Fochon Pharmaceuticals Doses First Patient in the US in Phase I Clinical Study of FCN-437, a CDK4/6 Inhibitor for Advanced Solid Tumors
Fochon Pharmaceutical Co., Ltd.(Fochon), a pharmaceutical company based in Chongqing and Shanghai focusing on R&D of small-molecule drugs, announced June 25, 2019 dosing of the first patient in the US in the recently initiated Phase I clinical trials of FCN-437 in patients with advanced solid tumors.
About FCN-437
FCN-437 is a novel, proprietary and orally active inhibitor of Cyclin Dependent Kinase 4 and 6 (CDK4/6) developed by Fochon to treat solid tumors. FCN-437 demonstrated much higher in vitro and in vivo potency and selectively inhibitory activities against CDK4/6 compared to approved CDK4/6 inhibitors. FCN-437 exhibited broad anti-tumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic properties, and improved toxicity profile in non-clinical studies. In particular, FCN-437 can distribute to the brain and provide an opportunity to treat tumors that have metastasized to the brain. Preclinical data of FCN-437 was presented by Fochon at 2019 AACR Annual meeting at Atlanta, USA.
Phase I clinical trials of FCN-437 is on-going in China in parallel with the US trial as Fochon also received the approval from China NMPA for the IND application of FCN-437 to treat patients with solid tumors.
CDK4/6 and solid tumors
CDK4/6 can form complex with Cyclin D to phosphorylate Retinoblastoma protein (Rb), which enables cell cycle progression. Phosphorylation of Rb leads to dissociation of Rb from the E2F family of transcription factors and allows transcription of E2F target genes progression that drives cell cycle transition from G1 to the S phase. Loss of cell cycle control caused by aberrations in the CDK/Rb signaling pathway are common in a variety of solid tumors. Inhibiting CDK4/6 blocks CDK/Rb signaling pathway, which prevents cell cycle progression through the G1 restriction point, thus arresting tumor cell growth.
About Fochon
Fochon Pharmaceutical Co., Ltd. is a pharmaceutical company focusing on research and development (R&D) of small-molecule drugs for advancing best-in-class therapies to improve human lives. We are based in Chongqing and Shanghai, with strong financial backing by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Fochon has a proven track record of accelerating the discovery of best-in-class potential small-molecule therapeutics to clinical development for cancer and metabolic diseases. Since its foundation, Fochon has built a significant R&D pipeline consist of drug candidates targeting ALK/ROS1, BCL-2, BTK, pan-TRK (1st & 2nd generation), CDK4/6, MEK, pan-HER, PI3Kdelta, URAT, DPP-4 and etc., of which FCN-005 (Fotagliptin, DPP-4 inhibitor) in Phase II/III is the most advanced.
