Latest news with #ZW251
Yahoo
3 days ago
- Business
- Yahoo
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
Second antibody-drug conjugate (ADC) to progress into clinical development utilizing our proprietary payload and optimized antibody Preclinical results demonstrate strong anti-tumor activity and favorable tolerability profile Phase 1 clinical trial evaluating ZW251 in hepatocellular carcinoma (HCC) expected to be initiated in 2025 VANCOUVER, British Columbia, July 28, 2025 (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, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW251, a novel glypican-3 (GPC3)-targeted ADC incorporating the company's proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of HCC. HCC is the most common type of primary liver cancer, with GPC3 expressed in over 75% of cases1. ZW251 is a potential first-in-class ADC engineered to selectively target GPC3. It is composed of a humanized IgG1 antibody conjugated to a novel camptothecin-based TOPO1i using a validated peptide cleavable linker. A drug-antibody-ratio (DAR) of four was selected for ZW251 as a lower DAR potentially could unlock a broader range of dose levels, a potential benefit as HCC patients are commonly challenged by impairment of liver function as a result of chronic liver disease and cirrhosis. In preclinical studies, ZW251 demonstrated strong activity in a range of HCC models, including a range of patient derived xenografts exhibiting a breadth of GPC3 expression and noteworthy tolerability in non-human primate toxicology studies at doses up to 120 mg/kg. 'This advancement marks the second ADC from our wholly-owned pipeline, utilizing our proprietary TOPO1i payload, to progress into clinical development, reinforcing confidence in our approach,' said Paul Moore, Ph.D., Chief Scientific Officer of Zymeworks. 'Like ZW191, which is currently in clinical trials, ZW251 utilizes the same payload paired with an optimized antibody. Our observations with ZW191 in the clinic to date provide a strong foundation as we initiate clinical development of this second ADC. With its novel design, unique mechanism of action, and promising preclinical activity, ZW251 offers the potential to meaningfully improve upon the current standard of care for HCC either as a monotherapy or in combination.' We plan to commence Phase 1 clinical studies for ZW251 in 2025. 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 conditions such as cancer, inflammation, and autoimmune disease. 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 BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China' s NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The European Commission (EC) has granted conditional marketing authorization for Ziihera® as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive biliary tract cancer in the U.S., Europe, and China. In addition, zanidatamab is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. 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 actively recruiting and ZW251 is expected to enter clinical trials in 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 and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking StatementsThis 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 efficacy and safety of zanidatamab and Zymeworks' product candidates; ongoing clinical studies and regulatory reviews; the potential addressable market of zanidatamab and Zymeworks' product candidates; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies, clinical trials and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab and Zymeworks' product candidates; and the commercial potential of technology platforms and product candidates. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'intend', 'continues', '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, including any required confirmatory 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; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; 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; zanidatamab and Zymeworks' product candidates may not be successfully commercialized; 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 and 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 InamdarSenior Director, Investor Relations(604) 678-1388ir@ Media Inquiries:Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@ _______________________ 1 Wang HL et al., Arch Pathol Lab Med 2008.
Toronto Star
3 days ago
- Business
- Toronto Star
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
Second antibody-drug conjugate (ADC) to progress into clinical development utilizing our proprietary payload and optimized antibody Preclinical results demonstrate strong anti-tumor activity and favorable tolerability profile Phase 1 clinical trial evaluating ZW251 in hepatocellular carcinoma (HCC) expected to be initiated in 2025 VANCOUVER, British Columbia, July 28, 2025 (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, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW251, a novel glypican-3 (GPC3)-targeted ADC incorporating the company's proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of HCC.
Hamilton Spectator
3 days ago
- Business
- Hamilton Spectator
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
VANCOUVER, British Columbia, July 28, 2025 (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, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW251, a novel glypican-3 (GPC3)-targeted ADC incorporating the company's proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of HCC. HCC is the most common type of primary liver cancer, with GPC3 expressed in over 75% of cases1. ZW251 is a potential first-in-class ADC engineered to selectively target GPC3. It is composed of a humanized IgG1 antibody conjugated to a novel camptothecin-based TOPO1i using a validated peptide cleavable linker. A drug-antibody-ratio (DAR) of four was selected for ZW251 as a lower DAR potentially could unlock a broader range of dose levels, a potential benefit as HCC patients are commonly challenged by impairment of liver function as a result of chronic liver disease and cirrhosis. In preclinical studies, ZW251 demonstrated strong activity in a range of HCC models, including a range of patient derived xenografts exhibiting a breadth of GPC3 expression and noteworthy tolerability in non-human primate toxicology studies at doses up to 120 mg/kg. 'This advancement marks the second ADC from our wholly-owned pipeline, utilizing our proprietary TOPO1i payload, to progress into clinical development, reinforcing confidence in our approach,' said Paul Moore, Ph.D., Chief Scientific Officer of Zymeworks. 'Like ZW191, which is currently in clinical trials, ZW251 utilizes the same payload paired with an optimized antibody. Our observations with ZW191 in the clinic to date provide a strong foundation as we initiate clinical development of this second ADC. With its novel design, unique mechanism of action, and promising preclinical activity, ZW251 offers the potential to meaningfully improve upon the current standard of care for HCC either as a monotherapy or in combination.' We plan to commence Phase 1 clinical studies for ZW251 in 2025. 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 conditions such as cancer, inflammation, and autoimmune disease. 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 BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China' s NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The European Commission (EC) has granted conditional marketing authorization for Ziihera® as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer previously treated with at least one prior line of systemic therapy. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive biliary tract cancer in the U.S., Europe, and China. In addition, zanidatamab is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. 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 actively recruiting and ZW251 is expected to enter clinical trials in 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 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 the efficacy and safety of zanidatamab and Zymeworks' product candidates; ongoing clinical studies and regulatory reviews; the potential addressable market of zanidatamab and Zymeworks' product candidates; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies, clinical trials and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab and Zymeworks' product candidates; and the commercial potential of technology platforms and product candidates. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'intend', 'continues', '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, including any required confirmatory 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; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; 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; zanidatamab and Zymeworks' product candidates may not be successfully commercialized; 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 and ). 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 Senior Director, Investor Relations (604) 678-1388 ir@ Media Inquiries: Diana Papove Senior Director, Corporate Communications (604) 678-1388 media@ _______________________ 1 Wang HL et al., Arch Pathol Lab Med 2008.
