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.
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“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.