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Abbisko Therapeutics Completes Dosing of the First Patient in the Phase II Clinical Trial for ABSK011 in Combination with an Anti-PD-L1 Antibody

Feb 08,2022
By Abbisko

8 February 2022, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter), a subsidiary of Abbisko Cayman Limited (Stock Code: 2256.HK), today is pleased to announce that the first patient has been dosed in the Phase II clinical trial for its ABSK011, an innovative oral inhibitor of FGFR4, in combination with atezolizumab, an anti-PD-L1 antibody provided by Roche. The Phase II clinical trial targets patients with advanced or unresectable hepatocellular carcinoma (HCC) overexpressing FGF19.

This clinical trial (ABSK-011-201, CTR20213287), which completed the first patient dosing, is a Phase II, multi-center, single-arm, open-label clinical trial in China, aiming to evaluate the safety and efficacy of ABSK011 in combination with atezolizumab in patients with advanced or unresectableor metastatic hepatocellular carcinoma (HCC) overexpressing FGF19.

ABSK011 is a novel FGFR4 inhibitor discovered and developed by Abbisko Therapeutics with global intellectual property rights. Aberrant activation of FGF19-FGFR4 signaling occurs in approximately 30% of HCC patients, which drives tumor growth and leads to liver cancer. In pre-clinical studies, ABSK011 demonstrated high potency in inhibiting FGFR4, great selectivity and favorable physical-chemical properties. The clinical trial of ABSK011 monotherapy is currently ongoing.

Studies have shown that combination therapies of precision oncology and immuno-oncology drugs demonstrated improved efficacy and safety profiles. With the development of the combination study of ABSK011 and atezolizumab, we hope to fast-track the clinical development in China and bring this potentially valuable treatment to a large population of cancer patients.

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