On April 7, 2020 Abbisko Therapeutics Co., Ltd. reported the completion of the cohort 1 study for ABSK-021 phase I clinical trial in the US and the enrollment of the first patient for ABSK-011 phase I trial in Taiwan, China (Press release, Abbisko Therapeutics, APR 7, 2020, View Source;article_id=142&brd=1 [SID1234556284]). ABSK-021 has demonstrated excellent PK properties in the first cohort of patients with strong target engagement. Both innovative drug candidates, independently discovered and developed by Abbisko Therapeutics, have officially entered into clinical stage development.
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ABSK-021 is a highly potent and selective small molecule inhibitor of CSF-1R with oral availability. Blocking CSF-1R signaling pathway can modulate tumor microenvironment, release tumor immunosuppression, and synergize with a variety of anticancer therapies such as tumor immune-checkpoint antibodies to achieve better tumor inhibition. Clinical studies have demonstrated that inhibition of CSF-1R activity can be used to treat tenosynovial giant cell tumor (TGCT) and many other human malignancies.
ABSK-011 is an oral, potent, and highly selective small molecule inhibitor of FGFR4 that exhibited strong anti-tumor effects in preclinical models with excessive activation of FGFR4 signaling. In December of 2019, ABSK-011 was first approved by the FDA of Taiwan (China) to enter into Phase I clinical study. In February, ABSK-011 was also approved for entering clinical studies by the national medical products administration of China (NMPA).