INNOVENT BIO (01801) globally pioneers the development of a groundbreaking therapy potential for the inclusion of PD-1/IL-2 dual-specific antibody fusion protein.

On May 23, the official website of the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) showed that INNOVENT BIO (01801) PD-1/IL-2 bispecific fusion protein IBI363 is intended to be included in breakthrough therapy for the treatment of locally advanced or metastatic squamous non-small cell lung cancer that has failed platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. IBI363 is a globally pioneering PD-1/IL-2-bias bispecific fusion protein developed independently by INNOVENT BIO, with both functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 has been designed and modified to retain its affinity for IL-2 R while weakening its binding ability to IL-2R and IL-2R, thereby reducing toxicity; whereas the PD-1 binding arm can achieve both blockade of PD-1 and selective delivery of IL-2. Due to the fact that newly activated tumor-specific T cells express both PD-1 and IL-2, this differential strategy can more accurately and effectively target and activate this subset of T cells. IBI363 has not only demonstrated good anti-tumor activity in various preclinical pharmacological models, but also showed outstanding antitumor efficacy in PD-1-resistant and metastatic models. Previously, IBI363 was included in the list of breakthrough therapy drugs by the CDE, with the proposed indication for unresectable locally advanced or metastatic acral and mucosal melanoma that have not been systemically treated. INNOVENT BIO is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 in targeting various malignant tumors. IBI363 has initiated its first pivotal registration clinical study for the treatment of mucosal and acral melanoma without prior immunotherapy. IBI363 has received two fast track designations from the US FDA, for the treatment of advanced squamous non-small cell lung cancer and melanoma.