Turning Point Therapeutics Announces FDA Clearance Of Investigational New Drug Application For TPX-0022, A Novel MET/CSF1R/SRC Inhibitor

SAN DIEGO, May 15, 2019 – Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs that address treatment resistance, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug (IND) application for TPX-0022, a novel 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.

“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.

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, and is planned to enter a registrational Phase 2 study in the second half of 2019. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.


Turning Point Therapeutics, Inc.
Jim Mazzola