Q&A: Behind Ignyta’s New Strategy on Cancer Drugs and Diagnostics

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much less attractive. In wanting to bring on strong drug discovery capabilities, we had a unique opportunity with the Actagene team, whose strength was in oncology, and hence the pivot from autoimmune to oncology.

X: What is the status of Ignyta’s original diagnostics technology for rheumatoid arthritis?

ZH: We have some intriguing diagnostic data for rheumatoid arthritis using purely epigenetic (DNA methylation) analysis. We have even more compelling, market-leading diagnostic data for systemic lupus erythematosus (SLE) using this same epigenetic approach, and our SLE diagnostic panel has been validated across more than 400 prospectively collected, blinded patient samples. Because of Ignyta’s [new] focus in oncology, we will not be taking these autoimmune Dx assets forward ourselves, but they are available for partnership with a company who wants to apply an innovative new modality (epigenetics) to high-value autoimmune diagnostics.

X: Will Ignyta stock continue to trade on the over-the-counter market? If not, what is the plan?

ZH: The company plans to move to the NASDAQ in [the first half of 2014] by meeting the Nasdaq qualification criteria. We are already taking the necessary steps to meet these criteria.

X: How far do you expect to get with the capital you’ve just raised?

ZH: The capital raised most recently is sufficient to take RXDX-101 [one of the anti-cancer drug candidates licensed from Nerviano] through the completion of its ongoing Phase I/II study and into its first randomized Phase IIb or Phase III study (depending on the indication) as well as take RXDX-102 [the other Nerviano compound] into the clinic.

X: What are the Spark discovery programs?

ZH: The Spark-1, Spark-2, and Spark-3 discovery programs are three novel undisclosed [cancer] targets, which Ignyta has identified through mining its proprietary Oncolome database…We have initiated target validation and/or small molecule discovery efforts against multiple targets. Our goal is to have an IND candidate against one or more of these targets by end of 2015, and the drugs that we develop against these targets will be paired with companion diagnostics.

X: How many employees does Ignyta have now?

ZH: As of our most recent public disclosure (11/14/13), we had seven part-time and two full-time employees.

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