Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer.
PT886, a potential first-in-class dual-target antibody with a natural IgG structure, targets both CLDN18.2 and CD47. This dual targeting enables direct tumor cell killing through the antibody-dependent cellular phagocytosis (ADCP) activity of macrophages and the antibody-dependent cellular cytotoxicity (ADCC) activity of natural killer (NK) cells. Additionally, PT886 aims to expand the range of tumor killing by targeting CLDN18.2 and CD47, which are highly expressed on tumor cells. The drug is also expected to induce the presentation of tumor neoantigens by guiding tumor cells into phagocytic antigen-presenting cells (APCs), indirectly activating T cells to kill tumor cells with low or no expression of CLDN18.2 by recognizing tumor neoantigens, thereby stimulating the immune system. The anti-CD47 component of PT886 is noted as highly differentiated, showing strong binding activity with CD47 on tumor cells while minimizing binding to human red blood cells in preclinical models. A Phase I study of the drug was initiated in the US in 2022, with preliminary data indicating good safety, tolerability, and pharmacokinetic characteristics. Orphan Drug Designation (ODD) status was granted by the US FDA in the same year for the treatment of pancreatic cancer.- Flcube.com
