10:09 AM EDT, 06/17/2024 (MT Newswires) -- BioNTech (BNTX) said Monday its partner MediLink Therapeutics has informed the company that the US Food and Drug Administration has placed a partial hold on enrolling new patients in the US for a Phase 1 trial evaluating its product candidate for advanced cancers due to safety concerns.

The company said the FDA told MediLink that higher doses of BNT326/YL202, an antibody-drug conjugate being tested for certain types of lung and breast cancers, may cause "unreasonable and significant risk of illness or injuries" to participants, according to a regulatory filing with the US Securities and Exchange Commission.

The FDA's decision requires MediLink to address safety concerns by reviewing clinical data, providing pharmacological information, and updating safety reports, BioNTech said. MediLink has halted new patient enrollment in the US, the company added.

Shares of BioNTech were down 2.4% in recent Monday trading.

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