SAN FRANCISCO & SUZHOU, China—Innovent Biologics, Inc. has announced that the company has successfully enrolled and dosed their first patient in a Phase 2 clinical trial evaluating IBI310 in combination with Tyvyt (sintilimab injection) for the treatment of patients with second-line or above advanced cervical cancer.
IBI310 is a recombinant, fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). IBI310 can interfere with the binding of CTLA-4 and CD80/CD86 on antigen presenting cells, thereby blocking the inhibitory effect on T cell activation. IBI310 can also reportedly promote the activation and amplification of T cells, and enhance the anti-tumor ability of the immune system.
“Cervical cancer is the 4th most common malignant tumor among women in the world. In China, it ranks the 6th highest incidence rate (154/100,000) and 8th highest mortality rate (69/100,000) across tumor types,” stated Professor Ding Ma of Tongji Hospital, affiliated to Huazhong University of Science and Technology, and primary investigator of the study. “Treatment option of advanced cervical cancer is limited. The five-year survival rate of Stage IVb cervical cancer is still at a low level of less than 17 percent.”
“Currently there is no standard treatment for patients with advanced cervical cancer who have failed platinum-based chemotherapy, representing a huge unmet clinical need. In recent years, immune checkpoint inhibitors have brought new hope to such patient population,” Ma continued.
The randomized, double-blind Phase 2 clinical trial will evaluate the efficacy and safety of IBI310 in combination with Tyvyt for advanced cervical cancer patients who have failed first and later lines of treatment, or who are intolerant of platinum-based chemotherapy. This clinical trial plans to enroll 174 patients with advanced cervical cancer.
Tyvyt is a fully human immunoglobulin G4 monoclonal antibody; it binds to PD-1 molecules on the surface of T-cells, blocks the PD-ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for Tyvyt to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
“CTLA-4 is an important immunosuppressive receptor. Currently, only one antibody drug targeting CTLA-4 has been approved and marketed globally, though lots of clinical trials on CTLA-4 targeted drugs have been conducted. So far there is no CTLA-4 targeted drug approved in China,” noted Dr. Hui Zhou, vice president and head of Medical Sciences and Oncology Strategy at Innovent. “With the most advanced progress in clinical development in China, IBI310 in combination with Tyvyt has shown promising preliminary anti-tumor potential value. We will evaluate the efficacy of IBI310 combined with Tyvyt in the Phase 2 trial, and we hope to provide more effective treatment to benefit patients and their families.”