The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that, the Food and Drug Administration of the United States has approved the Investigational New Drug application of its self-developed drug JAB-30300 (P53 Y220C activator). Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND application to the Center for Drug Evaluation of the National Medical Products Administration in China, and will conduct clinical studies in both China and the U.S. simultaneously once IND approval is received.

P53 is the single most frequently altered gene in human cancers, with mutations being presentin approximately 50% patients with invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with advanced or metastatic solid tumors harboring P53 Y220C mutation. JAB-30300 has shown very high binding affinity for P53 Y220C mutant proteins in studies.

Tumor regression was achieved in multiple cancer models covering various tumor types, such as gastric cancer, ovarian cancer, breast cancer and lung cancer. The synergistic effect was found when JAB-30300 was combined with chemo or oncogenic protein inhibitors, which indicates a widely combinatorial potential of JAB-30300. There is only one P53 Y220C activator program in the Phase I clinical stage globally.

JAB-30300 is expected to be one of the first P53 Y220C activators to be approved.