US-based Ignyta is planning to begin a Phase l trial of RXDX-106 to treat patients with locally advanced or metastatic solid tumours.
The first-in-human, open-label, multicentre, dose escalation trial will be named ‘Targeted Immunomodulatory TAM Antagonist’ (TITAN).
The trial will aim to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-106.
It follows an approval granted by the US FDA to the investigational new drug (IND) application filed by Ignyta for RXDX-106, a new oral immunomodulatory agent, and TAM inhibitor.
Ignyta chairman and CEO Jonathan Lim said: “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.
“This agent furthers our commitment to advancing new medicines to help patients in their fight against cancer. We look forward to commencing this Phase l study in early 2018.”
In a separate development, Ignyta signed a definitive merger agreement to sell its shares to Switzerland-based biotech company Roche for $1.7bn.
The merger agreement has been unanimously approved by the boards of Ignyta and Roche, and is expected to close in the first half of this year.