On November 8, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that interim results from the company’s ongoing Phase 1 clinical trial of RXDX-105, the company’s orally-available, small molecule multikinase inhibitor with potent activity against such key targets as RET and BRAF, were presented at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts (Press release, Ignyta, NOV 8, 2015, View Source [SID:1234508112]).

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"We are excited by the data from our Phase 1 clinical trial of RXDX-105, including the overall safety profile and the recent partial response in a non-small lung cancer patient," said Pratik Multani, M.D., Chief Medical Officer of Ignyta. "We believe we are close to determining the recommended phase 2 dose (RP2D) and we look forward to further study of this product candidate in cancer histologies and molecular alterations of interest."

The dose escalation clinical trial was designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), as well as preliminary anti-cancer activity, of single agent RXDX-105 in patients with advanced or metastatic solid tumors that were not selected based on any molecular alteration.

As of the October 26, 2015, data cut-off for the presentation, the findings showed:

A total of 41 patients with a range of solid tumors were dosed in the clinical trial;
RXDX-105 was well tolerated to date:

The most frequent treatment-emergent adverse events were fatigue, vomiting, nausea, decreased appetite, constipation, diarrhea, hypertension and muscle spasms;

Three Grade 3 dose-limiting toxicities were observed: maculopapular rash, fatigue and diarrhea, each of which resolved upon study drug interruption;

There were no treatment-related serious adverse events. Two Grade 4 adverse events had occurred, consisting of intestinal obstruction and anemia, neither of which was considered to be treatment-related. No Grade 5 treatment-related adverse events or cumulative adverse events were observed;

The MTD and RP2D had not yet been determined;

Pharmacokinetic measurements showed increased exposure with increasing dose, with a half-life compatible with once-daily dosing. Dosing in the fed state appears to further increase exposure;

Exposure was reaching levels expected to be efficacious based on tumor growth inhibition in animal models of RET- and BRAF-driven tumors; and

Tumor regression was observed in six patients treated with 275 mg, including one confirmed partial response (40% reduction) in a patient with non-small cell lung cancer with a KRAS G12C mutation. Two additional patients with thyroid cancer and squamous cell lung cancer exhibited reductions of 20% and 27%, respectively. In patients with tumor regression, there appears to be an exposure/response correlation.

On Monday, November 9, 2015, Ignyta will file a Form-8-K with the U.S. Securities and Exchange Commission (SEC) containing the materials presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium. The company’s SEC filings can be found on the company’s website at www.ignyta.com and on the SEC’s website at www.sec.gov.

At the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, Ignyta also presented a poster relating to the potent RET inhibitory activity of RXDX-105 in multiple preclinical models of RET-rearrangement driven cancer. This poster is available on the company’s website at www.ignyta.com.