Polyphor flops a phase 3, jeopardizing its future as shares more than halved

Swiss biotech Polyphor has seen its key cancer asset balixafortide fail a late-stage trial, leaving its future in the balance.

That trial, a phase 3 test know as Fortress, was studying Polyphor’s GPCR-derived med balixafortide in more than 400 patients with late-stage HER2-negative breast cancer, given with Eisia’s Halaven (eribulin) and pitted against use of Halaven on its own.

In an update Monday morning, Polyphor said the co-primary endpoint of the study, which was objective response rate (ORR), was not met (13% versus 13.7%, where the p-value was a terrible 1.00) in a third-line setting.

The clinical benefit rate, a key secondary endpoint indicating a stable disease or any confirmed response for a duration of at least six months as assessed by the independent radiological committee, was observed in 16.7% of patients in the balixafortide plus Halaven arm and 19.6% in the Halaven alone arm.

Polyphor said in a statement that it “will continue to analyse the data, review with the experts and will decide about the future of the study in mid-July.”

July will also be a key month for the company in its entirety: The Swiss biotech said this flop had triggered a “strategic assessment regarding the future of the company” from its board.

A decision from this, the options of which it did not share (but typically include a sales, ditching of assets and/or cuts), will be made no later than the end of next month.

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“Given the high unmet medical need for patients with HER2 negative breast cancer in a late stage of the disease, we are disappointed that the Fortress study did not meet its coprimary endpoint," said Gökhan Batur, CEO of Polyphor. “We thank all the patients, investigators and healthcare professionals as well as our employees for their active participation in this study.”

The biotech is also working on antibiotic R&D, though this is not a profitable area for any company, and its future income was very much riding on cancer.

European shares in Polyphor were slashed by around 70% early Monday morning on the news.