FDA Greenlights IND of JAB-30300 for Advanced Solid Tumors
JAB-30300, a P53 Y220C activator, received approval from the FDA for its investigational new drug application. A phase 1/2a clinical trial to investigate its safety and efficacy against advanced solid tumors will begin.
- JAB-30300 is an orally bioavailable small molecule activator.
- The agent is being evaluated for the treatment of patients with locally advanced or metastatic solid tumors harboring a P53 Y220C mutation.
- With this investigational new drug application (IND) approval granted by the FDA, a phase 1/2a trial of JAB-30300 will begin in patients with advanced solid tumors.
The FDA has granted an IND application to JAB-30300, a self-developed drug made by Jacobio Pharma, for the treatment of patients with advanced solid tumors.1
With this IND, there are plans to initiate a phase 1/2a clinical trial for the treatment of advanced solid tumors. Here, the safety and efficacy of JAB-30300 will be assessed across a variety of advanced solid tumors.
Tumor Cell: ©nevio - stock.adobe.com
JAB-30300 is a P53 Y220C activator, and P53 is the most frequently altered gene observed in cancers in humans. Mutations are present in approximately 50% of all invasive tumors. Currently, there is only 1 P53 Y220C activator program in the phase 1 clinical stage globally.
The orally bioavailable small molecule activator JAB-30300 is currently undergoing investigation in trials for the treatment of patients with solid tumors with P53 Y220C mutations.2 Prior studies have shown JAB-30300 to have high binding affinity to P53 Y220C mutant proteins, and the agent achieved tumor regression in multiple cancer models, including gastric cancer, ovarian cancer, breast cancer, and lung cancer.1
JAB-30300 also showed a synergistic effect when given in combination with chemotherapy or oncogenic protein inhibitors. Experts anticipate JAB-30300 to be one of the first P53 Y220C activators approved.
In addition to this IND, Jacobio Pharma plans to submit an IND in China. Once the IND is received and granted approval, they will begin to conduct clinical studies of JAB-30300.
