Pipeline

Our clinical and preclinical pipeline includes wholly owned and partnered therapeutic candidates targeting difficult-to-treat cancers and other serious diseases.

Product Candidate

Preclinical

Phase 1

Phase 2

Pivotal

Partner

Zanidatamab

Zanidatamab

HER2 x HER2 Bispecific Antibody

Zanidatamab is an investigational bispecific antibody (developed using Zymeworks proprietary Azymetric™ platform) that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz Pharmaceuticals Ltd. and BeiGene, Ltd. under license agreements from Zymeworks.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA).

Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.

Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

Product Status

Pivotal

Indications

  • Biliary Tract Cancers
  • Breast Cancer
  • Gastroesophageal Adenocarcinomas
  • Colorectal Cancer
  • HER2-Expressing Cancers

Partner

Technology

Product Candidate

1st-Line Gastroesophageal Adenocarcinomas

HERIZON-GEA-01
Chemotherapy Combination

Phase: Pivotal

Partner:

Product Candidate

2nd-Line Biliary Tract Cancers

HERIZON-BTC-01
Monotherapy
FDA Breakthrough Therapy Designation

Phase: Pivotal

Partner:

Product Candidate

1st-Line Gastrointestinal Cancers

Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Chemotherapy Combination

Phase: Pivotal

Partner:

Product Candidate

Late-Line Breast Cancer

Combination with Palbociclib & Fulvestrant

Phase: Phase 2

Partner:

Product Candidate

HER2-Expressing Cancers

Monotherapy & Chemotherapy Combination

Phase: Preclinical

Partner:

Zanidatamab Zovodotin

Zanidatamab Zovodotin

HER2 x HER2 Bispecific Antibody Drug Conjugate (ADC)

Zanidatamab zovodotin (ZW49) is a HER2-targeted bispecific antibody-drug conjugate (ADC) developed using Zymeworks’ proprietary Azymetric™ and ZymeLink™ Auristatin platforms technologies. Zanidatamab zovodotin combines the unique design of zanidatamab with the addition of a toxic chemotherapy that we developed in-house. Zanidatamab zovodotin delivers a novel auristatin (cell-killing compound) to tumor cells via a cleavable linker by taking advantage of the enhanced ability of its antibody (zanidatamab) to internalize into the tumor cell. In addition to its cytotoxic properties zanidatamab zovodotin’s unique design promotes immunogenic cell death.

Zanidatamab zovodotin, in combination with a checkpoint inhibitor, is planned to be evaluated in a Phase 2 trial in patients with HER2-overexpressing non-small cell lung cancer.

 

 

Product Status

Phase 1

Indications

  • HER2-Expressing Cancers

Technology

Product Candidate

HER2-Expressing Cancers

Monotherapy

Phase: Phase 1

Preclinical

Product Candidate

ZW191

Folate Receptor-⍺ Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate

Phase: Preclinical

ZW191

Folate Receptor-⍺ Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate

ZW191 is an antibody-drug conjugate that is engineered to target a protein called folate receptor-⍺ (FR⍺) found on the surface of a variety of tumors such as on ovarian, endometrial, and lung cancers. ZW191’s differentiated design increases its ability to internalize into FR⍺ -expressing cells. Further, it releases a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill tumor cells.

With promising preclinical tolerability and anti-tumor activity, ZW191 is currently in the Investigational New Drug (IND)-enabling stage of development and is projected to enter Phase I clinical trials in 2024.

