KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment of patients with advanced or metastatic solid tumors. KGX101, a next-generation pro-drug product of the cytokine IL-12, has previously received IND approval in the United States and is now set to begin its clinical research journey in China.
KGX101 is designed to target the tumor-specific antigen KLK2, which is highly expressed in prostate cancer, and to activate T cells by binding to CD3 on T cells, thereby inducing an immune response against KLK2-positive tumor cells. Clinical studies have shown that KLK2 plays a crucial role in the development of prostate cancer by promoting the transactivation of androgen receptors and accelerating the growth of prostate cancer cells. The design of KGX101 aims to bridge T cells and tumor cells, triggering T cell-mediated lysis of tumor cells and demonstrating potential immunomodulatory and antitumor effects.
According to ClinicalTrials.gov, KangaBio is conducting three Phase I clinical studies on KGX101, including monotherapy, combination therapy with the PSMA-CD28 bispecific antibody JNJ-87189401, and combination therapy with anti-PD-1 antibody cetrelimab, paclitaxel chemotherapy, or androgen receptor pathway inhibitors for metastatic castration-resistant prostate cancer.
At the 2024 European Society for Medical Oncology (ESMO) Congress, KangaBio presented the design of a Phase I clinical trial for the combination therapy of KGX101 and JNJ-87189401 for advanced prostate cancer. This combined therapy may enhance T cell activation by simultaneously activating the CD3 and CD28 pathways, leading to deeper and more lasting clinical responses.
As KLK2 emerges as a novel target for prostate cancer treatment, only a few targeted therapies have entered clinical study phases globally. KangaBio has positioned itself in this field with multiple innovative therapies, including the KLK2-CD3 bispecific antibody, CAR-T cell therapy JNJ-75229414, and radiotherapeutic drug JNJ-69086420 (JNJ-6420), all of which are in Phase I clinical study stages.- Flcube.com
