Ignyta Announces New Data Highlighting Immune Modulation of RXDX-106 at the Society for Immunotherapy of Cancer (SITC) Meeting

SAN DIEGO--(BUSINESS WIRE)-- Ignyta Inc (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced new preclinical data for RXDX-106 – a novel immunomodulatory agent that demonstrated potent anti-tumor activity, alone and in combination with checkpoint inhibitors, by modulating the tumor microenvironment (TME) through TYRO3, AXL, and MER (TAM) receptor tyrosine kinase (RTK) inhibition. In the TME, TAM RTKs contribute to cancer cell evasion of the immune system and progression by promoting anti-inflammatory and pro-tumorigenic activities. RXDX-106 is a potent and selective TAM inhibitor in late-stage preclinical development, designed to reverse TAM RTKs-mediated immunosuppression and inhibit tumor growth and progression. The data were presented in two posters (abstracts P90 and P473) at the 32^nd Annual SITC Meeting, in National Harbor, Maryland.

"We are excited by the immunomodulatory effects of RXDX-106 observed in a variety of preclinical models, and its potential to elicit and potentiate an immune response to cancer, both as a single agent and combined with checkpoint inhibitors,” said Jonathan Lim, M.D., chairman and CEO of Ignyta. “RXDX-106 represents a new class of immuno-oncologic precision medicines by targeting the TAM RTKs in the tumor microenvironment. We look forward to bringing it into clinical trials in early 2018 to continue our efforts to help patients in their fight against cancer.”

Using complementary approaches, including gene and protein modulation, RXDX-106 treatment resulted in the recruitment of both innate and adaptive immune cell subtypes to the TME. Using RNA sequencing, differential expression of immunomodulatory genes were observed in RXDX-106 treated compared to vehicle treated mouse cohorts, indicative of an enrichment in pro-inflammatory/anti-tumorigenic immune cell infiltration. In addition, RXDX-106 demonstrated immune-mediated, single-agent anti-tumor activity in multiple tumor models that was further enhanced by combination therapy with immune checkpoint inhibitors. These data further demonstrate the ability of RXDX-106 to activate both innate and adaptive immunity, as observed by treatment-mediated changes in relevant cytokine levels and immune cell biomarkers, and regulating cross-talk between immune and cancer cells. These promising early findings support further development of RXDX-106 to potentially treat a wide variety of cancers.

About Ignyta, Inc.

Blazing a New Future for Patients with Cancer™

At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular and immunological drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with rare cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.

For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the development of RXDX-106, the preclinical data or plans underlying RXDX-106, our ability to design and conduct development activities for RXDX-106, the timeline associated with such development program and the potential efficacy of RXDX-106. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta's plans to develop and commercialize its product candidates; the potential for final results of the ongoing clinical trials of entrectinib or other product candidates, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; our dependence on third party manufacturers for supply of our product candidates and any approved products; Ignyta's ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent Quarterly Reports on Form 10-Q.

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