On December 29, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RXDX-106, a novel oral immunomodulatory agent and TAM inhibitor, in patients with solid tumors (Press release, Ignyta, DEC 29, 2017, View Source [SID1234522787]).

Under this IND, the company intends to initiate the TITAN (Targeted Immunomodulatory TAM ANtagonist) study, a first-in-human, open label, multicenter, dose escalation study of RXDX-106 in patients with locally advanced or metastatic solid tumors. TITAN is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-106.

"RXDX-106 represents a new class of immuno-oncologic precision medicines that we are excited to advance to the clinic. In preclinical studies, RXDX-106 has demonstrated the potential to elicit and potentiate an immune response to cancer, by targeting the TAM family of receptors in the tumor microenvironment, both as a single agent and in combination with checkpoint inhibitors," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase 1 study in early 2018."