Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-⍺ Expressing Advanced Solid Tumors

ZYME 11.05.2024

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    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,” saidJeff Smith, M.D., FRCP, Executive Vice President and Chief Medical Officer atZymeworks. “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 ~75% of high-grade serous ovarian carcinomas1and ~70% of lung adenocarcinomas2. In data presented at theAmerican Association for Cancer Research(AACR) Annual Meeting in 2024, ZW191 was associated with greater anti-tumor activity compared to benchmark in FRα-expressing tumor models and was well-tolerated in cynomolgus monkeys up to 60 mg/kg3.

    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 inNorth America,Europe, and theAsia-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 ZW191ZW191 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 byZymeworksto kill tumor cells.

    AboutZymeworks Inc.

    Zymeworksis 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.Zymeworksengineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary AzymetricTM technology.Zymeworkshas entered into separate agreements with BeiGene, Ltd. (BeiGene) andJazz 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 theU.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 theCenter for Drug Evaluation(CDE) of theNational Medical Products Administration(NMPA) inChina. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in theU.S.andChina.Zymeworksis 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 aboutZymeworks, visitwww.zymeworks.comand follow@ZymeworksIncon 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.Zymeworksbelieves there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.Zymeworksmay 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 theSecurities and Exchange Commission(copies of which may be obtained atwww.sec.govandwww.sedar.com).

    AlthoughZymeworksbelieves 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,Zymeworksundertakes 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 InamdarDirector, Investor Relations(604) 678-1388ir@zymeworks.com

    Media Inquiries:

    Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@zymeworks.com

    1Köbel, M., Madore, J., Ramus, S. et al., BrJ Cancer111, 2297–2307 (2014).2O'Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.3Lawn S., et al. Presented at AACR 2024 (abst #1862).

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    Source: Zymeworks Inc.

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