Aug 19th, 2024 - MediLink Therapeutics (Suzhou) Co., Ltd. (MediLink), a clinical-stage biotech company, announced that on Aug 15th, 2024, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold that was placed on the Phase I trial evaluating YL202/BNT326 (NCT05653752).
YL202/BNT326 is a Human Epidermal Growth Factor Receptor 3 (HER3) targeting antibody-drug conjugate candidate that is being developed in collaboration between BioNTech SE (Nasdaq:BNTX, BioNTech) and MediLink. The trial recruitment will be re-initiated. Clinical development will focus on dose levels no higher than 3.0 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.
About MediLink Therapeutics
MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs with global competitiveness. MediLink has developed its proprietary TMALIN® ADC technology platform, enabling the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. MediLink aims to provide improved treatment options for global patients and address unmet medical needs. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US.
About YL202/BNT326
YL202/BNT326 is a next-generation antibody-drug conjugate (ADC) targeting Human Epidermal Growth Factor Receptor 3 (HER3), utilizing MediLink's TMALIN® technology. HER3 is a target that is overexpressed in various cancer types, such as non-small cell lung cancer and breast cancer and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment. MediLink and BioNtech have entered a global collaboration partnership on the development of YL202/BNT326, and the molecule is currently undergoing clinical evaluation in phase I/II studies.