Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug Application

Turning Point Therapeutics (NASDAQ:TPTX) has announced it has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for TPX-0022.

As quoted in the press release:

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 American Association for Cancer Research (AACR) Annual Conference in April and highlighted the ability of TPX-0022 to potently inhibit MET-driven cancer cells and the associated signaling of known cancer pathways. This dual mechanism of action showed tumor regression and growth inhibition in multiple xenograft tumor models harboring MET amplification and/or MET exon 14 skipping mutations.

Click here to read the full press release.