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FDA gives green light to BioNTech/Medilink cancer trial with lower dose after deaths

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

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

The agency paused the trial on June 17 after communicating to the companies its concerns that the drug could expose patients to an unreasonable and significant risk of disease.

The main treatment-emergent adverse events (TRAEs) of concern to the FDA were a decrease in neutrophil counts and an increasing number of mucositis events. These events are common TRAEs with established chemotherapies and increase a person's risk of developing serious infections.

In a presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 31 to June 4, the companies said the drug was encouraging, although they confirmed there had been three deaths in the trial, two in the fifth-dose cohort and one in the seventh-dose cohort.

On August 19, when the clinical suspension was lifted, the companies confirmed that they would focus on dose levels of 3 mg or less that demonstrated a balance of safety and clinical activity.

The companies will now begin recruiting patients in the 3 mg cohort again for the study, with all patients receiving a higher dose having their dose reduced to 3 mg.

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In the Phase I study (NCT05653752), BNT326/YL202 is being evaluated as a late-line treatment in heavily pretreated patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer.

Following the announcement, BioNTech's share price rose just over 6% on August 19, from an opening price of $85.25 to a high of $90.78.

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

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


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