Jul 26,2024 ——Jacobio Pharmaceuticals (1167.HK) announcedthat the first patient in its Phase I/IIa oncology clinical study has beendosed with its independently developed p53 Y220C activator, JAB-30355.
CFS extends our warmest congratulations to Jacobio! As Jacobio's CDMO partner, CFSprovided services for technology transfer and Phase I clinical manufacture for theoral formulations. Based on our deep understanding of the product'sformulation, process, and equipment performance, we designed a comprehensive technology transfer plan which ensured thesuccessful transfer the formulation process and completion of the GMP batchesand consequentlyenabled our client to achieve early patient enrollment and dosing.
AB-30355 exhibited dose-dependent anti-tumor activity in multiple CDX and PDX models withoverall good tolerability. The synergistic effect was observed when combinedwith other anti-cancer agents, indicating a broad potential for combinationaltherapy with JAB-30355. Currently, there is only one p53 Y220C activator atphase II stage globally. The clinical study of JAB-30335 is being conducted inboth China and the U.S.