Product Status

Preclinical

Indications

  • Ovarian cancer & gynaecological cancers
  • Non-small cell lung cancer

Technology

Product Candidate

ZW171

2+1 MSLN x CD3 Bispecific Antibody

Phase: Phase 1

ZW171

2+1 MSLN x CD3 Bispecific Antibody

ZW171 is a bispecific antibody designed to enable T cell-mediated tumor cell killing through simultaneous binding to the extracellular domain of mesothelin (MSLN) protein on tumor cells and the engagement of CD3 on T cells.  ZW171’s unique 2+1 format and incorporation of a novel low-affinity anti-CD3 binder aims to improve the therapeutic window in patients by limiting on-target, off-tumor effects and cytokine release syndrome (CRS) while maintaining potent anti-tumor activity against MSLN-expressing cancers. By selectively binding to tumors and sparing normal tissues, ZW171 is designed to improve both tolerability and anti-tumor activity against MSLN-expressing cancers. Engineered and optimized using our Azymetric™ and EFECT™4 technologies, ZW171 demonstrates enhanced anti-tumor activity and safety in preclinical models, inducing potent, preferential killing of MSLN-overexpressing cells while mitigating the risk of on-target, off-tumor activity, peripheral T cell activation, and CRS.

ZW171 is projected to enter Phase I clinical trials in the second half of 2024.

Product Status

Phase 1

Indications

  • Ovarian cancer
  • Non-small cell lung cancer
  • Mesothelioma
  • Other mesothelin-expressing cancers

Technology

Product Candidate

ZW251

Glypican-3 Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate

Phase: Preclinical

ZW251

Glypican-3 Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate

ZW251 is the first antibody-drug conjugate engineered to target a protein called glypican-3 (GPC3), which is found on a difficult-to-treat liver cancer, hepatocellular carcinoma (HCC). The antibody is uniquely designed to target and strongly bind to the GPC3 protein, then release a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill the tumor cells.

With promising preclinical tolerability and anti-tumor activity,  ZW251 is currently in the IND enabling stage of development and is projected to enter Phase I clinical trials in 2025.

Product Status

Preclinical

Indications

Hepatocellular carcinoma (HCC)

Technology

Product Candidate

ZW220

NaPi2b Targeted Topoisomerase 1 Inhibitor Antibody Drug Conjugate

Phase: Preclinical

ZW220

NaPi2b Targeted Topoisomerase 1 Inhibitor Antibody Drug Conjugate

ZW220 is an antibody-drug conjugate that is engineered to target a protein called sodium-dependent phosphate transporter 2b (NaPi2b) found on the surface of a variety of tumors, such as on ovarian, lung and pancreatic cancers. ZW220 differentiated design optimizes its ability to target and strongly bind to the NaPi2b protein and then effectively internalize into the cell. ZW220 releases a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill tumor cells.

With promising preclinical tolerability and anti-tumor activity, ZW220 is currently in the IND- enabling stage of development and is projected to enter Phase I clinical trials in 2025.

Product Status

Preclinical

Indications

  • Ovarian cancer
  • Non-small cell lung cancer

Technology

Partners

Product Candidate

XB002 Tissue Factor ADC

Phase: Phase 1

Partner:

XB002 Tissue Factor ADC

Product Status

Phase 1

Indications

  • Solid Tumors

Partner

Technology

Product Candidate

JNJ-78278343

(CD3 x KLK2)

Phase: Phase 1

Partner:

JNJ-78278343

(CD3 x KLK2)

Product Status

Phase 1

Indications

  • Castration-Resistant Prostate Cancer

Partner

Technology

Product Candidate

Bispecific

Phase: Pre-clinical

Partner:

Bispecific

Product Status

Pre-clinical

Indications

  • Undisclosed

Partner

Technology

Product Candidate

Bispecific

Phase: Pre-clinical

Partner:

Bispecific

Product Status

Pre-clinical

Indications

  • Immuno-Oncology

Partner

Technology

Product Candidate

Bispecific

Phase: Pre-clinical

Partner:

Bispecific

Product Status

Pre-clinical

Indications

  • Infectious Disease

Partner

Technology

Product Candidate

Undisclosed

Phase: Pre-clinical

Partner:

Undisclosed

Product Status

Pre-clinical

Indications

  • Undisclosed

Partner

Technology