On October 6, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,150,517, entitled "Bendamustine Derivatives and Methods of Using Same (Press release, Ignyta, OCT 6, 2015, View Source [SID:1234507655])." This patent contains claims that cover the composition of matter of Ignyta’s product candidate RXDX-107, and pharmaceutical compositions comprising RXDX-107. RXDX-107 is the company’s new chemical entity, next generation chemotherapeutic comprising an alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles. The patent has an expiration date of 2033, which does not include any potential patent term extension.

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"The issuance of this patent is an important development relating to maintaining exclusivity for our RXDX-107 product candidate"

"The issuance of this patent is an important development relating to maintaining exclusivity for our RXDX-107 product candidate," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We believe this patent will be eligible for listing in the FDA’s Orange Book, should RXDX-107 receive FDA approval, and the timing of the issuance is favorable because it allows us to begin accruing a period of patent term extension during the time this product candidate is undergoing clinical development."

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.

In July 2015, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application (IND) for RXDX-107. Ignyta has initiated a new Phase 1/1b, multicenter, open-label clinical trial of RXDX-107 in adult patients. This dose-escalation study is designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of RXDX-107 in patients with locally advanced or metastatic solid tumors.