Pharma Focus Asia

Jacobio Pharma Secures IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

Saturday, March 02, 2024

Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on targeting challenging drug sites, has disclosed that the FDA has granted approval for its Investigational New Drug (IND) application concerning JAB-30300. This milestone enables Jacobio to initiate a Phase I/IIa clinical trial in the United States, aimed at evaluating the safety and efficacy of JAB-30300 in treating advanced solid tumors. Jacobio also intends to seek IND approval in China and proceed with clinical studies upon authorization.

P53, a gene frequently mutated in human cancers, is a primary therapeutic target, with mutations occurring in roughly 50% of invasive tumors. JAB-30300, an orally bioavailable small molecule activator, specifically targets the P53 Y220C mutation. Preclinical studies have demonstrated JAB-30300's strong binding affinity to P53 Y220C mutant proteins and its ability to induce tumor regression across various cancer models, including gastric, ovarian, breast, and lung cancers. Additionally, combining JAB-30300 with chemotherapy or inhibitors of oncogenic proteins has shown synergistic effects, suggesting broad potential for combination therapies.

Presently, only one other P53 Y220C activator program is in the Phase I clinical stage globally. JAB-30300 is poised to be among the first of its kind to receive approval, potentially addressing a significant unmet need in cancer therapy.



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