Current Report Filing (8-k)
April 04 2017 - 1:16PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 4, 2017
IGNYTA, INC.
(Exact
Name of Registrant as Specified in its Charter)
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Delaware
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001-36344
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45-3174872
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(State
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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4545 Towne Centre Court
San Diego, California 92121
(Address of principal executive offices, including zip code)
Registrants telephone number, including area code:
(858) 255-5959
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Item 7.01 Regulation FD Disclosure
On April 4, 2017, Ignyta, Inc., (the Company) announced preclinical data on
RXDX-106
which
represents a novel class of immunomodulatory agents that appears to restore innate immunity in preclinical models via potent inhibition of the TYRO3, AXL and MER (or TAM) family of receptors presented at the 2017 Annual Meeting of the American
Association for Cancer Research (AACR) in Washington D.C. In addition, the Company will also showcase its first ever data in hematological malignancies for entrectinib an orally available,
CNS-active
tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions in molecularly defined acute myeloid leukemia (AML). The press release, dated April 4, 2017, announcing the new data is attached hereto as Exhibit 99.1.
The information contained in this Item 7.01 and in Exhibit 99.1 of this Current Report on Form
8-K
shall not be
deemed filed for purposes of Section 18 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, or the Exchange Act,
except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On April 4, 2017, the Company announced preclinical data on
RXDX-106
which represents a novel class of
immunomodulatory agents that appears to restore innate immunity in preclinical models via potent inhibition of the TAM family of receptors presented at the 2017 Annual Meeting of the AACR in Washington D.C. In addition, the Company will also
showcase its first ever data in hematological malignancies for entrectinib an orally available,
CNS-active
tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions in
molecularly defined AML.
In the presented
RXDX-106
data, researchers studied the activity of
RXDX-106
in a commonly studied syngeneic mouse colon carcinoma model in matched immunocompetent and immunocompromised mice, finding that
RXDX-106
had greater tumor growth
inhibition in the immunocompetent animals, which suggested that
RXDX-106
effects in this system were modulated by the immune system. Immuno-phenotypic modulation by
RXDX-106
was also observed in the mouse model, including an increase in tumor infiltrating lymphocytes (TILs), an increase in the ratio of M1/M2 macrophages, and an increase in expression of CD69 and
PD-1
on CD8 T Cells. In another syngeneic mouse model,
RXDX-106
inhibited tumor growth as a single agent and demonstrated further tumor growth inhibition in combination with
anti-PD-1
or
anti-CTLA-4
antibodies, which was accompanied by increased levels of IFNɣ in the blood. In a separate preclinical
investigation of
RXDX-106
targets, AXL and MER fusion proteins were shown to independently act as oncodrivers and, therefore, may be viable therapeutic targets for patients harboring such molecular
alterations. The preclinical data to be presented at the AACR Annual Meeting suggest that
RXDX-106
can act as both an anti-tumor immuno-modulator and TAM oncodriver inhibitor and support clinical development
of
RXDX-106
in a wide variety of cancers.
Researchers will also present new preclinical data investigating
entrectinib as a potential treatment for patients with NTRK rearranged acute myeloid leukemias. Entrectinib treatment inhibited cell proliferation in vitro with
sub-nanomolar
EC
50
values. In a mouse model, entrectinib treatment at clinically relevant doses resulted in tumor regression, which was accompanied by elimination of residual cancer cells from the bone marrow.
Based on these data, the Company intends to evaluate entrectinib further in molecularly defined hematological malignancies.
Item 9.01. Financial
Statements and Exhibits
(d)
Exhibits
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Exhibit
No.
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Description
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99.1
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Press Release, dated April 4, 2017.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Dated: April 4, 2017
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IGNYTA, INC.
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By:
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/s/ Jonathan E. Lim, M.D.
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Name:
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Jonathan E. Lim, M.D.
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Title:
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President and Chief Executive Officer
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EXHIBIT INDEX
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Exhibit
No.
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Description
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99.1
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Press Release, dated April 4, 2017.
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