Idera Pharmaceuticals, Inc. : Idera Pharmaceuticals Announces Efficacy Data for IMO-8400 in Preclinical Models of Lupus and Psoriasis
05/07/2012| 07:05am US/Eastern
IMO-8400 is a Lead Candidate for Development in Lupus
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced data from
preclinical studies of IMO-8400, demonstrating a novel mechanism of
action that may be applicable to the treatment of systemic lupus
erythematosus (SLE) and psoriasis. IMO-8400 is an inhibitor of specific
Toll-like receptors (TLRs). The data were presented at the American
Association of Immunologists (AAI) meeting being held in Boston,
Massachusetts May 4-8, 2012.
"We are encouraged by the preclinical results with IMO-8400 as a novel
approach for the treatment of lupus and other autoimmune disorders,"
said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. "The
dose-dependent protection we see in the lupus-prone mouse model suggests
that pharmacologic inhibition of TLR7, 8, and 9 with IMO-8400 may
provide a therapeutic strategy to suppress many lupus disease-associated
parameters, including autoimmune antibodies, multiple pro-inflammatory
serum cytokines, and indicators of kidney damage."
A characteristic of SLE is the production of antinuclear autoantibodies
complexed with self-RNA or -DNA. These abnormal antibodies
inappropriately activate TLR7, 8, and 9 and initiate immune responses
that damage the body's own tissues and organs, thereby releasing more
self-RNA and DNA. The data presented at AAI demonstrate that inhibition
of TLR7, 8 and 9 with IMO-8400 suppressed the cycle between autoimmune
antibody production and tissue damage, leading to improved renal
function in lupus-prone mice. No treatment-related side effects were
observed in the mice from IMO-8400 treatment at the doses employed in
Idera expects to submit an Investigational New Drug application for
IMO-8400 to the FDA during the fourth quarter of 2012, and has selected
lupus as the initial disease indication for clinical development.
The oral presentation entitled "IMO-8400, a novel TLR7, TLR8 and TLR9
antagonist, inhibits disease development in lupus-prone NZBW/F1 mice"
was made on May 5th. In addition a poster presentation
entitled "IMO-8400, a novel TLR7, TLR8, and TLR9 antagonist, inhibits
disease development in mouse models of psoriasis" was presented at AAI
on May 6th. In the poster presentation, data demonstrated
that IMO-8400 suppressed lesion development and related immunological
makers in mouse models of psoriasis.
In addition to the above presentations, a poster presentation entitled
"Modification of immune activation in HIV-1 infected humanized mouse
model using TLR7/9 antagonists" was given in the Vaccine and
Immunotherapy session on Sunday, May 6th at 2:30 pm by
investigators from the Ragon Institute of MIT, Massachusetts General
Hospital, and Harvard Medical School in collaboration with Idera
These presentations are accessible on the Idera Pharmaceuticals website.
About TLRs and Idera's Pipeline
Toll-like Receptors (TLRs) represent a class of proteins that play a key
role in both inflammation and immunity. Of the 10 human TLRs identified
to date, Idera is focusing on compounds targeted to TLRs 3, 7, 8, and 9,
which are expressed in different cells and serve unique functions. For
example, activation of TLR7 and TLR9 present in certain dendritic cells
and lymphocytes may be useful for the treatment of various types of
cancer by stimulating immunity. In contrast, inhibition of specific TLRs
may be useful in treating autoimmune disorders, such as psoriasis and
lupus, by blocking the production of multiple pro-inflammatory
mediators. Using its chemistry-based approach, Idera is advancing novel
drug candidates to modulate immune response through activation or
inhibition of specific TLRs to treat a broad range of diseases,
including autoimmune diseases and cancer, and to enhance the
effectiveness of vaccines.
In autoimmune diseases, Idera is developing inhibitors of TLRs 7, 8, and
9 for the potential treatment of psoriasis, lupus, and other diseases.
Idera's lead clinical candidate is IMO-3100, an antagonist of TLR7 and
TLR9, which is in Phase 2 development for psoriasis. IMO-8400 is an
antagonist of TLRs 7, 8, and 9. Idera expects to submit an IND
application for IMO-8400 during the fourth quarter of 2012. Idera has
selected lupus as the initial disease indication for clinical
development of IMO-8400.
In oncology, Idera's lead product candidate is IMO-2055, which is
designed to activate TLR9. IMO-2055 has been the subject of several
clinical trials including: A randomized, controlled Phase 2 trial in
combination with Erbitux® as a second-line therapy for patients with
recurrent or metastatic squamous cell carcinoma of the head and neck
that have not been previously treated with Erbitux; a Phase 1b trial in
combination with Tarceva® and Avastin® for the treatment of non-small
cell lung cancer; and a Phase 1b trial in combination with FOLFIRI and
Erbitux in patients with advanced colorectal cancer who progressed
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease where the body's immune system
becomes hyperactive and attacks normal healthy tissue. This results in
symptoms such as inflammation, swelling, and damage to joints and almost
every major organ in the body, including the heart, kidneys, skin, lungs
and brain. According to The Lupus Foundation of America, an estimated
1.5 million Americans and at least five million people worldwide have a
form of lupus.
Erbitux® is a registered trademark of ImClone LLC, a wholly-owned
subsidiary of Eli Lilly and Company. Tarceva® is a registered trademark
of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.
Avastin® is a registered trademark of Genentech, Inc.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR)
drug discovery platform to create immunomodulatory drug candidates and
has clinical development programs in autoimmune diseases and cancer.
Additionally, Idera has a collaboration with Merck & Co. for the use of
TLR-targeted candidates as vaccine adjuvants. The Company is also
advancing its gene-silencing oligonucleotide (GSO) technology for the
purpose of inhibiting the expression of disease-promoting genes. For
more information, visit http://www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera
Pharmaceuticals, Inc. that involve a number of risks and uncertainties.
For this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be forward-looking
statements. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "expects," "estimates," "intends," "should,"
"could," "will," "may," and similar expressions are intended to identify
forward-looking statements. There are a number of important factors that
could cause Idera's actual results to differ materially from those
indicated by such forward-looking statements, including whether results
obtained in preclinical studies such as the studies referred to in this
release will be indicative of results obtained in future clinical
trials; whether products based on Idera's technology will advance into
or through the clinical trial process on a timely basis or at all and
receive approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if the Company's
products receive approval, they will be successfully distributed and
marketed; whether the Company will be able to license IMO-2055 for
further development for oncology on a timely basis or at all; whether
the Company's collaboration with Merck & Co, Inc., will be successful;
whether the patents and patent applications owned or licensed by the
Company will protect the Company's technology and prevent others from
infringing it; whether Idera's cash resources will be sufficient to fund
the Company's operations; and such other important factors as are set
forth under the caption "Risk Factors" in Idera's Annual Report on Form
10-K for the year ended December 31, 2011 which important factors are
incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
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