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Abbisko Therapeutics Obtained Clinical Trial Approval for ABSK061, A Selective Inhibitor of FGFR2 and FGFR3, by the U.S. FDA

Oct 25,2021
By Abbisko

25 October, 2021, Shanghai – Abbisko Therapeutics Co., Ltd., a subsidiary of Abbisko Cayman Limited (Stock Code: 2256.HK, “Abbisko Therapeutics” hereafter) today announces that it has obtained the regulatory approval from the Food and Drug Administration (FDA) of the U.S. to initiate a first-in-human phase I clinical study for ABSK061, a selective FGFR2/3 inhibitor, in subjects with solid tumors.

ABSK061 is a next-generation, orally available, selective and potent inhibitor of FGFR2 and FGFR3 independently discovered and development by Abbisko Therapeutics, with global IP rights. Many types of tumors harboring FGFR2 and FGFR3 alterations are known to respond clinically to pan-FGFR inhibitors but with limited benefit to patients. With reduced FGFR1 activity while maintaining strong potency against FGFR2/3, ABSK061 is rationally designed to mitigate side effects associated with FGFR1 inhibition, thus achieving improved therapeutic window and clinical efficacy in treating cancer patients, as well as better opportunities for treating non-oncology indications. ABSK061 becomes the only known selective dual inhibitor of FGFR2/3 in clinical development globally. 

“We are very pleased to receive the regulatory approval of ABSK061 in the U.S., which is a critical first step for our following clinical trials.” said Dr. Jing Ji, Chief Medical Officer of Abbisko Therapeutics, “ABSK061 pre-clinical data demonstrated favorable drug metabolism and pharmacokinetic (DMPK) properties across species, as well as physicochemical properties and safety profiles. We believe ABSK061 has the potential to be a second generation FGFR inhibitor with its improved selectivity over current FGFR inhibitors. As a highly selective FGFR2/3 inhibitor, ABSK061 complements our pan-FGFR inhibitor to achieve comprehensive indication coverage .”

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