Roche Does Last-Minute Christmas Shopping, Drops $1.7 Billion on San Diego Biotech

Basel, Switzerland-based Roche got in some last-minute Christmas shopping, shelling out $1.7 billion for San Diego’s Ignyta.

Roche is paying $27 per share in cash for the company, which is approximately a 74 percent premium on Ignyta’s share price yesterday. Roche will acquire all outstanding shares of Ignyta common stock.

Ignyta focuses on gene therapy for treating cancer. On Oct. 18, it updated results from its STARTRK-2 clinical trial of entrectinib in non-small cell lung cancer (NSCLC). The compound is a CNS-active, selective tyrosine kinase inhibitor being developed for tumors that have NTRK fusions or ROS1 fusions. In the interim data presented, entrectinib showed a 78 percent confirmed overall response rate (ORR) and a 69 percent confirmed ORR, using separate metrics, in 32 patients with locally advanced or metastatic NSCLC that harbored ROS1 fusions.

The drug received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and PRIME designation from the European Medicines Agency (EMA). Based on guidance from the FDA, Ignyta is on track for dual new drug application (NDA) submissions in both the NTRK tissue-agnostic and the ROS1-positive NSCLC indications in 2018.

Ignyta is expected to continue operating in San Diego and handle the ongoing entrectinib trial. Jonathan Lim, Ignyta’s chairman, chief executive officer and co-founder, said in a statement, "Ignyta has been singularly focused on developing precisely targeted therapeutics guided by diagnostics for patients with rare cancers. We are excited that Roche, the global leader in both oncology and personalized healthcare, recognizes this powerful approach and shares our passion for advancing entrectinib for the benefit of patients."

Roche has indicated it plans to focus on small bolt-on deals like this one to build out its portfolio. Bloomberg notes that only five weeks ago Bayer dropped $1.55 billion to license Loxo Oncology’s larotrectinib, an experimental cancer therapeutic similar to entrectinib.

Ignyta was founded in 2011 by Gary Firestine, a researcher at the University of California, San Diego, and Lim, former chief executive officer of Halozyme Therapeutics.

In addition to entrectinib, Ignyta’s pipeline includes RXDX-105, a VEGFR-sparing RET inhibitor which has completed enrollment in a Phase Ib clinical trial, Taladegib, an Hh/SMO inhibitor currently in a Phase Ib trial in ovarian cancer, and RXDX-106, a TYR03, AXL and MER inhibitor presently in late-stage preclinical development.

Part of Ignyta’s approach is to connect its therapeutics with companion diagnostic tests. It offers Trailblaze Pharos Diagnostic Suite, which can identify actionable gene fusions in solid tumors to qualify patients for enrollment in its STARTRK-2 cancer clinical trial. It also utilizes Next-Generation Sequencing (NGS) and Immunohistochemistry (IHC) to identify tumors that might respond best to entrectinib. The IHC measures protein expression levels for various genes, including NTRK1, NTRK2, NTRK3, ROS1 and ALK. The company then uses NGS to identify gene rearrangements of interest.

"Cancer is a highly complex disease and many patients suffer from mutations which are difficult to detect and treat," said Daniel O’Day, Roche Pharmaceuticals’ chief executive officer, in a statement. "The agreement with Ignyta builds on Roche’s strategy of fitting treatments to patients and will allow Roche to broaden and strengthen its oncology portfolio globally."