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Wednesday, May 15, 2019

Turning Point Therapeutics announces FDA clearance of TPZ-0022 IND

Turning Point Therapeutics announced clearance by the FDA of its investigational new drug, or IND, application for TPX-0022, a therapy targeting solid tumors by inhibiting the MET, CSF1R and SRC kinases. Under the IND, the company plans to initiate a Phase 1 first-in-human, open-label clinical study later this year at multiple U.S. sites. The study is designed to assess the safety, tolerability and preliminary clinical activity of TPX-0022 at escalating doses in patients with advanced or metastatic solid tumors harboring genetic alterations in MET. TPX-0022 has been designed to target MET-driven tumor cells, and also modulate the tumor microenvironment by inhibition of CSF1R.

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