Gelonghui March 1 | Gacos-B (01167.HK) announced that the new drug clinical trial application (“IND”) for the P53 Y220C activator JAB-30300 developed independently by the company has been approved by the US Food and Drug Administration (“FDA”). Gacos will conduct phase i/IIa clinical trials for advanced solid tumors in the US to evaluate the safety and efficacy of JAB30300. At the same time, Gacos plans to submit clinical applications for new drugs to the Drug Evaluation Center of the State Drug Administration in China. After approval, clinical trials will be carried out simultaneously in China and the US.
P53 is the single gene with the most common genetic mutation in human cancer. About 50% of cancer patients have P53 gene mutations. JAB-30300 is an oral bioactive small molecule activator for treating patients with locally advanced or metastatic solid tumors carrying P53 Y220C mutations. Research shows that JAB-30300 shows a very high affinity for the P53 Y220C mutant protein. Tumor regression has been achieved in various tumor models, such as gastric cancer, ovarian cancer, breast cancer, and lung cancer. Synergistic effects have been found when used in combination with chemotherapy or carcinogenic protein inhibitors, which indicates that JAB-30300 has broad combinatorial potential. Currently, only one similar project of the P53 Y220C activator in the world is in the first clinical phase. The JAB-30300 is expected to be one of the first products to be launched.