4 July, 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (HKEX Stock Code: 2256.HK, referred to “Abbisko Therapeutics” hereafter) today announced the completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally.

The clinical trial (ABSK061-101, NCT05244551) is a First-in-Human Phase 1 study of ABSK061 to assess the safety, tolerability, and pharmacokinetics in patients with advanced solid tumors, and to determine the Recommended Phase 2 Dose (RP2D) and evaluate preliminary anti-tumor activities. The trial is currently being conducted in both China and US.

ABSK061 is a next-generation, orally available, highly potent and selective small molecule FGFR2/3 inhibitor independently discovered and developed by Abbisko Therapeutics with global intellectual property rights. Several first-generation pan-FGFR inhibitors have demonstrated clinical efficacy in multiple types of tumor carrying FGFR2/3 alterations and have been approved globally, including China and US. Their therapeutic window and efficacy, however, are limited by the side effects associated with FGFR1 inhibition. With reduced FGFR1 activity while maintaining strong potency against FGFR2/3, ABSK061 is expected to achieve improved therapeutic window and clinical efficacy as a second-generation FGFR inhibitor. In addition to oncology indications, ABSK061 also has great potential to expand its use in non-oncology indications, such as achondroplasia.

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