Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug Application for TPX-0022, a Novel MET/CSF1R/SRC Inhibitor
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.
“The clearance of our IND for TPX-0022 is another important milestone toward our goal to bring a new class of precision therapies to patients,” said Athena Countouriotis, M.D., president and chief executive officer. “With our lead drug candidate repotrectinib advancing toward its registrational study, we look forward to beginning our clinical assessment of TPX-0022 in the second half of 2019 following the encouraging preclinical data we recently presented last month at AACR.”
Preclinical data for TPX-0022 were presented for the first time at the
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy and therapeutic potential of TPX-0022, and progress and expected timing of Turning Point Therapeutics’ clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, and the other risks described in Turning Point Therapeutics’ filings with the
Source: Turning Point Therapeutics, Inc.