First patient injected With cancer therapeutic Tribody CBA-1535 in a Phase I clinical trial

Chiome Bioscience Inc. announced that the first patient has been dosed with CBA-1535 in a Phase I clinical trial. The first part of the trial will evaluate the safety tolerability, pharmacokinetics, and identification of biomarker for the solid tumor patients . In the expansion part, exploratory efficacy will be evaluated in combination with cancer immunotherapy agent Pembrolizuma. This first in human study is conducted at National Cancer Center Hospital and Shizuoka Cancer Center (Japan).

CBA-1535 is cancer therapeutic antibody with three antigen binding sites; two of them are used for the binding with 5T4 protein that expresses multiple type of solid tumor, and one is for the binding with CD3 protein on the surface of immune T cells. CBA 1535 is anticipated to have strong cytotoxicity arisen from T-cell proliferation and activation. CBA-1535 is targeted for refractory cancer such as malignant mesothelioma, small cell lung cancer, and non small cell lung cancer and for solid tumor such as kidney, ovarian, and breast.

CBA-1535 is produced by the trispecific antibody generation technology called as Tribody™. This is the first-in human study of multi-specific antibody in Tribody™ and consists of 2 parts. The first part is a dose escalation to assess the safety and initial pharmacokinetics as a single agent. The second part is an expansion part where safety and preliminary efficacy are evaluated in combination with cancer immunotherapy agent. In addition to the safety and efficacy, obtaining proof of concept as a T cell engager is a major objective. Once it is proved Tribody™ technology could be applicable to multiple types of tumor antigen. 5T4 expresses on malignant mesothelioma, small cell lung cancer, and non-small cell lung cancer, and other solid tumors.

Chiome Bioscience press release