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Abbisko Therapeutics Launches Phase I Trial of FGFR2/3 Inhibitor for Solid Tumors

NEW YORK – Abbisko Therapeutics announced Wednesday that the first cancer patient has received its FGFR2/3 inhibitor ABSK061 in a Phase I trial.

The trial will assess safety, tolerability, and pharmacokinetics of the drug in 85 patients with solid tumors. It will also provide a preliminary assessment of ABSK061's anti-tumor activity and identify a recommended dose for Phase II studies. The trial is being conducted at sites in China and the US.

According to Shanghai-based Abbisko, ABSK061 has strong potency against FGFR2 and FGFR3 but reduced activity against FGFR1, which lowers the risk of side effects that can limit the therapeutic window and efficacy of other drugs in this class.

The US Food and Drug Administration approved the first FGFR inhibitor, Janssen's FGFR1/2/3/4 inhibitor Balversa (erdafitinib), in 2019 for metastatic bladder cancer, followed by Incyte's FGFR1/2/3 inhibitor Pemazyre (pemigatinib) in 2020, and BridgeBio Pharma/Helsinn Group's FGFR1/2/3 inhibitor Truseltiq (infigratinib) in May 2021 for bile duct cancer.

Abbisko's other clinical-stage precision oncology programs include the FGFR4 inhibitor ABSK011 and the pan-FGFR inhibitor ABSK091. In December 2021, Abbisko started a Phase II study of ABSK091 in urothelial carcinoma patients bearing FGFR2/3 alterations. It partnered with Burning Rock Biotech in April 2021 to develop a companion diagnostic for that program. And in February, the company began a Phase II trial of ABSK011 in patients with advanced or unresectable hepatocellular carcinoma overexpressing FGF19.