Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30355 in the US

Beijing, Shanghai & Boston, Mar 1, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company, announced it received IND (Investigational New Drug) approval for its self-developed drug JAB-30355 (P53 Y220C activator) from the FDA of the U.S. The company plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., aiming to evaluate the safety and efficacy of JAB-30355. Additionally, Jacobio intends to submit an IND in China and will conduct clinical studies upon receiving approval.

P53 is the most frequently altered gene in human cancers, with mutations present in about 50% of all invasive tumors. JAB-30355 is an orally bioavailable small molecule activator designed for treating patients with solid tumors that harbor the P53 Y220C mutation. Preclinical studies have demonstrated that JAB-30355 exhibits high binding affinity to P53 Y220C mutant proteins and has achieved tumor regression in various cancer models, including gastric, ovarian, breast, and lung cancers. The drug also shows potential for combination therapy, as it has synergistic effects when used with chemotherapy or oncogenic protein inhibitors.

Globally, JAB-30355 is one of the few P53 Y220C activators in the Phase I clinical stage, positioning it as a potential leader in its class. Jacobio Pharma is dedicated to developing innovative products and solutions to improve health outcomes, with a pipeline focused on novel molecular targets across six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB, and MYC. The company operates R&D centers in Beijing, Shanghai, and Boston, leveraging its Induced Allosteric Drug Discovery Platform (IADDP) and iADC Platform to advance its drug development efforts.