바이오스펙테이터

by Jongwon Jang

The clinical trial, employing the PentambodyTM, the bispecific antibody platform developed spontaneously by Beijing Hanmi, the local subsidiary of Hani Pharmaceutical Co., Ltd. in China was started and is in progress. The Innovent Biologics Co., Ltd., which is collaborating with Beijing Hanmi for the development of new drugs based on Pentambody, announced, “… the administration of immuno-anticancer bispecific antibody candidate of new drug employing Pentambody was completed successfully for the first patient participating in the Phase I Clinical Trial targeted for HER2 manifested progressive malicious solid cancer”, on the 27th of November. The clinical trial has been conducted to test the safety and tolerance of IBI315 and identification of initial efficacy of the drug. Innovent Biologics Co. Ltd. is a Chinese enterprise, which recently concluded several contracts for commercialization and co-development of diverse types of new drugs with global pharmaceutical companies.

The IBI315, prescribed for the first time to patients participating in the clinical trial, is a PD-1/HER2 targeted recombination of completely humanized bispecific antibody presenting possibility as a new therapeutic agent for HER2 manifesting carcinoma, the candidate material for new drug for which the collaboration under the global partnership concluded the development and commercialization of new drugs between Beijing Hanmi and Innovent Biologics Co. Ltd. in China in 2017. IBI315 cuts off the signal transfer channel of PD-1/PD-L1 and HER2, and induces the proximity between PD-1 manifesting T-Cells and HER2 manifesting cancer cells by which the synergetic effect of immuno-anticancer treatment and targeted anticancer treatment can be expected.

Pentambody is a name derived from ‘Penta amino acid mutated bispecific antibody’. It is a product of next-generation bispecific antibody platform technology enabling one antibody to simultaneously combine with two targets and thereby two kinds of treatment, immuno-antibody treatment, and targeted anticancer treatment, are enabled. In particular, it is equipped with structural features similar to natural immunoglobulin G (lgG), exhibiting excellent immunogenicity and safety, together with the advantage of higher production efficiency.

The Vice-President of the Division of Anticancer Business of Hui Zhou of Innovent Biologics Co., Ltd., stated, “…IBI315 is a candidate material for PD-1/HER2 bispecific antibody therapeutic agent and had entered into the clinical trial for the first time in the world. It is a key pipeline of immuno-anticancer treatment agent of Innovent Biologics…”, “…based on the analysis of safety and potential treatment effect of the material, we will try to provide patients with effective treatment options.”.

President, Kwon Se-Chang of Hanmi Pharmaceutical Co., Ltd. also stated, “… the clinical trial of new candidate material for the new drug employing Pentambody, the infra-technology developed by Hanmi Pharmaceutical Co., Ltd., is in progress successfully. The advancement in clinical stage and commercialization thereof will be spurred by putting all the efforts on R&D based on close cooperation with partners…”.