Yahoo
06-03-2025
- Business
- Yahoo
Zymeworks Inc (ZYME) Q4 2024 Earnings Call Highlights: Strategic Shifts and Financial Insights
Net Loss: $122.7 million for the year-ended December 31, 2024, compared to $118.7 million in 2023. Revenue: $76.3 million for the year-ended December 31, 2024, compared to $76 million in 2023. Partnership Earnings: Over $45 million earned from partnerships in the past 12 months. Cash Resources: $324.2 million as of December 31, 2024, compared to $456.3 million as of December 31, 2023. Operating Expenses: $213.4 million for the year-ended December 31, 2024, compared to $214.1 million in 2023. Other Income, Net: $20.5 million for the year-ended December 31, 2024, compared to $18.8 million in 2023. Shares Outstanding: Approximately 69.6 million shares of common stock and 5.1 million shares issuable under prefunded warrants. Research Milestone from GSK: $14 million achieved in January 2025. Net Product Sales by Jazz: $1.1 million in Q4 2024. Warning! GuruFocus has detected 5 Warning Signs with ZYME. Release Date: March 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Zymeworks Inc (NASDAQ:ZYME) reported a successful quarter marked by the approval of zanidatamab and progress in clinical development. The company has earned over $45 million from partnerships in the past 12 months, highlighting the strength of its collaborations. Zymeworks Inc (NASDAQ:ZYME) has a strong financial position with $324.2 million in cash resources, providing a cash runway into the second half of 2027. The company is expanding its focus into autoimmune and inflammatory diseases, as well as hematological oncology, reflecting its commitment to innovation. Zymeworks Inc (NASDAQ:ZYME) has initiated two global Phase I clinical trials for ZW171 and ZW191, with steady progress in patient recruitment across multiple regions. Zymeworks Inc (NASDAQ:ZYME) reported a net loss of $122.7 million for the year-ended December 31, 2024, an increase from the previous year. The increase in net loss was primarily due to a $17.3 million noncash impairment charge related to zanidatamab, zovodotin. Revenue for 2024 was relatively flat compared to 2023, with only a slight increase from $76 million to $76.3 million. The company decided to discontinue the zanidatamab, zovodotin clinical development program, resulting in a noncash impairment charge. Zymeworks Inc (NASDAQ:ZYME) experienced a decrease in cash resources from $456.3 million as of December 31, 2023, to $324.2 million as of December 31, 2024. Q: On ZW251, should we expect an urgency to initiate combination cohorts quicker than for other compounds? A: Kenneth Galbraith, CEO: We have the same strategy for the entire portfolio, focusing on early signs of tumor activity. We believe ADCs and T cell engagers used in combination with standard-of-care might create sustainable responses. For ZW251 in HCC, given the poor prognosis, we aim to study it in dose escalation and then in combination cohorts for stronger outcomes. Q: What prompted the prioritization of ZW251 over ZW220? A: Kenneth Galbraith, CEO: We actively manage our portfolio and prioritize based on resource allocation. We are excited about ZW251 and have accelerated its clinical studies. ZW220 remains interesting and is IND-ready, but our focus is on ZW251 due to its potential impact on a different patient population. Q: Is the delay in the HERIZON-GEA-01 trial readout due to slower enrollment or event rate accumulation? A: Kenneth Galbraith, CEO: We can't speculate on clinical data specifics. Jazz provided guidance on the trial's timing and rationale. I refer you to their recent updates for more details. Q: Was there a standout result in ZW251's preclinical work that influenced its prioritization? A: Kenneth Galbraith, CEO: We always seek to accelerate clinical studies. ZW251's preclinical data, particularly in HCC models, has been exciting and supports our decision to prioritize it. We aim to bring it to patients as soon as possible. Q: What are the gating factors for filing the IND for ZW1528 in autoimmune and inflammatory diseases? A: Paul Moore, CSO: We are excited about ZW1528's preclinical profile. We need to complete IND-enabling activities, including tox study plans and material preparation. We aim for a realistic timeline, targeting the second half of 2026. Q: How does ZW191's linker stability compare to competitors, and what is its expected toxicity profile? A: Paul Moore, CSO: Our linker stability is traditional, avoiding highly stable linkers. We focus on a tolerable profile to allow higher dosing and combination strategies. Preclinical data supports this approach, aiming for a more efficacious response. Q: How are you thinking about data disclosure for ZW171 and ZW191? A: Kenneth Galbraith, CEO: We will provide updates at peer-reviewed meetings once we have meaningful data. The studies are progressing well, and we aim to present data that is significant and informative. Q: Can you share thoughts on multi-payload ADCs? A: Paul Moore, CSO: We consider multi-payload ADCs and are investigating additional payloads. The decision depends on the therapeutic rationale and the biology of the target indication. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
