On March 1, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, reported it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. 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 (Press release, Jacobio Pharmaceuticals, MAR 1, 2024, View Source [SID1234640707]). Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval.

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P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. 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 combined with chemo or oncogenic protein inhibitors which indicates a widely combo 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 activator to be approved.