Ignyta: Precision Medicine for Oncology Integrating Companion Diagnostics

Teva Deal Expands Portfolio and Diagnostic Capabilities

Adding RXDX to Rayno Small Cap Portfolio

Ignyta, Inc. (RXDX) is an emerging biopharmaceutical Company targeting new oncology drugs that inhibit Tyrosine kinase receptors (Trk) with integrated biomarker-based companion diagnostics for each product candidate. The Company has two clinical stage products in Phase 1:  RXDX-106 its lead product entrectinib, an oral Trk, ROS1, ALK small molecule inhibitor targeting solid tumor indications; and RXDX-105, a BRAF, EGFR and RET inhibitor.  In February 2015 the Company announced that the FDA granted the company orphan drug designation for entrectinib for treatment of blastoma and for treatment of non-small cell lung cancer, colorectal cancer as well as a rare pediatric disease. The global PhaseI/IIa clinical trial called STARTRK-1 began in July 2014 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations. Interim positive results were presented in September 2014.

RXDX-103 was licensed from Nerviano Medical Sciences and is an inhibitor of the cell cycle division 7-related (Cdc7) protein kinase which interferes with the DNA replication process. This program is currently in development for potential treatment of multiple cancers.

RXDX-105 and three additional pre-clinical pipeline products were recently acquired from Teva Pharmaceutical Industries (TEVA). The Teva transaction included the four oncology R&D assets and a CLIA laboratory with proprietary multiplexed diagnostic assays was announced on March 17 included a $42M equity investment by Teva and others which implies some validation of product potential. There are no milestones due Teva for this transaction but Ignyta will assume existing sublicense obligations including royalties.

The Company believes these compounds target important oncogenic driver mutations which account for up to 80% of known driver mutations across multiple solid tumor indications for example lung cancer (NSCLC) and a significant portion for colorectal cancer. A Master Protocol study design expected in 2H’15 with the upcoming STARTRK-2 clinical trial will screen NSCLC patients for a range of histologies.

Ignyta is pairing their oncology drugs with their Trailblaze(R) suite of proprietary diagnostic tests beginning with ROS1 and ALK biomarker tests and NTRK1 coming soon. The companion diagnostic capability should assist clinical development

Updates on entrectinib are expected at ASCO including data from three European cohorts and one US cohort.

Q4 2014 Financial Review

The Company has cash and cash equivalents of about $51.8M with total stockholder equity of $55.9 M. Debt from Silicon Valley Bankcorp. is $10M maturing in December 2017.

 

Disclosure: Long RXDX

 

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