FDA stops BioNTech MediLink study due to 'significant risks,' adverse events

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U.S. Food and Drug Administration (FDA) concerns over outcomes and safety findings of a phase I oncology clinical trial dropped a partial hold on a BioNTech collaborator MediLink Therapeutics' antibody–drug conjugate (ADC) study, BioNTech announced in a U.S. Securities and Exchange Commission (SEC) filing.

The MediLink-sponsored multicenter, open-label, first-in-human study (NCT05653752), and the FDA's intervention, involve product candidate BNT326/YL202 for non-small cell lung cancer (NSCLC) and breast cancer. Conducted in both the U.S. and China, the YL202 study aimed to evaluate the safety and tolerability of the ADC as a later-line treatment in heavily pretreated patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or HR+/HER2-negative breast cancer.

In the June 17 SEC filing, BioNTech announced that the FDA placed a partial clinical hold on the study and specified grade 5 adverse events (AE) observed in studies YL202-INT-101-01 and YL202-CN-201-01. The National Cancer Institute refers to grade 5 AEs as the most severe events that may lead to death; however, the number of deaths and other circumstances were not disclosed. The hold affects the enrollment of new patients in the trial in the U.S.

"The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries," the SEC filing stated. "In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency, and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed."

According to information available at clinicaltrials.gov, YL202 is provided as a 200 mg/vial lyophilized powder that is given intravenously once every three weeks as a cycle, with the initial dose IV-infused into each patient. If study participants experienced no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 were infused into each patient. The study began in 2022.

Founded in 2020, MediLink Therapeutics is based in Suzhou, China. BioNTech is based in Mainz, Germany.

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