Ignyta Announces Exploration Of Strategic Options For Taladegib, Enabled By Amendment Of Taladegib License Agreement With Eli Lilly

SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that it is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program. Ignyta had previously disclosed it was in discussions with Lilly regarding the optimal path forward for taladegib in the context of its pipeline priorities, which are focused substantially on molecularly targeted therapies, including its lead product candidate, entrectinib.

The agreement amends and restates the prior license, development and commercialization agreement, dated November 6, 2015, by and between Ignyta and Lilly. Taladegib is a potent, orally bioavailable small molecule hedgehog/smoothened antagonist that has achieved clinical proof-of-concept and a recommended Phase 2 dose based on results from prior clinical studies.

“Ignyta is excited to continue to develop potential combinations of taladegib with other products to address residual disease, while exploring strategic options for single agent taladegib oral and the topical formulation of taladegib by sub-licensing or selling the franchise to dermatology-focused companies who may have an interest in superficial, nodular, and advanced basal cell carcinoma (BCC). We have received inbound interest on these assets in these BCC indications, and will be weighing the merits of these potential partnerships with other opportunities to develop taladegib internally for the benefit of patients with rare cancers outside of BCC. We are pleased to have achieved an amicable resolution with Lilly to provide Ignyta with a clear path forward for pursuing these various strategic options for taladegib,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta.

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 companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with the rarest 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.

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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 Ignyta's product candidates and Ignyta’s efforts to explore strategic options for single agent taladegib oral and the topical formulation of taladegib. 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 taladegib or other product candidates, or any future clinical trials of taladegib 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; 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.