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Lucy Chard
17 May 2023

Roche acquires rights to Zion Pharma's HER2-positive breast cancer therapeutic

Roche launches into a new agreement with Zion Pharma, a leading Chinese pharmaceutical company, to help develop and commercialise their flagship small molecule tyrosine kinase inhibitor, ZN-A-1041. 

Currently, Zion Pharma is testing the kinase inhibitor in a Phase I clinical trial in the US and China. The trial recruited patients with solid tumours who were also being treated with either chemotherapy capecitabine and/or Roche’s Herceptin (trastuzumab). The next phase of the trial will include patients with HER2-positive breast cancer, this is where Roche’s experience will be invaluable. 

Roche has commanded the HER2-positive breast cancer pharmaceutical market for several years now, with three effective HER2-targeting treatments on the market. These take the form of monoclonal antibodies Herceptin and Perjeta (pertuzumab), and the antibody-drug conjugate Kadcyla (trastuzumab emtansine). Also developed is a subcutaneous fixed-dose co-formulation of Perjeta and Herceptin (Phesgo).

Competition in the ADC market is rife, with Daiichi Sankyo and AstraZeneca’s Enhertu closely following Roche’s Kadcyla and threatening its position as the first port of call for second-line treatment. 

Roche will pay $70 million to Zion Pharma initially, and then a potential further $610 million if certain targets are met. 

Acquisition of ZN-A-1041 could improve the outlook for Roche. ZN-A-1041 is an orally administered selective tyrosine kinase inhibitor, specific to HER2. The particularly advantageous aspect of ZN-A-1041 is that it can penetrate the blood–brain barrier. This means that the drug could be especially effective in the prevention or treatment of brain metastasis in HER2-positive metastatic breast cancer patients. 

Zack Cheng, Zion Pharma Chairman, CEO and Co-founder stated: 

“Our agreement with Roche is the culmination of a tremendous team effort to deliver a potentially best-in-class therapy for patients with HER2-positive breast cancer, particularly in the field of brain metastasis by virtue of the high blood-brain barrier permeability of this asset.

“Within five years, we have gone from company formation to first-in-human to finding a partner in Roche, who has the resources and expertise to bring ZN-A-1041 to patients with few other therapeutic options.”

Nearly 50% of patients with HER2-positive breast cancer develop brain metastases, and those patients have a median progression-free survival rate of 8 months. Treatment options for these patients are in urgent need. 
In a recent Phase II trial, TUXEDO-1, Enhertu demonstrated good efficacy and safety in patients with new and recurring brain metastases. Roche hopes that their equivalent therapeutic, ZN-A-1041 will therefore be looked upon favourably with approval bodies and development and testing accelerated. 

Roche is hopeful that if initial data from ZN-A-1041 testing is positive, it could be used in even further HER2-positive settings. 

Lucy Chard
Digital Editor - Pharma

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