Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-⍺ Expressing Advanced Solid Tumors
Zymeworks (NASDAQ: ZYME) has initiated dosing in a global Phase 1 clinical trial for ZW191, targeting folate receptor-⍺ (FR⍺) expressing advanced solid tumors. The trial (NCT06555744) will evaluate safety and tolerability in treating advanced ovarian, endometrial, and non-small cell lung cancers. The two-part study aims to enroll 145 adult patients across North America, Europe, and Asia-Pacific. ZW191 showed promising pre-clinical results with greater anti-tumor activity compared to benchmark in FR⍺-expressing tumor models. FR⍺ is present in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas.
Zymeworks (NASDAQ: ZYME) ha dato inizio alla somministrazione in un trial clinico globale di fase 1 per ZW191, indirizzato ai tumori solidi avanzati che esprimono il recettore del folato-⍺ (FR⍺). Lo studio (NCT06555744) valuterà la sicurezza e la tollerabilità nel trattamento di carcinoma ovarico avanzato, carcinoma endometriale e carcinoma polmonare non a piccole cellule. Il trial, suddiviso in due parti, mira a reclutare 145 pazienti adulti in Nord America, Europa e Asia-Pacifico. ZW191 ha mostrato risultati preclinici promettenti con una maggiore attività antitumorale rispetto al benchmark nei modelli tumorali che esprimono FR⍺. Il FR⍺ è presente in circa il 75% dei carcinomi ovarici sierosi di alto grado e nel 70% degli adenocarcinomi polmonari.
Zymeworks (NASDAQ: ZYME) ha iniciado la administración en un ensayo clínico global de fase 1 para ZW191, dirigido a tumores sólidos avanzados que expresan el receptor de folato-⍺ (FR⍺). El ensayo (NCT06555744) evaluará la seguridad y tolerabilidad en el tratamiento de cáncer de ovario avanzado, cáncer endometrial y cáncer de pulmón no microcítico. El estudio, que consta de dos partes, tiene como objetivo reclutar a 145 pacientes adultos en América del Norte, Europa y Asia-Pacífico. ZW191 mostró resultados preclínicos prometedores con una mayor actividad antitumoral en comparación con el estándar en modelos tumorales que expresan FR⍺. El FR⍺ se encuentra presente en aproximadamente el 75% de los carcinomas serosos de ovario de alto grado y en el 70% de los adenocarcinomas de pulmón.
Zymeworks (NASDAQ: ZYME)는 ZW191의 글로벌 1상 임상 시험에서 투여를 시작했습니다. 이 시험은 엽산 수용체-⍺ (FR⍺)를 발현하는 고급 고형 종양을 대상으로 합니다. 시험(NCT06555744)은 고급 난소암, 자궁내막암 및 비소세포 폐암 치료의 안전성과 내약성을 평가할 것입니다. 두 부분으로 나누어진 연구는 북미, 유럽 및 아시아-태평양 지역에서 145명의 성인 환자를 등록하는 것을 목표로 하고 있습니다. ZW191은 FR⍺ 발현 종양 모델에서 기준에 비해 더 큰 항종양 활성으로 유망한 전임상 결과를 보여주었습니다. FR⍺는 고급 세포성 난소암의 약 75%와 폐 선암의 70%에 존재합니다.
Zymeworks (NASDAQ: ZYME) a lancé la phase de dosage d'un essai clinique mondial de phase 1 pour ZW191, ciblant les tumeurs solides avancées exprimant le récepteur du folate-⍺ (FR⍺). L'essai (NCT06555744) évaluera la sécurité et la tolérabilité dans le traitement du cancer de l'ovaire avancé, du cancer de l'endomètre et du cancer du poumon non à petites cellules. L'étude en deux parties vise à recruter 145 patients adultes en Amérique du Nord, en Europe et en Asie-Pacifique. ZW191 a montré des résultats précliniques prometteurs avec une activité antitumorale supérieure par rapport aux références dans les modèles tumoraux exprimant FR⍺. FR⍺ est présent dans environ 75 % des carcinomes séreux de l'ovaire de haut grade et 70 % des adénocarcinomes pulmonaires.
