FCN-411 is a novel, proprietary and highly potent pan-HER inhibitor developed by Fochon for the treatment of metastatic NSCLC and HSNCC. Members of the epidermal growth factor recept or (EGFR) tyrosine kinase family, including EGFR (also called HER-1, ErbB-1), HER-2 (neu, ErbB-2), HER-3 (ErbB-3) and HER-4 (ErbB-4), play a crucial role in regulating cell proliferation and differentiation in many tissue types. More than 90% of all solid tumors overexpress at least one EGFR family member.

FCN-411 inhibited the kinase activity of EGFR, HER2, HER4, thereby inhibiting down stream signaling and leading to tumor-growth inhibition. Compared to approved EGFR tyrosine kinase inhibitors, FCN-411 shows greatest in vitro and in vivo potency against EGFR activating and resistance mutations including EGFR T790M/L858R. It exhibits favorable pharmacokinetic properties with superior brain penetration and good safety profile.

Phase I clinical trial of FCN-411 is under preparation to target gefitinib/erotinib resistant EGFR-positive metastatic NSCLC patients including brain metastasis patients. Fochon plans to leverage clinical proof-of-concept data of FCN-411 from China to accelerate worldwide clinical development as the first line treatment.

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