Innovent Biologics doses first patient in phase 3 trial of IBI363 for advanced colorectal cancer

Innovent Biologics, Inc. doses the first patient in its Phase 3 trial of IBI363, a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, combined with bevacizumab for advanced colorectal cancer. The study in China plans to enroll 550 patients to evaluate overall survival. Developed with Takeda, IBI363 targets 'immune-cold' tumors, which represent 86% of cases and are typically resistant to standard immunotherapies.

IBI363 phase 3 trial initiation

• ▪In May 2026, China's National Medical Products Administration granted Breakthrough Therapy Designation to IBI363 in combination with bevacizumab for advanced microsatellite stable or mismatch repair-proficient colorectal cancer.
• ▪The primary endpoint of the Phase 3 clinical trial evaluating IBI363 in combination with bevacizumab for advanced colorectal cancer is overall survival.
• ▪The Phase 3 clinical trial of IBI363 in combination with bevacizumab plans to enroll 550 patients in China with advanced colorectal cancer refractory or intolerant to standard treatment.
• ▪Innovent Biologics, Inc. announced on August 15, 2026, that the first patient was dosed in a Phase 3 clinical trial evaluating IBI363 combined with bevacizumab for advanced colorectal cancer.

PD-1/IL-2α bispecific mechanism

• ▪IBI363 is an investigational, potential first-in-class PD-1/IL-2α-biased bispecific fusion protein designed to block PD-1 while stimulating tumor-specific CD8+ T cells.
• ▪The dual antitumor mechanism of IBI363 aims to overcome the immunosuppressive state of immune-cold tumors by turning them into immune-active states.

Phase 1 efficacy results

• ▪The Phase 1 clinical study of IBI363 combined with bevacizumab demonstrated a disease control rate of 61.6% and a median progression-free survival of 4.7 months.
• ▪In a Phase 1 clinical study presented at the 2025 ASCO Annual Meeting, IBI363 combined with bevacizumab achieved a confirmed objective response rate of 15.1% among 73 patients.

Safety profile data

• ▪In the Phase 1 study of IBI363 combined with bevacizumab, the incidence of Grade 3 or higher treatment-related adverse events was 35.6%.
• ▪The most common treatment-related adverse events observed in the Phase 1 study of IBI363 combined with bevacizumab were arthralgia, anemia, rash, and hypothyroidism.

Cold tumor immunotherapy strategy

• ▪Patients with microsatellite stable colorectal cancer represent the vast majority of colorectal cancer cases and are largely insensitive to current immune checkpoint inhibitors.
• ▪Approximately 86% of colorectal cancers exist in an immune-desert or immune-suppressed state, making them traditionally unresponsive to standard immune checkpoint inhibitors.

Innovent-Takeda collaboration

• ▪Prior to the colorectal cancer trial, Innovent Biologics, Inc. initiated a Phase 2 trial for melanoma in China and a global Phase 3 trial for squamous non-small cell lung cancer.
• ▪Takeda holds exclusive rights to commercialize IBI363 worldwide outside of the United States and greater China, while Innovent Biologics, Inc. retains development and commercialization rights in China.
• ▪Innovent Biologics, Inc. and Takeda are co-developing IBI363 globally and will co-commercialize the bispecific fusion protein in the United States.

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