The company might be close to commercializing its most advanced pipeline program.
BioNTech (BNTX 8.62%), the Germany-based biotech that scored big early in the pandemic era with the Comirnaty vaccine it developed with Pfizer, had some fresh news from the lab to report on Friday. Investors clearly liked what they heard, as they traded up the German biotech’s American depositary receipts (ADRs) by 10% that day.
Promising results from a cancer drug
BioNTech and Chinese peer Duality Biologics announced before market open that a phase 3 clinical trial of their cancer drug trastuzumab pamirtecan met its primary endpoint of progression-free survival. The medication was administered to patients with unresectable or metastatic breast cancer who had previously received certain types of chemotherapy.
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The antibody-drug conjugate (ADC) treatment targets a surface protein on cancer cells. It was put through its paces in a head-to-head study with a related medicine, trastuzumab emtansine. The trial was conducted by Duality in its native China.
The two healthcare companies said that Duality aims to discuss potential next steps with that country’s Center for Drug Evaluation to file a biologics license application (BLA) for trastuzumab pamirtecan. The pair also aim to submit applications in other jurisdictions, including the European Union and the United States.
BioNTech said that the treatment is its first late-stage oncology drug to meet its primary endpoint in a phase 3 study. Its press release quoted co-founder and chief medical officer Özlem Türeci as saying that it has “enormous potential which makes it an important asset in our global oncology strategy including combinational approaches.”
A possible blockbuster
In the press release touting the results, BioNTech and Duality pointed out that China alone has more than 350,000 new cases of breast cancer every year. The disease also has significant numbers in the U.S., so the addressable market is large. It isn’t surprising that investors were so encouraged by the news.
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Pfizer. The Motley Fool recommends BioNTech Se. The Motley Fool has a disclosure policy.