggesting potential for high doses in humans. The Company expects to submit an IND and non-U.S. applications to commence Phase 1 clinical studies for ZW220 in 1H-2025.
ZW251: Glypican-3 targeted topoisomerase I ADC
ZW251, a potential first-in-class DAR4 ADC designed for the treatment of glypican 3 (GPC3)-expressing hepatocellular carcinoma (HCC), incorporates the Company’s proprietary TOPO1i-based payload technology, ZD06519. In preclinical studies, anti-tumor activity for ZW251 was observed in multiple patient-derived xenograft models of HCC reflecting a range of GPC3 over-expression. In animal studies, ZW251 displayed significant tolerability at doses up to 120 mg/kg. The Company expects to submit an IND and non-U.S. applications to commence Phase 1 clinical studies for ZW251 in 2H-2025.
The Company continues to develop and advance additional solid tumor product candidates beyond the 5 x 5 portfolio, with a specific focus on GI tract cancers, supporting further potential IND applications in 2027 and beyond.
Expansion into AIID & Hematology Oncology
Zymeworks’ strategic expansion into AIID and hematology oncology is driven by a targeted approach leveraging multispecific antibody therapeutics. By focusing on clinically validated targets with complex biology, the Company aims to address serious diseases affecting large patient populations who currently have restricted access to advanced therapeutics. The Company’s platform technologies offer a high-efficacy, convenient, and cost-effective solution, applying learnings from existing programs. Through innovative fragment crystallizable (Fc) modifications and a deep understanding of disease mechanisms, Zymeworks is advancing therapies designed to deliver meaningful improvements for these patient populations.
ZW1528: IL-4R⍺ x IL-33 bispecific antibody
ZW1528, the Company’s first program in AIID, is a novel IL-4R⍺ x IL-33 bispecific molecule designed to address respiratory inflammation such as mixed-type chronic obstructive pulmonary disease (COPD), by inhibiting multiple pathways. By targeting three cytokines in a single biologic, ZW1528 offers a unique approach that leverages clinically validated targets. The bispecific antibody is designed to provide complete, prolonged IL-4R⍺ blockade with simultaneous blockade of IL-33. Based on non-clinical studies, with native IgG-like geometry, ZW1528 demonstrates high manufacturability and incorporates half-life extending Fc modifications. The Company expects to file an IND and non-U.S. applications to commence Phase 1 clinical studies for ZW1528 in 2H-2026.
The Company continues to develop and advance additional product candidates beyond ZW1528 in multiple different product formats in selected therapeutic indications in AIID and hematological cancers, with further potential IND applications planned from 2027 and beyond.
“Our expansion into AIID and hematology oncology, along with continued efforts in solid tumors, represents a carefully considered R&D strategy to create meaningful value for our stockholders, driven by the exceptional creativity and scientific rigor of our R&D organization. By strategically expanding our research to additional selected therapeutic indications that align with our technological strengths in multifunctional therapeutics, our goal is to continue delivering meaningful breakthroughs for patients building on our experience in the discovery and development of zanidatamab,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “By maintaining disciplined pipeline progression, and embracing selective, strategic partnerships, we are seeking to build transformative solutions that have the potential to redefine treatment paradigms, while preserving our focus and capital efficiency. I am deeply encouraged by our progress since our previous R&D Day in 2022 and excited about the groundbreaking work ahead and the potential impact we may deliver for patients.”
R&D Day Webcast Information
A live webcast of the Company’s R&D Day event will be available on the Investors section of Zymeworks’ website. A replay of the webcast will be available following the presentation.
About Zymeworks Inc.
Zymeworks is a global clinical-stage 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. The U.S. FDA granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). Ziihera® is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. A BLA has also been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with investigational new drug applications for ZW220 and ZW251 planned for 2025. In addition to Zymeworks’ 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 regulatory submissions and the timing thereof; expectations regarding future regulatory filings and approvals and the timing thereof; the timing of and results of interactions with regulators; the timing and status of ongoing and future studies and the related data; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; anticipated preclinical and clinical data presentations; the potential addressable market of zanidatamab and Zymeworks’ other product candidates; potential safety profile and therapeutic effects of zanidatamab and Zymeworks’ other product candidates; the commercial potential of technology platforms and product candidates; Zymeworks’ early-stage pipeline; Zymeworks’ ability to execute new collaborations and partnerships 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: 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; zanidatamab and any of Zymeworks’ other product candidates may not be successfully commercialized; Zymeworks may not achieve milestones or receive additional payments 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; the impact of pandemics and other health crises on Zymeworks’ 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’ behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; 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 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.
Contacts
Investor Inquiries:
Shrinal Inamdar
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com
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1 Lawn S., et al. Presented at AACR 2024 (abst #1862)
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