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▎WuXi AppTec content team editor
Zanidatamab, a HER2-targeted, bispecific antibody with a novel mechanism of action, has demonstrated compelling antitumor activity in several HER2-expressing cancers, either as monotherapy or in combination with chemotherapy and other drugs
.
At present, zanidatamab is in a critical trial stage
as a second-line treatment for HER2-expressing biliary tract cancer and HER2-positive gastroesophageal adenocarcinoma.
The press release noted that in biliary tract cancer, there is currently no approved HER2-targeted therapy, and the U.
S.
FDA has granted Zamidataab breakthrough therapy designation and fast-track designation, positioning it as a potential "first-in-class" therapy
.
In gastroesophageal adenocarcinoma, based on phase 2 clinical trial data, zanidatamab combined with chemotherapy is expected to be a potential "best-in-class" therapy
.
Zanidatamab was developed based on Zymeworks' Azymetric platform that can bind two nonoverlapping epitopes of HER2 simultaneously, which is known as bispecific binding
.
This innovative design has led to multiple new mechanisms of action, including dual HER2 signal blocking, enhanced binding and clearance of HER2 proteins from the cell surface, and potent effector functions to generate encouraging anti-tumor activity
in patients.
Mr.
Kenneth Galbraith, Chairman and Chief Executive Officer of Zymeworks, said, "We are excited to partner with Jazz, a leading global biopharmaceutical company, who bring extensive oncology development and commercial experience and share our vision and passion
for improving outcomes for cancer patients worldwide 。 Zymeworks and Jazz are committed to advancing the development of zanidatamab as quickly as possible, potentially providing a foundational HER2-targeted therapy
for patients with refractory cancers with limited treatment options today.
”
On October 19, Jazz Pharmaceuticals ("Jazz") and Zymeworks jointly announced that Jazz and Zymeworks BC, a subsidiary of Zymeworks, have entered into an exclusive licensing agreement under which Jazz will acquire Zymeworks' zanidatamab in the United States, Europe, and Europe.
Exclusive development and commercialization rights for all indications in regions such as Japan, except for previously licensed Asia/Pacific regions
.
Previously, in November 2018, BeiGene obtained an exclusive license
for the development and marketing of zanidatamab (ZW25) in Asia (excluding Japan), Australia and New Zealand.
Under the terms of the agreement, Zymeworks will receive an upfront payment of $50 million, an optional second payment of $325 million from Jazz, and further potential regulatory and commercialization, with a milestone total payment of up to $1.
76 billion, among other
things.
It is expected that by the end of 2022, top-line clinical data from zanidatamab for biliary tract cancer (HERIZON-BTC-01) will be readout or may support the drug's first global regulatory filing
.
Biliary tract cancer (BTC), including gallbladder cancer and cholangiocarcinoma, accounts for about 3% of all adult cancers and is often associated with
a poor prognosis.
Globally, more than 210,000 people are diagnosed with biliary tract cancer each year, and the majority of patients (>65%) are diagnosed with tumors
that cannot be removed inoperably.
Human epidermal growth factor receptor 2 (HER2) is a well-validated target in anti-cancer therapy
.
About 5%~19% of biliary tract cancer patients express HER2 in tumors, which may be positioned as a potential benefit
from HER2-targeted therapy.
Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer worldwide, with about 20% of patients being HER2-positive
.
HER2-positive GEA has high morbidity and mortality, and patients urgently need new treatment options
.
Zanidatamab, a HER2-targeted, bispecific antibody with a novel mechanism of action, has demonstrated compelling antitumor activity in several HER2-expressing cancers, either as monotherapy or in combination with chemotherapy and other drugs
.
At present, zanidatamab is in a critical trial stage
as a second-line treatment for HER2-expressing biliary tract cancer and HER2-positive gastroesophageal adenocarcinoma.
The press release noted that in biliary tract cancer, there is currently no approved HER2-targeted therapy, and the U.
S.
FDA has granted Zamidataab breakthrough therapy designation and fast-track designation, positioning it as a potential "first-in-class" therapy
.
In gastroesophageal adenocarcinoma, based on phase 2 clinical trial data, zanidatamab combined with chemotherapy is expected to be a potential "best-in-class" therapy
.
Zanidatamab was developed based on Zymeworks' Azymetric platform that can bind two nonoverlapping epitopes of HER2 simultaneously, which is known as bispecific binding
.
This innovative design has led to multiple new mechanisms of action, including dual HER2 signal blocking, enhanced binding and clearance of HER2 proteins from the cell surface, and potent effector functions to generate encouraging anti-tumor activity
in patients.
Mr.
Kenneth Galbraith, Chairman and Chief Executive Officer of Zymeworks, said, "We are excited to partner with Jazz, a leading global biopharmaceutical company, who bring extensive oncology development and commercial experience and share our vision and passion
for improving outcomes for cancer patients worldwide 。 Zymeworks and Jazz are committed to advancing the development of zanidatamab as quickly as possible, potentially providing a foundational HER2-targeted therapy
for patients with refractory cancers with limited treatment options today.
”
Resources:
[1] Jazz Pharmaceuticals and Zymeworks Announce Exclusive License Agreement to Develop and Commercialize Zanidatamab, a HER2-Targeted Bispecific Antibody.
Retrieved 2022-10-19, from style="display: none;">