Zymeworks (NASDAQ: ZYME) hat die Dosisverabreichung in einer globalen Phase-1-Studie für ZW191 gestartet, die auf fortgeschrittene solide Tumoren abzielt, die den Folsäurerezeptor-⍺ (FR⍺) exprimieren. Die Studie (NCT06555744) wird die Sicherheit und Verträglichkeit bei der Behandlung von fortgeschrittenem Eierstock-, Endometrium- und nicht-kleinzelligem Lungenkrebs bewerten. Die zweigeteilte Studie zielt darauf ab, 145 erwachsene Patienten in Nordamerika, Europa und Asien-Pazifik zu rekrutieren. ZW191 zeigte vielversprechende präklinische Ergebnisse mit einer höheren antitumoralen Aktivität im Vergleich zu Standardwerten in FR⍺-exprimierenden Tumormodellen. FR⍺ ist in etwa 75% der hochgradigen serösen Eierstockkarzinome und 70% der Lungenadenokarzinome vorhanden.
- Pre-clinical data showed superior anti-tumor activity compared to benchmark
- Large addressable market with FR⍺ present in 75% of ovarian carcinomas and 70% of lung adenocarcinomas
- Global trial expansion across multiple regions increases potential patient reach
- Early-stage Phase 1 trial indicates long path to potential commercialization
- Significant competition in the oncology space
Insights
The initiation of ZW191's Phase 1 trial represents a significant development in Zymeworks' oncology pipeline. The trial targets folate receptor-α (FRα), which is highly expressed in
The preclinical data showing superior anti-tumor activity compared to benchmarks and good tolerability up to 60 mg/kg in animal models provides a promising foundation. The two-part study structure, focusing first on safety and dose-finding before expanding to efficacy evaluation, follows a well-established clinical development pathway. However, investors should note that Phase 1 trials typically have a
Global Phase 1 clinical trial will evaluate the safety and tolerability of ZW191 in treatment of advanced cancers including ovarian, endometrial, and non-small cell lung cancers
VANCOUVER, British Columbia, Nov. 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 that the first patient has been dosed in the company’s first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the investigational therapy ZW191 in the treatment of advanced folate receptor-⍺ (FR⍺)-expressing solid tumors including ovarian, endometrial, and non-small cell lung (NSCLC) cancers.
“Our team is excited to initiate this important clinical trial to assess the safety and tolerability of ZW191, our first antibody-drug conjugate utilizing ZD06519, our novel proprietary payload, in patients with difficult-to-treat cancers,” said Jeff Smith, M.D., FRCP, Executive Vice President and Chief Medical Officer at Zymeworks. “This global study represents a significant milestone in our mission to bring innovative and urgently needed therapies to patients in need. This announcement also follows the recent initiation of our Phase 1 trial of ZW171, marking an additional important step forward in advancing the many promising therapies in our wholly-owned pipeline.”
FRα is found in ~
The Phase 1 trial is a two-part, multi-center, global study that aims to enroll 145 adult patients with advanced FR⍺-expressing cancers. The Company expects to enroll patients at investigator sites in North America, Europe, and the Asia-Pacific region. Part one of the study will evaluate the safety and tolerability of ZW191 and involve dose escalation in patients with advanced ovarian, endometrial, and NSCLC cancers, with secondary endpoints assessing pharmacokinetics and confirmed objective response rate. Part two of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.
About ZW191
ZW191 is an antibody-drug conjugate that is engineered to target a protein called folate receptor-⍺ (FR⍺) that is found on the surface of a variety of tumors such as on ovarian, endometrial, and lung cancers. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.
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. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for zanidatamab as a treatment for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) has been accepted and granted Priority Review. A BLA has also been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S. and 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. 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.
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 the timing and status of ongoing and future studies and the release of data; expectations regarding future regulatory filings and approvals and the timing thereof; the timing of and results of interactions with regulators; anticipated regulatory submissions and the timing thereof; Zymeworks’ preclinical pipeline; the anticipated benefits of the collaboration agreements with Jazz and BeiGene; the commercial potential of technology platforms and product candidates; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; the potential addressable market of zanidatamab; potential safety profile and therapeutic effects of zanidatamab and Zymeworks’ other product candidates; 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”, “anticipate”, “potential”, “will”, “continues”, 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 and any future 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 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; 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 “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
1 Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
2 O'Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.
3 Lawn S., et al. Presented at AACR 2024 (abst #1862).
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