SAN DIEGO, CA, USA I April 18, 2015 I Ignyta, Inc. (Nasdaq:RXDX), a precision oncology biotechnology company, today announced three poster presentations at the 106th Annual Meeting of the American Association for Cancer Research (AACR), being held April 18-22, 2015 in Philadelphia, Pennsylvania.

Each of the presentations highlights developments relating to entrectinib (formerly known as RXDX-101), Ignyta’s proprietary oral pan-Trk, ROS1 and ALK tyrosine kinase inhibitor targeting solid tumor indications. The first of the poster presentations describes the similarities and differences between Trk rearrangements and overexpression as potential oncogenic drivers and provides support for further exploration of entrectinib in cancers with Trk overexpression. The second presentation highlights a newly-developed biomarker assay to enable rapid screening of patient tumor samples to assess expression of TrkA, TrkB, TrkC and ROS1. The third poster presents data generated in collaboration with The Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine, showing that entrectinib treatment resulted in significant tumor growth inhibition in a neuroblastoma xenograft model, both alone and in combination with conventional chemotherapy, providing support for the potential clinical evaluation of entrectinib in neuroblastoma patients.

Details of the presentations are as follows:

Date/time:     Sunday, April 19, 2015, 1:00 PM – 5:00 PM, Eastern time  
Title:     Overexpression of neurotrophic tyrosine receptor kinases (NTRKs) as a potential therapeutic target for cancer. (Abstract number 127; Poster board number 10)  
Poster Session:     PO.MCB04.02 Kinases and Inhibitors  
         
Date/time:     Tuesday, April 21, 2015, 8:00 AM – 12:00 PM, Eastern time  
Title:     A multiplexed immunohistochemistry test to screen for protein overexpression of ROS1, TrkA, TrkB and TrkC in multiple tumor tissue types. (Abstract number 3389; Poster board number 10)  
Poster session:     PO.CL11.10 Development of Prognostic and Predictive Biomarker Assays  
         
Date/time:     Wednesday, April 22, 2015, 8:00 AM – 12:00 PM, Eastern time  
Title:     The Trk inhibitor RXDX-101 enhances the efficacy of temozolimide and irinotecan in a xenograft model of neuroblastoma. (Abstract number 5390; Poster board number 2)  
Poster session:     PO.ET06.07 Kinase Inhibitors and Other Targets  
         

About Entrectinib

Entrectinib is a potent, novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins. Entrectinib is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to NTRK1 (encoding TrkA), NTRK2 (encoding TrkB), NTRK3 (encoding TrkC), ROS1 (encoding ROS1) or ALK (encoding ALK). Entrectinib has demonstrated in vivo antitumor activity against various TrkA, ROS1 and ALK-driven mouse xenograft models of different human cancers.

Entrectinib is currently in two Phase I/II clinical trials, the STARTRK-1 trial and the ALKA-372-001 trial. The company presented interim results from the ALKA-372-001 study in September 2014 at the ESMO annual meeting. The interim findings at such date showed:

  • No dose-limiting toxicities were observed, and only one Grade 3 or higher possibly drug-related adverse event was observed (Grade 3 fatigue, which subsided with dose reduction);
  • Eight patients remained on active treatment across the three dosing schedules, with four patients having received 9 to 21 cycles of treatment;
  • Entrectinib demonstrated a complete response in a patient with ROS1-positive non-small cell lung cancer (NSCLC);
  • Entrectinib demonstrated five partial responses, in patients with three different cancer histologies (colorectal cancer, NSCLC and neuroblastoma) and in patients with each of TrkA, ROS1 and ALK alterations; and
  • Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.

The FDA has granted orphan drug designation for entrectinib for the treatment of neuroblastoma and for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive non-small cell lung cancer and colorectal cancer. The FDA has also granted rare pediatric disease designation for entrectinib for the treatment of neuroblastoma.

About Ignyta, Inc.

Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer. It aims to achieve this goal by pairing each of its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.

SOURCE: Ignyta