BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause the enrollment of new patients in a Phase I clinical trial (NCT05653752), which is being managed by MediLink. The trial is evaluating BNT326 as a later-line treatment for patients with heavily pretreated advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) or HR+/HER2-negative breast cancer.
According to BioNTech’s stock exchange release, the FDA has expressed concerns that BNT326 at higher doses may pose an unreasonable significant risk of adverse effects. This decision followed findings of Grade 5 adverse events in two studies – YL202-INT-101-01 and YL202-CN-201-01 – with Grade 5 indicating a patient death as a result of treatment. A BioNTech investor roundup during the American Society of Clinical Oncology (ASCO) summit meeting on June 14 revealed three patient deaths during the two studies, two in the 18-patient fifth dosing cohort (4.0 mg/kg) and one patient in the three-patient seventh dosing cohort (5.5 mg/kg). BioNTech stated that ongoing clinical development of BNT326 will focus on dose levels below 4.0 mg/kg due to the more manageable safety profile, as reported by Genetic Engineering & Biotechnology News. MediLink will be required by the FDA to review clinical and safety data and share pharmacological data with the FDA, while patients already enrolled in the trial can continue to be treated.
In an October 2023 deal, MediLink handed over a HER3 ADC to BioNTech for co-development outside Greater China, with the German firm paying USD 70 million upfront and committing to up to USD 1 billion in further milestone payments. The two firms struck a second deal for another ADC candidate in May this year.- Flcube.com
