BioNTech and MediLink announced the Phase I trial will resume with a focus on a lower dose to make the safety profile more manageable. Image credit: Shutterstock / rawf8.

The US Food and Drug Administration (FDA) has granted clearance to BioNTech and Medilink to resume a Phase I oncology trial of BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC), at a lower dose.

The agency paused the trial on June 17 after sharing concerns with the companies that the drug may expose patients to an unreasonable and significant risk of illness.

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The main treatment-related adverse events (TRAE) of concern to the FDA were neutrophil count decrease and an increasing rate of mucositis events. These events are common TRAEs of established chemotherapies and increase a person’s risk of developing serious infections.

The companies announced the drug looked encouraging in a presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting held in Chicago between 31 May to 4 June, despite confirming there had been three deaths in the trial, two in the fifth dose cohort, and one in the seventh dose cohort.

On 19 August, as the clinical hold was lifted, the companies confirmed they would be focusing on dose levels at 3mg or lower which had a balanceable safety-to-clinical activity ratio.

The companies will now start enrolling patients on the trial again in the 3mg cohort, with any patients on a higher dose to be lowered to 3mg.

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The Phase I 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.

BioNTech’s stock increased by just over 6% on August 19 following the announcement, from an opening price of $85.25 before reaching a high of $90.78.

MediLink is also running two Phase II trials of BNT326/YL202 in China. One trial (NCT06107686) is evaluating the candidate in patients with NSCL, breast cancer, head, and neck squamous cell carcinoma (HNSC), colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, and other solid tumours. The second trial (NCT06439771) evaluates the drug in patients with locally advanced or metastatic breast cancer with triple-negative breast cancer, HR-positive, HER2-zero-expression or HER2-low-expression.

In October 2023, BioNTech paid MediLink $70m upfront in a $1bn deal to collaborate in the development of BNT326/YL202. MediLink retains the rights for the drug in China, Hong Kong, and Macau while BioNTech claims the rights for the rest of the world.