BioNTech and Roche have halted a cancer vaccine trial. What does this mean for the industry?

The German biotechnology company BioNTech, which specializes in immunotherapy, vaccines, and oncology, and the Swiss company Roche have halted one of their trials of a personalized cancer vaccine. In doing so, they have dashed hopes for the success of this new medical field, which had recently been bolstered by positive results from a competing drug developed by Moderna, according to Bloomberg.

BioNTech and Roche Holding decided to discontinue one of the trial arms for a personalized cancer vaccine following a recommendation from an independent committee, BioNTech announced on Friday, August 28.

BioNTech and Roche tested the drug autogene cevumeran (autogene cevumeran, BNT122/RO7198457)—an experimental personalized mRNA immunotherapy designed based on the individual set of mutations in a patient’s tumor. The companies decided to halt the Phase II BNT122-01 trial in patients with Stage II–III colorectal cancer whose tumors had been surgically removed but who still had circulating tumor DNA in their blood. An independent committee found that overall survival rates differed between the two study groups and concluded that continuing the trial was unlikely to change the assessment of the drug’s efficacy.

However, a trial of the same therapy for pancreatic cancer—the Phase II IMCODE003 study—is proceeding as planned, according to a statement from BioNTech.

BioNTech's American Depositary Receipts (ADRs) fell as much as 11% on August 28, marking their sharpest intraday decline since March 10. The shares then slowed their decline to 7.6%. Year-to-date, they remain up by more than 8%.

BioNTech's setback came shortly after the success of a competing mRNA cancer vaccine being developed by Moderna in collaboration with Merck & Co. However, the companies' trials focused on different types of cancer, Bloomberg noted.

Moderna’s success marks the first such achievement in more than 100 years of clinical trials of therapeutic vaccines against late-stage cancer, according to Reuters. Oncologists have called the results the dawn of an era of personalized vaccines that train the immune system to fight a specific patient’s tumor, the agency notes. In a study involving more than 1,000 patients with localized melanoma, the vaccine reduced the risk of the tumor returning or spreading.

Although the full results of the study have not yet been published, Wall Street is already estimating the drug’s potential sales at billions of dollars, according to Reuters. Moderna CEO Stéphane Bancel compared the moment he learned of the study’s results to the day in late 2020 when the company announced the results of its COVID-19 vaccine trials.

“It was a moment we had been working toward for a very long time and with great determination. “We understood just how much was at stake for the entire planet in the case of COVID,” Bansel said in an interview with Reuters. According to him, the situation with cancer is similar, since this disease affects almost everyone at one point or another.”

BioNTech is best known for the COVID-19 vaccine it developed in collaboration with Pfizer. However, the company is currently undergoing a period of significant change, according to Bloomberg. Its co-founders, husband-and-wife team Ugur Sahin and Ozlem Tureci, plan to leave BioNTech by the end of the year to start a new business, the company announced in March.

In August, BioNTech lowered its revenue forecast because demand for its COVID-19 vaccine had declined more sharply than expected.

Bloomberg notes that one of the key questions for BioNTech investors remains whether the late-stage clinical trials of its cancer drugs will prove successful.

Wall Street has so far maintained a positive outlook on BioNTech shares: 15 out of 21 analysts tracking the company’s American depositary receipts recommended buying them, according to MarketWatch data. Another five recommended holding them in a portfolio, and only one recommended selling.

This article was AI-translated and verified by a human editor