Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA
therapeutics for patients with cancer and rare diseases, today is
reporting additional data from the dose-escalation phase of its
ongoing Phase 1/2 clinical trial of intratumoral IMO-2125, an
agonist of TLR9 in combination with ipilimumab or pembrolizumab for
treatment of patients with metastatic melanoma with disease that is
refractory to PD-1 inhibitors.
In the poster presentation at the 2017 ASCO-SITC Clinical
Immuno-Oncology Symposium, entitled, “Intratumoral (i.t.) IMO-2125,
a TLR9 agonist is active in combination with ipilimumab (ipi) in
PD-(L)1 refractory melanoma (RM),” Marc Uemura, M.D. from the
University of Texas, MD Anderson Cancer Center, presented an update
on the clinical and translational findings from the ongoing
trial.
A copy of the poster presentation is currently available on
Idera’s corporate website at
http://www.iderapharma.com/our-approach/key-publications/.
“We are very pleased to have achieved successful completion of
all our objectives in the Phase 1 portion of this trial which
established safety across all doses tested, and demonstrated
preliminary evidence of clinical activity, including durable
responses of over one year in two of the evaluable patients so
far,” stated Mark Cornfeld, M.D., Idera’s Medical Lead,
Oncology. “Additionally from a scientific standpoint, we’ve
established proof of mechanism through our translational effort
which has gone well beyond the norm compared to what is typically
done in oncology drug development.”
Continued Cornfeld, “At this point we have very clear
justification to further the development of IMO-2125 and we’ll soon
be moving to the phase 2 portion of the trial, which will expand to
multiple centers. Additionally we are undertaking a parallel
development pathway for IMO-2125 in combination with pembrolizumab
and while that is not the focus of this presentation today, we are
making good progress with safety and dose evaluation in that
arm.”
The company is also announcing the acceptance of two abstracts
at the upcoming American Association for Cancer Research (AACR)
2017 Annual Meeting being held April 1-5, in Washington DC. Idera
has gained acceptance of two presentations related to IMO-2125.
On Wednesday, April 5, 2017, Dr. Cara Haymaker of MD Anderson
Cancer Center will present an update on the translational data
outcomes in a poster presentation entitled, “Translational evidence
of reactivated innate and adaptive immunity with intratumoral
IMO-2125 in combination with systemic checkpoint inhibitors from a
Phase 1/2 study in patients with anti-PD-1 refractory metastatic
melanoma.”
Additionally, on the same day, Daqing Wang, Ph.D., Principal
Scientist, Idera Pharmaceuticals will present new IMO-2125
pre-clinical data in a poster entitled, “Local treatment with novel
TLR9 agonist IMO-2125 demonstrates anti-tumor activity in
preclinical models of pancreatic cancer.”
About IMO-2125Toll-like receptors (TLRs) play a
central role in the innate immune system, the body's first line of
defense against invading pathogens, as well as damaged or
dysfunctional cells including cancer cells. The innate immune
system is also involved in activating the adaptive immune system,
which marshals highly specific immune responses to target pathogens
or tissue. Cancer cells may exploit regulatory checkpoint pathways
to avoid being recognized by the immune system, thereby shielding
the tumor from immune attack. Checkpoint inhibitors such as agents
targeting CTLA4 or programmed cell death protein 1 (PD1) are
designed to enable the immune system to recognize tumor cells. In
this setting, intratumoral TLR9 agonist administration may increase
the tumor-infiltrating lymphocytes (TILs), and thereby potentiate
anti-cancer activity of checkpoint inhibitors in the injected tumor
as well as systemically.
Idera’s TLR9 agonist, IMO-2125 has been created using the
company's proprietary chemistry-based discovery platform.
IMO-2125 has been shown in various scientific presentations and
publications to activate dendritic cells and induce interferon.
Idera selected IMO-2125 to advance into clinical development in
combination with checkpoint inhibitors based on this immunological
profile. In previously completed clinical trials,
subcutaneous administration of IMO-2125 was generally well
tolerated in about 80 patients with hepatitis C. Idera has
conducted further preclinical research evaluating the potential of
IMO-2125 to enhance the anti-tumor activity of other checkpoint
inhibitors in cancer immunotherapy with data being presented at
several medical conferences during the past twelve months.
The posters from these presentations can be found at
http://www.iderapharma.com/our-approach/key-publications.
About Metastatic MelanomaMelanoma is a type of
skin cancer that begins in a type of skin cell called
melanocytes. As is the case in many forms of cancer, melanoma
becomes more difficult to treat once the disease has spread beyond
the skin to other parts of the body such as by through the
lymphatic system (metastatic disease). Melanoma accounts for
only one percent of skin cancer cases, but causes a large majority
of skin cancer deaths. The American Cancer Society estimates
that in 2016, there will be 76,380 new cases of melanoma in the
U.S., and about 10,130 will die of this disease.
About Idera
Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company
developing novel nucleic acid-based therapies for the treatment of
certain cancers and rare diseases. Idera’s proprietary technology
involves designing synthetic oligonucleotide-based drug candidates
to modulate the activity of specific TLRs. In addition to its TLR
programs, Idera has used its proprietary knowledge to create a
third generation antisense technology platform which inhibits the
production of disease-associated proteins by targeting RNA. To
learn more about Idera, visit www.iderapharma.com.
Forward Looking StatementsThis 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 interim results from a clinical trial,
such as preliminary results reported in this release, will be
predictive of the final results of the trial, whether results
obtained in preclinical studies and clinical trials such as the
preclinical data 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 and on Form 10-Q for the period ended
September 30, 2016. 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.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484‐639‐7235
rdoody@iderapharma.com
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