Biopharmaceutical firm Innovent Biologics has dosed the first patient in a Phase I clinical trial of IBI315, a recombinant fully human IgG1 bispecific antibody that targets programmed cell death receptor-1 (PD-1) and human epidermal growth factor receptor 2 (HER2) simultaneously.
The antibody is being developed by Innovent and Hanmi Pharmaceutical under a global partnership announced in March 2017.
Innovent is leading the antibody’s clinical development in China. The Phase I CIBI315A101 trial is designed to evaluate IBI315 in the treatment of patients with HER2-expressing advanced solid malignancies.
Safety, tolerability and initial efficacy are the primary objectives of the study, in addition to the recommended Phase II dose of IBI315 either as monotherapy or in combination with chemotherapy.
In preclinical studies, it has been demonstrated that the bridging effects between T cells and tumour cells introduced by IBI315 could improve anti-tumour activity.
Innovent Hui Zhou 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.”
Innovent said IBI315 can simultaneously block the PD-1/PD-L1 signalling pathway, the HER2 signalling pathway, and bridge PD-1-expressing T cells to HER2-expressing tumour cells.
The antibody integrates targeted therapy and immunotherapy mechanisms of action to improve anti-tumour activity and increase anti-tumour efficacy.
Innovent has built a pipeline of 21 assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas using its fully-integrated platform.
The company has also formed partnerships with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies.