On March 31, 2025,Innovent Biologics announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.
About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein)
IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models.
Clinical trials of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies. The first pivotal study of IBI363 has been initiated, for the treatment of IO-naive mucosal or acral melanoma.
Furthermore, IBI363 has received two fast track designations (FTD) from the U.S. FDA, for the treatment of melanoma and squamous NSCLC, respectively. IBI363 has also received breakthrough therapy designation from the NMPA of China for the treatment of melanoma.
Innovent Presents Phase 1 Clinical Data of First-in-class PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) in Melanoma at the 2024 ASCO Annual Meeting.
67 subjects with locally advanced or metastatic melanoma who failed or intolerant to standard treatment were enrolled and received IBI363 intravenously at dose levels between 100 μg/kg QW and 2 mg/kg Q3W. 89.6% of subjects had received prior immunotherapy, and 61.2% of subjects had ≥ 2 lines of prior systemic therapy. 25.4% of subjects had baseline liver metastasis and 70.1% of subjects were acral or mucosal subtypes.
As of Jan 11, 2024, 57 subjects had at least 1 post-baseline tumor assessment. The best overall response was complete response (CR) in 1 subject, partial response (PR) in 15 subjects respectively. The overall response rate (ORR) was 28.1% (95%CI: 17.0-41.5) and DCR was 71.9% (95%CI: 58.5-83.0). In 25 immunotherapy (IO) treated subjects in 1mg/kg Q2W dose group (n=25), the ORR was 32.0% (95%CI: 14.9-53.5), DCR was 80.0% (95%CI: 59.3-93.2).
As for safety, 16 (23.9%) subjects had grade ≥3 treatment emergent adverse events (TEAEs). Most common TEAEs were arthralgia (34.3%), hyperthyroidism (29.9%), and anemia (25.4%). Grade ≥3 immune related adverse events (irAEs) occurred in 8 (11.9%) subjects. No TRAE leading to death occurred.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Apr-01-2025