Zymeworks Inc.

1215 4th Avenue
Suite 2100 Seattle, Washington United States of America

Compounds:

Zanidatamab
Zanidatamab

Zanidatamab is an investigational drug. It is a novel humanized, bispecific antibody that binds to the same 2 extracellular domains of HER2 as trastuzumab (ECD4) and pertuzumab (ECD2). Binding of zanidatamab results in blockade of ligand-dependent and independent growth and potent activation of antibody-dependent cellular cytotoxicity (ADCC). The unique binding geometry of zanidatamab also leads to increased tumor cell binding, receptor clustering, and receptor internalization relative to trastuzumab, including in settings of lower HER2 expression.

Expanded Access to Zanidatamab

ZWI-ZW25-EAP is an expanded access / compassionate use protocol, reviewed by the US Food and Drug Administration (FDA) and Health Canada. In addition, the protocol has been approved by an IRB. The objective of this protocol is to make zanidatamab available for patients with HER2-positive cancers who do not qualify for participation in, or who are otherwise unable to access an ongoing clinical study for zanidatamab. Find out more information about the zanidatamab EAP on ClinicalTrials.gov (NCT04578444)

Enrollment to ZWI-ZW25-EAP is available for patients not eligible for zanidatamab clinical trials. Currently, the EAP is available in Canada and the United States.

Safety Reporting

A written description of any serious adverse event, using the Zymeworks SAE report form, must be sent by email within 24 hours after awareeness of the event:

Zanidatamab Pregnancy Report Form

Zanidatamab Safety Report Form

Available in These Countries:

United States of America

Canada

France

Italy

Spain

United Kingdom

Access to Investigational Medicines

Zymeworks' mission is to develop transformative treatments that help patients return home to their loved ones, disease-free. In order to bring new treatments to patients, we conduct clinical trials to assess the safety and efficacy of our investigational medicines. This information is submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and Health Canada, to enable approval for patient use. Most patients access Zymeworks investigational medicines through participation in one of our clinical trials. However, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies.Therefore, Zymeworks will consider all requests for access to our pipeline of investigational medicines through Expanded Access or Compassionate Use.