BioNTech Cancer Drug Licensed From MediLink Faces FDA Delay

 The Food and Drug Administration delayed a breast- and lung-cancer trial of an experimental treatment that BioNTech SE licensed from Chinese biotech MediLink Therapeutics Ltd., citing safety concerns.

MediLink stopped enrolling US patients in the study, which had aimed to recruit 80 volunteers to test a new antibody-drug conjugate, a type of medicine designed to deliver targeted therapy to a tumor, BioNTech said on Monday.

Run in China and the US, the study had been scheduled to deliver results at the end of this year, according to a US government registry of clinical trials.

The FDA told MediLink that it was concerned that the compound “may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries,” BioNTech said in a statement. The companies will need to share pharmacological data as well as more information on bad health outcomes during the study, the company said.

The BioNTech-MediLink partnership is one in a growing number of deals in which European companies licensed assets from Chinese counterparts. The German biotech, seeking to bolster its pipeline as Covid-19 vaccine sales drop, agreed to pay Suzhou-based MediLink up to more than $1 billion for global rights to its antibody-drug conjugate, a highly competitive area of drug development.

BioNTech’s US depositary receipts were little changed before exchanges opened. The ADRs have dropped almost 13% this year.

The paused study was being run by MediLink. It focused on particularly sick people: patients whose cancer had already become advanced or spread, and who had already tried standard treatments without success.

https://finance.yahoo.com/news/biontech-cancer-drug-licensed-medilink-125512423.html