On March 10, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported the selection of a recommended Phase 2 dose (RP2D) and initiation of the Phase 1b portion of its Phase 1/1b clinical trial of RXDX-105, the company’s orally available, small molecule multikinase inhibitor with potent activity against such targets as RET and BRAF (Press release, Ignyta, MAR 10, 2016, View Source [SID:1234509455]). The Phase 1b portion of the study utilizes a basket design focusing on patients with solid tumors that contain molecular alterations of RET or BRAF. Schedule your 30 min Free 1stOncology Demo! "We are excited to embark on further clinical evaluation of RXDX-105 in selected, molecularly-defined patient populations through this Phase 1b clinical trial expansion," said Pratik Multani, M.D., Chief Medical Officer of Ignyta. "In the now-completed Phase 1 dose escalation and dose finding portion of this clinical study, patients were enrolled without selection for molecular alterations. Given the performance of RXDX-105 in that setting, we now look forward to evaluating this investigational agent at the RP2D in targeted patient populations. We also look forward to providing a clinical data update on this program at an upcoming scientific conference."
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About RXDX-105
RXDX-105 is an orally available, small molecule multikinase inhibitor with potent activity against such targets as RET and BRAF.
In November 2015, Ignyta announced interim results from the Phase 1 clinical trial of RXDX-105, which were presented at the 27th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts.
The dose escalation clinical trial was designed to determine the maximum tolerated dose (MTD) and/or 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;
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.
About Ignyta, Inc.
At Ignyta, we fight cancer – a formidable opponent that manifests as thousands of different molecularly defined diseases and takes away millions of lives globally, every year. In this fight, our big hairy audacious goal (BHAG) is not just to shrink tumors but to eradicate residual disease – the source of cancer relapse and recurrence – in precisely defined patient populations by 2030. We will work tirelessly to achieve this BHAG by pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. Our Rx efforts are focused on discovering, in-licensing or acquiring, then developing and commercializing, molecularly targeted therapies that, sequentially or in combination, are foundational for eradicating residual disease. Our Dx efforts aim to pair these product candidates with biomarker-based companion diagnostics that are designed to precisely identify, at the molecular level, the patients who are most likely to benefit from the therapies we develop. We believe that only through this integrated Rx/Dx approach can we succeed in this fight. For more information, please visit: www.ignyta.com.