3:00 PM
 | 
Jul 11, 2019
 |  BC Innovations  |  Product Development

How Zymeworks aims to take on Roche’s $10B HER2 franchise

Zymeworks is taking on Roche’s $10B HER2 franchise using bispecifics in a ‘displace and expand’ strategy

Zymeworks is going head to head with one of the biggest commercial cancer franchises -- Roche’s Herceptin trastuzumab and Perjeta pertuzumab -- as it pursues clinical proof-of-concept for its protein engineering platform.

Pivotal readouts in 2022 from its lead bispecific program, along with additional data from the biotech’s first ADC, will provide the first glimpse of whether Zymeworks Inc.'s technologies can generate best-in-class molecules that outperform combinations of individual mAbs.

After nearly eight years of aggressively partnering its suite of bispecific customization technologies, Zymeworks raised $175 million in an upsized follow-on on June 19 to accelerate the development of its internal pipeline.

Its two clinical programs are both based on a bispecific mAb targeting two different epitopes of HER2.

ZW25 is the backbone mAb and targets the same HER2 epitopes as Herceptin and Perjeta -- one with each arm -- aiming to deliver even better efficacy than the combo, which recorded nearly $10 billion in 2018 sales.

ZW49 is an antibody-drug conjugate (ADC) version of the HER2 bispecific carrying an auristatin cytotoxic payload.

The strategy is audacious given Herceptin’s 20-year reign as standard of care in metastatic HER2-positive breast cancer and the entry of cheaper biosimilars. Five biosimilars are approved in the U.S., with the first expected to launch this half, and several are already marketed in Europe.

But President and CEO Ali Tehrani said better efficacy and safety could enable ZW49 and ZW25 to "displace and expand the market" to include patients with lower levels of HER2 expression.

Zymeworks plans to start two pivotal studies of ZW25 next year in gastric cancer and niche cancer settings like biliary cancer, and start enrolling expansion cohorts in a Phase I trial for ZW49 that will generate efficacy data.

Generating POC

Though Zymeworks had been partnering its technologies for nearly a decade, its partners were no farther ahead because the deals involved handing them the technology for in-house development of candidates from scratch.

Promising initial Phase I data from ZW25 provided Zymeworks the impetus to accelerate the program, said Tehrani.

Recognizing that a platform’s value is only as good as the products it generates, Zymeworks raised follow-on funding to push ZW25 into two registrational studies next year that would...

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