- Data supports TLR antagonism as
potential therapeutic approach for genetically defined forms of
B-cell lymphoma –
- IMO-8400 in Phase 1/2 trial for
Waldenstr�m’s macroglobulinemia –
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today presented new
preclinical data demonstrating the ability of its Toll-like
receptor (TLR) antagonist, IMO-8400, to inhibit the survival and
proliferation of B-cell lymphoma cells harboring the oncogenic
MYD88 L265P genetic mutation. These data add to the growing body of
research which supports the Company’s efforts to develop IMO-8400
for the treatment of genetically defined forms of B-cell lymphoma.
The findings were presented today in a poster session titled
“Immune Modulatory Agents and Interventions” at the 2014
American Association for Cancer Research (AACR) Annual Meeting in
San Diego, California.
The data presented today at AACR build upon reports from several
independent investigators and provide additional evidence that the
MYD88 L265P mutation, which is present in certain B-cell lymphomas,
results in over-activation of TLR7 and TLR9 mediated signaling.
Blocking these TLRs leads to tumor cell death. IMO-8400, a
first-in-class synthetic oligonucleotide-based antagonist of TLRs
7, 8, and 9, is in clinical development for the treatment of
patients with Waldenstr�m’s macroglobulinemia and patients with
diffuse large B-cell lymphoma (DLBCL) who harbor the MYD88 L265P
mutation.
In the presentation, entitled “IMO-8400, a selective antagonist
of TLRs 7, 8 and 9, inhibits MYD88 L265P mutation-driven signaling
and cell survival: A potential novel approach for treatment of
B-cell lymphomas harboring MYD88 L265P mutation,” Idera observed
that the knockdown of TLR7 and TLR9 expression in DLBCL cells with
the MYD88 L265P mutation led to decreased cell signaling, and
inhibition of cell survival, consistent with previous reports of
other investigators. In the experiments presented today, treatment
of DLBCL cells expressing the MYD88 L265P mutation with IMO-8400
led to cell death and decreased proliferative cell signaling. Key
signaling pathways inhibited include IRAK-1, IRAK-4, BTK, STAT-3,
Iκ-Bα, and NFκ-B. Treatment with IMO-8400 also inhibited growth of
established tumors of human DLBCL cells harboring the MYD88 L265P
mutation in a mouse model. In addition, treatment with IMO-8400 of
Waldenstr�m’s macroglobulinemia cells expressing the MYD88 L265P
mutation led to similar negative effects on cell signaling and
survival.
"These preclinical data provide evidence that upstream blockade
of the TLR signaling pathway can limit the proliferative effect of
the oncogenic MYD88 L265P mutation. Blocking activation of this
pathway via TLR antagonism represents a novel and promising
approach to treating multiple B-cell lymphomas characterized by
MYD88 L265P, when compared to the downstream inhibition of specific
proteins," stated Lou Brenner, M.D., Senior Vice President and
Chief Medical Officer of Idera Pharmaceuticals. "We have carved out
a distinct position for IMO-8400 in the clinical development
landscape for potential therapies to treat genetically defined
forms of B-cell lymphoma and feel that this preclinical data
provides additional support for our ongoing efforts.”
“IMO-8400 has been well tolerated in a recently completed
clinical proof-of-concept trial in patients with psoriasis, with a
treatment duration of up to twelve weeks, and has shown clinical
activity,” said Sudhir Agrawal, D. Phil, Chief Executive Officer of
Idera Pharmaceuticals. “With the accumulated clinical data on
IMO-8400 and the preclinical data presented today, we have a strong
foundation to accelerate clinical development in patients with
B-cell lymphomas harboring the MYD88 L265P mutation.”
Idera has opened enrollment in a Phase 1/2 trial of IMO-8400
designed to evaluate IMO-8400’s safety, tolerability and potential
clinical activity in patients with Waldenstr�m’s macroglobulinemia
who are refractory to prior therapies. The Company anticipates that
patient treatment in this trial will begin in the second quarter of
2014. Idera has also submitted a separate protocol to the U.S. Food
and Drug Administration (FDA) to conduct a Phase 1/2 trial in
patients with DLBCL who harbor the MYD88 L265P mutation.
A copy of the presentation, entitled “IMO-8400, a selective
antagonist of TLRs 7, 8 and 9, inhibits MYD88 L265P mutation-driven
signaling and cell survival: A potential novel approach for
treatment of B-cell lymphomas harboring MYD88 L265P mutation"
(Abstract #2570), is available at the following link:
http://www.iderapharma.com/our-science/key-presentations-and-publications.
About IMO-8400
Idera’s TLR antagonist drug candidates have been created using a
proprietary chemistry-based drug discovery platform. IMO-8400 is a
first-in-class synthetic oligonucleotide-based antagonist of TLRs
7, 8, and 9. IMO-8400 has shown activity in preclinical models of
autoimmune diseases, including psoriasis, lupus, and arthritis.
IMO-8400 has been well-tolerated in a Phase 1 trial in 42 healthy
subjects at single and multiple escalating doses up to 0.6 mg/kg
for four weeks, and has shown inhibition of immune responses
mediated by TLRs 7, 8, and 9. In addition, recently announced
top-line data from a Phase 2 trial demonstrated that IMO-8400 was
well-tolerated and showed evidence of clinical activity in patients
with psoriasis who were treated at doses of up to 0.3 mg/kg/week
for 12 weeks. Idera is pursuing clinical development of IMO-8400 in
genetically defined forms of B-cell lymphoma, including
Waldenstr�m’s macroglobulinemia and diffuse large B-cell lymphoma,
and orphan autoimmune diseases, including polymyositis and
dermatomyositis.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical stage biopharmaceutical
company developing a novel therapeutic approach for the treatment
of genetically defined forms of B-cell lymphoma and orphan
autoimmune diseases. Idera’s proprietary technology involves
creating novel nucleic acid therapeutics designed to inhibit
over-activation of Toll-like Receptors (TLRs). In addition to its
TLR programs, Idera is developing gene silencing oligonucleotides
that it has created using its proprietary technology to inhibit the
production of disease-associated proteins by targeting RNA.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements, other than statements of historical fact,
included or incorporated in this press release, including
statements regarding the Company’s strategy, future operations,
collaborations, intellectual property, cash resources, financial
position, future revenues, projected costs, prospects, plans, and
objectives of management, are forward-looking statements. The words
“believes,” “anticipates,” “estimates,” “plans,” “expects,”
“intends,” “may,” “could,” “should,” “potential,” “likely,”
“projects,” “continue,” “will,” and “would” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company’s
forward-looking statements. There are a number of important factors
that could cause Idera’s actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether results
obtained in preclinical studies and clinical trials such as the
results described in this release will be indicative of the results
that will be generated in future clinical trials, including in
clinical trials in different disease indications; 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; and such other important factors as are set forth
under the caption “Risk Factors” in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2013. Although Idera may
elect to do so at some point in the future, the Company does not
assume any obligation to update any forward-looking statements and
it disclaims any intention or obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Idera Pharmaceuticals, Inc.Lou Arcudi,
617-679-5517larcudi@iderapharma.comorStern Investor Relations,
Inc.Sarah McCabe, 212-362-1200sarah@sternir.com
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