IGNYTA, INC. (NASDAQ:RXDX) Files An 8-K Regulation FD Disclosure
Item7.01
| Regulation FD Disclosure |
On April27, 2017, Ignyta, Inc., (Ignyta or the Company) announced
a comprehensive program update on entrectinib – an
investigational, orally available, CNS-active tyrosine kinase
inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions –
currently being studied in a registration-enabling Phase 2
clinical trial known as STARTRK-2. The press release, dated
April27, 2017, announcing the new data is attached hereto as
Exhibit 99.1 and an investor presentation made on April27, 2017
highlighting this and other data is attached hereto as Exhibit
99.2.
The information contained in this Item7.01 and in Exhibits 99.1
and 99.2 of this Current Report on Form 8-K shall not be deemed
filed for purposes of Section18 of the Securities Exchange Act of
1934, as amended (the Exchange Act), or incorporated by reference
in any filing under the Securities Act of 1933, as amended (the
Securities Act), except as expressly set forth by specific
reference in such a filing.
| Item8.01 | Other Events |
On April27, 2017, the Company announced a program update on
entrectinib – an investigational, orally available, CNS-active
tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1
or ALK fusions – currently being studied in a
registration-enabling Phase 2 clinical trial known as STARTRK-2.
Entrectinib development highlights:
TRK –
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Based on written feedback from the U.S. Food and Drug Administration (the FDA), Ignyta intends to pursue an NDA submission for entrectinib to support a TRK fusion-positive, tissue agnostic indication. |
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Ignytas entrectinib program is more than 85% enrolled to goal for the primary efficacy analysis for a TRK tissue agnostic NDA submission, and is on track to complete enrollment by the third quarter of 2017. |
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Within STARTRK-2, several dozens of patients with TRK fusions have been enrolled, across more than 15 different tumor types, and investigators in approximately twelve different countries on four continents currently have experience treating patients with entrectinib. |
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Ignyta plans to announce top-line NDA registration-enabling data from STARTRK-2, after consultation with the FDA, in the first half of 2018. |
ROS1 –
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Ignyta is simultaneously pursuing an NDA submission for entrectinib to support a ROS1 fusion-positive NSCLC indication. |
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More than 50 ROS1 fusion-positive NSCLC patients have been enrolled to support a potential ROS1 NSCLC NDA for entrectinib, greater than the number that formed the basis of crizotinibs approval in this setting. |
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Ignyta reported interim data from 32 patients with ROS1 fusion-positive NSCLC, including new patients from STARTRK-2 who were enrolled as of December16, 2016. |
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24 out of the 32 patients had confirmed RECIST responses, for an objective response rate (ORR) of 75%. |
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The median duration of response (DOR) was 17.2 months among the responder patients, and the median progression free survival (PFS) was 19.1 months among all patients. |
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11 out of the 32 patients, or 34%, had CNS metastases at baseline. |
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Of these 11 patients with CNS disease, 7 had confirmed RECIST responses, for an ORR of 64% in ROS1 NSCLC patients with CNS metastases. |
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When aggregated with Ignytas Phase 1 data set of patients with primary and secondary CNS disease, a total of 10 out of 16 patients had confirmed RECIST responses, for an ORR of 63% in TRK, ROS1 or ALK patients with CNS disease. |
Entrectinib commercial highlights:
|
Based upon analysis of more than 120,000 cancer patient samples from internal and external sources, Ignyta believes that in the U.S. each year there are approximately 1,000-2,000 new patients with TRK fusion-positive advanced solid tumors, and 2,000 new patients with ROS1 fusion-positive NSCLC. |
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Entrectinib is simultaneously tracking towards TRK tissue agnostic NDA and ROS1 NSCLC NDA submissions in 2018, with anticipated U.S. launch in 2019. |
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Based upon these dual indications, Ignyta believes the total addressable market for entrectinib could be in excess of $1billion annually in the U.S. alone. |
* * *
This current report on Form 8-K contains forward-looking
statements about Ignyta as that term is defined in Section 27A of
the Securities Act and Section 21E of the Exchange. Statements in
this current report on Form 8-K that are not purely
historical are forward-looking statements. Such forward-looking
statements include, among other things, references to the
development of entrectinib and our other product candidates,
including the ability to reduce the size of certain CNS tumors;
the clinical and/or non-clinical data or plans underlying
entrectinib or any of our other development programs, and the
timelines associated with such programs; our ability to design
and conduct development activities for entrectinib and our other
development programs; our ability to develop or access companion
diagnostics for our product candidates; our ability to obtain and
maintain intellectual property protection for our product
candidates; our ability to adequately fund our development
programs; our ability to obtain regulatory approvals in order to
market any of our product candidates or companion diagnostic
tests; references to the potential market size for our products;
and our ability to successfully commercialize any approved
products. 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; Ignytas ability to develop, initiate
or complete preclinical studies and clinical trials for, obtain
approvals for and commercialize any of its product candidates;
changes in Ignytas plans to develop and commercialize its product
candidates; the ability of our contract manufacturers to produce
the active pharmaceutical ingredient and/or drug product
necessary for clinical trials or commercialization of entrectinib
or our other product candidates; the potential for final results
of the ongoing clinical trials of entrectinib or other product
candidates, or any future clinical trials of entrectinib or other
product candidates, to differ from preliminary or expected
results; Ignytas 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; Ignytas 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 current report on Form 8-K, 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 Ignytas Annual Report
on Form 10-K for the year ended December31, 2016 and subsequent
Quarterly Reports on Form 10-Q.
| Item9.01. | Financial Statements and Exhibits |
(d)Exhibits.
|
Exhibit No. |
Description |
|
| 99.1 | Press Release, dated April27, 2017. | |
| 99.2 | Investor Presentation, made April27, 2017. |
About IGNYTA, INC. (NASDAQ:RXDX)
Ignyta, Inc. is an oncology biotechnology company. The Company focuses on an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. Its Rx is focused on discovering, in licensing or acquiring, then developing and commercializing molecularly targeted therapies that, sequentially or in combination, are foundational for eradicating residual disease. Its Dx focuses on pairing the product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients likely to benefit from the therapies. Its entrectinib is an orally bioavailable, small molecule tyrosine kinase inhibitor directed to the tropomyosin receptor kinase (Trk) family tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and anaplastic lymphoma kinase (ALK) proteins for the treatment of solid tumors. Its entrectinib is in Phase II/III of clinical development. Its taladegib is a small molecule and hedgehog or smoothened antagonist. IGNYTA, INC. (NASDAQ:RXDX) Recent Trading Information
IGNYTA, INC. (NASDAQ:RXDX) closed its last trading session down -0.45 at 8.75 with 436,450 shares trading hands.