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.

Forward-looking statements      
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.