The three deaths in BioNTech’s Phase I trial evaluating the early-stage antibody-drug conjugate (ADC) BNT326/YL202 occurred in patients in dose level cohorts of 4.0mg/kg and above. Credit: Seda Yalova/ Shutterstock.com.

The US Food and Drug Administration (FDA) has placed a partial clinical hold on BioNTech’s Phase I trial evaluating the early-stage antibody-drug conjugate (ADC) BNT326/YL202 after deaths were reported.

BioNTech said in a Form 6-k filed with the US Securities and Exchange Commission (SEC) is had been informed by MediLink, the trial sponsor, that the FDA held concerns that BNT326/YL202 may, at higher doses, expose human subjects to “unreasonable and significant risk of illness or injuries”.

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The first-in-human trial (NCT05653752) is evaluating BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer.

The partial clinical hold follows BioNTech’s presentation of data from the Phase I trial at the recent American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held in Chicago between May 31 to June 4, which showed that three patient deaths were observed in two dose cohorts.

The dose level (DL) scale escalated from 0.5mg/kg in DL1 to 5.5mg/kg in DL7. Three patients died from treatment-related adverse events (AEs) – two from the 4.0mg/kg cohort and one from the 5.5mg/kg cohort.

A slide from BioNTech’s ASCO presentation on June 4 said its further clinical development of BNT326/YL202 would focus on dose levels below 4.0 mg/kg, where the safety profile was manageable and promising clinical activity was observed.

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To address the FDA’s concerns, BioNTech must review clinical and safety data, share available pharmacological data with the agency and provide additional information in the investigators brochure regarding its safety findings.

MediLink has confirmed that it has taken actions to pause enrolment of new patients in the US and address the FDA’s requirements.

The clinical hold comes weeks after BioNTech signed a $25m upfront payment deal with MediLink for the use of the Chinese company’s solid tumour TMALIN ADC platform towards several undisclosed targets. The overall deal will be worth up to $1.8bn to Medilink, pending milestones reached.

Under a separate deal forged in October 2023, BioNTech paid Medilink $70m upfront in a deal that could be worth up to $1bn, for the development and a worldwide licensing agreement of one of MediLink’s ADC candidates against Human Epidermal Growth Factor Receptor 3 (HER3).

Other big pharma companies including Pfizer, Merck and AbbVie also presented data from their ADC trials at the ASCO 2024 meeting.