San Diego-based Ignyta Inc., a precision oncology company, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application milestone for the company’s tumor-fighting compound known as RXDX-107.
The next phase is designed to determine the maximum tolerated dose for patients with locally advanced or metastatic solid tumors.
“Although we just recently acquired rights to RXDX-107 from Teva in March, our team has worked hard in the meantime to fully integrate this product candidate into our business and prepare and submit the IND just a quarter later,” said Jonathan Lim, Ignyta chairman and CEO. “This IND represents Ignyta’s second successful IND filing with the FDA, and RXDX-107 will be our third product candidate in the clinic. We look forward to beginning to treat cancer patients with this product candidate.”
Ignyta’s goal is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer.