Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a clinical stage
biopharmaceutical company developing a novel therapeutic approach for
the treatment of autoimmune diseases and genetically defined forms of
B-cell lymphoma, today announced that enrollment is open for a Phase 1/2
clinical trial of IMO-8400 in patients with Waldenström’s
macroglobulinemia, following acceptance of its Investigational New Drug
(IND) application by the U.S. Food and Drug Administration (FDA). The
objectives of the trial are to evaluate the compound’s safety,
tolerability, and potential clinical activity.
“The trial of IMO-8400 in patients with Waldenström’s macroglobulinemia
advances a highly targeted mutation-specific approach with the potential
to address the significant needs of patients and is an important
clinical milestone for Idera,” said Sudhir Agrawal, D. Phil., Chief
Executive Officer of Idera Pharmaceuticals. “We believe that recent
independent research and our own pre-clinical studies provide a strong
scientific rationale for the clinical evaluation of IMO-8400 in B-cell
lymphoma patients who harbor this specific genetic mutation.”
Idera’s program in genetically defined forms of B-cell lymphoma is based
on recent reports from several independent investigators1
identifying a specific genetic mutation known scientifically as MYD88
L265P. These reports offered evidence that in certain B-cell lymphomas
the presence of the MYD88 L265P mutation led to over-activation of TLR7
and TLR9 signaling, and that blocking these TLRs accelerated tumor cell
death. The mutation has been identified in approximately 90% of the
patients with Waldenström’s macroglobulinemia, which is classified as a
non-Hodgkin lymphoma of malignant lymphoplasmacytic B-cells. The cells
typically produce immunoglobulin M, or IgM, resulting in high serum
levels of the protein and, potentially, hyperviscosity syndrome, with
thickening of the blood, decrease in circulation and oxygen delivery,
and ultimately impaired function of almost any organ in the body.
“The MYD88 L265P mutation is highly characteristic of Waldenström’s
macroglobulinemia and has been identified as potentially oncogenic.
IMO-8400 targets the activation of the TLR signaling pathway and
represents a novel approach to the treatment of these patients,” said
Robert D. Arbeit, M.D., Vice President of Clinical Development at Idera.
The IND application for the Phase 1/2 trial was supported by preclinical
research conducted by Idera, which the Company intends to present at one
or more scientific meetings in 2014. The IND was further supported by
clinical safety data from a Phase 1 trial of IMO-8400, in which dosages
up to 0.6 mg/kg were well-tolerated and inhibited immune responses
mediated through TLR7, TLR8, and TLR9.
The Phase 1/2 clinical trial will enroll patients with Waldenström’s
macroglobulinemia who have a history of relapse or failure to respond to
one or more prior therapies. The protocol includes three dose-escalation
cohorts to evaluate the safety and tolerability of IMO-8400 and a
provision to expand enrollment at selected dose levels to allow further
evaluation of clinical activity. Idera expects to enroll a total of
approximately 30 patients. Patients and their caregivers interested in
more detail about the trial can visit http://www.iderapharma.com/clinical-trials.
Idera previously announced that it intends to submit a protocol to the
FDA to conduct a Phase 1/2 trial in patients with diffuse large B-cell
lymphoma (DLBCL) in the first quarter of 2014. DLBCL is an aggressive
lymphoma. Approximately 30% of the patients with the activated
B-cell-like, or ABC, sub-type are reported to also have MYD88 L265P
mutation.
1 Lim, K, et al., AACR 2013, Abstract #2232; Treon,
S.P., et al., N Engl J Med 2012, 367:826-833; Ngo, V.N., et al., Nature
2011, 470:115-119
About Idera Pharmaceuticals, Inc.
Idera's technology platform involves creating novel synthetic RNA- and
DNA-based compounds to modulate immune responses. Idera has applied this
platform to develop proprietary Toll-like receptor (TLR) antagonists as
immunomodulatory drug candidates. Toll-like receptor antagonists block
the over-activation of immune factors which can cause a range of
pathological effects. Idera is conducting clinical development of TLR
antagonists in autoimmune and inflammatory diseases, and for use in
certain genetically defined forms of B-cell lymphoma. More information
on Idera is available at www.iderapharma.com.
Forward Looking Statements
This press release includes statements concerning Idera Pharmaceuticals,
Inc. and its future expectations, plans and prospects that constitute
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995 and 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 early research, preclinical studies and
clinical trials will be indicative of the results that will be generated
in future preclinical and clinical studies; 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 FDA 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 Idera's Quarterly Report on Form 10-Q for the
period ended September 30, 2013, which important factors are
incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.
Source: Idera Pharmaceuticals, Inc.
Copyright Business Wire 2013