On January 11, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported its key accomplishments in 2020 and updated its corporate priorities (Press release, Zymeworks, JAN 11, 2021, View Source [SID1234573790]).
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"2020 was a leap forward for our lead clinical program in terms of a potential first approval and future approvals," said Ali Tehrani, Ph.D., President and CEO at Zymeworks. "The launch of our first pivotal trial and achievement of Breakthrough Therapy designation for zanidatamab mark important milestones towards our accelerated commercialization strategy, and our new clinical partnerships further strengthen zanidatamab’s broad therapeutic profile. 2021 promises to be a data-rich year for both zanidatamab and ZW49 as we continue to demonstrate their potential to become foundational therapies in the treatment of HER2-expressing cancers."
2020 Achievements
Zanidatamab Enters Late-Stage Clinical Development with Accelerated Strategy
Zymeworks initiated a global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC). This single arm trial is designed to support accelerated approval based on a primary endpoint of objective response rate and may enable submission of a Biologics License Application (BLA) as early as 2022.
Zanidatamab received additional drug review special designations in the U.S. and the European Union. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for BTC and the European Commission (EC) granted Orphan Drug designation for gastroesophageal adenocarcinoma (GEA), expediting potential commercialization. Previously the FDA granted two Fast Track designations to zanidatamab, in BTC and GEA, in addition to Orphan Drug designations for BTC, GEA, and ovarian cancer.
Zanidatamab Data and Partnerships Continue to Support Broad Therapeutic Potential
Gastric Cancer: Clinical data from patients with refractory GEA treated with zanidatamab monotherapy as well as zanidatamab in combination with chemotherapy were updated and support plans to launch a second pivotal trial as 1st line treatment for advanced HER2-positive GEA in mid-2021 with partner BeiGene. These data will be updated as part of an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, January 15, 2021.
Breast Cancer: Clinical collaborations were initiated to evaluate zanidatamab in combination with a CD47 blocker (ALX Oncology’s ALX148) in patients with advanced HER2‑expressing breast cancer and with a CDK4/6 inhibitor (Pfizer’s Ibrance) in patients with HER2‑positive, HR-positive breast cancer.
Endometrial Cancer: Zymeworks’ first investigator-led trial was initiated by Dr. Vicky Makker at Memorial Sloan Kettering Cancer Center. The Phase 2 trial will evaluate zanidatamab monotherapy in HER2-overexpressed advanced endometrial cancers and carcinosarcomas.
Clinical Advancement of HER2 Bispecific ADC, ZW49, for HER2 Expressing Cancers
ZW49 is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers that have progressed following treatment with existing approved therapies, including HER2-targeted agents. Clinical studies continued in 2020 with dose escalation to determine the safety and efficacy profile of ZW49. Zymeworks will be providing a clinical progress update for ZW49 by webcast on Wednesday, January 27, 2021 at 4:30 pm ET.
Commercial, Clinical and Scientific Competencies Added to Leadership Team
Zymeworks welcomed key commercial, scientific and clinical development talent to the leadership team with the additions of Guowei Fang, Ph.D., as Senior Vice President, Research, James Priour as Senior Vice President, Commercial, Manny Duenas as Vice President, Global Value and Access, and Pamela Farmer, MD, as Vice President, Global Patient Safety.
Partnerships Advance: Milestone Payments Received and Deal Values Increase
Our partnerships continued to advance in 2020 with Iconic/Exelixis achieving a milestone for ZymeLink together with new and expanded Azymetric and EFECT collaborations with Merck and BMS. Zymeworks has nine active collaborations that could result in up to US$8.6 billion in potential milestone payments in addition to royalties on potential product sales.
Balance Sheet Strengthened and Cash Runway Extended
In early 2020, Zymeworks completed an oversubscribed public financing raising US$320.8 million, extending its runway into 2022 and potentially beyond. The Company also received non-dilutive capital from several of its pharmaceutical partners.
Updated Corporate Priorities
Complete enrolment of zanidatamab pivotal trial in HER2+ biliary tract cancer
Launch pivotal trial in 1st line HER2+ GEA and present supporting Phase 2 clinical data
Present data to support zanidatamab breast cancer development strategy
Advance ZW49 into and complete cohort expansion
Present data from new therapeutic programs and technology platforms