ZYME - Zymeworks Outlines Strategic Priorities and Outlook for 2024 and 2025 | Benzinga
- Company well-positioned for further progress and broadening of R&D pipeline
- Cash resources of approximately $455 million as of December 31, 2023 (unaudited)
- Expected cash runway, including proceeds from recent private placement, into 2H 2027
- Top-line data readout from the Phase 3 trial evaluating zanidatamab in HER2-positive gastroesophageal adenocarcinoma (GEA), HERIZON-GEA-01, expected in 2024
- Expected regulatory reviews ongoing during 2024 for zanidatamab in second-line biliary tract cancers (BTC) in the United States and China with our partners Jazz Pharmaceuticals and BeiGene
- Expected Investigational New Drug (IND) applications and first-in-human (FIH) studies for ZW171 and ZW191 candidates in 2024 and ZW220 and ZW251 in 2025
- Progression on ‘5 by 5' portfolio and ADVANCE with R&D Day scheduled for Q4-24
- Additional leadership appointments announced separately today
- Company presentation on Thursday, January 11, 2024 at 08:15 a.m. Pacific Time (PT) at the J.P. Morgan 42nd Annual Healthcare Conference
VANCOUVER, British Columbia, Jan. 04, 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 provided an update on key strategic priorities for 2024 and 2025.
"We begin 2024 in an exciting position, having met key objectives set for our programs in 2022 and 2023, including generating data supporting the clinical development of zanidatamab, identifying strong new preclinical product candidates and ensuring that we continue to have the financial resources and leadership necessary to support the Company's strategic objectives," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. "We're looking forward to 2024 as we approach a pivotal Phase 3 data readout this year with our partners Jazz Pharmaceuticals and BeiGene from the HERIZON-GEA-01 clinical trial for our lead candidate, zanidatamab, in first-line gastroesophageal andenocarcinoma. These data, coupled with the potential for initial regulatory approvals for zanidatamab in second-line biliary tract cancers in 2025 or earlier, are expected to be significant events in our progress to make a meaningful difference in the lives of cancer patients. Beyond zanidatamab, our growing global presence helps position us to achieve efficiency in clinical development, with a continued focus on advancing nominated product candidates from our ‘5 by 5' portfolio and our ADVANCE R&D strategy. We will continue to evaluate opportunities to broaden or accelerate our development efforts through the formation of strategic partnerships and collaborations."
"Our most important current R&D priority is to progress our differentiated portfolio of antibody-drug conjugates (ADCs) into clinical studies during 2024 and 2025, especially our potential best-in-class folate receptor-alpha-targeted ADC, ZW191, expected to enter FIH studies during 2024. Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025. All three ADCs were designed with our moderate-potency, proprietary topoisomerase 1 inhibitor, ZD06519. Beyond ADCs, we look to make progress in our differentiated approach to next-generation multi-specific antibodies, starting with our planned IND filing and FIH studies in 2024 for ZW171, our 2+1 mesothelin-directed T-cell engager."
"We were also able to strengthen our board of directors with the additions of Carlos Campoy, Dr. Nancy Davidson and Derek Miller in 2023," said Mr. Galbraith. "These appointments, together with the separate announcement today of the broadening of the Zymeworks leadership team, underscore our commitment to having the expertise and experience in place at all levels to achieve our business objectives in 2024 and 2025."
Key 2023 Accomplishments:
- Our partner, Jazz Pharmaceuticals, presented positive pivotal Phase 2b trial data (NCT04466891) evaluating zanidatamab in HER2-amplified BTC at the American Society of Clinical Oncology annual meeting and initiated rolling Biologics License Application (BLA) submission for accelerated approval in second-line BTC with completion expected in the first half of 2024;
- Our partner, Jazz Pharmaceuticals, gained alignment with FDA on the confirmatory trial evaluating zanidatamab in first-line metastatic BTC patients;
- Continued patient enrollment in the HERIZON-GEA-01 (NCT05152147) pivotal clinical study for zanidatamab in first-line HER2-positive GEA remains on track to announce top-line data during 2024;
- Nominated two new preclinical product candidates (ZW220 and ZW251) that leverage Zymeworks' novel ADC technology platforms, with planned IND applications for both candidates in 2025;
- Through a series of publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of IND candidates in our ‘5 by 5' program (ZW171, ZW191, ZW220, and ZW251);
- Regained full development rights for zanidatamab zovodotin (ZW49) with plans to conduct a Phase 2 study in NSCLC in 2024;
- Strengthened board of directors through the addition of three new members, Carlos Campoy, Dr. Nancy Davidson, and Derek Miller;
- Expanded the global footprint of our Early-Stage Development team into Dublin, California, and Singapore while retaining key talent and establishing fit-for-purpose facilities;
- Inclusion of common stock in Russell 3000 Index and Nasdaq Biotechnology Index (NBI) as a result of redomicile to Delaware and switch from NYSE to Nasdaq completed in 2022; and
- Completed $50 million private placement to EcoR1 Capital, with proceeds expected to help extend cash runway into H2 2027.
"2023 was an important year for Zymeworks and for our shareholders," said Mr. Galbraith. "With the significant accomplishments of last year, we believe we have the resources and expertise in place to continue to make substantial progress in 2024 and 2025, to advance our fully unencumbered development programs, and execute on our ...