Ignyta has filed an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for its RXDX-101, an oral tyrosine kinase inhibitor targeting solid tumour indications.

The company plans to conduct STARTRK-1 (Study Targeting ALK, ROS1 or TRKA/B/C), a multicentre Phase I/II clinical study of RXDX-101, at clinical sites in the US, Europe, and possibly Asia, subject to the approval of the IND application.

The open-label, single-arm, Phase I/IIa study of oral RXDX-101 will be conducted on adult patients with metastatic cancer confirmed to be positive for relevant molecular alterations.

Ignyta chairman and CEO Dr Jonathan Lim said: "I would like to acknowledge the hard work of our team in accelerating the achievement of this milestone one quarter ahead of schedule, as we had previously guided to a submission of the RXDX-101 IND in the second quarter of this year and we assumed responsibility for this programme from Nerviano only three months ago.

"It is gratifying to see the team firing on all cylinders with this programme, as we are impatient to potentially make RXDX-101 available to patients as soon as possible."

"We are impatient to potentially make RXDX-101 available to patients as soon as possible."

RXDX-101 is an orally available, selective tyrosine kinase inhibitor of the Trk family tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins.

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The drug is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK.

It was preclinically tested in vivo in mice, rats and dogs, which showed in vivo antitumour activity against various TrkA, ROS1 or ALK-driven mouse xenograft models of different human cancers, demonstrated oral bioavailability and has been observed to efficiently cross the blood brain barrier in all three species tested.

RXDX-101 is currently in a Phase I/II clinical study at two clinical sites in Italy in patients with solid tumours who are positive for alterations in TrkA, ROS1 or ALK.

Image: Oral tyrosine kinase inhibitor. Photo: courtesy of