- Swiss drugmaker Roche has acquired rights to an oral breast cancer medicine that targets the same protein as its infusible treatments Herceptin and Perjeta, the drug’s developer, China-based Zion Pharma, said Tuesday.
- The deal gives Roche rights to a drug that targets the protein HER2 and is currently in Phase 1 testing in the U.S. and China. In addition to the $70 million in upfront and near-term milestone payments, Zion could receive another $610 million if the drug hits certain development, regulatory and commercial goals, as well as royalties on future sales.
- Zion said its drug, dubbed ZN-A-1041, can cross the blood-brain barrier, allowing it to treat breast tumors that have spread to the brain. Around half of the patients who have HER2-positive breast cancers develop brain tumors, the company said.
Herceptin and other drugs like it have dramatically improved the outlook for patients with HER2-positive breast cancers, a particularly aggressive form of the disease.
Yet HER2 tumors can develop resistance to drugs, creating the need for better treatments. That need is particularly acute for those whose cancers have spread the brain. Patients with HER2-positive brain metastases survive for a median of about 13 months after diagnosis, according to published research.
Furthermore, the antibody drugs widely used to treat HER2 tumors have a tough time crossing the blood-brain barrier. One recent approval for such tumors, for instance, is a combination of Seagen’s small molecule drug Tukysa, Herceptin and chemotherapy, which regulators cleared April 2020. That regimen was cleared based on an ability to improve progression-free survival by 52%, after one year, compared to Herceptin and chemo alone.
Like Tukysa, Zion’s drug is a small molecule blocking an enzyme, tyrosine kinase, involved in cancer growth. Zion said the drug was designed to penetrate the blood-brain barrier and should have a better chance of doing so than older HER2-targeting medicines.
Zion has already started Phase 1 trials in the U.S. and China. The U.S.-based study aims to enroll 210 people with HER2-positive breast or gastric tumors — including those with brain metastases — that have progressed after early-line therapies. It’s being tested at various dosing levels as a single therapy, and alongside HER2-targeting drugs like Herceptin, Perjeta and Enhertu.
“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,” said Zack Cheng, M.D., Zion’s CEO, said in a statement.
If successful, Zion’s drug would also compete with Puma Biotech’s Nerlynx, another an oral HER2 drug.