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Abbisko Therapeutics Announces the IND Approval by NMPA for Phase II Clinical Trial of ABSK011

Oct 19,2021
By Abbisko
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October 19, 2021, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today  is pleased to announced that it has obtained the an IND approval from the China National Medical Products Administration (NMPA) for the initiation of a phase II clinical trial of ABSK011, a novel small molecule inhibitor of FGFR4, in combination with Atezolizumab, an anti-PD-L1 antibody, provided by Roche. The phase II clinical study will be conducted in patients with advanced or unresectable hepatocellular carcinoma (HCC) overexpressing FGF19.

ABSK011 is a novel FGFR4 inhibitor discovered and developed by Abbisko with global intellectual property rights. Aberrant activation of FGF19-FGFR4 signaling occurs in approximately 30% of HCC patients and drives tumor growth. 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 various  small  molecule  precision  oncology drugs significantly improve the overall survival time of patients. Similarly, combination therapies of precision oncology and immuno-oncology drugs have demonstrated improved efficacy  and safety profiles in many patients. With the upcoming studies of ABSK011 in combination of Atezolizumab, we hope to fast-track the clinical development of our agent in China and bring this potentially valuable treatment to a large population of cancer patients.

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