Ignyta Announces Six Upcoming Presentations at the 2016 EORTC-NCI-AACR Annual Meeting

Substantial Phase Ib clinical data update of RXDX-105, Ignyta’s VEGFR-sparing, potent RET inhibitor

Late-breaking oral plenary presentation of clinical and preclinical data of an entrectinib combination regimen designed to overcome resistance to TRK inhibition

Four additional posters on pipeline of molecularly targeted oncology therapies, including first disclosed preclinical data of RXDX-106, Ignyta’s Tyro-3, Axl and Mer (or TAM) and cMET inhibitor

SAN DIEGO--()--Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced six data presentations at the 2016 EORTC-NCI-AACR (ENA) Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany.

One poster presentation will include updated clinical safety and efficacy data from the Phase 1b basket study of RXDX-105, the company’s VEGFR-sparing, potent RET inhibitor.

The company’s data that examine a novel combination of entrectinib — the company’s orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions — with trametinib, designed to overcome drug resistance to TRK inhibition, will be presented as a late-breaking oral plenary presentation.

The company also announced four additional poster presentations related to its robust pipeline of molecularly targeted oncology therapies — entrectinib, RXDX-105, and RXDX-106. These will be the first data Ignyta has disclosed for RXDX-106, and the data presented in the posters highlight both immuno-therapeutic and targeted activity of this novel agent.

“We are excited to provide updated clinical and preclinical data across multiple compounds from our cancer precision medicine pipeline,” said Pratik Multani, M.D., Ignyta’s Chief Medical Officer. “In particular, the team is excited to present new clinical data on RXDX-105, and is honored that the ENA Scientific Program Committee has chosen entrectinib for an oral plenary presentation.”

Details of the presentations are as follows:

Late-Breaking Oral Plenary Presentation:

 
Title:          

Overcoming drug resistance to Trk inhibition by rational combination of entrectinib and trametinib: from bench to bedside (Abstract number 8LBA)

Presenter: Alexander Drilon, M.D., Memorial Sloan Kettering Cancer Center
Date/Time: Plenary Session 8: Exceptional Response and Expected Resistance

 

Friday, December 2, 2016, 10:30 am CET

 

Poster Presentations:

 

Entrectinib

Title:

Entrectinib, a highly potent pan-Trk, ROS1, and ALK inhibitor, has broad-spectrum, histology-agnostic anti-tumor activity in molecularly defined cancers (Abstract number 78, Poster number P049)

Date/Time: Tuesday, November 29, 2016, 11:45 am – 18:30 pm CET
 

RXDX-105

Title:

A phase 1/1b study of RXDX-105, an oral RET and BRAF inhibitor, in patients with advanced solid tumors (Abstract number 437, Poster number P116)

Date/Time: Thursday, December 1, 2016, 10:15 am – 17:00 pm CET
 
Title:

RXDX-105 demonstrates anti-tumor efficacy in multiple preclinical cancer models driven by molecular alterations in RET or BRAF oncogenes (Abstract number 85, Poster number P056)

Date/Time: Tuesday, November 29, 2016, 11:45 am – 18:30 pm CET
 

RXDX-106

Title:

Immuno-oncologic efficacy of RXDX-106, a selective, TAM family small molecule kinase inhibitor (Abstract number 65, Poster number P036)

Date/Time: Tuesday, November 29, 2016, 11:45 am – 18:30 pm CET
 
Title:

RXDX-106 is an orally-available, potent and selective TAM/MET inhibitor demonstrating preclinical efficacy in MET-dependent human malignancies (Abstract number 73, Poster number P044)

Date/Time: Tuesday, November 29, 2016, 11:45 am – 18:30 pm CET
 

A copy of the presentation and posters will be made available during the sessions in the Scientific Presentations section of the company's website at http://www.ignyta.com, and will be archived and available at that site.

About Ignyta, Inc.

Blazing a New Future for Patients with Cancer™

At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with the rarest cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class and best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.

For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the results of the Phase 1 clinical study of RXDX-105 and the development of Ignyta's product candidates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta's plans to develop and commercialize its product candidates; the potential for final results of the ongoing clinical trials of RXDX-105 or other product candidates, or any future clinical trials of RXDX-105 or other product candidates, to differ from preliminary or expected results; Ignyta's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta's ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta's Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent Quarterly Reports on Form 10-Q.

Contacts

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com

Contacts

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com