Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40

Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of its pipeline candidate drug HBM9027, a bispecific antibody (BsAb) targeting PD-L1 and CD40, initially in patients with general advanced solid tumors.

HBM9027 was developed using Harbour’s proprietary HBICE bispecific technology and Harbour Mice platforms. The molecule has demonstrated excellent safety and potent anti-tumor efficacy in pre-clinical studies.- Flcube.com

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