On July 15, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody (Press release, Innovent Biologics, JUL 15, 2021, View Source [SID1234584893]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The objective of this open-label, multi-center Phase 1a/1b dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI319 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment. The trial is being conducted in China.
In preclinical studies, IBI319 has demonstrated synergistically targeting both PD-1 and CD137 to simultaneously achieve anti-tumor activity and enhance efficacy.
Professor Yilong Wu, Tenured Professor of Guangdong Provincial People’s Hospital and Honorary Director of Guangdong Lung Cancer Research Institute, stated, "While immune checkpoint inhibitors have shown efficacy in treating a variety of tumor types, we still face challenges of primary and secondary drug resistance. The development of next-generation bispecific antibodies can have important clinical value implications. CD137 is a key co-stimulatory immune checkpoint molecule that plays a role in maintaining immune homeostasis and enhancing anti-tumor immune memory. With the innovative mechanism of a bispecific antibody that provides additional immune activation through CD137 axis in the suppressed tumor microenvironment, the preclinical research results of IBI319 are very promising."
Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, stated: "Currently, there is no other bispecific antibody with the same target in clinical development in the world. Preclinical results have shown that IBI319 can further enhance the immune activation with improved convenience of administration, compared to the combination of two monoclonal antibodies. "
About IBI319 (anti-PD-1/CD137 bispecific antibody)
IBI319 was discovered through a collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. The IND for IBI319 has been approved by the NMPA in China, and clinical trial in China are actively being conducted.
About the Phase 1 Study of IBI319 (CIBI319A101)
Conducted by Innovent in China, this Phase 1a/1b study (CIBI319A101) will assess the efficacy and safety of IBI319 in patients with advanced malignant tumors. Phase 1a of the study will evaluate dosing and Phase 1b will further explore the efficacy of IBI319 in a variety of solid and hematological tumors (ClinicalTrials.gov, NCT04708210).