FDA Pauses BioNTech's Chinese-Licensed Cancer Drug Trial Over Safety Issues

By Thea Felicity

Jun 17, 2024 02:02 PM EDT

An employee holds up a vial of an oncological product under development, at the BioNTeCH research institute in Mainz, Rhineland-Palatinate, western Germany, on October 5, 2022.
(Photo : ANDRE PAIN/AFP via Getty Images)

The Food and Drug Administration (FDA) has made a significant move by delaying a momentous breast and lung cancer trial. This trial, which was set to involve an experimental treatment licensed by BioNTech SE from Chinese biotech firm MediLink Therapeutics Ltd., has been put on hold due to safety concerns. 

In a report by Bloomberg, BioNTech stated that the FDA halted enrollment of US patients in the study, which aimed to recruit 80 volunteers to test a novel antibody-drug conjugate designed for targeted therapy delivery to tumors. 

Initially scheduled to conclude by year-end, the trial spanned China and the US and focused on patients with advanced-stage cancer resistant to standard treatments. 

The FDA expressed worries that the treatment could pose serious health risks at higher doses, prompting the companies to provide additional pharmacological data and detailed information on adverse health outcomes encountered during the study.

READ MORE: BioNTech Embarks on Breast Cancer Precision Drug Late-Stage Trial, Challenging AstraZeneca

BioNTech's Stocks Following the Delayed Cancer Drug Trial

As a result, Yahoo Finance reported that shares of BioNTech's US depositary receipts fell by as much as 4.3% in New York following the announcement, which is a decline of over 15% for the year. 

BioNTech's collaboration with MediLink, worth about $1 billion, is part of a larger pattern where European companies acquire resources from Chinese counterparts. The specific drug discussed, an antibody-drug conjugate, is designed to deliver potent therapy directly to cancer cells while sparing healthy tissue, which is important for effective and less harmful cancer treatment strategies.

At present, there is no specified date for the resumption of the cancer drug trial. Furthermore, it remains unclear whether this delay is linked to recent US regulatory actions that have been targeting Chinese-backed companies and projects.

READ NEXT: AstraZeneca Announces $1.5 Billion Cancer Drug Manufacturing Plant in Singapore

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