JAB-30300, P53 Y220C activator, received IND approval in the United States

JACUS Pharmaceuticals (1167.HK) announced that its independently developed P53 Y220C activator JAB-30300 has been approved for new drug clinical trial application (IND) in the United States and will conduct a Phase I/IIa late-stage solid tumor clinical trial in the United States to evaluate Safety and effectiveness of JAB-30300. Jakosi also plans to submit a clinical application for a new drug in China. Once approved, clinical trials will be carried out simultaneously in China and the United States.

P53 is the most commonly mutated single gene in human cancers, and about 50% of cancer patients have P53 gene mutations. JAB-30300 is an oral bioactive small molecule activator indicated for the treatment of patients with locally advanced or metastatic solid tumors harboring the P53 Y220C mutation. Relevant studies have shown that JAB-30300 shows very high affinity for the P53 Y220C mutant protein and achieved tumor regression in a variety of tumor models, including gastric cancer, ovarian cancer, breast cancer, and lung cancer. JAB-30300 also has the potential to be used in combination with chemotherapy or oncogenic protein inhibitors to bring more treatment options to patients.

Currently, there is only one similar project of P53 Y220C activator in the world that is in the first clinical phase, and JAB-30300 is expected to be one of the first products to be launched.