On January 11, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported its aspirational "5×5" Goal and announced its strategic priorities for 2016 (Press release, Ignyta, JAN 11, 2016, View Source [SID:1234508751]).
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"2015 was yet another transformational year for Ignyta. With the successful acquisition or licensing of six new assets, three of which were either in the clinic or entered the clinic in 2015, Ignyta’s development stage pipeline quadrupled – undergoing an impressive transformation in less than one year," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "Based on our successes in 2015, we believe that Ignyta is uniquely positioned among companies of our size to develop meaningful treatment options for the benefit of cancer patients. We are relentlessly driven by this patient focus, which underlies our previously announced overarching, ‘audacious’ goal of eradicating residual disease in precisely defined cancer patient populations by 2030."
"In 2016, we want to continue to advance our robust pipeline of targeted first-in-class and best-in-class product candidates in pursuit of this goal, and also to more closely tie development successes from our pipeline to this goal," continued Dr. Lim. "That is why we have set an aspirational ‘5×5’ Goal for the company, which means the achievement of five new product or indication approvals in five years, by the end of 2020. This is certainly a very high bar, but we are impatient to make new therapies available to patients, and are building on a strong foundation of four clinical stage assets, three of which have already demonstrated clinical proof-of-concept. We believe that the best way to make meaningful progress in improving the lives of cancer patients is through the pursuit of audacious goals."
Ignyta’s strategic priorities for 2016 will include:
With respect to entrectinib, the company’s novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK, continuing to initiate new clinical sites and enroll patients in its STARTRK-2 global, potentially registration-enabling clinical trial of this product candidate;
With respect to taladegib, the company’s novel, orally available, hedgehog/ smoothened inhibitor, initiating one or more pivotal Phase 2 clinical trials in advanced basal cell carcinoma, as well as potentially initiating a Phase 1b basket study for patients with other solid tumors harboring a hedgehog pathway alteration;
With respect to RXDX-105, Ignyta’s multikinase inhibitor with potent activity against such targets as RET and BRAF, achieving clinical proof of concept in patients with activating RET alterations and initiating the Phase 1b portion of the ongoing clinical trial in patients with solid tumors harboring RET or BRAF alterations;
With respect to RXDX-107, the company’s new chemical entity comprising an alkyl ester of bendamustine encapsulated in human serum albumin to form nanoparticles, completing the Phase 1a portion of the ongoing clinical trial and identifying the recommended Phase 2 dose for this product candidate;
With respect to RXDX-106, the company’s potent, pseudo-irreversible inhibitor of TYRO3, AXL and Mer (TAM) and cMET with potential application in immuno-oncology settings, filing an IND to begin clinical evaluation of this product candidate; and
With respect to Ignyta’s other programs, conducting all activities necessary to advance them toward the clinic, as warranted by the data that Ignyta generates.