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Zymeworks Inc. (Nasdaq: ZYME) is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. The company's mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases.
Zymeworks specializes in developing best-in-class bi-specific antibodies and antibody-drug conjugates (ADCs) to treat oncology, autoimmunity, and inflammatory diseases. Their proprietary platforms, including Azymetric™, Albucore™, and ZymeLink™, enable the creation of highly potent bi-specific antibodies and multivalent protein therapeutics targeting a range of indications.
The company's leading therapeutic candidate, zanidatamab, is a novel HER2-targeted bispecific antibody currently in multiple Phase 1, Phase 2, and pivotal clinical trials globally. Zanidatamab is being developed as a targeted treatment for patients with HER2-expressing cancers. Recent milestones include the acceptance of a Biologics License Application (BLA) by the FDA and China's National Medical Products Administration (NMPA) for second-line treatment of HER2-positive biliary tract cancers (BTC).
Zymeworks is also advancing a deep preclinical pipeline, including candidates like zanidatamab zovodotin (ZW49) and new investigational drugs ZW171 and ZW191, with plans for multiple IND filings in 2024 and 2025. The company is financially robust, with a cash runway extending into the second half of 2027, bolstered by strategic partnerships with BeiGene and Jazz Pharmaceuticals, among others.
The company's complementary therapeutic platforms and fully integrated drug development engine enable precise engineering of differentiated product candidates, offering potential best-in-class treatments for various challenging diseases. For more information, visit www.zymeworks.com.
Zymeworks Inc. (Nasdaq: ZYME) has appointed Leone Patterson as Executive Vice President, and Chief Business and Financial Officer, effective September 1, 2024. With over 20 years of public company biotech experience, Patterson brings expertise in guiding strategy, finance, operations, and governance through various growth phases. She will be instrumental in supporting Zymeworks' '5 by 5' goal of having five novel antibody-drug conjugates or T cell engagers in clinical studies by 2026, and advancing R&D programs into clinical studies by 2027.
Patterson's prior roles include Chief Financial and Business Officer at Tenaya Therapeutics and leadership positions at Adverum Biotechnologies. She currently serves on the boards of Nkarta, Inc. and Oxford Biomedica. Based in Zymeworks' new Redwood City, California location, Patterson will focus on developing long-term financial strategies and supporting strategic business decisions.
Zymeworks Inc. (Nasdaq: ZYME) announced FDA clearance of its Investigational New Drug (IND) application for ZW191, a novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor antibody-drug conjugate (ADC). ZW191 targets FR⍺-expressing tumors, including ovarian, gynecological cancers, and non-small cell lung cancer (NSCLC). The drug incorporates a unique combination of antibody-linker stability and payload potency, with strong bystander activity.
Key features of ZW191 include:
- A drug-antibody ratio of eight for balanced tolerability and efficacy
- In-house generated FR⍺ monoclonal antibody for enhanced internalization
- Ability to target high, mid, and low levels of FR⍺ expression
- Robust anti-tumor activity and strong safety profile in preclinical models
Zymeworks, a clinical-stage biotech firm listed on Nasdaq under the symbol ZYME, will announce its Q2 2024 financial results after market close on August 1, 2024. The company develops novel biotherapeutics for hard-to-treat diseases. Following the financial release, Zymeworks' management will host a conference call and webcast at 4:30 pm ET on the same day to discuss the results and provide a corporate update. The webcast will be available live, with replays accessible on the Zymeworks website.
Zymeworks (Nasdaq: ZYME) announced that the FDA has cleared its investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting bispecific antibody designed to treat mesothelin (MSLN)-expressing cancers such as ovarian cancer, non-small cell lung cancer, and mesothelioma.
ZW171 aims to improve upon current bispecific T-cell engagers by enhancing tumor selectivity and safety, demonstrating promising preclinical results.
The company plans to initiate clinical trials in 2024 and seek regulatory approval in other regions in the latter half of 2024, aligning with its ‘5 by 5’ strategy to advance additional therapies over the next two years.
ZW171 has shown potential to provide a more effective and tolerable treatment option, leveraging Zymeworks' Azymetric™ and EFECT™ technologies to enhance anti-tumor activity and safety.
Zymeworks announced the acceptance of the Biologics License Application (BLA) for zanidatamab by the National Medical Products Administration (NMPA) in China for second-line treatment of HER2-positive biliary tract cancer (BTC). This acceptance triggers an $8 million milestone payment from BeiGene, with potential for up to $164 million in future milestones and royalties on product sales. The application is based on data from the HERIZON-BTC-01 trial, showing a 41.3% objective response rate, a 12.9-month median duration of response, and a 5.5-month median progression-free survival. Additionally, the U.S. FDA recently accepted a BLA for zanidatamab for priority review, with a target action date of November 29, 2024. Zymeworks has already received $53 million in payments under its collaboration with BeiGene, not including the recent $8 million milestone.
Zymeworks, a clinical-stage biotechnology company focusing on novel biotherapeutics for difficult-to-treat diseases, has announced its participation in several upcoming investor conferences.
Management will engage in one-on-one meetings and presentations at these events:
1. Jefferies Global Healthcare Conference: June 5-6, with a fireside chat on June 5 at 10:30 am ET in New York.
2. Goldman Sachs 45th Annual Global Healthcare Conference: June 12 at 2:00 pm ET in Miami.
3. Citi’s 2024 European Healthcare Conference: Virtual one-on-one meetings on June 20.
Zymeworks Inc. reported $420.5 million in cash resources as of March 31, 2024, with projected funding into 2H 2027. They completed a BLA filing with the FDA for zanidatamab and plan a Phase 3 trial for breast cancer patients. The company also announced multiple IND submissions and abstract presentations at key oncology meetings. Revenue for Q1 2024 was $10.0 million, with a net loss of $31.7 million.
Zymeworks Inc. (ZYME) will be participating in the Bank of America Securities Health Care Conference and the J.P. Morgan Biotech Virtual Call Series on May 15th, 2024. The company is focused on developing innovative biotherapeutics to address challenging medical conditions.
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