Sep 21 2015
Ignyta, Inc., a precision oncology biotechnology company, announced today the initiation of the company’s Phase 1/1b clinical trial of RXDX-107, its next generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles.
This multicenter, open-label, dose-escalation clinical trial is designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in adult patients with locally advanced or metastatic solid tumors.
“We are excited to be able to begin dosing patients with this product candidate at leading cancer centers in this clinical trial,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “RXDX-107 represents our third product candidate in the clinic, furthering our goal of attacking cancer on multiple fronts for the benefit of cancer patients. The speed with which we have been able to file an IND and bring this molecule into clinical development six months after acquisition from Teva is a testament to the Ignyta team’s strong execution.”
About RXDX-107
RXDX-107 is a new chemical entity comprising an alkyl ester of bendamustine encapsulated in HSA to form nanoparticles. RXDX-107 is designed to have increased half-life and improved tissue biodistribution by leveraging the affinity characteristics of albumin for tumor cells, while retaining the unique cytotoxic properties of bendamustine. These improvements may provide meaningful benefit to patients with solid tumors. In preclinical pharmacology studies, RXDX-107 has demonstrated anti-tumor activity in multiple in vitro and in vivo studies, including cell line-based and patient-derived xenograft models of solid tumors.