NEW YORK – Jacobio Pharmaceuticals said on Sunday that the US Food and Drug Administration has cleared the company's investigational new drug application for its KRAS G12C inhibitor, JAB-21822, and that Jacobio expects to begin enrolling patients in clinical trials for the drug during the second half of 2021.
The FDA IND acceptance follows the same from the Chinese National Medical Products Association in mid-March. Now, Beijing-based Jacobio will begin evaluating the agent as a treatment for patients in the US and China whose cancers harbor the KRAS G12C mutation. Cancer types will include non-small cell lung cancer and colorectal cancer, among others.
According to Jacobio, preclinical research has demonstrated that JAB-21822 has a superior pharmacokinetic profile and favorable tolerability versus other KRAS G12C inhibitors. Jacobio also plans to evaluate JAB-21822 in combination with SHP2 inhibitors it is developing in-house.
Beyond KRAS G12C, Jacobio also has KRAS G12D and KRAS G12V agents in its pipeline, for which it plans to submit IND applications in the coming years.
"The R&D of KRAS G12D inhibitors draws on our experience and expertise of the KRAS G12C inhibitor," Steve Zhou, Jacobio's senior VP, said in a statement. "The combination of various advantages including development experience, coupled with our in-house chemical library and focused library design, as well as small molecule drug development capabilities based on the allosteric inhibitor platform, puts us in a favorable position in the global R&D landscape of KRAS inhibitors."