Innovent Biologics and Beijing Hanmi Pharmaceutical, a subsidiary of Hanmi Pharmaceutical, said that the first patient has been dosed in a phase 1 clinical trial in China for evaluating IBI315 for the treatment of advanced solid malignancies.

IBI315, which has been co-developed by the companies, is a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and human epidermal growth factor receptor 2 (HER2) [anti-PD-1/HER2 bispecific antibody].

The drug candidate is being assessed in the early-stage trial called CIBI315A101 for its safety, tolerability, initial efficacy and recommended phase 2 dose (RP2D) in the treatment of patients having HER2-expressing advanced solid malignancies. IBI315 is being evaluated as monotherapy and also in combination with chemotherapy.

Se Chang Kwon – CEO of Hanmi Pharmaceutical said: “The new drug candidate developed upon Hanmi’s PENTAMBODY bispecific platform technology has successfully entered into clinical stage. We will continue to cooperate closely with our partner Innovent to focus on our R&D to further advance clinical and commercial development.”

IBI315 is a recombinant fully human IgG1 bispecific antibody that targets PD-1 and HER2, which may give a novel solution for the treatment of HER2-expressing malignancies, said Innovent Biologics.

The Chinese biopharma company further said that IBI315 can simultaneously inhibit the PD-1/PD-L1 signaling pathway, the HER2 signaling pathway, and bridge PD-1-expressing T cells to HER2-expressing tumor cells.

IBI315 is said to combine the targeted therapy and the immunotherapy mechanisms of action, as a result, potentially improving anti-tumor activity and boosting anti-tumor efficacy.

Dr. Hui Zhou – Innovent Biologics Vice President and Head of Oncology Strategy and Medical Sciences said: “IBI315, as one of our pivotal drug candidates in our pipeline of cancer immunotherapies, is the world’s first PD-1/HER2 bispecific antibody that has entered clinical development.

“The development of IBI315 is therefore highly valuable and we hope that this new therapeutic bispecific antibody will offer a novel and more effective solution to patients’ unmet medical needs and ultimately benefit more patients.”

  Beijing Hanmi Pharmaceutical, cancer, China, Dr. Hui Zhou, Hanmi Pharmaceutical, IBI315, Innovent Biologics, Oncology, Se Chang Kwon