BioNTech Cancer Drug Licensed From MediLink Faces FDA Delay

(Bloomberg) -- 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 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. 

BioNTech’s US depositary receipts fell as much as 4.3% as of 11:39 a.m. in New York. They have dropped more than 15% this year. 

BioNTech’s partnership with MediLink is among a growing number in which European companies have 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 as much as about $1 billion for global rights to its drug, which is in a highly competitive area. Antibody-drug conjugates tightly target doses of toxic therapy, thereby allowing higher doses to be used without as much harm to surrounding tissue. 

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. 

--With assistance from Lisa Pham.

(Updates shares in the fifth paragraph.)

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